Resynchronization/Defibrillation for Ambulatory Heart Failure Trial
NCT ID: NCT00251251
Last Updated: 2023-08-28
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
1798 participants
Study Classification
INTERVENTIONAL
Study Start Date
2003-04-30
Study Completion Date
2011-05-31
Brief Summary
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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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Detailed Description
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Cardiovascular mortality is decreasing in most industrial countries, however mortality for congestive heart failure is increasing. The most important predictors of mortality in heart failure patients are depressed left ventricular function, severity of symptoms (NYHA class), and ventricular conduction abnormality manifested as wide QRS. Recent advances in pharmacological therapy including ACE inhibitors, beta-blocker and spironolactone have resulted in improvement of symptoms and reduction in mortality. Population epidemiological studies demonstrated that mortality and hospitalization rate for heart failure remains very high despite recent pharmacological therapeutic progress. Recent short-term clinical trials demonstrated that cardiac resynchronization therapy (CRT) is effective in improving symptoms of heart failure, functional capacity and quality of life in patients with moderate to severe heart failure and conduction abnormality optimally treated with drug therapy. However, the data for morbidity and mortality in mild to moderate heart failure is lacking.
The objective of this trial is to determine if the addition of CRT to optimal pharmacological therapy and ICD is effect in reducing mortality and morbidity in patients with poor LV function, wide QRS and mild to moderate heart failure symptoms.
This is a double-blinded randomized control trial. A total of 1800 patients with mild to moderate heart failure symptoms, LVEF ≤ 30%, and QRS ≥ 120 ms will be included in the study. Patients will be randomized to either "ICD plus Optimal Medical Therapy (control)" or "CRT/ICD plus Optimal Medical Therapy (experimental)" in a 1:1 randomization ratio. Patients in the control group will be implanted with a single or dual chamber ICD. Patients in the experimental group will receive a device with the capabilities of CRT and ICD. Optimal Medical Therapy will include ACE inhibitors and beta-blockers. Patients will be followed on a regular basis and will have clinical evaluation, quality of life assessment, and six minute walk tests performed. The primary outcome is a composite of total mortality and heart failure hospitalization. Secondary outcome measures will include total mortality, cardiovascular mortality, sudden arrhythmic death, health related quality of life and cost economics. Patient accruement is scheduled for 4.5 years and a minimum follow of 18 months.
DFT sub study:
Overview of sub-study Design Patients participating in the RAFT trial, at participating sites, will be randomized to have DFT testing or no testing at the time of device implant. Up to 450 patients will be eligible for enrollment at Canadian and European centres. The study will have two primary outcomes: a short-term safety outcome and a long-term efficacy outcome. The safety outcome will be a composite of all adverse events potentially related to DFT that occur within 30 days following ICD implant. The long-term efficacy outcome will be a composite of failed first appropriate clinical ICD shock and sudden death. This pilot study is intended primarily to confirm the anticipated rates of events and to demonstrate feasibility of enrollment, but will not have statistical power to determine if intra-operative DFT testing is associated with significant short-term risk. If complication rates are as high as predicted and enrollment is feasible, then a larger study would be justified to determine the impact of intra-operative DFT testing on long-term rates of failed appropriated ICD shocks and sudden death. Events rates determined in this pilot study would then be used to estimate the sample size of this larger study.
Sub-study Long-Term Outcomes of the Resynchronization-Defibrillation for Ambulatory Heart Failure Trial (RAFT)
Coordinating Investigator:
John L. Sapp, Jr., MD, FRCPC
Funder:
John Sapp, QEII Div. of Cardiology, Halifax, NS
Coordinating Center:
QEII Heart Rhythm Research, Halifax, NS
The Resynchronization-Defibrillation for Ambulatory Heart Failure Trial (RAFT) was a multicenter, double-blind, randomized, controlled trial that aimed to determine whether the addition of CRT to an ICD, along with optimal medical therapy would reduce mortality and the rate of hospitalizations for HF, as compared to an ICD and optimal medical therapy alone. However, despite the established benefits of CRT among patients with mild to moderate HF, long term data is still lacking. We propose to determine the sustained, long-term outcomes of CRT among this high-risk patient population. A total of 8 sites enrolled more than 100 patients. Those 8 sites will ascertain long-term rates of survival, heart transplant and implantation of ventricular assist devices in a total of 1050 patients. The primary outcome will be all cause mortality. A secondary outcome will be the composite of mortality, implantation of ventricular assist device, and transplant. The 8 sites include UOHI, LHSC, QEII, Libin CV Calgary, HHSC, MHI, VCAT and Mazankowski Alberta Heart Institute.
