The Prelieve Trial - Pilot Study to Assess Safety and Efficacy of a Novel Atrial Flow Regulator (AFR) in Heart Failure Patients (PRELIEVE)
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|ClinicalTrials.gov Identifier: NCT03030274|
Recruitment Status : Completed
First Posted : January 24, 2017
Last Update Posted : September 15, 2022
|Condition or disease||Intervention/treatment||Phase|
|Heart Failure Low Output Heart Failure||Device: Occlutech AFR device||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||106 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Actual Study Start Date :||October 11, 2017|
|Actual Primary Completion Date :||May 1, 2021|
|Actual Study Completion Date :||March 2, 2022|
Experimental: Occlutech AFR Device
Prospective, non-randomized, pilot study to assess safety and efficacy of a novel Atrial Flow Regulator in Heart Failure Patients with with reduced Ejection Fraction (HFrEF) and Heart Failure Patients with preserved Ejection Fraction (HFpEF); the AFR-Prelieve Trial
Device: Occlutech AFR device
Catheter-guided placement of an AFR device following balloon atrial septostomy.
- Serious Adverse Device Effects (SADE) within 3 month following implantation. [ Time Frame: 0-3 month ]
Incidence of Serious Adverse Device Effects (SADE) following implantation such as:
- device dislocation / embolization
- damage to the tricuspid or mitral valve caused by the device
- intractable arrhythmias caused by the device
- any circumstances that require device removal.
- Serious Adverse Device Effects (SADE) between 3-12 month following implantation [ Time Frame: 3-12 month ]Incidence of all Serious Adverse Device Effects (SADE) following implantation
- Device placement [ Time Frame: 0-12 month ]Device placement in situ
- Left to Right shunt through the AFR device [ Time Frame: 0-12 month ]Evidence of Left to Right shunt through the AFR device
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03030274