REDUCE LAP-HF TRIAL II
- Conditions
- Heart Failure
- Registration Number
- NCT03088033
- Lead Sponsor
- Corvia Medical
- Brief Summary
Multicenter, Prospective, Randomized Controlled, Blinded Trial, with a Non-implant Control group; 1:1 randomization.
- Detailed Description
Following supine bicycle exercise testing to assess eligibility, the eligible patients are randomized to the treatment or control group.
All patients will be sedated, and both treatment and control arm patients will undergo placement of a femoral venous access sheath after randomization.
Patients randomized to the treatment arm will undergo a fluoroscopically and intra-cardiac echocardiography (ICE), or transesophageal echocardiography (TEE) guided trans-septal puncture and IASD System II implant procedure. Patients randomized to the control arm will undergo ICE from the femoral vein or TEE for examination of the atrial septum and left atrium.
Patients will be evaluated at pre-specified time intervals and followed for 5 years.
All patients will be unblinded after the 24 month follow up visit.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 608
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Primary Outcome Measures
Name Time Method Composite Primary Endpoint Up to 24 months The primary endpoint is the composite of (a) incidence of and time-to-cardiovascular mortality or first non-fatal, ischemic stroke through 12 months; (b) total rate (first plus recurrent) per patient year of heart failure (HF) events, defined as hospital admissions, acute healthcare facility visits or urgent unscheduled outpatient visits for IV diuresis or intensification of oral diuretics for HF up to 24 months, analyzed when the last randomized subject completes 12 months follow-up, and time-to-first HF event; and (c) change in baseline KCCQ total summary score at 12 months.
- Secondary Outcome Measures
Name Time Method Change in Kansas City Cardiomyopathy Questionnaire 12 months Change in KCCQ score between baseline and 12 months, categorized as ≤0, \>0 - 5, \>5 - 10, \>10 - 15, \>15 - 20, \>20 - 25, \>25.
Change in NYHA Class 12 months Change in NYHA functional Class assessed by a blinded physician between baseline and 12 months
Rate of heart failure admissions Up to 24 months Total rate (first plus recurrent) per patient year of heart failure (HF) events, defined as hospital admissions, acute healthcare facility visits, or urgent unscheduled outpatient visits for IV diuresis or intensification of oral diuretics for HF up to 24 months, analyzed when the last randomized subject completes 12-month follow-up
Composite safety endpoint defined as follows: 12 months 1. Cardiovascular mortality
2. Non-fatal, ischemic stroke
3. New onset or worsening of kidney dysfunction (defined as eGFR decrease of \> 20 ml/min)
4. Major adverse cardiac events through 12-months defined as: i. Cardiac death; ii. Myocardial infarction; iii. Cardiac tamponade; iv. Emergency cardiac surgery
5. Thrombo-embolic complications (TIA, systemic embolization)
6. Newly acquired persistent or permanent AF or atrial flutter through
7. ≥30% increase in RV size/decrease in TAPSE
Trial Locations
- Locations (91)
Arizona Cardiovascular Research Center
🇺🇸Phoenix, Arizona, United States
University of Arizona College of Medicine
🇺🇸Tucson, Arizona, United States
Scripps Clinic
🇺🇸La Jolla, California, United States
Kaiser Permanente San Diego
🇺🇸La Jolla, California, United States
Kaiser Permanente San Francisco Medical Center
🇺🇸San Francisco, California, United States
South Denver Cardiology Associates
🇺🇸Littleton, Colorado, United States
Yale University
🇺🇸New Haven, Connecticut, United States
Medstar Washington Hospital Center
🇺🇸Washington, District of Columbia, United States
Holy Cross Hospital
🇺🇸Fort Lauderdale, Florida, United States
Sarasota Memorial Hospital
🇺🇸Sarasota, Florida, United States
Scroll for more (81 remaining)Arizona Cardiovascular Research Center🇺🇸Phoenix, Arizona, United States