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

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ClinicalTrials.gov Identifier: NCT00839566
Recruitment Status : Terminated (Number of eligible patients too small.)
First Posted : February 9, 2009
Last Update Posted : February 15, 2017
Sponsor:
Collaborator:
Medtronic
Information provided by (Responsible Party):
Medtronic Bakken Research Center

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

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Heart Failure Procedure: Ablation Other: Rate Control Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Permanent Atrial Fibrillation in Heart Failure Trial
Study Start Date : November 2008
Actual Primary Completion Date : March 2012
Actual Study Completion Date : July 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: 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



Primary Outcome Measures :
  1. End systolic left ventricular diameter [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. NYHA-Class, Echo-parameters, ECG-parameters, VO2 max,6 minutes hallwalk-test [ Time Frame: 12 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Medtronic Bakken Research Center
ClinicalTrials.gov Identifier: NCT00839566     History of Changes
Other Study ID Numbers: CEN_G_CA_9
First Posted: February 9, 2009    Key Record Dates
Last Update Posted: February 15, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Not applicable as NO is selected above for 'Plan to share IPD?"

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