- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00875732
Choosing the Right Pacing Mode in Heart Failure - The CHOICE Trial (CHOICE)
CHOosing the rIght paCing Mode in Heart failurE : Should Heart Failure Patients With Bradycardia Receive Biventricular Pacemakers Rather Than Conventional Pacemakers?
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 Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
UK
-
Dundee, UK, United Kingdom, DD1 9SY
- Ninewells Hospital & Medical School
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
Biventricular Pacing
|
|
Active Comparator: 2
Right Ventricular Pacing
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
6 minute hall walk test
Time Frame: Baseline, 3, 6, 9 and 12 months
|
Baseline, 3, 6, 9 and 12 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Endothelial Function
Time Frame: Baseline, 3, 6, 9 and 12 months
|
Baseline, 3, 6, 9 and 12 months
|
Cardiac Output
Time Frame: Baseline, 3, 6, 9 and 12 months
|
Baseline, 3, 6, 9 and 12 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ELD001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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