Back to resultsChoosing the Right Pacing Mode in Heart Failure - The CHOICE Trial (CHOICE)
Primary Purpose
Heart Failure
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Bi Ventricular Pacing
Right Ventricular Pacing
Sponsored by
About this trial
This is an interventional treatment trial for Heart Failure focused on measuring Resynchronization, Device, Bradycardia, atrioventricular block, Cardiac Resynchronization
Eligibility Criteria
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.
Sites / Locations
- Ninewells Hospital & Medical School
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1
2
Arm Description
Biventricular Pacing
Right Ventricular Pacing
Outcomes
Primary Outcome Measures
6 minute hall walk test
Secondary Outcome Measures
Endothelial Function
Cardiac Output
Full Information
NCT ID
NCT00875732
First Posted
March 31, 2009
Last Updated
July 7, 2017
Sponsor
University of Dundee
Collaborators
Chest, Heart and Stroke Association Scotland, Abbott Medical Devices
1. Study Identification
Unique Protocol Identification Number
NCT00875732
Brief Title
Choosing the Right Pacing Mode in Heart Failure - The CHOICE Trial
Acronym
CHOICE
Official Title
CHOosing the rIght paCing Mode in Heart failurE : Should Heart Failure Patients With Bradycardia Receive Biventricular Pacemakers Rather Than Conventional Pacemakers?
Study Type
Interventional
2. Study Status
Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
September 2010 (Actual)
Study Completion Date
January 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Dundee
Collaborators
Chest, Heart and Stroke Association Scotland, Abbott Medical Devices
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
Resynchronization, Device, Bradycardia, atrioventricular block, Cardiac Resynchronization
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
22 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Biventricular Pacing
Arm Title
2
Arm Type
Active Comparator
Arm Description
Right Ventricular Pacing
Intervention Type
Device
Intervention Name(s)
Bi Ventricular Pacing
Intervention Type
Device
Intervention Name(s)
Right Ventricular Pacing
Primary Outcome Measure Information:
Title
6 minute hall walk test
Time Frame
Baseline, 3, 6, 9 and 12 months
Secondary Outcome Measure Information:
Title
Endothelial Function
Time Frame
Baseline, 3, 6, 9 and 12 months
Title
Cardiac Output
Time Frame
Baseline, 3, 6, 9 and 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Ninewells Hospital & Medical School
City
Dundee
State/Province
UK
ZIP/Postal Code
DD1 9SY
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
Choosing the Right Pacing Mode in Heart Failure - The CHOICE Trial
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