Choosing the Right Pacing Mode in Heart Failure - The CHOICE Trial

Not Applicable

Completed

• Conditions: Heart Failure
• Interventions: Device: Right Ventricular Pacing; Device: Bi Ventricular Pacing

• Registration Number: NCT00875732
• Lead Sponsor: University of Dundee

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-03-31
• Study First Submitted QC: 2009-03-31
• Study First Posted: 2009-04-03
• Study Start: 2009-09
• Primary Completion: 2010-09
• Study Completion: 2011-01
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-07
• Last Update Posted: 2017-07-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
2	Right Ventricular Pacing	Right Ventricular Pacing
1	Bi Ventricular Pacing	Biventricular Pacing

Primary Outcome Measures

Name	Time	Method
6 minute hall walk test	Baseline, 3, 6, 9 and 12 months

Secondary Outcome Measures

Name	Time	Method
Cardiac Output	Baseline, 3, 6, 9 and 12 months
Endothelial Function	Baseline, 3, 6, 9 and 12 months

Trial Locations

Locations (1)

Ninewells Hospital & Medical School; 🇬🇧 Dundee, UK, United Kingdom