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

Phase 4

Terminated

• Conditions: Atrial Fibrillation; Heart Failure
• Interventions: Other: Rate Control; Procedure: Ablation

• Registration Number: NCT00839566
• Lead Sponsor: Medtronic Bakken Research Center

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
• 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
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-14
• Last Update Posted: 2017-02-15

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

Arm && Interventions

Group	Intervention	Description
Rate control	Rate Control	Rate control by drugs
AV ablation	Ablation	-

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