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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT00251251
Registration number
NCT00251251
Ethics application status
Date submitted
8/11/2005
Date registered
9/11/2005
Date last updated
28/08/2023
Titles & IDs
Public title
Resynchronization/Defibrillation for Ambulatory Heart Failure Trial
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Scientific title
Resynchronization/Defibrillation for Ambulatory Heart Failure Trial
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Secondary ID [1]
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FRN 63208
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Secondary ID [2]
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FRN 63208
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Universal Trial Number (UTN)
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Trial acronym
RAFT
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Heart Failure, Congestive
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Condition category
Condition code
Cardiovascular
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Coronary heart disease
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Cardiovascular
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Other cardiovascular diseases
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Devices - Optimal Medical Therapy plus ICD
Treatment: Devices - Optimal Medical Therapy plus CRT/ICD
Active Comparator: 1. Optimal Medical therapy plus ICD -
Active Comparator: 2. Optimal Medical Therapy plus CRT/ICD -
Treatment: Devices: Optimal Medical Therapy plus ICD
ICD vs CRT/ICD
Treatment: Devices: Optimal Medical Therapy plus CRT/ICD
ICD vs CRT/ICD
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Intervention code [1]
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Treatment: Devices
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Primary outcome is a composite of all cause total mortality and hospitalization for CHF
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Assessment method [1]
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Timepoint [1]
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Study end
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Secondary outcome [1]
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Total mortality
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Assessment method [1]
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Timepoint [1]
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Study end
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Secondary outcome [2]
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Cardiovascular mortality
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Assessment method [2]
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Timepoint [2]
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Study end
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Secondary outcome [3]
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Sudden arrhythmic death
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Assessment method [3]
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Timepoint [3]
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Study end
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Secondary outcome [4]
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Progressive HF death
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Assessment method [4]
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Timepoint [4]
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Secondary outcome [5]
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All cause hospitalization rate
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Assessment method [5]
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Timepoint [5]
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Secondary outcome [6]
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CHF hospitalization rate
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Assessment method [6]
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Timepoint [6]
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Secondary outcome [7]
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Health related quality of life
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Assessment method [7]
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Timepoint [7]
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Study end
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Secondary outcome [8]
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Cost economics
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Assessment method [8]
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Timepoint [8]
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Study end
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Eligibility
Key inclusion criteria
- New York Heart Association (NYHA) Class II
- Left ventricular ejection fraction (LVEF) less than or equal to 30% by multigated
acquisition scan (MUGA)/catheterization OR LVEF less than or equal to 30% and LV end
diastolic dimension = 60 mm (by echocardiogram) within 6 months prior to randomization
- Intrinsic QRS complex width = 120 ms OR paced QRS measurement = 200 ms
- ICD indication for primary or secondary prevention
- Optimal heart failure pharmacological therapy
- Normal sinus rhythm; OR chronic persistent atrial tachyarrhythmia with resting
ventricular heart rate = 60 beats per minute (bpm) and 6 minute hall walk ventricular
heart rate of = 90 bpm; OR chronic persistent atrial tachyarrhythmia with resting
ventricular heart rate > 60 bpm and 6 minute hall walk ventricular heart rate of > 90
bpm and booked for atrioventricular junction ablation.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Intravenous inotropic agent in the last 4 days
- Patients with a life expectancy of less than one year from non-cardiac cause
- Expected to undergo cardiac transplantation within one year (status I)
- In hospital patients who have acute cardiac or non-cardiac illness that requires
intensive care
- Uncorrected or uncorrectable primary valvular disease
- Restrictive, hypertrophic, or reversible form of cardiomyopathy
- Severe primary pulmonary disease such as cor pulmonale
- Tricuspid prosthetic valve
- Patients with an existing ICD (patients with an existing pacemaker may be included if
the patients satisfy all other inclusion/exclusion criteria)
- Coronary revascularization (coronary artery bypass graft surgery [CABG] or
percutaneous coronary intervention [PCI]) < 1 month if previously determined LVEF >
30%. Patients with a more recent revascularization can be included if a previously
determined LVEF was = 30%.
- Patients with an acute coronary syndrome including myocardial infarction (MI) can be
included if the patients have had a previous MI with LV dysfunction (LVEF = 30%).
- Patients included in another clinical trial that will affect the objectives of this
study
- History of noncompliance to medical therapy
- Unable or unwilling to provide informed consent
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/04/2003
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/05/2011
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Sample size
Target
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Accrual to date
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Final
1798
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Royal Adelaide Hospital - Adelaide
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Recruitment hospital [2]
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Sir Charles Gairdner Hospital - Perth
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Recruitment postcode(s) [1]
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5000 - Adelaide
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Recruitment postcode(s) [2]
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6009 - Perth
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Recruitment outside Australia
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Belgium
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State/province [1]
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Leuven
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Canada
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Alberta
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Canada
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British Columbia
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Canada
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New Brunswick
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Canada
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Newfoundland and Labrador
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Country [6]
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Canada
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Nova Scotia
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Canada
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Ontario
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Canada
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Quebec
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Denmark
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Aarhus
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Germany
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Bad Berka
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Germany
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Frankfurt
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Germany
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Giessen
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Germany
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State/province [13]
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Ludwigshafen
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Germany
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State/province [14]
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Mainz
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Netherlands
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State/province [15]
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Zwolle
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Turkey
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State/province [16]
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Izmir
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Funding & Sponsors
Primary sponsor type
Other
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Name
Ottawa Heart Institute Research Corporation
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Address
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Other collaborator category [1]
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Other
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Name [1]
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Canadian Institutes of Health Research (CIHR)
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Address [1]
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Other collaborator category [2]
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Commercial sector/Industry
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Name [2]
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Medtronic
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Address [2]
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Ethics approval
Ethics application status
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Summary
Brief summary
Congestive heart failure (CHF) is a common health problem that leads to frequent
hospitalizations and an increased death rate. In spite of advances in drug therapy, it
remains a significant public health problem. Recently, a new therapy has been developed for
advanced heart failure patients with a ventricular conduction abnormality. This new therapy,
called cardiac resynchronization (CRT), is a device which stimulates the atrium, the right
ventricle, and the left ventricle providing synchronization of the contraction of the heart
chambers. It is the addition of this therapy to an implantable cardioverter defibrillator
(ICD) that will be evaluated in this study. This study will compare whether the implantation
of this new therapy device, in combination with an implantable cardioverter defibrillator,
will reduce total mortality and hospitalizations for CHF.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00251251
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Anthony Tang, MD
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Address
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Ottawa Heart Institute Research Corporation
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Phone
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Fax
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Email
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Contact person for public queries
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00251251
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