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Vurdering af kombineret CCM og ICD Device i HFrEF (INTEGRA-D)

3. november 2026 opdateret af: Impulse Dynamics

Vurdering af sikkerheden og effektiviteten af ​​en kombineret hjertekontraktilitetsmodulation og implanterbar cardioverter-defibrillator-enhed til forsøgspersoner med hjertesvigt og reduceret ejektionsfraktion

The goal of this clinical trial is to demonstrate that the OPTIMIZER® Integra CCM-D System (the "CCM-D System") can safely and effective convert induced ventricular fibrillation (VF) and spontaneous ventricular tachycardia and/or ventricular fibrillation (VT/VF) episodes in subjects with Stage C or D heart failure who remain symptomatic despite being on guideline-directed medical therapy (GDMT), are not indicated for cardiac resynchronization therapy (CRT), and have heart failure with reduced left ventricular ejection fraction (LVEF ≤40%).

Eligible subjects will be implanted with the CCM-D System. A subset of subjects will be induced into ventricular fibrillation "on the table" in the implant procedure room. During the follow-up period, inappropriate shock rate and device-related complications will be evaluated. The follow-up period is expected to last at least two years.

Studieoversigt

Status

Aktiv, ikke rekrutterende

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

300

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Arizona
      • Glendale, Arizona, Forenede Stater, 85306
        • Phoenix Heart
      • Mesa, Arizona, Forenede Stater, 85208
        • Southwest Cardiovascular Associates
      • Mesa, Arizona, Forenede Stater, 85206
        • CardioVascular Associates of Mesa
      • Phoenix, Arizona, Forenede Stater, 85016
        • Arizona Heart Rhythm
      • Phoenix, Arizona, Forenede Stater, 85032
        • CVC Cardiovascular Consultants
      • Phoenix, Arizona, Forenede Stater, 85306
        • Phoenix Heart
      • Scottsdale, Arizona, Forenede Stater, 85258
        • Honor Health
    • California
      • Los Angeles, California, Forenede Stater, 90033
        • University of Southern California
      • Los Angeles, California, Forenede Stater, 90048
        • Cedars Sinai Medical Center
    • Connecticut
      • Hartford, Connecticut, Forenede Stater, 06102
        • Hartford HealthCare
    • Florida
      • Fort Lauderdale, Florida, Forenede Stater, 33316
        • Broward Health Medical Center
      • Miami, Florida, Forenede Stater, 33173
        • Baptist Health South Florida
      • Miami Beach, Florida, Forenede Stater, 33140
        • Mount Sinai Medical Center Miami Beach
      • Orlando, Florida, Forenede Stater, 32803
        • Advent Health Orlando
    • Iowa
      • West Des Moines, Iowa, Forenede Stater, 50266
        • Iowa Heart Center
    • Kansas
      • Kansas City, Kansas, Forenede Stater, 66103
        • University of Kansas Medical Center
    • Kentucky
      • Lexington, Kentucky, Forenede Stater, 40503
        • Baptist Health Lexington
    • Massachusetts
      • Boston, Massachusetts, Forenede Stater, 02114
        • Massachusetts General Hospital
    • Missouri
      • Kansas City, Missouri, Forenede Stater, 64111
        • Saint Luke's Hospital
      • St Louis, Missouri, Forenede Stater, 63136
        • St. Louis Heart and Vascular
      • St Louis, Missouri, Forenede Stater, 63106
        • St. Louis VA
    • New Jersey
      • Browns Mills, New Jersey, Forenede Stater, 08015
        • Deborah Heart and Lung Center
      • Cherry Hill, New Jersey, Forenede Stater, 08034
        • Virtua
      • Hackensack, New Jersey, Forenede Stater, 07601
        • Hackensack University Medical Center
      • Haddon Heights, New Jersey, Forenede Stater, 08035
        • The Heart House - Cardiovascular Associates of the Delaware Valley
      • Newark, New Jersey, Forenede Stater, 07103
        • Rutgers New Jersey Medical School
    • New York
      • New York, New York, Forenede Stater, 10065
        • Weill Cornell Medicine
      • New York, New York, Forenede Stater, 10016
        • NYU Langone
      • New York, New York, Forenede Stater, 10029
        • Mount Sinai New York
      • New York, New York, Forenede Stater, 10032
        • Columbia University Medical Center / NewYork-Presbyterian
    • North Carolina
      • Chapel Hill, North Carolina, Forenede Stater, 27599
        • University of North Carolina
      • Charlotte, North Carolina, Forenede Stater, 28277
        • Sanger Heart and Vascular Institute
    • Ohio
      • Cleveland, Ohio, Forenede Stater, 44195
        • Cleveland Clinic
      • Cleveland, Ohio, Forenede Stater, 44106
        • Louis Stokes Cleveland VA Medical Center
      • Columbus, Ohio, Forenede Stater, 43210
        • The Ohio State University Wexner Medical Center
    • Oklahoma
      • Tulsa, Oklahoma, Forenede Stater, 74136
        • St. Francis Tulsa
    • Oregon
      • Portland, Oregon, Forenede Stater, 97239
        • Portland VA Medical Center
    • Pennsylvania
      • Bethlehem, Pennsylvania, Forenede Stater, 18015
        • St. Luke's Bethlehem
      • Bryn Mawr, Pennsylvania, Forenede Stater, 19010
        • Bryn Mawr Medical Specialists Association
      • Lancaster, Pennsylvania, Forenede Stater, 17602
        • Lancaster General Hospital
      • Philadelphia, Pennsylvania, Forenede Stater, 19140
        • Temple University
      • Philadelphia, Pennsylvania, Forenede Stater, 19104
        • Penn Presbyterian
      • Pittsburgh, Pennsylvania, Forenede Stater, 15212
        • Allegheny General Hospital
      • Pittsburgh, Pennsylvania, Forenede Stater, 15219
        • University of Pittsburgh Medical Center
    • South Carolina
      • Greenville, South Carolina, Forenede Stater, 29601
        • Prisma Health
    • Tennessee
      • Germantown, Tennessee, Forenede Stater, 38138
        • Stern Cardiovascular Foundation
    • Texas
      • Austin, Texas, Forenede Stater, 78705
        • Texas Cardiac Arrhythmia Research Foundation
      • Dallas, Texas, Forenede Stater, 75230
        • Medical City Dallas
      • Dallas, Texas, Forenede Stater, 75390
        • UT Southwestern
      • Fort Worth, Texas, Forenede Stater, 76104
        • Medical City Fort Worth
      • Houston, Texas, Forenede Stater, 77030
        • Houston Methodist
      • Houston, Texas, Forenede Stater, 77030
        • Houston VA Hospital
      • Houston, Texas, Forenede Stater, 77030
        • UT Memorial Hermann
      • Tyler, Texas, Forenede Stater, 75702
        • Christus Trinity Clinic
    • Virginia
      • Lynchburg, Virginia, Forenede Stater, 24501
        • Centra Health
      • Richmond, Virginia, Forenede Stater, 23298
        • Virginia Commonwealth University
      • Richmond, Virginia, Forenede Stater, 23225
        • Chippenham Hospital
    • Washington
      • Seattle, Washington, Forenede Stater, 98122
        • Swedish
      • Seattle, Washington, Forenede Stater, 98108
        • Seattle VA

