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Studie zur Bewertung der Sicherheit und Wirksamkeit der mechanischen Kreislaufunterstützung bei Patienten mit fortschreitender Herzinsuffizienz (TEAM-HF)

3. November 2026 aktualisiert von: Abbott Medical Devices

The purpose of TEAM-HF IDE clinical trial is to evaluate safety and effectiveness of the HeartMate 3 LVAS compared to guideline directed medical therapy (GDMT) in a population of ambulatory advanced heart failure patients who are not dependent on intravenous inotrope.

Studienübersicht

Status

Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

Patients with heart failure (HF) suffer from a high degree of morbidity and mortality. Left ventricular assist device (LVAD) therapy has become the standard of care for the treatment of advanced HF patients who are deemed to be dependent on continuous intravenous inotropes, extending life expectancy, enhancing overall quality of life, and improving functional capacity. However, use of LVADs in ambulatory, non-inotrope dependent advanced HF population is limited. Elevated mean pulmonary artery pressure (PAP) secondary to left ventricular failure has emerged as a potential predictor of increased mortality risk for patients refractory to maximally tolerated guideline directed medical therapy (GDMT). In these patients, left ventricular failure with elevated mean PAP may represent objective criteria to identify advanced HF patients requiring heart replacement therapies such as LVAD.

The TEAM-HF IDE trial will enroll approximately 850 subjects with New York Heart Association (NYHA) Class IIIB/IV HF who had a prior heart failure hospitalization and an elevated mean PAP secondary to left ventricular failure. Elevated mean PAP will be identified using an implanted PAP monitoring sensor, the CardioMEMS PA Sensor. All subjects enrolled can have a previously implanted CardioMEMS PA Sensor or, if not, will be implanted with the CardioMEMS PA Sensor after enrollment. The overall objectives of TEAM-HF trial are two-fold: 1) To determine whether PAP can objectively identify patients most at risk for worsening HF and therefore most likely to benefit from earlier intervention with LVAD therapy and 2) To determine the benefit of LVAD therapy in non-inotrope advanced HF patients with elevated mean PAP refractory to GDMT.

The trial will include approximately 75 global sites and consists of a Randomized Arm and a Single Arm Registry.

The TEAM-HF Randomized Arm is a prospective, randomized, open-label study of the HeartMate 3 (HM3) left ventricular assist system (LVAS) versus continued GDMT in non-inotrope dependent HF patients. The objectives of the Randomized Arm are 1) To establish an objective disease-state criteria to trigger referral for a HM3 LVAS and 2) Demonstrate improvement in survival when non-inotrope dependent advanced HF patients are treated with the HM3 LVAS compared to being managed on medical therapy alone.

The TEAM-HF Single Arm Registry is a prospective, single-arm, open-label study of non-inotrope dependent HF patients who do not meet a mean PAP threshold after GDMT optimization. The objective of the Single Arm Registry is to characterize the progression of patients with non-inotrope dependent HF without elevated PAP.

Studientyp

Interventionell

Einschreibung (Geschätzt)

