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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2009 by University of Dundee.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Chest, Heart and Stroke Association Scotland
St. Jude Medical
Information provided by:
University of Dundee
ClinicalTrials.gov Identifier:
NCT00875732
First received: March 31, 2009
Last updated: June 24, 2010
Last verified: March 2009
  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 Pacing

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

Resource links provided by NLM:


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 Function [ 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: September 2009
Arms Assigned Interventions
Experimental: 1
Biventricular Pacing
Device: Bi Ventricular Pacing
Active Comparator: 2
Right Ventricular Pacing
Device: Right Ventricular Pacing

  Eligibility

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

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Ninewells Hospital & Medical School Recruiting
Dundee, UK, United Kingdom, DD1 9SY
Contact: choy       a.choy@dundee.ac.uk   
Sponsors and Collaborators
University of Dundee
Chest, Heart and Stroke Association Scotland
St. Jude Medical
  More Information

No publications provided

Responsible Party: Dr Anna MariaChoy, University of Dundee
ClinicalTrials.gov Identifier: NCT00875732     History of Changes
Other Study ID Numbers: ELD001
Study First Received: March 31, 2009
Last Updated: June 24, 2010
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by University of Dundee:
Resynchronization
Device
Bradycardia
atrioventricular block
Cardiac Resynchronization

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 18, 2014