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

This study has been terminated.
Sponsor:
Collaborator:
Medtronic
Information provided by (Responsible Party):
Medtronic Bakken Research Center
ClinicalTrials.gov Identifier:
NCT00839566
First received: January 13, 2009
Last updated: October 17, 2012
Last verified: October 2012
History of Changes
  Purpose

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:

U.S. FDA Resources

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00839566

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

No publications provided

Responsible Party: Medtronic Bakken Research Center
ClinicalTrials.gov Identifier: NCT00839566     History of Changes
Other Study ID Numbers: CEN_G_CA_9
Study First Received: January 13, 2009
Last Updated: October 17, 2012
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:
Atrial Fibrillation
Heart Failure
Arrhythmias, Cardiac
 Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 16, 2013