850

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studienorte

  • Deutschland
    • Saxon
      • Hanover, Saxon, Deutschland, 30625
        • Rekrutierung
        • Medizinische Hochschule Hannover
        • Hauptermittler:
          • Dominik Berliner, MD
        • Kontakt:
    • Saxony
    • State of Berlin
      • Berlin, State of Berlin, Deutschland, 13353
        • Rekrutierung
        • Deutsches Herzzentrum der Charité
        • Hauptermittler:
          • Felix Schoenrath, MD
        • Kontakt:
  • Dänemark
    • Copenhagen
      • Copenhagen, Copenhagen, Dänemark, 2100
        • Rekrutierung
        • Rigshospitalet
        • Kontakt:
        • Hauptermittler:
          • Kasper Rossing, MD
  • Italien
    • Piedmont
      • Turin, Piedmont, Italien, 10126
        • Rekrutierung
        • A.O.U. Citta della Salute e della Scienza di Torino
        • Kontakt:
        • Hauptermittler:
          • Antonino Loforte, MD
  • Niederlande
    • Holland
      • Rotterdam, Holland, Niederlande, 3015 CE
        • Rekrutierung
        • Erasmus MC - Thoraxcenter
        • Kontakt:
        • Hauptermittler:
          • Rudolf De Boer, MD
    • Utrecht
      • Utrecht, Utrecht, Niederlande, 3584 CX
        • Rekrutierung
        • UMC Utrecht
        • Hauptermittler:
          • Linda Van Laake, MD
        • Kontakt:
  • Saudi-Arabien
    • Riyadh Region
      • Riyadh, Riyadh Region, Saudi-Arabien, 11525
        • Rekrutierung
        • King Fahad Medical City
        • Hauptermittler:
          • Mohammed Alreshidan, MD
        • Kontakt:
      • Riyadh, Riyadh Region, Saudi-Arabien, 12713
        • Rekrutierung
        • King Faisal Specialist Hospital
        • Kontakt:
        • Hauptermittler:
          • Jehad Abdulhamid Al Buraiki, MD
  • Tschechien
    • CBohmia
      • Prague, CBohmia, Tschechien, 14021
        • Rekrutierung
        • IKEM Prague
        • Hauptermittler:
          • Ivan Netuka, MD
        • Kontakt:
  • Vereinigte Staaten
    • Arizona
      • Phoenix, Arizona, Vereinigte Staaten, 85006
        • Zurückgezogen
        • Banner-University Medical Center Phoenix
    • Arkansas
      • Little Rock, Arkansas, Vereinigte Staaten, 72205
        • Rekrutierung
        • Baptist Health Medical Center
        • Hauptermittler:
          • Patrick Campbell, MD
        • Kontakt:
    • California
      • Sacramento, California, Vereinigte Staaten, 95816
        • Rekrutierung
        • Sutter Medical Center
        • Kontakt:
        • Hauptermittler:
          • Michael Gibson, MD
      • San Francisco, California, Vereinigte Staaten, 94143
        • Rekrutierung
        • University of California at San Francisco
        • Kontakt:
        • Hauptermittler:
          • Shweta Motiwala, MD
    • District of Columbia
      • Washington D.C., District of Columbia, Vereinigte Staaten, 20010
        • Rekrutierung
        • Washington Hospital Center
        • Hauptermittler:
          • Sheikh Farooq, MD
        • Kontakt:
    • Florida
      • Gainesville, Florida, Vereinigte Staaten, 32610
        • Rekrutierung
        • Shands at the University of Florida
        • Hauptermittler:
          • Mustafa Ahmed, MD
        • Kontakt:
      • Weston, Florida, Vereinigte Staaten, 33331
        • Rekrutierung
        • Cleveland Clinic Florida
        • Kontakt:
        • Hauptermittler:
          • Mauricio Velez, MD
    • Georgia
