ACTIVE_NOT_RECRUITING

Assessment of Combined CCM and ICD Device in HFrEF

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Conditions

Heart FailureHeart Failure With Reduced Ejection FractionImplantable Defibrillator UserCCM TherapyNon-ischemic CardiomyopathyIschemic CardiomyopathySudden Cardiac ArrestArrhythmias, CardiacVentricular TachycardiaVentricular FibrillationHFrEFStage C Heart FailureStage D Heart FailureDefibrillation Efficacy TestingInduced Ventricular FibrillationImplantable cardioverter defibrillator

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Assessment of the Safety and Efficacy of a Combined Cardiac Contractility Modulation and Implantable Cardioverter Defibrillator Device for Subjects With Heart Failure and Reduced Ejection Fraction

Quick Facts

Study Start:2023-05-17
Study Completion:2027-07
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05855135

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Patient is aged 18 years or older;
  2. 2. Patient meets the Stage C or D criteria of the Universal Definition of Heart Failure ;
  3. 3. Patient has HFrEF (LVEF ≤40%);
  4. 4. Patient is on GDMT for heart failure;
  5. 5. Patient has a Class I or Class II indication for an ICD
  6. 6. Patient has a reasonable expectation of meaningful survival of \> 1 year;
  7. 7. Patient has either non-ischemic cardiomyopathy or ischemic cardiomyopathy and is at least 40 days post-MI, if an MI occurred;
  8. 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.
  1. 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. 2. Patients who have undergone mitral valve repair or clip within 90 days prior to study consent;
  3. 3. Cardiac surgery within 90 days or a PCI procedure within 30 days prior to study consent;
  4. 4. Prior heart transplant or ventricular assist device;
  5. 5. Implanted mechanical tricuspid valve;
  6. 6. PR interval greater than 375ms or advanced AV block;
  7. 7. In situ S-ICD, pacemaker, or CRT device;
  8. 8. Indicated for CRT;
  9. 9. End stage renal disease, currently on dialysis, or with other major medical disorder (e.g. liver failure, terminal cancer);
  10. 10. Indicated for permanent bradyarrhythmia pacing;
  11. 11. Unstable angina pectoris within 30 days prior to study consent;
  12. 12. Pregnant or planning to become pregnant during the study;
  13. 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. 14. Other criteria that preclude Optimizer INTEGRA CCM-D implantation and/or CCM therapy, as determined by Investigator.

Contacts and Locations

Principal Investigator

Niraj Varma, MD, PhD
PRINCIPAL_INVESTIGATOR
The Cleveland Clinic
Nir Uriel, MD
PRINCIPAL_INVESTIGATOR
Columbia University

Study Locations (Sites)

