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

This study is not yet open for participant recruitment.

Verified by University of Dundee, March 2009

First Received: March 31, 2009 No Changes Posted

Sponsors and Collaborators:	University of Dundee Chest Heart and Stroke Scotland St Jude Medical (UK) Ltd.
Information provided by:	University of Dundee
ClinicalTrials.gov Identifier:	NCT00875732

Purpose

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.

Condition	Intervention
Heart Failure	Device: Bi Ventricular Pacing Device: Right Ventricular Pccing

MedlinePlus related topics: Heart Failure

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Crossover Assignment, Efficacy Study
Official Title:	CHOosing the rIght paCing Mode in Heart failurE : Should Heart Failure Patients With Bradycardia Receive Biventricular Pacemakers Rather Than Conventional Pacemakers?

Further study details as provided by University of Dundee:

Primary Outcome Measures:

6 minute hall walk test [ Time Frame: Baseline, 3, 6, 9 and 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Endothelial Funtion [ Time Frame: Baseline, 3, 6, 9 and 12 months ] [ Designated as safety issue: No ]
Cardiac Output [ Time Frame: Baseline, 3, 6, 9 and 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	40
Study Start Date:	August 2009

Arms	Assigned Interventions
1: Experimental Biventricular Pacing	Device: Bi Ventricular Pacing
2: Active Comparator Right Ventricular Pacing	Device: Right Ventricular Pccing

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00875732

Contacts

Contact: Anna Maria Choy, MBChB

01382 660111 ext 33448

a.choy@dundee.ac.uk

Locations

United Kingdom, UK
Ninewells Hospital & Medical School
Dundee, UK, United Kingdom, DD1 9SY

Sponsors and Collaborators

University of Dundee

Chest Heart and Stroke Scotland

St Jude Medical (UK) Ltd.

More Information

No publications provided

Responsible Party:	University of Dundee ( Dr Anna MariaChoy )
Study ID Numbers:	ELD001
Study First Received:	March 31, 2009
Last Updated:	March 31, 2009
ClinicalTrials.gov Identifier:	NCT00875732 History of Changes
Health Authority:	United Kingdom: NHS Tayside ethics committee

Keywords provided by University of Dundee:

Resynchronization
Device
Bradycardia
atrioventricular block
Cardiac Resynchronization

Study placed in the following topic categories:

Heart Failure
Heart Diseases
Bradycardia
Atrioventricular Block

Additional relevant MeSH terms:

Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 07, 2009