      • Atlanta, Georgia, Vereinigte Staaten, 30309
        • Rekrutierung
        • Piedmont Heart Institute
        • Hauptermittler:
          • Catherine Marti, MD
        • Kontakt:
      • Augusta, Georgia, Vereinigte Staaten, 30901
        • Rekrutierung
        • Piedmont Augusta Hospital
        • Hauptermittler:
          • Darshak Karia, MD
        • Kontakt:
      • Marietta, Georgia, Vereinigte Staaten, 30060
        • Rekrutierung
        • WellStar Kennestone Hospital
        • Hauptermittler:
          • Abdul Bikak, MD
        • Kontakt:
    • Illinois
      • Chicago, Illinois, Vereinigte Staaten, 60637
        • Rekrutierung
        • University of Chicago
        • Kontakt:
        • Hauptermittler:
          • Nikhil Narang, MD
      • Oakbrook Terrace, Illinois, Vereinigte Staaten, 60181
        • Rekrutierung
        • Advocate Health & Hospitals Corporation
        • Kontakt:
        • Hauptermittler:
          • Vinh Chau, MD
    • Indiana
      • Indianapolis, Indiana, Vereinigte Staaten, 46240
        • Rekrutierung
        • St. Vincent Hospital
        • Hauptermittler:
          • Ashwin Ravichandran, MD
        • Kontakt:
    • Iowa
      • Iowa City, Iowa, Vereinigte Staaten, 52242
        • Rekrutierung
        • University of Iowa Hospitals & Clinics
        • Kontakt:
        • Hauptermittler:
          • Anthony Panos, MD
    • Kansas
      • Kansas City, Kansas, Vereinigte Staaten, 66160
        • Rekrutierung
        • Kansas University Medical Center
        • Kontakt:
        • Hauptermittler:
          • Zubair Shah, MD
    • Kentucky
      • Lexington, Kentucky, Vereinigte Staaten, 40536
        • Beendet
        • University of Kentucky
      • Louisville, Kentucky, Vereinigte Staaten, 40202
        • Rekrutierung
        • Norton Hospital
        • Kontakt:
        • Hauptermittler:
          • Alkhalil Bassel, MD
    • Maine
      • Portland, Maine, Vereinigte Staaten, 04102
        • Rekrutierung
        • Maine Medical Center
        • Kontakt:
        • Hauptermittler:
          • Peter Kennel, MD
    • Massachusetts
      • Boston, Massachusetts, Vereinigte Staaten, 02114
        • Rekrutierung
        • Massachusetts General Hospital
        • Kontakt:
        • Hauptermittler:
          • Erin Coglianese, MD
    • Michigan
      • Detroit, Michigan, Vereinigte Staaten, 48202
        • Rekrutierung
        • Henry Ford Hospital
        • Kontakt:
        • Hauptermittler:
          • Lindsey Aurora, MD
      • Grand Rapids, Michigan, Vereinigte Staaten, 49503
        • Rekrutierung
        • Spectrum Health Butterworth Hospital
        • Kontakt:
        • Hauptermittler:
          • Matthew Gonzalez, MD
    • Minnesota
      • Minneapolis, Minnesota, Vereinigte Staaten, 55407
        • Rekrutierung
        • Minneapolis Heart Institute
        • Hauptermittler:
          • Mosi Bennett, MD
        • Kontakt:
      • Rochester, Minnesota, Vereinigte Staaten, 55905
        • Rekrutierung
        • Mayo Clinic
        • Kontakt:
        • Hauptermittler:
          • Andrew Rosenbaum, MD
    • Missouri
      • Kansas City, Missouri, Vereinigte Staaten, 64111
        • Rekrutierung
        • St. Luke's Hospital
        • Hauptermittler:
          • Timothy Fendler, MD
        • Kontakt:
    • Nebraska
      • Omaha, Nebraska, Vereinigte Staaten, 68198
        • Rekrutierung
        • University of Nebraska Medical Center
        • Kontakt:
