REDUCE LAP-HF TRIAL II

  • STATUS
    Recruiting
  • End date
    Aug 26, 2027
  • participants needed
    608
  • sponsor
    Corvia Medical
Updated on 5 May 2021
Investigator
Jan Komtebedde, DVM
Primary Contact
The University of Tokyo Hospital (1.8 mi away) Contact
+126 other location
ejection fraction
heart failure
dyspnea
pulmonary congestion
diuretics
orthopnea
congestion
b-type natriuretic peptide

Summary

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

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. Patients randomized to the control arm will be allowed to cross-over to the treatment arm at 24 months post-control procedure provided patient selection criteria are met at that time. Cross-over patients will then be followed for 5 years after cross-over.

Details
Condition Heart failure, Heart disease, Congestive Heart Failure, Cardiac Disease, cardiac failure, congestive heart disease
Treatment IASD System II implant, intra-cardiac echocardiography (ICE), or transesophageal echocardiography (TEE)
Clinical Study IdentifierNCT03088033
SponsorCorvia Medical
Last Modified on5 May 2021

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