Heart Failure
Conditions
Keywords
Resynchronization, Device, Bradycardia, atrioventricular block, Cardiac Resynchronization
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.
Interventions
DEVICEBi Ventricular Pacing
DEVICERight Ventricular Pacing
Sponsors
Chest, Heart and Stroke Association Scotland
Abbott Medical Devices
University of Dundee
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Left ventricular systolic dysfunction. 2. Atrio-ventricular node disease. 3. Anticipated to be more than 40% paced, (including patients in permanent atrial fibrillation). 4. Ability to walk independently (walking aid permitted).
Exclusion criteria
1. Patients meeting criteria for CRT by current guidelines will be excluded. 2. Life expectancy less than12 months. 3. Inability to walk independently. 4. Patients not likely to be compliant with follow-up. 5. Bradyarrhythmia due with sino-atrial disease only.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 6 minute hall walk test | Baseline, 3, 6, 9 and 12 months |
Secondary
| Measure | Time frame |
|---|---|
| Endothelial Function | Baseline, 3, 6, 9 and 12 months |
| Cardiac Output | Baseline, 3, 6, 9 and 12 months |
Countries
United Kingdom
Outcome results
None listed