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REDUCE LAP-HF RANDOMIZED TRIAL I

NCT02600234 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2023-03-10

No results posted yet for this study

Summary

A study to evaluate the Corvia Medical, Inc. IASD® System II to REDUCE Elevated Left Atrial Pressure in Patients with Heart Failure.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Corvia Medical

    lead INDUSTRY

Principal Investigators

  • Sanjiv Shah, MD · Northwestern University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-12-31
Primary Completion
2016-12-31
Completion
2026-08-31

Countries

  • United States
  • Australia
  • Belgium
  • Netherlands
  • 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 NCT02600234 on ClinicalTrials.gov