REDUCE LAP-HF RANDOMIZED TRIAL I

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02600234
• Other study ID #: 1501
• Status: Active, not recruiting
• Phase: N/A
• Start date: December 2015
• Est. completion date: August 2026

Study information

• Verified date: June 2022
• Source: Corvia Medical
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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 information / eligibility

• 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

Related Conditions & MeSH terms

• Heart Failure

Intervention

Device:
• Inter-Atrial Shunt Device
An implantable device placed in the interatrial septum

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

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Corvia Medical

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  Netherlands,  United Kingdom, 

Outcome

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