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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
Scientific title
Resynchronization/Defibrillation for Ambulatory Heart Failure Trial
Secondary ID [1] 0 0
FRN 63208
Secondary ID [2] 0 0
FRN 63208
Universal Trial Number (UTN)
Trial acronym
RAFT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Heart Failure, Congestive 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Primary outcome is a composite of all cause total mortality and hospitalization for CHF
Timepoint [1] 0 0
Study end
Secondary outcome [1] 0 0
Total mortality
Timepoint [1] 0 0
Study end
Secondary outcome [2] 0 0
Cardiovascular mortality
Timepoint [2] 0 0
Study end
Secondary outcome [3] 0 0
Sudden arrhythmic death
Timepoint [3] 0 0
Study end
Secondary outcome [4] 0 0
Progressive HF death
Timepoint [4] 0 0
Study end
Secondary outcome [5] 0 0
All cause hospitalization rate
Timepoint [5] 0 0
Study end
Secondary outcome [6] 0 0
CHF hospitalization rate
Timepoint [6] 0 0
Study end
Secondary outcome [7] 0 0
Health related quality of life
Timepoint [7] 0 0
Study end
Secondary outcome [8] 0 0
Cost economics
Timepoint [8] 0 0
Study end

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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
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
Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/04/2003
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/05/2011
Sample size
Target
Accrual to date
Final
1798
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [2] 0 0
Sir Charles Gairdner Hospital - Perth
Recruitment postcode(s) [1] 0 0
5000 - Adelaide
Recruitment postcode(s) [2] 0 0
6009 - Perth
Recruitment outside Australia
Country [1] 0 0
Belgium
State/province [1] 0 0
Leuven
Country [2] 0 0
Canada
State/province [2] 0 0
Alberta
Country [3] 0 0
Canada
State/province [3] 0 0
British Columbia
Country [4] 0 0
Canada
State/province [4] 0 0
New Brunswick
Country [5] 0 0
Canada
State/province [5] 0 0
Newfoundland and Labrador
Country [6] 0 0
Canada
State/province [6] 0 0
Nova Scotia
Country [7] 0 0
Canada
State/province [7] 0 0
Ontario
Country [8] 0 0
Canada
State/province [8] 0 0
Quebec
Country [9] 0 0
Denmark
State/province [9] 0 0
Aarhus
Country [10] 0 0
Germany
State/province [10] 0 0
Bad Berka
Country [11] 0 0
Germany
State/province [11] 0 0
Frankfurt
Country [12] 0 0
Germany
State/province [12] 0 0
Giessen
Country [13] 0 0
Germany
State/province [13] 0 0
Ludwigshafen
Country [14] 0 0
Germany
State/province [14] 0 0
Mainz
Country [15] 0 0
Netherlands
State/province [15] 0 0
Zwolle
Country [16] 0 0
Turkey
State/province [16] 0 0
Izmir

Funding & Sponsors
Primary sponsor type
Other
Name
Ottawa Heart Institute Research Corporation
Address
Country
Other collaborator category [1] 0 0
Government body
Name [1] 0 0
Canadian Institutes of Health Research (CIHR)
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Commercial sector/industry
Name [2] 0 0
Medtronic
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Anthony Tang, MD
Address 0 0
Ottawa Heart Institute Research Corporation
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT00251251