PAF-HEFT (Permanent Atrial Fibrillation in Heart Failure Trial)

Phase 4

Terminated

• Conditions: Atrial Fibrillation; Heart Failure

• Registration Number: NCT00839566
• Lead Sponsor: Medtronic Cardiac Rhythm and Heart Failure

Brief Summary

Examination of CRT efficacy in patients with progressive heart failure and atrial fibrillation at the same time

Detailed Description

Not available

Study Timeline

• Study Start: 2008-11-01
• Study First Submitted: 2009-01-13
• Study First Submitted QC: 2009-02-06
• Study First Posted: 2009-02-09
• Primary Completion: 2012-03
• Study Completion: 2012-07-01
• Status Verified: 2017-02
• Last Update Submitted: 2025-06-30
• Last Update Posted: 2025-07-03

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

• LVEF <35%
• QRS time ≥150ms LBB
• NYHA classification ≥ NYHA III
• permanent (> 6 months) Atrial Fibrillation
• sinus rhythm (control group)
• Condition after Implantation of a Medtronic CRT device
• written informed consent

Exclusion Criteria

• exchange of the current CRT device
• mitral incompetence (2. degree)
• no compliance
• participation in another study
• pregnancy
• patients with AV node
• patients after heart transplant or those who are on the transplant list

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
End systolic left ventricular diameter	12 months

Secondary Outcome Measures

Name	Time	Method
NYHA-Class, Echo-parameters, ECG-parameters, VO2 max,6 minutes hallwalk-test	12 months

Trial Locations

Locations (1)

Professor Dr. med. Christian Perings; 🇩🇪 Luenen, Germany

Professor Dr. med. Christian Perings

🇩🇪Luenen, Germany