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
  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:


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 April 17, 2014