NCT03088033

REDUCE LAP-HF TRIAL II

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: 608 (estimated)
• Sponsor: Corvia Medical · Industry
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

Summary

Multicenter, Prospective, Randomized Controlled, Blinded Trial, with a Non-implant Control group; 1:1 randomization.

Detailed description

Following supine bicycle exercise testing to assess eligibility, the eligible patients are randomized to the treatment or control group. All patients will be sedated, and both treatment and control arm patients will undergo placement of a femoral venous access sheath after randomization. Patients randomized to the treatment arm will undergo a fluoroscopically and intra-cardiac echocardiography (ICE), or transesophageal echocardiography (TEE) guided trans-septal puncture and IASD System II implant procedure. Patients randomized to the control arm will undergo ICE from the femoral vein or TEE for examination of the atrial septum and left atrium. Patients will be evaluated at pre-specified time intervals and followed for 5 years. All patients will be unblinded after the 24 month follow up visit.

Conditions

• Heart Failure

Interventions

Type	Name	Description
DEVICE	IASD System II implant	The primary component of the system is an implant placed in the atrial septum designed to allow left to right flow between the left atrium and right atrium to reduce the elevated left atrial pressure.
OTHER	intra-cardiac echocardiography (ICE), or transesophageal echocardiography (TEE)	intra-cardiac echocardiography (ICE), or transesophageal echocardiography (TEE) for examination of the atrial septum and left atrium.

Timeline

• Start date: 2017-06-01
• Primary completion: 2021-07-29
• Completion: 2026-09-01
• First posted: 2017-03-23
• Last updated: 2023-02-22

Locations

91 sites across 15 countries: United States, Australia, Austria, Belgium, Canada, Croatia, Denmark, France, Germany, Italy, Japan, Netherlands, Poland, Spain, United Kingdom

Regulatory

• FDA-regulated device study