NCT00875732CompletedNot Applicable
CHOosing the rIght paCing Mode in Heart failurE : Should Heart Failure Patients With Bradycardia Receive Biventricular Pacemakers Rather Than Conventional Pacemakers?
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Dundee
- 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
AChoy
Dr. Anna Maria Choy
University of Dundee
Study Sites (2)
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