NCT05136820View on ClinicalTrials.gov

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

NAActive, not recruitingINTERVENTIONAL
Enrollment

15

Participants

Timeline

Start Date

March 9, 2023

Primary Completion Date

February 28, 2026

Study Completion Date

February 28, 2029

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.

Trial Locations (2)

10075

North Shore Northwell University Hospital Lenox Hill, New York

85016

Arizona Heart Rhythm Center, Phoenix

Sponsors
All Listed Sponsors
lead

Occlutech International AB

INDUSTRY