        • Hauptermittler:
          • Adam Burdorf, DO
    • New Jersey
      • Hackensack, New Jersey, Vereinigte Staaten, 07601
        • Rekrutierung
        • Hackensack University Medical Center
        • Hauptermittler:
          • Kanika Mody, MD
        • Kontakt:
      • Newark, New Jersey, Vereinigte Staaten, 07112
        • Rekrutierung
        • Newark Beth Israel Medical Center
        • Hauptermittler:
          • Igor Gosev, MD
        • Kontakt:
    • New Mexico
      • Albuquerque, New Mexico, Vereinigte Staaten, 87102
        • Rekrutierung
        • New Mexico Heart Institute
        • Kontakt:
        • Hauptermittler:
          • Dana Booth, MD
    • New York
      • Manhasset, New York, Vereinigte Staaten, 11030
        • Rekrutierung
        • North Shore University Hospital
        • Kontakt:
        • Hauptermittler:
          • Maria Avila, MD
      • New York, New York, Vereinigte Staaten, 10032
        • Rekrutierung
        • New York-Presbyterian/Columbia University Medical Center
        • Kontakt:
        • Hauptermittler:
          • Dor Lotan, MD
      • Rochester, New York, Vereinigte Staaten, 14642
        • Rekrutierung
        • University of Rochester Medical Center
        • Kontakt:
        • Hauptermittler:
          • Leway Chen, MD
      • The Bronx, New York, Vereinigte Staaten, 10467
        • Rekrutierung
        • Montefiore Medical Center - Moses Campus
        • Hauptermittler:
          • Yogita Rochlani, MD
        • Kontakt:
    • North Carolina
      • Chapel Hill, North Carolina, Vereinigte Staaten, 27599
        • Rekrutierung
        • University of North Carolina at Chapel Hill
        • Kontakt:
        • Hauptermittler:
          • William Mostertz, MD
      • Charlotte, North Carolina, Vereinigte Staaten, 28203
        • Rekrutierung
        • Carolinas Medical Center
        • Kontakt:
        • Hauptermittler:
          • Joseph Mishkin, MD
    • Ohio
      • Cincinnati, Ohio, Vereinigte Staaten, 45219
      • Cleveland, Ohio, Vereinigte Staaten, 44195
        • Rekrutierung
        • The Cleveland Clinic Foundation
        • Kontakt:
          • Barbara Gus
          • Telefonnummer: 216-445-6552
          • E-Mail: gusb@ccf.org
        • Hauptermittler:
          • Michael Tong, MD
    • Oklahoma
      • Oklahoma City, Oklahoma, Vereinigte Staaten, 73112
        • Rekrutierung
        • Integris Baptist Medical Center
        • Kontakt:
        • Hauptermittler:
          • Luke Cunningham, MD
      • Tulsa, Oklahoma, Vereinigte Staaten, 74104
        • Rekrutierung
        • Oklahoma Heart Institute at Utica
        • Kontakt:
        • Hauptermittler:
          • Luis David Meggo Quiroz, MD
      • Tulsa, Oklahoma, Vereinigte Staaten, 74136
        • Rekrutierung
        • Saint Francis Hospital
        • Hauptermittler:
          • Douglas Ensley, MD
        • Kontakt:
    • Oregon
      • Portland, Oregon, Vereinigte Staaten, 97239
        • Rekrutierung
        • Oregon Health & Science University
        • Hauptermittler:
          • Johannes Steiner, MD
        • Kontakt:
    • Pennsylvania
      • Abington, Pennsylvania, Vereinigte Staaten, 19001
        • Rekrutierung
        • Abington Memorial Hospital
        • Kontakt:
        • Hauptermittler:
          • Alexander Shpilman, MD
      • Hershey, Pennsylvania, Vereinigte Staaten, 17033
        • Rekrutierung
        • Penn State Milton S. Hershey Medical Center
