NCT03030274

The Prelieve Trial - Pilot Study to Assess Safety and Efficacy of a Novel Atrial Flow Regulator (AFR) in Heart Failure Patients

Prospective, Non-randomized, Pilot Study to Assess Safety and Efficacy of a Novel Atrial Flow Regulator (AFR) in Heart Failure Patients With Reduced Ejection Fraction or in Heart Failure Patients With Preserved Ejection Fraction

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 106 (actual)
• Sponsor: Occlutech International AB · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study aims to investigate safety and efficacy of the Occlutech® AFR device in patients with HFrEF (Heart failure with reduced ejection fraction) and HFpEF (Heart failure with preserved ejection fraction)

Detailed description

This study will enroll subjects with HFrEF or HFpEF, until a maximum of 100 patients have undergone implantation with the Occlutech® AFR device. Enrolled patients will be stratified according to their ejection fraction as either HFrEF (ejection fraction \> 15% and \<40 %) or HFpEF ( ejection Fraktion \> 40 % to 70 %). It is planned to enroll at least 100 patients per stratification subgroup.

Conditions

• Heart Failure Low Output
• Heart Failure

Interventions

Type	Name	Description
DEVICE	Occlutech AFR device	Catheter-guided placement of an AFR device following balloon atrial septostomy.

Timeline

• Start date: 2017-10-11
• Primary completion: 2021-05-01
• Completion: 2022-03-02
• First posted: 2017-01-24
• Last updated: 2022-09-15

Locations

26 sites across 3 countries: Belgium, Germany, Turkey (Türkiye)