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Extended IASD Investigation: REDUCE LAP-HF IV

NCT04632160 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2021-08-02

No results posted yet for this study

Summary

Multicenter, Prospective, Open Label, Single Arm, Clinical Trial.

The primary objective of this clinical trial is to further evaluate the safety and clinical efficacy of the IASD System II in symptomatic heart failure patients with an left ventricular ejection fraction (LVEF) ≥ 40%, and elevated left sided filling pressures despite standard Guideline Directed Medical Therapy (GDMT); and to compare the safety and efficacy results to those from the treatment arm of the REDUCE LAP-HF Randomized Trial II (Corvia protocol 1601).

Conditions

Interventions

DEVICE

IASD System II

The implant is placed across the interatrial septum using a percutaneous transcatheter approach.

Sponsors & Collaborators

  • Corvia Medical

    lead INDUSTRY

Principal Investigators

  • Sanijv Shah, MD · Northwestern Memorial Hospital

  • Marty Leon, MD · Columbia University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-12-01
Primary Completion
2022-01-01
Completion
2027-01-01
FDA Device
Yes

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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 NCT04632160 on ClinicalTrials.gov