        • Hauptermittler:
          • John Boehmer, MD
        • Kontakt:
      • Philadelphia, Pennsylvania, Vereinigte Staaten, 19104
      • Philadelphia, Pennsylvania, Vereinigte Staaten, 15213
        • Rekrutierung
        • University of Pittsburgh Medical Center (UPMC)
        • Hauptermittler:
          • Gavin Hickey, MD
        • Kontakt:
      • Pittsburgh, Pennsylvania, Vereinigte Staaten, 15212
        • Rekrutierung
        • Allegheny General Hospital
        • Hauptermittler:
          • Matthew Lander, MD
        • Kontakt:
    • South Carolina
      • Charleston, South Carolina, Vereinigte Staaten, 29425
        • Rekrutierung
        • Medical University of South Carolina
        • Hauptermittler:
          • Arman Kilic, MD
        • Kontakt:
      • Columbia, South Carolina, Vereinigte Staaten, 29203
    • Tennessee
      • Memphis, Tennessee, Vereinigte Staaten, 38120
        • Rekrutierung
        • The Stern Cardiovascular Foundation
        • Kontakt:
        • Hauptermittler:
          • Todd Edwards, MD
    • Texas
      • Austin, Texas, Vereinigte Staaten, 78705
        • Rekrutierung
        • Ascension Texas Cardiovascular
        • Kontakt:
        • Hauptermittler:
          • Raymond Bietry, MD
      • Dallas, Texas, Vereinigte Staaten, 75246
        • Rekrutierung
        • Baylor University Hospital
        • Kontakt:
        • Hauptermittler:
          • Cesar Guerrero-Miranda, MD
      • Houston, Texas, Vereinigte Staaten, 77030
        • Rekrutierung
        • Houston Methodist
        • Kontakt:
        • Hauptermittler:
          • Cindy Martin, MD
      • Houston, Texas, Vereinigte Staaten, 77030
        • Rekrutierung
        • CHI St. Luke's Health Baylor College of Medicine Medical Center
        • Hauptermittler:
          • Ajith Nair, MD
        • Kontakt:
      • Houston, Texas, Vereinigte Staaten, 77030
        • Rekrutierung
        • UTHealth Memorial Hermann
        • Kontakt:
        • Hauptermittler:
          • Nathan Sriram, MD
      • Plano, Texas, Vereinigte Staaten, 75093
        • Rekrutierung
        • The Heart Hospital Baylor Plano
        • Kontakt:
        • Hauptermittler:
          • Aasim Afzal, MD
      • Temple, Texas, Vereinigte Staaten, 76508
        • Rekrutierung
        • Scott & White Memorial Hospital
        • Kontakt:
        • Hauptermittler:
          • Yevgeniy Khariton, MD
    • Utah
      • Salt Lake City, Utah, Vereinigte Staaten, 84132
        • Rekrutierung
        • University of Utah Hospital
        • Hauptermittler:
          • Craig Selzman, MD
        • Kontakt:
    • Virginia
      • Charlottesville, Virginia, Vereinigte Staaten, 22908
        • Rekrutierung
        • University of Virginia Medical Center
        • Kontakt:
        • Hauptermittler:
          • Mirnela Byku, MD
      • Richmond, Virginia, Vereinigte Staaten, 23219
        • Rekrutierung
        • Virginia Commonwealth University
        • Hauptermittler:
          • Keyur Shah, MD
        • Kontakt:
    • Wisconsin
      • Milwaukee, Wisconsin, Vereinigte Staaten, 53215
        • Rekrutierung
        • Aurora Medical Group
        • Hauptermittler:
          • Nasir Sulemanjee, MD
        • Kontakt:
  • Österreich
    • State of Vienna
      • Vienna, State of Vienna, Österreich, 1090
        • Rekrutierung
        • AKH -Wien
        • Kontakt:
        • Hauptermittler:
          • Daniel Zimpfer, MD