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

Individuals must meet all the following:

  1. Patient is aged 18 years or older;
  2. Patient meets the Stage C or D criteria of the Universal Definition of Heart Failure ;
  3. Patient has HFrEF (LVEF ≤40%);
  4. Patient is on GDMT for heart failure;
  5. Patient has a Class I or Class II indication for an ICD
  6. Patient has a reasonable expectation of meaningful survival of > 1 year;
  7. Patient has either non-ischemic cardiomyopathy or ischemic cardiomyopathy and is at least 40 days post-MI, if an MI occurred;
  8. Patient is willing to give informed consent, available for scheduled study follow-up visits, and able to complete all testing described in the study protocol at the investigational site location.

Exclusion Criteria:

An individual who meets any of the following criteria will be excluded from participation in this study:

  1. Patients should not have severe AI or AS, and should not have MS; additionally, patients undergoing DE testing should not have severe MR;
  2. Patients who have undergone mitral valve repair or clip within 90 days prior to study consent;
  3. Cardiac surgery within 90 days or a PCI procedure within 30 days prior to study consent;
  4. Prior heart transplant or ventricular assist device;
  5. Implanted mechanical tricuspid valve;
  6. PR interval greater than 375ms or advanced AV block;
  7. In situ S-ICD, pacemaker, or CRT device;
  8. Indicated for CRT;
  9. End stage renal disease, currently on dialysis, or with other major medical disorder (e.g. liver failure, terminal cancer);
  10. Indicated for permanent bradyarrhythmia pacing;
  11. Unstable angina pectoris within 30 days prior to study consent;
  12. Pregnant or planning to become pregnant during the study;
  13. Participating in another cardiac investigational device or drug study at the same time (or within 30 days prior to study consent); Note: Registries and other observational studies are acceptable.
  14. Other criteria that preclude Optimizer INTEGRA CCM-D implantation and/or CCM therapy, as determined by Investigator.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: CCM-D Implant

