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Clinical Trials/NCT00875732
NCT00875732CompletedNot Applicable

CHOosing the rIght paCing Mode in Heart failurE : Should Heart Failure Patients With Bradycardia Receive Biventricular Pacemakers Rather Than Conventional Pacemakers?

University of Dundee2 sites in 1 country22 target enrollmentStarted: September 2009Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
22
Locations
2
Primary Endpoint
6 minute hall walk test

Study Overview

Brief Summary

The aim of the study is to see if biventricular pacemakers offer any advantage over conventional pacemakers in patients with heart failure who require pacemakers. The endpoints will be the 6 minute walking distance along with markers of cardiovascular function.

The investigators' hypothesis is that biventricular pacing is preferable to conventional pacing in these heart failure patients.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Left ventricular systolic dysfunction.
  • Atrio-ventricular node disease.
  • Anticipated to be more than 40% paced, (including patients in permanent atrial fibrillation).
  • Ability to walk independently (walking aid permitted).

Exclusion Criteria

  • Patients meeting criteria for CRT by current guidelines will be excluded.
  • Life expectancy less than12 months.
  • Inability to walk independently.
  • Patients not likely to be compliant with follow-up.
  • Bradyarrhythmia due with sino-atrial disease only.

Outcomes

Primary Outcomes

6 minute hall walk test

Time Frame: Baseline, 3, 6, 9 and 12 months

Secondary Outcomes

  • Cardiac Output(Baseline, 3, 6, 9 and 12 months)
  • Endothelial Function(Baseline, 3, 6, 9 and 12 months)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

AChoy

Dr. Anna Maria Choy

University of Dundee

Study Sites (2)

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