MedTrace Logo

Flow Regulation by Opening the SepTum in Patients With Heart Failure; a Prospective, Randomized, Sham-controlled, Double-blind, Global Multicenter Study

NCT05136820 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2025-08-08

No results posted yet for this study

Summary

The purpose of this clinical study is to assess the safety and effectiveness of the Atrial Flow Regulator in the treatment of subjects, 18 years of age or older, who have symptomatic heart failure with preserved ejection fraction (HFpEF) or heart failure with reduced ejection fraction (HFrEF) while on stable guideline directed medical therapy (GDMT) as outlined in the Guidelines for the Management of Heart Failure.

Conditions

  • Heart Failure With Preserved Ejection Fraction (HFpEF)
  • Heart Failure With Reduced Ejection Fraction (HFrEF)

Interventions

DEVICE

Atrial Flow Regulator

Subjects will be randomized 1:1:1 where subjects will either receive the 6mm AFR device, 8mm AFR device or Sham procedure.

DEVICE

Sham Comparator

Subjects will be randomized 1:1:1 where subjects will either receive the 6mm AFR device, 8mm AFR device or Sham procedure.

Sponsors & Collaborators

  • Occlutech International AB

    lead INDUSTRY

Principal Investigators

  • Megan Coylewright, MD, MPH, FSCAI, FACC · Erlanger Health System

  • Muthiah Vaduganathan, MD, MPH · Brigham and Women's Hospital Heart and Vascular Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-03-09
Primary Completion
2026-02-28
Completion
2029-02-28
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

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 NCT05136820 on ClinicalTrials.gov