Dilated Cardiomyopathy Clinical Trial
Official title:
Randomized Clinical Evaluation of the AccuCinch® Ventricular Restoration System in Patients Who Present With Symptomatic Heart Failure With Reduced Ejection Fraction (HFrEF): The CORCINCH-HF Study
Prospective, randomized, open-label, international, multi-center clinical study to evaluate the safety and efficacy of the AccuCinch Ventricular Restoration System in patients with heart failure and reduced ejection fraction (HFrEF).
Status | Recruiting |
Enrollment | 400 |
Est. completion date | December 21, 2030 |
Est. primary completion date | June 21, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. Age 18-years or older 2. Ejection Fraction: =20% and =40% measured by transthoracic echocardiography (TTE) and assessed by an echocardiography (echo) core lab 3. LV end-diastolic diameter =55 mm measured by TTE and assessed by an echo core lab 4. Symptom Status: 1. NYHA III, 2. NYHA ambulatory IV, or 3. NYHA II with a heart failure hospitalization within the prior 12 months (of signing the consent) 5. Able to complete six-minute walk test with distance between 100 m and 450 m. 6. Diagnosis and treatment for heart failure should be established at least 90 days before the date of consent. Subjects should be on stable, optimally titrated medical therapy for at least 30 days, as recommended according to current guidelines as standard-of-care for Heart Failure therapy, with any intolerance documented. 1. "Stable" is defined as no more than a 100% increase or a 50% decrease of total daily doses. Medication changes within this range do not require any additional waiting before the screening assessments 2. When a total daily dose increase or decrease exceeds that which is considered stable, the screening TTE and CT will be postponed 30 days after the medication change 3. When additional titration is required to optimize a subject's medication that exceeds what is considered stable, the screening TTE and CT will be postponed at least 30 days after achieving the optimal dose (provided the optimal dose remains outside of the stable parameters) 4. When a dose-for-dose equivalent change in the class of medication change is made, no additional waiting is required before the screening assessments 5. When a change in class medication change exceeds what is considered stable, OR a new class of medication is added, the screening TTE and CT will be postponed 30 days after the medication change 6. If an SGLT2 inhibitor is added to a subject's medications, the screening TTE and CT will be postponed at least 30 days after the addition 7. If an SGLT2 inhibitor dose changes per the stable definition above, no additional waiting is required before the screening assessments 8. If an SGLT2 inhibitor dose change exceeds what is considered stable, the screening TTE and CT will be postponed at least 30 days after achieving the optimal dose (provided the dose remains outside of the stable parameters) 9. When applicable, for guideline-directed device-based therapies: a CRT device must be placed > 90 days before the screening TTE and CT, and an ICD must be placed > 30 days before the screening TTE and CT 7. Able and willing to complete all qualifying diagnostic and functional tests, willing to accept blood product transfusion if required and agrees to comply with study follow-up schedule Exclusion Criteria: Cardiovascular 1. Myocardial infarction or any percutaneous cardiovascular intervention, cardiovascular surgery, or carotid surgery within 90 days prior to consent 2. Untreated clinically significant coronary artery disease (CAD) requiring revascularization 3. Fluoroscopic or echocardiographic evidence of severe aortic arch calcification, mobile aortic atheroma, intracardiac mass, thrombus or vegetation 4. Suboptimal ventricular anatomy or wall thickness as determined from screening echocardiography and/or CT scan 5. Heart failure on the basis other than ischemic or non-ischemic dilated cardiomyopathy (e.g., hypertrophic cardiomyopathy, amyloid cardiomyopathy, restrictive cardiomyopathy, uncorrected congenital heart disease, constrictive pericarditis) 6. Hemodynamic instability within 30 days prior to the implant defined as subject requiring inotropic support or mechanical hemodynamic support 7. Any planned cardiac surgery or interventions within the next 180 days post-randomization (including therapeutic right heart procedures) 8. Active bacterial endocarditis 9. Severe RV dysfunction assessed by right heart catheterization (RHC) and/or TTE 10. Fixed pulmonary hypertension with PA systolic pressure >70 mmHg not responsive to vasodilator therapy 11. History of any stroke within the prior 90 days of consent or documented Modified Rankin Scale = 2 disability from any prior stroke Valvular 12. Mitral regurgitation grade 3+ (moderate-severe) or 4+ (severe) 13. Untreated degenerative (primary) mitral valve disease (mild prolapse with no need for intervention is allowable) 