REDUCE LAP-HF RANDOMIZED TRIAL I
- Conditions
- Heart Failure
- Registration Number
- NCT02600234
- Lead Sponsor
- Corvia Medical
- Brief Summary
A study to evaluate the Corvia Medical, Inc. IASD® System II to REDUCE Elevated Left Atrial Pressure in Patients with Heart Failure.
- Detailed Description
The primary objective of this randomized controlled clinical study is to evaluate the peri-procedural safety and potential effectiveness (mechanistic effect) of implanting the IASD System II in heart failure patients with an LV ejection fraction \>40%, elevated left sided filling pressures, and who remain symptomatic despite optimal Guideline Directed Medical Therapy (GDMT). Clinical outcomes will also be evaluated.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 44
- Chronic symptomatic Heart Failure
- Ongoing stable GDMT HF management and management of potential comorbidities
- Age ≥ 40 years old
- LV ejection fraction ≥ 40% within the past 3 months, without previously documented ejection fraction <30%.
- Elevated left atrial pressure with a gradient compared to right atrial pressure (RAP) documented by end-expiratory PCWP during supine ergometer exercise ≥ 25mm Hg, and greater than RAP by ≥ 5 mm Hg
Key
- MI and/or percutaneous cardiac intervention within past 3 months; CABG in past 3 months, or current indication for coronary revascularization
- Cardiac Resynchronization Therapy initiated within the past 6 months
- Severe heart failure
- Inability to perform 6 minute walk test (distance < 50 m), OR 6 minute walk test > 600m
- History of stroke, transient ischemic attack (TIA), deep vein thrombosis (DVT), or pulmonary emboli within the past 6 months
- Presence of significant valve disease
- Known clinically significant untreated carotid artery stenosis
- Currently requiring dialysis; or estimated-GFR <25ml/min/1.73 m2 by CKD-Epi equation
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Primary Outcome Measures
Name Time Method Peri-procedural, and 1 month Major Adverse Cardiac, Cerebrovascular, and Renal Events (MACCRE) 1 Month Post Implant The primary safety outcome measure is the incidence of one or more of the following major adverse cardiac, cerebrovascular embolic, or renal events (MACCRE) defined as:
1. Cardiovascular death through 1-month post implant;
2. Embolic stroke through 1-months post implant;
3. Device and or procedure related adverse cardiac events through 1-month post implant;
4. New onset or worsening of kidney dysfunction (defined as eGFR decrease of \> 20 ml/min) through 1-month post implantChange in supine exercise pulmonary capillary wedge pressure (PCWP) 1 Month Post Implant Change in supine exercise pulmonary capillary wedge pressure (PCWP), as assessed by an independent blinded hemodynamic core laboratory, across the four values measured at each visit (values at 20W, 40W, 60W and 80W).
- Secondary Outcome Measures
Name Time Method Rate of total (first plus recurrent) HF admissions/emergency clinic visits or acute care facilities for IV diuresis for HF 12 Months Change in Quality Of Life Questionnaire (EQ-5D) 12 Months Change in exercise PEAK pulmonary capillary wedge pressure (PCWP) from baseline 1 Month Cardiovascular death 12 Months Change in Kansas City Cardiomyopathy Questionnaire (KCCQ score) 12 Months
Trial Locations
- Locations (21)
University of Arizona College of Medicine
🇺🇸Tucson, Arizona, United States
Yale University
🇺🇸New Haven, Connecticut, United States
Northwestern University
🇺🇸Chicago, Illinois, United States
Evanston Northshore Healthcare
🇺🇸Evanston, Illinois, United States
Cardiovascular Institute of the South
🇺🇸Houma, Louisiana, United States
Ochsner Medical Center
🇺🇸New Orleans, Louisiana, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
University of Michigan Health System
🇺🇸Ann Arbor, Michigan, United States
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
Columbia University Medical Center/NewYork Presbyterian Hospital
🇺🇸New York, New York, United States
Scroll for more (11 remaining)University of Arizona College of Medicine🇺🇸Tucson, Arizona, United States