Heart Failure Clinical Trial
Official title:
REDUCE LAP-HF RANDOMIZED TRIAL I: A Study to Evaluate the Corvia Medical, Inc. IASD® System II to REDUCE Elevated Left Atrial Pressure in Patients With Heart Failure
Verified date | June 2022 |
Source | Corvia Medical |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
A study to evaluate the Corvia Medical, Inc. IASD® System II to REDUCE Elevated Left Atrial Pressure in Patients with Heart Failure.
Status | Active, not recruiting |
Enrollment | 44 |
Est. completion date | August 2026 |
Est. primary completion date | December 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 40 Years and older |
Eligibility | Key Inclusion Criteria: - 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 Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
Australia | The Alfred Hospital | Melbourne | |
Belgium | OLVZ Aalst | Aalst | |
Netherlands | UMC Groningen | Groningen | |
United Kingdom | Golden Jubilee Hospital | Glasgow | |
United States | University of Michigan Health System | Ann Arbor | Michigan |
United States | Massachusetts General Hospital | Boston | Massachusetts |
United States | Medical University of South Carolina | Charleston | South Carolina |
United States | Northwestern University | Chicago | Illinois |
United States | Ohio Health | Columbus | Ohio |
United States | Ohio State University College of Medicine | Columbus | Ohio |
United States | Evanston Northshore Healthcare | Evanston | Illinois |
United States | Cardiovascular Institute of the South | Houma | Louisiana |
United States | Yale University | New Haven | Connecticut |
United States | Ochsner Medical Center | New Orleans | Louisiana |
United States | Columbia University Medical Center/NewYork Presbyterian Hospital | New York | New York |
United States | Mt. Sinai Hospital | New York | New York |
United States | New York University | New York | New York |
United States | University of Pennsylvania | Philadelphia | Pennsylvania |
United States | Mayo Clinic | Rochester | Minnesota |
United States | University of Arizona College of Medicine | Tucson | Arizona |
United States | Wake Forest | Winston-Salem | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Corvia Medical |
United States, Australia, Belgium, Netherlands, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Peri-procedural, and 1 month Major Adverse Cardiac, Cerebrovascular, and Renal Events (MACCRE) | 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: Cardiovascular death through 1-month post implant; Embolic stroke through 1-months post implant; Device and or procedure related adverse cardiac events through 1-month post implant; New onset or worsening of kidney dysfunction (defined as eGFR decrease of > 20 ml/min) through 1-month post implant |
1 Month Post Implant | |
Primary | Change in supine exercise pulmonary capillary wedge pressure (PCWP) | 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). | 1 Month Post Implant | |
Secondary | Change in exercise PEAK pulmonary capillary wedge pressure (PCWP) from baseline | 1 Month | ||
Secondary | Cardiovascular death | 12 Months | ||
Secondary | Rate of total (first plus recurrent) HF admissions/emergency clinic visits or acute care facilities for IV diuresis for HF | 12 Months | ||
Secondary | Change in Quality Of Life Questionnaire (EQ-5D) | 12 Months | ||
Secondary | Change in Kansas City Cardiomyopathy Questionnaire (KCCQ score) | 12 Months |
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