14. Prior mitral or aortic valve replacement 15. Tricuspid regurgitation grade 4+ (severe) 16. Moderate or severe aortic valve stenosis (AVA less than 1.5 cm2 or peak velocity AV Vmax >300 cm/sec) 17. Aortic regurgitation grade 2+ (moderate), 3+ (moderate-severe), or 4+ (severe) Procedural 18. Anatomical pathology or constraints preventing appropriate access/implant of the AccuCinch Ventricular Restoration System (e.g., femoral arteries will not support a 20F Introducer sheath) 19. Renal insufficiency (i.e., eGFR of <25 ml/min/1.73 m2) 20. Subjects in whom anticoagulation during the procedure is contraindicated 21. Subjects in whom 90 days of antiplatelet therapy is contraindicated 22. Known allergy to nitinol, polyester, or polyethylene 23. Any prior true anaphylactic reaction to contrast agents; defined as known anaphylactoid or other non-anaphylactic allergic reactions to contrast agents that cannot be adequately pre-medicated prior to the index procedure General 24. Life expectancy <1 year due to non-cardiac conditions 25. Currently participating in another interventional investigational study 26. Subjects on high dose steroids or immunosuppressant therapy 27. Female subjects who are pregnant, of child-bearing potential without a documented birth control method, or who are lactating |
Country | Name | City | State |
---|---|---|---|
Belarus | Republican Scientific and Practical Centre of Cardiology | Minsk | |
Belgium | OLV Heart Centre | Aalst | |
Belgium | AZ Sint-Jan-Oostende AV Campus Brugge | Brugge | |
Czechia | St. Anne's University Hospital | Brno | |
Czechia | Na Homolce Hospital | Prague | |
France | Hôpital de la Timone | Marseille | |
France | CHU de Rennes - Hôpital Pontchaillou | Rennes | |
France | Clinique-Pasteur | Toulouse | |
Netherlands | St. Antonius Ziekenhuis | Nieuwegein | |
Netherlands | Erasmus Medical Center | Rotterdam | |
Serbia | Institute of Cardiovascular Diseases | Belgrade | |
Serbia | Institute of Cardiovascular Diseases of Vojvodina | Belgrade | |
Serbia | University Clinical Centre of Serbia | Belgrade | |
United States | University of Michigan | Ann Arbor | Michigan |
United States | Emory University | Atlanta | Georgia |
United States | Northside Hospital | Atlanta | Georgia |
United States | Piedmont Heart Institute | Atlanta | Georgia |
United States | JFK Medical Center | Atlantis | Florida |
United States | University of Colorado | Aurora | Colorado |
United States | Ascension Texas Cardiovascular | Austin | Texas |
United States | Austin Heart | Austin | Texas |
United States | University of Maryland Medical Center | Baltimore | Maryland |
United States | Northern Light Eastern Maine Medical Center | Bangor | Maine |
United States | Our Lady of the Lake Regional Medical Center | Baton Rouge | Louisiana |
United States | Grandview Medical Group Research, LLC | Birmingham | Alabama |
United States | University of Alabama at Birmingham | Birmingham | Alabama |
United States | Beth Israel Deaconess Medical Center | Boston | Massachusetts |
United States | Massachusetts General Hospital | Boston | Massachusetts |
United States | Montefiore Medical Center | Bronx | New York |
United States | Deborah Heart & Lung | Browns Mills | New Jersey |
United States | University at Buffalo | Buffalo | New York |
United States | Charleston Area Medical Center | Charleston | West Virginia |
United States | Medical University of South Carolina | Charleston | South Carolina |
United States | University of Virginia Health System | Charlottesville | Virginia |
United States | Northwestern University | Chicago | Illinois |
United States | University of Chicago Medical Center | Chicago | Illinois |
United States | The Christ Hospital | Cincinnati | Ohio |
United States | Cleveland Clinic | Cleveland | Ohio |
United States | UH Cleveland Medical Center | Cleveland | Ohio |
United States | Prisma Health | Columbia | South Carolina |
United States | Ohio State University | Columbus | Ohio |
United States | Metropolitan Heart and Vascular Institute & Mercy Hosp | Coon Rapids | Minnesota |
United States | Baylor Scott & White Research Institute | Dallas | Texas |
United States | Geisinger Clinic | Danville | Pennsylvania |
United States | Advocate Good Samaritan Hospital | Downers Grove | Illinois |
United States | Spectrum Health | Grand Rapids | Michigan |
United States | Hackensack University Medical Center | Hackensack | New Jersey |
United States | Pinnacle Health Cardiovascular Institute | Harrisburg | Pennsylvania |
United States | Hartford Health | Hartford | Connecticut |
United States | Penn State Hershey Medical Center | Hershey | Pennsylvania |
United States | Cardiovascular Institute of the South | Houma | Louisiana |
United States | Baylor College of Medicine St. Luke's Medical Center | Houston | Texas |
United States | Houston Heart | Houston | Texas |
United States | Houston Methodist Hospital | Houston | Texas |
United States | UT Health | Houston | Texas |