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre und älter (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

Inclusion Criteria:

  1. Subject has provided written informed consent by signing the study Informed Consent Form (ICF) prior to any clinical investigation-related procedure
  2. LVEF ≤30% and Cardiac Index ≤ 2.5 L/min/m²
  3. Limited functional status as demonstrated by 6MWT ≤ 350 m due to HF related reasons OR peak VO2 ≤ 14 mL/kg/min (or <50% of predicted peak VO2 value)
  4. NYHA Class IIIB or NYHA Class IV
  5. Subject has ≥ 1 Heart Failure Hospitalization in the last 12 months
  6. Subject is already implanted with a CardioMEMS PA Sensor OR willing to undergo a CardioMEMS PA Sensor implant
  7. Subject is willing and able to be implanted with the HM3 LVAS if randomized to HM3 Group

Randomization Criteria:

  1. Subject has been implanted with a CardioMEMS PA Sensor for at least 90 days.
  2. Subject is receiving guideline directed medical therapy with optimal doses (or documented medication contraindication or intolerance) of betablockers, Angiotensin-Converting-Enzyme-inhibitors or Angiotensin II Receptor Blockers or angiotensin receptor neprilysin inhibitor (if eligible), Mineralocorticoid Receptor Antagonists, Sodium-Glucose co-Transporter-2 (SGLT2) inhibitors, and diuretics for at least 30 of the last 90 days.
  3. mean PAP ≥ 30 mmHg.
  4. The subject will not be randomized if they have any other factor that represents inordinate risk for either continued GDMT or LVAD implant.

Single Arm Registry Criteria:

  1. Subject has received a CardioMEMS PA Sensor implant following enrollment in the trial.
  2. Subject is receiving guideline directed medical therapy with optimal doses (or documented medication contraindication or intolerance) of betablockers, Angiotensin-Converting-Enzyme-inhibitors or Angiotensin II Receptor Blockers or angiotensin receptor neprilysin inhibitor (if eligible), Mineralocorticoid Receptor Antagonists, Sodium-Glucose co-Transporter-2 (SGLT2) inhibitors, and diuretics for at least 30 of the last 90 days.
  3. mean PAP <30 mmHg

Exclusion Criteria:

  1. Subject is < 18 years of age at the time of informed consent.

  2. Dependent on IV inotrope in the last 30 days.

  3. Contra-indications to HM3 LVAS or CardioMEMS HF system.

  4. Etiology of HF due to or associated with uncorrected thyroid disease, obstructive cardiomyopathy, pericardial disease, amyloidosis, or restrictive cardiomyopathy.

  5. Technical obstacles to LVAD or CardioMEMS implantation which pose an inordinately high surgical risk, in the judgment of the implanter.

  6. Existence of ongoing MCS.

  7. Presence of mechanical aortic valve that will not be either converted to a bioprosthesis or oversewn at the time of LVAD implant.

  8. History of any solid organ transplant.

  9. Psychiatric disease/disorder, irreversible cognitive dysfunction or psychosocial issues that are likely to impair compliance with the study protocol and LVAS management.

  10. Presence of an active, uncontrolled infection.

  11. Complex congenital heart disease.

  12. Currently Pregnant or capable of becoming Pregnant and Unwilling to Use Contraception with LVAD.

  13. History of pulmonary embolism within 30 days prior to enrollment or history of recurrent (>1 episode) pulmonary embolism and/or deep vein thrombosis.

  14. Planned VAD or Bi-VAD support prior to enrollment.

  15. Presence of any one of the following risk factors for or indications of severe end organ dysfunction or failure:

    1. An INR ≥ 2.0 not due to anticoagulation therapy
    2. An eGFR < 30 mL/min/1.73 m2 and nonresponsive to diuretic therapy or receiving chronic dialysis.
    3. Biopsy proven liver cirrhosis.
    4. Need for chronic renal replacement therapy.
    5. History of severe chronic obstructive pulmonary disease (COPD) defined by Forced Expiratory Volume FEV1 < 30% predicted.
    6. History of cerebrovascular disease with significant (> 80%) uncorrected internal carotid stenosis.
    7. Significant peripheral vascular disease (PVD) accompanied by ischemic rest pain or extremity ulceration.

  16. Any condition other than HF that could limit survival to less than 24 months.

  17. Participation in any other clinical investigation with an active treatment arm that is likely to confound study results or affect the study outcome.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Randomized Arm - HM3 Group

Patients with elevated mean PAP (mean PAP ≥ 30 mmHg) and randomized to the HM3 group will receive the device within 14 days of randomization.
Gerät: CardioMEMS HF System

The CardioMEMS™ HF System is comprised of a lead-less and battery-less pressure sensor which remotely transmits pulmonary artery pressure measurements.

