NCT02600234

REDUCE LAP-HF RANDOMIZED TRIAL I

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 44 (actual)
• Sponsor: Corvia Medical · Industry
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Heart Failure

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2015-12-01
• Primary completion: 2016-12-01
• Completion: 2026-08-01
• First posted: 2015-11-09
• Last updated: 2023-03-10

Locations

21 sites across 5 countries: United States, Australia, Belgium, Netherlands, United Kingdom