REDUCE LAP-HF TRIAL II

Status Active, not recruiting

Clinical Trial Summary

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

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Heart Failure

Clinical Trial Details

NCT number	NCT03088033
Study type	Interventional
Source	Corvia Medical
Contact
Status	Active, not recruiting
Phase	N/A
Start date	June 1, 2017
Completion date	September 2026

View Details

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