Andere Namen:
  • CardioMEMS
  • CardioMEMS PA-Sensor
Gerät: HeartMate 3 Left Ventricular Assist System

The HeartMate 3 LVAS is a mechanical circulatory support pump with Full MagLev Technology that assumes some or all of the workload of the left ventricle. The HeartMate 3 LVAS is used in advanced heart failure patients needing short or long-term mechanical circulatory support.

Andere Namen:
  • HM3
Sonstiges: Guideline Medical Directed Therapy

Optimal doses of medical therapy per established heart failure guidelines which includes the following stable combination of Beta Blockers, ACE-inhibitors or ARB or ARNi, MRA and SGLT2 inhibitors.

Andere Namen:
  • GDMT
Experimental: Randomized Arm - Control Group

Patients with elevated mean PAP (mean PAP ≥ 30 mmHg) and randomized to the control group will continue their medical therapy per established heart failure guidelines.
Gerät: CardioMEMS HF System

The CardioMEMS™ HF System is comprised of a lead-less and battery-less pressure sensor which remotely transmits pulmonary artery pressure measurements.

Andere Namen:
  • CardioMEMS
  • CardioMEMS PA-Sensor
Sonstiges: Guideline Medical Directed Therapy

Optimal doses of medical therapy per established heart failure guidelines which includes the following stable combination of Beta Blockers, ACE-inhibitors or ARB or ARNi, MRA and SGLT2 inhibitors.

Andere Namen:
  • GDMT
Experimental: Single Arm Registry

Patients who do not meet the mean PAP threshold (mean PAP <30 mmHg) and are enrolled in the single arm will continue their medical therapy per established heart failure guidelines.
Gerät: CardioMEMS HF System

The CardioMEMS™ HF System is comprised of a lead-less and battery-less pressure sensor which remotely transmits pulmonary artery pressure measurements.

Andere Namen:
  • CardioMEMS
  • CardioMEMS PA-Sensor
Sonstiges: Guideline Medical Directed Therapy

Optimal doses of medical therapy per established heart failure guidelines which includes the following stable combination of Beta Blockers, ACE-inhibitors or ARB or ARNi, MRA and SGLT2 inhibitors.

Andere Namen:
  • GDMT

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Survival at 2 years free of disabling stroke, reoperation to replace the device, or worsening HF requiring listing for urgent heart transplantation or mechanical circulatory support, enrollment into hospice, or dependence on IV inotropes
Zeitfenster: 2 years

The powered primary endpoint will be analyzed at 2 years following the Com-Nougue method and will be compared between the HM3 Group (HM3 LVAD) and the Control Group (GDMT) within the Intention-to-treat (ITT) population.
2 years

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Rate of Safety Outcomes at 1-year
Zeitfenster: 1 year

The powered secondary endpoint of Rate of Safety Outcomes at 1-year will be evaluated within the Intention-to-treat (ITT) population against a pre-specified performance goal.

Components consist of the following:

  1. Heart failure hospitalization

  2. Major Adverse Event (MAE) including:

    • Stroke
    • Non-surgical bleeding (>14 days post implant) requiring hospitalization
    • Renal failure requiring hospitalization
    • Driveline infection requiring hospitalization
1 year
Survival at 2 years
Zeitfenster: 2 years

The powered secondary endpoint of survival at 2-years will be compared between the HM3 Group and the Control Group within the Intention-to-treat (ITT) population.
2 years
Quality of life score assessed with the Kansas City Cardiomyopathy Questionnaire
Zeitfenster: 2 years

The secondary endpoint of Quality-of-life score at 2-years will be compared between the HM3 Group and the Control Group within the Intention-to-treat (ITT) population. Additionally, the secondary endpoint of Quality of life at 2-years will be descriptively compared between the Single Arm Registry and both the HM3 Group and Control Group of the Randomized Arm separately.

