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Vurdering av kombinert CCM og ICD-enhet i HFrEF (INTEGRA-D)

3. november 2026 oppdatert av: Impulse Dynamics

Vurdering av sikkerheten og effektiviteten til en kombinert hjertekontraktilitetsmodulasjon og implanterbar cardioverter-defibrillatorenhet for forsøkspersoner med hjertesvikt og redusert ejeksjonsfraksjon

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.

Studieoversikt

Status

Aktiv, ikke rekrutterende

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

300

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: CCM-D Implant

The subject is implanted with the CCM-D device.
Enhet: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Impulse Dynamics

Etterforskere

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

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

17. mai 2023

Primær fullføring (Faktiske)

31. desember 2025

Studiet fullført (Antatt)

1. juli 2027

Datoer for studieregistrering

Først innsendt

3. mai 2023

Først innsendt som oppfylte QC-kriteriene

3. mai 2023

Først lagt ut (Faktiske)

11. mai 2023

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

6. november 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

3. november 2026

Sist bekreftet

1. november 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • RG_PRO_345

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Ja

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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