REDUCE LAP-HF RANDOMIZED TRIAL I

N/AActive Not RecruitingNCT02600234

Corvia Medical44 enrolled

Overview

A study to evaluate the Corvia Medical, Inc. IASD® System II to REDUCE Elevated Left Atrial Pressure in Patients with Heart Failure.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Heart Failure

Interventions

Inter-Atrial Shunt DeviceDEVICE

An implantable device placed in the interatrial septum

Intracardiac EchoOTHER

Patients randomized to the control arm will undergo intra cardiac echocardiography, with examination of the atrial septum and left atrial appendage.

Eligibility

Sex: ALLMin age: 40 Years

Medical Language ↔ Plain English

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

Locations (21)

University of Arizona College of Medicine

Tucson, Arizona, United States

Yale University

Outcomes

Primary Outcomes

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: 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 implant

Time frame: 1 Month Post Implant

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).

Time frame: 1 Month Post Implant

Secondary Outcomes

Change in exercise PEAK pulmonary capillary wedge pressure (PCWP) from baseline

Time frame: 1 Month

Cardiovascular death

Time frame: 12 Months

Rate of total (first plus recurrent) HF admissions/emergency clinic visits or acute care facilities for IV diuresis for HF

Time frame: 12 Months

Change in Quality Of Life Questionnaire (EQ-5D)

Time frame: 12 Months

Change in Kansas City Cardiomyopathy Questionnaire (KCCQ score)

Time frame: 12 Months

Data from ClinicalTrials.gov

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