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

This study has been terminated.
Information provided by (Responsible Party):
Medtronic Bakken Research Center Identifier:
First received: January 13, 2009
Last updated: January 3, 2017
Last verified: January 2017
Examination of CRT efficacy in patients with progressive heart failure and atrial fibrillation at the same time

Condition Intervention Phase
Atrial Fibrillation
Heart Failure
Procedure: Ablation
Other: Rate Control
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Permanent Atrial Fibrillation in Heart Failure Trial

Resource links provided by NLM:

Further study details as provided by Medtronic Bakken Research Center:

Primary Outcome Measures:
  • End systolic left ventricular diameter [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • NYHA-Class, Echo-parameters, ECG-parameters, VO2 max,6 minutes hallwalk-test [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Enrollment: 12
Study Start Date: November 2008
Study Completion Date: July 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: AV ablation Procedure: Ablation
AV-node ablation
Active Comparator: Rate control
Rate control by drugs
Other: Rate Control
Rate control by drug
No Intervention: sinus rhythm


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00839566

Professor Dr. med. Christian Perings
Luenen, Germany, 44534
Sponsors and Collaborators
Medtronic Bakken Research Center
Principal Investigator: Christian Perings, MD marien Hospital Luenen
  More Information

Responsible Party: Medtronic Bakken Research Center Identifier: NCT00839566     History of Changes
Other Study ID Numbers: CEN_G_CA_9 
Study First Received: January 13, 2009
Last Updated: January 3, 2017
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Medtronic Bakken Research Center:
Atrial Fibrillation
Heart Failure

Additional relevant MeSH terms:
Heart Failure
Atrial Fibrillation
Heart Diseases
Cardiovascular Diseases
Arrhythmias, Cardiac
Pathologic Processes processed this record on January 18, 2017