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REDUCE LAP-HFREF TRIAL

NCT03093961 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2024-02-06

No results posted yet for this study

Summary

The objective of this pilot study is to evaluate the safety and performance of implanting the IASD® System II in Heart Failure patients with reduced ejection fraction and elevated left sided filling pressures, who remain symptomatic despite Guideline Directed Medical Therapy (GDMT).

Conditions

Interventions

DEVICE

IASD implant

Single arm for implant

Sponsors & Collaborators

  • Corvia Medical

    lead INDUSTRY

Principal Investigators

  • Jan Komtebedde, DVM · Corvia Medical

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-03-10
Primary Completion
2026-12-31
Completion
2027-12-31
FDA Device
Yes

Countries

  • United States
  • Australia
  • Czechia

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 NCT03093961 on ClinicalTrials.gov