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Clinical Trials/NCT00839566
NCT00839566
Terminated
Phase 4

Permanent Atrial Fibrillation in Heart Failure Trial

Medtronic Cardiac Rhythm and Heart Failure1 site in 1 country12 target enrollmentNovember 1, 2008
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ConditionsAtrial FibrillationHeart Failure

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Atrial Fibrillation
Sponsor
Medtronic Cardiac Rhythm and Heart Failure
Enrollment
12
Locations
1
Primary Endpoint
End systolic left ventricular diameter
Status
Terminated
Last Updated
10 months ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief Summary

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

Registry
clinicaltrials.gov
Start Date
November 1, 2008
End Date
July 1, 2012
Last Updated
10 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Medtronic Cardiac Rhythm and Heart Failure
Responsible Party
Sponsor

Eligibility 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 (
  • •no compliance
  • •participation in another study
  • •pregnancy
  • •patients with AV node
  • •patients after heart transplant or those who are on the transplant list

Outcomes

Primary Outcomes

End systolic left ventricular diameter

Time Frame: 12 months

Secondary Outcomes

  • NYHA-Class, Echo-parameters, ECG-parameters, VO2 max,6 minutes hallwalk-test(12 months)

Study Sites (1)

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