The KCCQ scores are represented on a 0-to-100-point scale, where lower scores represent more severe symptoms and/or limitations and scores of 100 indicate no symptoms, no limitations, and excellent quality of life. Improvement of KCCQ by at least 10 points is considered clinically significant.
2 years
Six-minute walk distance
Zeitfenster: 2 years

The secondary endpoint of six-minute walk distance at 2-years will be compared between the HM3 Group and the Control Group within the Intention-to-treat (ITT) population. Additionally, the secondary endpoint of six-minute walk distance at 2-years will be descriptively compared between the Single Arm Registry and both the HM3 Group and Control Group of the Randomized Arm separately.
2 years
Hospitalizations for HF and/or Urgent HF Visit
Zeitfenster: 2 years

The secondary endpoint of Hospitalizations for HF and/or Urgent HF Visit at 2-years will be compared between the HM3 Group and the Control Group within the Intention-to-treat (ITT) population. Additionally, the secondary endpoint of Hospitalizations for HF and/or Urgent HF Visit at 2-years will be descriptively compared between the Single Arm Registry and both the HM3 Group and Control Group of the Randomized Arm separately.
2 years
Days alive and outside of the hospital
Zeitfenster: 2 years

The secondary endpoint of days alive and outside of the hospital at 2-years will be compared between the HM3 Group and the Control Group within the Intention-to-treat (ITT) population. Additionally, the secondary endpoint of days alive and outside of the hospital at 2-years will be descriptively compared between the Single Arm Registry and both the HM3 Group and Control Group of the Randomized Arm separately.
2 years
All-cause hospitalizations
Zeitfenster: 2 years

The secondary endpoint of all-cause hospitalizations at 2-years will be compared between the HM3 Group and the Control Group within the Intention-to-treat (ITT) population. Additionally, the secondary endpoint of all-cause hospitalizations at 2-years will be descriptively compared between the Single Arm Registry and both the HM3 Group and Control Group of the Randomized Arm separately.
2 years
All adverse events (including all strokes) regardless of severity
Zeitfenster: 2 years

The secondary endpoint of all adverse events (including all strokes) regardless of severity at 2-years will be compared between the HM3 Group and the Control Group within the Intention-to-treat (ITT) population. Additionally, the secondary endpoint of all adverse events (including all strokes) regardless of severity at 2-years will be descriptively compared between the Single Arm Registry and both the HM3 Group and Control Group of the Randomized Arm separately.
2 years

Andere Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Finkelstein-Schoenfeld Win Ratio
Zeitfenster: 5 years

The Finkelstein-Schoenfeld Win Ratio will be explored at 5 years as an additional analysis with the following hierarchy:

  1. Survival
  2. Days alive outside of the hospital
  3. Quality of Life assessed with the KCCQ (considered a tie if within 10 points)
  4. Functional Capacity (Six-minute walk distance)

The Finkelstein-Schoenfeld Win Ratio will be analyzed between the HM3 Group and the Control Group within the Intention-to-treat (ITT) population. Additionally, the Finkelstein-Schoenfeld Win Ratio will be descriptively analyzed between the Single Arm and both the HM3 Group and Control Group of the Randomized Arm separately.
5 years
Survival free of urgent LVAD or transplant
Zeitfenster: 5 years

This additional descriptive analysis at 5-years will be performed to evaluate the proportion of patients who are alive and free of device replacement or transplant in the HM3 Group compared to the Single Arm Registry (de novo implant or transplant)
5 years

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Abbott Medical Devices

Ermittler

  • Studienleiter: Kelly O'Connell, PhD, Abbott

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Nützliche Links

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

13. Dezember 2024

Primärer Abschluss (Geschätzt)

1. September 2029

Studienabschluss (Geschätzt)

1. September 2032

Studienanmeldedaten

Zuerst eingereicht

24. Juli 2024

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

24. Juli 2024

Zuerst gepostet (Tatsächlich)

29. Juli 2024

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

5. November 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

3. November 2026

Zuletzt verifiziert

1. November 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • ABT- CIP-10521

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Ja

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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