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

NCT ID: NCT00875732

Last Updated: 2017-07-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-30

Study Completion Date

2011-01-31

Brief Summary

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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

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Conditions

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Heart Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

Biventricular Pacing

Group Type EXPERIMENTAL

Bi Ventricular Pacing

Intervention Type DEVICE

2

Right Ventricular Pacing

Group Type ACTIVE_COMPARATOR

Right Ventricular Pacing

Intervention Type DEVICE

Interventions

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Bi Ventricular Pacing

Intervention Type DEVICE

Right Ventricular Pacing

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chest, Heart and Stroke Association Scotland

OTHER

Sponsor Role collaborator

Abbott Medical Devices

INDUSTRY

Sponsor Role collaborator

University of Dundee

OTHER

Sponsor Role lead

Responsible Party

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AChoy

Dr. Anna Maria Choy

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Ninewells Hospital & Medical School

Dundee, UK, United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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ELD001

Identifier Type: -

Identifier Source: org_study_id

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