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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
NA
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
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.
Trial website
https://clinicaltrials.gov/study/NCT00251251
Trial related presentations / publications
Manlucu J, Sharma V, Koehler J, Warman EN, Wells GA, Gula LJ, Yee R, Tang AS. Incremental Value of Implantable Cardiac Device Diagnostic Variables Over Clinical Parameters to Predict Mortality in Patients With Mild to Moderate Heart Failure. J Am Heart Assoc. 2019 Jul 16;8(14):e010998. doi: 10.1161/JAHA.118.010998. Epub 2019 Jul 11.
Bennett MT, Leader N, Sapp J, Parkash R, Gardner M, Healey JS, Thibault B, Sterns L, Essebag V, Birnie D, Sivakumaran S, Nery P, Andrade JG, Krahn AD, Tang A. Differentiating Ventricular From Supraventricular Arrhythmias Using the Postpacing Interval After Failed Antitachycardia Pacing. Circ Arrhythm Electrophysiol. 2018 Apr;11(4):e005921. doi: 10.1161/CIRCEP.117.005921.
Linde C, Cleland JGF, Gold MR, Claude Daubert J, Tang ASL, Young JB, Sherfesee L, Abraham WT. The interaction of sex, height, and QRS duration on the effects of cardiac resynchronization therapy on morbidity and mortality: an individual-patient data meta-analysis. Eur J Heart Fail. 2018 Apr;20(4):780-791. doi: 10.1002/ejhf.1133. Epub 2018 Jan 4.
Sapp JL, Parkash R, Wells GA, Yetisir E, Gardner MJ, Healey JS, Thibault B, Sterns LD, Birnie D, Nery PB, Sivakumaran S, Essebag V, Dorian P, Tang AS. Cardiac Resynchronization Therapy Reduces Ventricular Arrhythmias in Primary but Not Secondary Prophylactic Implantable Cardioverter Defibrillator Patients: Insight From the Resynchronization in Ambulatory Heart Failure Trial. Circ Arrhythm Electrophysiol. 2017 Mar;10(3):e004875. doi: 10.1161/CIRCEP.116.004875.
Wilton SB, Exner DV, Wyse DG, Yetisir E, Wells G, Tang AS, Healey JS. Frequency and Outcomes of Postrandomization Atrial Tachyarrhythmias in the Resynchronization/Defibrillation in Ambulatory Heart Failure Trial. Circ Arrhythm Electrophysiol. 2016 May;9(5):e003807. doi: 10.1161/CIRCEP.115.003807.
Gillis AM, Kerr CR, Philippon F, Newton G, Talajic M, Froeschl M, Froeschl S, Swiggum E, Yetisir E, Wells GA, Tang AS. Impact of cardiac resynchronization therapy on hospitalizations in the Resynchronization-Defibrillation for Ambulatory Heart Failure trial. Circulation. 2014 May 20;129(20):2021-30. doi: 10.1161/CIRCULATIONAHA.112.000417. Epub 2014 Mar 7.
Birnie DH, Ha A, Higginson L, Sidhu K, Green M, Philippon F, Thibault B, Wells G, Tang A. Impact of QRS morphology and duration on outcomes after cardiac resynchronization therapy: Results from the Resynchronization-Defibrillation for Ambulatory Heart Failure Trial (RAFT). Circ Heart Fail. 2013 Nov;6(6):1190-8. doi: 10.1161/CIRCHEARTFAILURE.113.000380. Epub 2013 Aug 30.
Cleland JG, Abraham WT, Linde C, Gold MR, Young JB, Claude Daubert J, Sherfesee L, Wells GA, Tang AS. An individual patient meta-analysis of five randomized trials assessing the effects of cardiac resynchronization therapy on morbidity and mortality in patients with symptomatic heart failure. Eur Heart J. 2013 Dec;34(46):3547-56. doi: 10.1093/eurheartj/eht290. Epub 2013 Jul 29.
Healey JS, Hohnloser SH, Exner DV, Birnie DH, Parkash R, Connolly SJ, Krahn AD, Simpson CS, Thibault B, Basta M, Philippon F, Dorian P, Nair GM, Sivakumaran S, Yetisir E, Wells GA, Tang AS; RAFT Investigators. Cardiac resynchronization therapy in patients with permanent atrial fibrillation: results from the Resynchronization for Ambulatory Heart Failure Trial (RAFT). Circ Heart Fail. 2012 Sep 1;5(5):566-70. doi: 10.1161/CIRCHEARTFAILURE.112.968867. Epub 2012 Aug 14.
Healey JS, Gula LJ, Birnie DH, Sterns L, Connolly SJ, Sapp J, Crystal E, Simpson C, Exner DV, Kus T, Philippon F, Wells G, Tang AS. A randomized-controlled pilot study comparing ICD implantation with and without intraoperative defibrillation testing in patients with heart failure and severe left ventricular dysfunction: a substudy of the RAFT trial. J Cardiovasc Electrophysiol. 2012 Dec;23(12):1313-6. doi: 10.1111/j.1540-8167.2012.02393.x. Epub 2012 Jul 12.
Tang AS, Wells GA, Talajic M, Arnold MO, Sheldon R, Connolly S, Hohnloser SH, Nichol G, Birnie DH, Sapp JL, Yee R, Healey JS, Rouleau JL; Resynchronization-Defibrillation for Ambulatory Heart Failure Trial Investigators. Cardiac-resynchronization therapy for mild-to-moderate heart failure. N Engl J Med. 2010 Dec 16;363(25):2385-95. doi: 10.1056/NEJMoa1009540. Epub 2010 Nov 14.
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00251251