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REDUCE LAP-HF TRIAL II

NCT03088033 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 608

Last updated 2023-02-22

No results posted yet for this study

Summary

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

Conditions

Interventions

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.

Sponsors & Collaborators

  • Corvia Medical

    lead INDUSTRY

Principal Investigators

  • Sanjiv Shah, MD · Northwestern Memorial Hospital

  • Marty Leon, MD · Columbia University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-06-01
Primary Completion
2021-07-29
Completion
2026-09-30
FDA Device
Yes

Countries

  • United States
  • Australia
  • Austria
  • Belgium
  • Canada
  • Croatia
  • Denmark
  • France
  • Germany
  • Italy
  • Japan
  • Netherlands
  • Poland
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03088033 on ClinicalTrials.gov