United States | Jackson Heart Clinic | Jackson | Mississippi |
United States | Tennova Healthcare-Turkey Creek Medical Center | Knoxville | Tennessee |
United States | Scripps Health | La Jolla | California |
United States | University of California San Diego | La Jolla | California |
United States | HCA Florida Largo Hospital | Largo | Florida |
United States | Baptist Health Heart Failure & Transplant Institute | Little Rock | Arkansas |
United States | University of Southern California | Los Angeles | California |
United States | Norton Heart Specialists | Louisville | Kentucky |
United States | Texas Tech University Health Sciences Center | Lubbock | Texas |
United States | Northwell Health | Manhasset | New York |
United States | University of Miami | Miami | Florida |
United States | Aurora St. Luke's Medical Center | Milwaukee | Wisconsin |
United States | Medical College of Wisconsin | Milwaukee | Wisconsin |
United States | Minneapolis Heart Institute Foundation | Minneapolis | Minnesota |
United States | University of Minnesota | Minneapolis | Minnesota |
United States | Morristown Medical Center | Morristown | New Jersey |
United States | Ascension Saint Thomas | Nashville | Tennessee |
United States | Vanderbilt University Medical Center | Nashville | Tennessee |
United States | Yale University | New Haven | Connecticut |
United States | CUMC/New York Presbyterian Hospital | New York | New York |
United States | Mount Sinai Hospital | New York | New York |
United States | NYU Langone Health | New York | New York |
United States | Weill Cornell Medicine-New York Presbyterian Hospital | New York | New York |
United States | Sentara Norfolk General Hospital | Norfolk | Virginia |
United States | INTEGRIS Baptist Medical Center | Oklahoma City | Oklahoma |
United States | Oklahoma Heart Hospital | Oklahoma City | Oklahoma |
United States | Ascension Sacred Heart | Pensacola | Florida |
United States | Thomas Jefferson University | Philadelphia | Pennsylvania |
United States | Phoenix Cardiovascular Research Group | Phoenix | Arizona |
United States | Allegheny General Hospital | Pittsburgh | Pennsylvania |
United States | UPMC Heart and Vascular Institute | Pittsburgh | Pennsylvania |
United States | Baylor Scott & White | Plano | Texas |
United States | Oregon Health & Science University | Portland | Oregon |
United States | Providence St. Vincent Medical Center | Portland | Oregon |
United States | Vassar Brothers Medical Center | Poughkeepsie | New York |
United States | Rhode Island Hospital | Providence | Rhode Island |
United States | NC Heart and Vascular Research, LLC | Raleigh | North Carolina |
United States | CJW Chippenham Medical Center | Richmond | Virginia |
United States | Carilion Roanoke Memorial Hospital | Roanoke | Virginia |
United States | St. Francis Hospital | Roslyn | New York |
United States | William Beaumont Hospital | Royal Oak | Michigan |
United States | Washington University in St. Louis | Saint Louis | Missouri |
United States | Intermountain Medical Center | Salt Lake City | Utah |
United States | Methodist Healthcare System, San Antonio | San Antonio | Texas |
United States | Kaiser Permanente San Francisco | San Francisco | California |
United States | University of California, San Francisco | San Francisco | California |
United States | University of Washington | Seattle | Washington |
United States | Ascension Providence Hospital | Southfield | Michigan |
United States | Providence Sacred Heart Medical Center | Spokane | Washington |
United States | University of South Florida | Tampa | Florida |
United States | Tucson Medical Center | Tucson | Arizona |
United States | Oklahoma Heart Institute | Tulsa | Oklahoma |
United States | Medstar Health Research Institute | Washington | District of Columbia |
United States | Cardiovascular Research Institute of Kansas | Wichita | Kansas |
United States | Valley Health Winchester | Winchester | Virginia |
United States | University of Massachusetts | Worcester | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Ancora Heart, Inc. |
United States, Belarus, Belgium, Czechia, France, Netherlands, Serbia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Changes from baseline in mitral effective regurgitant orifice area (EROA) | 30 days, 90 days, 180 days, 365 days, 730 days | ||
Other | Changes from baseline in left atrial strain measured by Echo | 30 days, 90 days, 180 days, 365 days, 730 days | ||
Other | Changes from baseline in left ventricular global longitudinal strain measured by Echo | 30 days, 90 days, 180 days, 365 days, 730 days | ||
Other | Changes from baseline in right ventricular free wall longitudinal strain measured by Echo | 30 days, 90 days, 180 days, 365 days, 730 days | ||
Other | Changes from baseline in Kansas City Cardiomyopathy Questionnaire (KCCQ) individual domains | Higher scores in the KCCQ reflect better health status | 30 days, 90 days, 180 days, 365 days, 545 days, 730 days | |