Phoenix Heart
Glendale, Arizona, 85306
United States
CardioVascular Associates of Mesa
Mesa, Arizona, 85206
United States
Southwest Cardiovascular Associates
Mesa, Arizona, 85208
United States
Arizona Heart Rhythm
Phoenix, Arizona, 85016
United States
CVC Cardiovascular Consultants
Phoenix, Arizona, 85032
United States
Phoenix Heart
Phoenix, Arizona, 85306
United States
Honor Health
Scottsdale, Arizona, 85258
United States
University of Southern California
Los Angeles, California, 90033
United States
Cedars Sinai Medical Center
Los Angeles, California, 90048
United States
Aurora Denver Cardiology Associates
Aurora, Colorado, 80012
United States
Hartford HealthCare
Hartford, Connecticut, 06102
United States
Broward Health Medical Center
Fort Lauderdale, Florida, 33316
United States
Mount Sinai Medical Center Miami Beach
Miami Beach, Florida, 33140
United States
Baptist Health South Florida
Miami, Florida, 33173
United States
Advent Health Orlando
Orlando, Florida, 32803
United States
Cleveland Clinic Weston
Weston, Florida, 33331
United States
Iowa Heart Center
West Des Moines, Iowa, 50266
United States
University of Kansas Medical Center
Kansas City, Kansas, 66103
United States
Baptist Health Lexington
Lexington, Kentucky, 40503
United States
Massachusetts General Hospital
Boston, Massachusetts, 02114
United States
Saint Luke's Hospital
Kansas City, Missouri, 64111
United States
St. Louis VA
Saint Louis, Missouri, 63106
United States
St. Louis Heart and Vascular
Saint Louis, Missouri, 63136
United States
Deborah Heart and Lung Center
Browns Mills, New Jersey, 08015
United States
Virtua
Cherry Hill, New Jersey, 08034
United States
Hackensack University Medical Center
Hackensack, New Jersey, 07601
United States
The Heart House - Cardiovascular Associates of the Delaware Valley
Haddon Heights, New Jersey, 08035
United States
Rutgers New Jersey Medical School
Newark, New Jersey, 07103
United States
NYU Langone
New York, New York, 10016
United States
Mount Sinai New York
New York, New York, 10029
United States
Columbia University Medical Center / NewYork-Presbyterian
New York, New York, 10032
United States
Weill Cornell Medicine
New York, New York, 10065
United States
University of North Carolina
Chapel Hill, North Carolina, 27599
United States
Sanger Heart and Vascular Institute
Charlotte, North Carolina, 28277
United States
Cleveland Clinic
Cleveland, Ohio, 44195
United States
The Ohio State University Wexner Medical Center
Columbus, Ohio, 43210
United States
St. Francis Tulsa
Tulsa, Oklahoma, 74136
United States
Portland VA Medical Center
Portland, Oregon, 97239
United States
St. Luke's Bethlehem
Bethlehem, Pennsylvania, 18015
United States
Bryn Mawr Medical Specialists Association
Bryn Mawr, Pennsylvania, 19010
United States
Lancaster General Hospital
Lancaster, Pennsylvania, 17602
United States
Penn Presbyterian
Philadelphia, Pennsylvania, 19104
United States
Temple University
Philadelphia, Pennsylvania, 19140
United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212
United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15219
United States
Prisma Health
Greenville, South Carolina, 29601
United States
Stern Cardiovascular Foundation
Germantown, Tennessee, 38138
United States
Texas Cardiac Arrhythmia Research Foundation
Austin, Texas, 78705
United States
Medical City Dallas
Dallas, Texas, 75230
United States
UT Southwestern
Dallas, Texas, 75390
United States
Medical City Fort Worth
Fort Worth, Texas, 76104
United States
Houston Methodist
Houston, Texas, 77030
United States
Houston VA Hospital
Houston, Texas, 77030
United States
Christus Trinity Clinic
Tyler, Texas, 75702
United States
Centra Health
Lynchburg, Virginia, 24501
United States
Chippenham Hospital
Richmond, Virginia, 23225
United States
Virginia Commonwealth University
Richmond, Virginia, 23298
United States
Seattle VA
Seattle, Washington, 98108
United States
Swedish
Seattle, Washington, 98122
United States

Collaborators and Investigators

Sponsor: Impulse Dynamics

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-05-17
Study Completion Date2027-07

Study Record Updates

Study Start Date2023-05-17
Study Completion Date2027-07

Terms related to this study

Keywords Provided by Researchers

  • Heart Failure
  • HFrEF
  • Stage C Heart Failure
  • Stage D Heart Failure
  • Defibrillation Efficacy Testing
  • Induced Ventricular Fibrillation
  • Ventricular fibrillation
  • Ventricular tachycardia
  • Implantable cardioverter defibrillator
  • Sudden cardiac arrest

Additional Relevant MeSH Terms

  • Heart Failure
  • Heart Failure With Reduced Ejection Fraction
  • Implantable Defibrillator User
  • CCM Therapy
  • Non-ischemic Cardiomyopathy
  • Ischemic Cardiomyopathy
  • Sudden Cardiac Arrest
  • Arrhythmias, Cardiac
  • Ventricular Tachycardia
  • Ventricular Fibrillation