The subject is implanted with the CCM-D device.
Enhed: OPTIMIZER® Integra CCM-D System (Treatment Arm)

The CCM-D System is an implantable cardiac device system that combines cardiac contractility modulation and implantable cardioverter defibrillator (ICD) modules into one device. CCM-D is also known as a "Cardiac Contractility Modulation - Defibrillator". All 300 subjects will be implanted with the CCM-D System and followed for a period of at least two years.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Device Effectiveness in Converting Induced Ventricular Fibrillation (Primary Efficacy Objective)
Tidsramme: Implant

Evaluate the device effectiveness in converting induced VF at the time of implantation.
Implant
Device-related Complications (Primary Safety Objective)
Tidsramme: Implant to 6 months

Evaluate device-related complications through 6-months (excluding lead-related complications).
Implant to 6 months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Inappropriate Shock Rate out to 6-months (Secondary Safety Objective)
Tidsramme: Implant to 6 months

Evaluate the incidence of inappropriate ICD shocks through the time when the last subject enrolled completes the 6-month visit.
Implant to 6 months

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Inappropriate Shock Rate out to 2-years
Tidsramme: Implant to 2 years

Evaluate the device effectiveness in converting spontaneous VT/VF through the time when the last subject enrolled completes the 6-month visit. Each subject will be followed for 2-years after implant to capture additional spontaneous episodes that may occur.
Implant to 2 years
Charging non-compliance
Tidsramme: Implant to 2 years

Evaluate subject charging non-compliance defined as >14 days between interval charging sessions, overall and frequency of non-compliance in the same subject.
Implant to 2 years
Longitudinal levels of activity
Tidsramme: Implant to 2 years

Track longitudinal levels of activity weekly via OPTIhome (when available) and identification of trends.
Implant to 2 years
Battery degradation and longevity
Tidsramme: Implant to 2 years

Assess battery degradation and longevity either remotely or during an in-person follow-up at 2 years (+/- 60 days) by recording QHR battery voltage as measured by the Integra CCM-D IPG. The measurement under nominal conditions is expected to be 2.85V or higher, consistent with a 20-year device longevity.
Implant to 2 years
Compare worsening heart failure events pre- and post-implant
Tidsramme: 12 months prior to implant and 12 months post-implant

Track unscheduled cardiovascular-related healthcare encounters from 12 months prior to implant, if available, to 12 months post-implant
12 months prior to implant and 12 months post-implant
All-cause mortality
Tidsramme: 1 and 2 years post-implant

Assess all-cause mortality using Seattle Heart Failure Model (SHFM) and comorbidity burden as a predictive comparator at 1 year and 2 years post-implant
1 and 2 years post-implant
Kansas City Cardiomyopathy Questionnaire (KCCQ)
Tidsramme: Baseline to 6-months

Compare change in subject's perception of their heart failure symptoms, as measured by KCCQ, from baseline to 6 months.
Baseline to 6-months
EQ-5D-5L
Tidsramme: Baseline to 6-months

Compare change in subject's perception of their health status, as measured by the EQ-5D-5L, from baseline to 6 months.
Baseline to 6-months
Six Minute Walk Distance (6MWD)
Tidsramme: Baseline to 6 months

Compare change in functional capacity, as measured by 6MWD, from baseline to 6 months.
Baseline to 6 months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Impulse Dynamics

Efterforskere

  • Ledende efterforsker: Nir Uriel, MD, Columbia University
  • Ledende efterforsker: Niraj Varma, MD, PhD, The Cleveland Clinic

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

17. maj 2023

Primær færdiggørelse (Faktiske)

31. december 2025

Studieafslutning (Anslået)

1. juli 2027

Datoer for studieregistrering

Først indsendt

3. maj 2023

Først indsendt, der opfyldte QC-kriterier

3. maj 2023

Først opslået (Faktiske)

11. maj 2023

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

6. november 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

3. november 2026

Sidst verificeret

1. november 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • RG_PRO_345

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ja

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