Other | Changes from baseline in EuroQol Five Dimension Five Level (EQ-5D-5L) Quality of Life Questionnaire | Lower scores in the EQ-5D-5L reflect better health status | 30 days, 90 days, 180 days, 365 days, 545 days, 730 days | |
Other | Changes from baseline in right ventricular (RV) fractional area change measured by Echo | Measured by percent change | 30 days, 90 days, 180 days, 365 days, 730 days | |
Other | Changes from baseline in tricuspid annular plane systolic excursion (TAPSE) measured by Echo | Measured in centimeters or millimeters | 30 days, 90 days, 180 days, 365 days, 730 days | |
Other | Changes from baseline in tricuspid regurgitation measured by Echo | Measured using effective regurgitant orifice area (mm2) and regurgitant volume (mL) | 30 days, 90 days, 180 days, 365 days, 730 days | |
Primary | Freedom from device- or femoral artery access-related major adverse events (MAE) | MAE defined as:
All-cause death, Myocardial infarction, Stroke, Need for non-elective cardiovascular surgery, Worsening of heart-failure requiring mechanical circulatory support for more than 24 hours Acute kidney injury requiring renal replacement therapy |
180 days | |
Primary | Change from baseline in Kansas City Cardiomyopathy Questionnaire Quality of Life Questionnaire (KCCQ) Score | Higher scores in the KCCQ reflect better health status | 180 days | |
Primary | 6-Minute Walk Test (6MWT) distance (m) | Change in 6MWT distance (m) from baseline | 180 days | |
Primary | Freedom from device- or femoral artery access-related major adverse events (MAE) | MAE defined as:
All-cause death, Myocardial infarction, Stroke, Need for non-elective cardiovascular surgery, Worsening of heart-failure requiring mechanical circulatory support for more than 24 hours Acute kidney injury requiring renal replacement therapy |
365 days | |
Primary | A hierarchical composite endpoint of all-cause deaths, left ventricular assist device (LVAD) implants or heart transplants, heart failure hospitalizations, and changes from baseline in Kansas City Cardiomyopathy Questionnaire Overall Score (KCCQ-OS) | A hierarchical composite endpoint of number of all-cause deaths, number of left ventricular assist device (LVAD) implants or heart transplants, number of heart failure hospitalizations, and change from baseline in Kansas City Cardiomyopathy Questionnaire Overall Score (KCCQ-OS), evaluated using the Win Ratio method | 365 days | |
Secondary | Number of all-cause deaths or all-cause hospitalizations | 30 days, 90 days, 180 days, 365 days, 545 days, 730 days | ||
Secondary | Number of all-cause deaths | 30 days, 90 days, 180 days, 365 days, 545 days, 730 days | ||
Secondary | Number of all-cause hospitalizations | 30 days, 90 days, 180 days, 365 days, 545 days, 730 days | ||
Secondary | Incidence of all serious adverse events, including device- and procedure- related complications | 30 days, 90 days, 180 days, 365 days, 545 days, 730 days | ||
Secondary | Changes from baseline in New York Heart Association (NYHA) functional class | 30 days, 90 days, 180 days, 365 days, 545 days, 730 days | ||
Secondary | Changes from baseline in Kansas City Cardiomyopathy Questionnaire Overall Score (KCCQ-OS) | Higher scores in the KCCQ reflect better health status | 30 days, 90 days, 365 days, 545 days, 730 days | |
Secondary | Changes from baseline in 6-Minute Walk Test (6MWT) | Measure in meters | 30 days, 90 days, 365 days, 545 days, 730 days | |
Secondary | Changes in left ventricular ejection fraction (LVEF) from baseline and from post-procedure/pre-hospital discharge as assessed by echo | 30 days, 90 days, 365 days, 730 days | ||
Secondary | Changes in left ventricular ejection fraction (LVEF) from baseline and from post-procedure/pre-hospital discharge as assessed by echo and CT | 180 days | ||
Secondary | Changes in left ventricular end-diastolic volume (LVEDV) from baseline and from post-procedure/pre-hospital discharge as assessed by echo | 30 days, 90 days, 365 days, 730 days | ||
Secondary | Changes in left ventricular end-diastolic volume (LVEDV) from baseline and from post-procedure/pre-hospital discharge as assessed by echo and CT | 180 days | ||
Secondary | Changes in left ventricular end-systolic volume (LVESV) from baseline and from post-procedure/pre-hospital discharge as assessed by echo | 30 days, 90 days, 365 days, 730 days | ||
Secondary | Changes in left ventricular end-systolic volume (LVESV) from baseline and from post-procedure/pre-hospital discharge as assessed by echo and CT | 180 days | ||
Secondary | Rate and number of cardiovascular death events | 30 days, 90 days, 180 days, 365 days, 545 days, 730 days | ||
Secondary | Rate and number of heart failure death events | 30 days, 90 days, 180 days, 365 days, 545 days, 730 days | ||
Secondary | Rate and number of heart failure-related hospitalizations | 30 days, 90 days, 180 days, 365 days, 545 days, 730 days |
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