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).
The CORCINCH-HF Study is a prospective, randomized, open-label, multicenter, international, clinical safety and efficacy investigation of the AccuCinch Ventricular Restoration System. Subjects will be randomized in a 1:1 ratio: 1. Treatment group: AccuCinch Ventricular Restoration System plus guideline-directed medical therapy (GDMT) (n\~200) 2. Control group: Guideline-directed medical therapy (GDMT) (n\~200)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
400
AccuCinch Ventricular Restoration System
Guideline-Directed Medical Therapy
Grandview Medical Group Research, LLC
Birmingham, Alabama, United States
TERMINATEDUniversity of Alabama at Birmingham
Birmingham, Alabama, United States
WITHDRAWNDignity Health St. Joseph's Hospital and Medical Center
Phoenix, Arizona, United States
RECRUITINGPhoenix Cardiovascular Research Group
Phoenix, Arizona, United States
Freedom from device- or femoral artery access-related major adverse events (MAE)
MAE defined as: 1. All-cause death, 2. Myocardial infarction, 3. Stroke, 4. Need for non-elective cardiovascular surgery, 5. Worsening of heart-failure requiring mechanical circulatory support for more than 24 hours 6. Acute kidney injury requiring renal replacement therapy
Time frame: 180 days
Change from baseline in Kansas City Cardiomyopathy Questionnaire Quality of Life Questionnaire (KCCQ) Score
Higher scores in the KCCQ reflect better health status
Time frame: 180 days
6-Minute Walk Test (6MWT) distance (m)
Change in 6MWT distance (m) from baseline
Time frame: 180 days
Freedom from device- or femoral artery access-related major adverse events (MAE)
MAE defined as: 1. All-cause death, 2. Myocardial infarction, 3. Stroke, 4. Need for non-elective cardiovascular surgery, 5. Worsening of heart-failure requiring mechanical circulatory support for more than 24 hours 6. Acute kidney injury requiring renal replacement therapy
Time frame: 365 days
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
Time frame: 365 days
Number of all-cause deaths or all-cause hospitalizations
Time frame: 30 days, 90 days, 180 days, 365 days, 545 days, 730 days
Number of all-cause deaths
Time frame: 30 days, 90 days, 180 days, 365 days, 545 days, 730 days
Number of all-cause hospitalizations
Time frame: 30 days, 90 days, 180 days, 365 days, 545 days, 730 days
Incidence of all serious adverse events, including device- and procedure- related complications
Time frame: 30 days, 90 days, 180 days, 365 days, 545 days, 730 days
Changes from baseline in New York Heart Association (NYHA) functional class
Time frame: 30 days, 90 days, 180 days, 365 days, 545 days, 730 days
Changes from baseline in Kansas City Cardiomyopathy Questionnaire Overall Score (KCCQ-OS)
Higher scores in the KCCQ reflect better health status
Time frame: 30 days, 90 days, 365 days, 545 days, 730 days
Changes from baseline in 6-Minute Walk Test (6MWT)
Measure in meters
Time frame: 30 days, 90 days, 365 days, 545 days, 730 days
Changes in left ventricular ejection fraction (LVEF) from baseline and from post-procedure/pre-hospital discharge as assessed by echo
Time frame: 30 days, 90 days, 365 days, 730 days
Changes in left ventricular ejection fraction (LVEF) from baseline and from post-procedure/pre-hospital discharge as assessed by echo and CT
Time frame: 180 days
Changes in left ventricular end-diastolic volume (LVEDV) from baseline and from post-procedure/pre-hospital discharge as assessed by echo
Time frame: 30 days, 90 days, 365 days, 730 days
Changes in left ventricular end-diastolic volume (LVEDV) from baseline and from post-procedure/pre-hospital discharge as assessed by echo and CT
Time frame: 180 days
Changes in left ventricular end-systolic volume (LVESV) from baseline and from post-procedure/pre-hospital discharge as assessed by echo
Time frame: 30 days, 90 days, 365 days, 730 days
Changes in left ventricular end-systolic volume (LVESV) from baseline and from post-procedure/pre-hospital discharge as assessed by echo and CT
Time frame: 180 days
Rate and number of cardiovascular death events
Time frame: 30 days, 90 days, 180 days, 365 days, 545 days, 730 days
Rate and number of heart failure death events
Time frame: 30 days, 90 days, 180 days, 365 days, 545 days, 730 days
Rate and number of heart failure-related hospitalizations
Time frame: 30 days, 90 days, 180 days, 365 days, 545 days, 730 days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Tucson Medical Center
Tucson, Arizona, United States
RECRUITINGBaptist Health Heart Failure & Transplant Institute
Little Rock, Arkansas, United States
WITHDRAWNUniversity of California San Diego
La Jolla, California, United States
RECRUITINGScripps Health
La Jolla, California, United States
RECRUITINGUniversity of Southern California
Los Angeles, California, United States
RECRUITINGKaiser Permanente San Francisco
San Francisco, California, United States
COMPLETED...and 122 more locations