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Completed

NCT Number: NCT00875732

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

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.

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Key information

Conditions

Heart Failure Arrhythmias, Cardiac Atrioventricular Block Bradycardia Cardiac Conduction System Disease Cardiovascular Diseases Heart Block Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ninewells Hospital & Medical School

Dundee, UK, DD1 9SY, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Bi Ventricular Pacing

Device

Right Ventricular Pacing

Device

Primary outcomes

  1. 6 minute hall walk test

    Time frame: Baseline, 3, 6, 9 and 12 months

Secondary outcomes

  1. Endothelial Function

    Time frame: Baseline, 3, 6, 9 and 12 months

  2. Cardiac Output

    Time frame: Baseline, 3, 6, 9 and 12 months

Sponsors and collaborators

Lead sponsor

University of Dundee

Other

Collaborators

  • Abbott Medical Devices
  • Chest, Heart and Stroke Association Scotland

Registry information

Official study title

CHOosing the rIght paCing Mode in Heart failurE : Should Heart Failure Patients With Bradycardia Receive Biventricular Pacemakers Rather Than Conventional Pacemakers?

Acronym: CHOICE

Important dates

Study start
2009
Primary completion
2010
Study completion
2011
First posted
Apr 3, 2009
Registry last updated
Jul 11, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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