The primary outcome is mortality (all cause). The primary analysis will compare the CRT-D and ICD groups for time to mortality. The survival experience (time-to-event) in each of the two groups will be analyzed using Kaplan-Meier product limit estimates and the nonparametric log-rank test. The hazard ratio (HR) and associated 95% CI will be calculated. In addition, the Cox proportional hazards model will be used to assess the consistency of the therapy group effect on this outcome taking the randomization stratification factors (clinical center, atrial rhythm (atrial fibrillation or flutter or sinus-atrial pacing), and a planned implantation of a single- or dual-chamber ICD)); as well, the Cox proportional hazards model analysis will be conducted as a sensitivity analysis to assess the therapy group effect on mortality while accounting for important baseline characteristics (any variable with a p value of less than 0.10 at baseline). Underlying assumptions for these statistical procedures will be assessed; in particular, the proportional hazard's assumption will be assessed using graphical (i.e., visual inspection of the log-negative-log plot) and numerical tests (i.e., test of the interaction term group x time). Should this assumption fail, a stratified Cox model will be fitted in order to correct for non-proportional hazards or, if ineffective, time-dependent variables will be introduced. In addition, chi-square tests will be used to compare the Kaplan-Meier (actuarial) rate of event-free survival at 10 years. The ITT population will be used.
The secondary outcome is the composite outcome of ventricular assist device implant (LVAD) or heart transplant or mortality (all cause). The primary analysis will compare the CRT-d and ICD groups for this composite outcome. For this analysis, the time-to-event analysis for Study Questions 1 will be followed. In addition, chi-square tests will be used to compare the Kaplan-Meier (actuarial) rate of event-free survival at 10 years. Also, the event rates for the composite outcome will be calculated for each therapy group and the relative risk (RR) and 95% CI calculated.
Secondary analysis - As a sensitivity analysis, the analysis for the primary and secondary questions 1 and will be repeated for the PP population.
Subgroup analysis - Subgroup analyses based on patient characteristics will be undertaken, primarily for sensitivity analyses to assess the robustness of the results, as well as for exploratory purposes for hypothesis generation. In particular, planned subgroups include: age (\<65, ≥65), sex (male, female), NYHA Class (I, II), ischemic heart disease (\<150, ≥150) paced QRS, LV ejection fraction, atrial rhythm (permanent Afib/flutter, sinus or atrial paced). The interaction of the therapy and subgroup will be included in the models.
The objective of this trial is to determine if the addition of CRT to optimal pharmacological therapy and ICD is effect in reducing mortality and morbidity in patients with poor LV function, wide QRS and mild to moderate heart failure symptoms.
This is a double-blinded randomized control trial. A total of 1800 patients with mild to moderate heart failure symptoms, LVEF ≤ 30%, and QRS ≥ 120 ms will be included in the study. Patients will be randomized to either "ICD plus Optimal Medical Therapy (control)" or "CRT/ICD plus Optimal Medical Therapy (experimental)" in a 1:1 randomization ratio. Patients in the control group will be implanted with a single or dual chamber ICD. Patients in the experimental group will receive a device with the capabilities of CRT and ICD. Optimal Medical Therapy will include ACE inhibitors and beta-blockers. Patients will be followed on a regular basis and will have clinical evaluation, quality of life assessment, and six minute walk tests performed. The primary outcome is a composite of total mortality and heart failure hospitalization. Secondary outcome measures will include total mortality, cardiovascular mortality, sudden arrhythmic death, health related quality of life and cost economics. Patient accruement is scheduled for 4.5 years and a minimum follow of 18 months.
DFT sub study:
Overview of sub-study Design Patients participating in the RAFT trial, at participating sites, will be randomized to have DFT testing or no testing at the time of device implant. Up to 450 patients will be eligible for enrollment at Canadian and European centres. The study will have two primary outcomes: a short-term safety outcome and a long-term efficacy outcome. The safety outcome will be a composite of all adverse events potentially related to DFT that occur within 30 days following ICD implant. The long-term efficacy outcome will be a composite of failed first appropriate clinical ICD shock and sudden death. This pilot study is intended primarily to confirm the anticipated rates of events and to demonstrate feasibility of enrollment, but will not have statistical power to determine if intra-operative DFT testing is associated with significant short-term risk. If complication rates are as high as predicted and enrollment is feasible, then a larger study would be justified to determine the impact of intra-operative DFT testing on long-term rates of failed appropriated ICD shocks and sudden death. Events rates determined in this pilot study would then be used to estimate the sample size of this larger study.
Sub-study Long-Term Outcomes of the Resynchronization-Defibrillation for Ambulatory Heart Failure Trial (RAFT)
Coordinating Investigator:
John L. Sapp, Jr., MD, FRCPC
Funder:
John Sapp, QEII Div. of Cardiology, Halifax, NS
Coordinating Center:
QEII Heart Rhythm Research, Halifax, NS
The Resynchronization-Defibrillation for Ambulatory Heart Failure Trial (RAFT) was a multicenter, double-blind, randomized, controlled trial that aimed to determine whether the addition of CRT to an ICD, along with optimal medical therapy would reduce mortality and the rate of hospitalizations for HF, as compared to an ICD and optimal medical therapy alone. However, despite the established benefits of CRT among patients with mild to moderate HF, long term data is still lacking. We propose to determine the sustained, long-term outcomes of CRT among this high-risk patient population. A total of 8 sites enrolled more than 100 patients. Those 8 sites will ascertain long-term rates of survival, heart transplant and implantation of ventricular assist devices in a total of 1050 patients. The primary outcome will be all cause mortality. A secondary outcome will be the composite of mortality, implantation of ventricular assist device, and transplant. The 8 sites include UOHI, LHSC, QEII, Libin CV Calgary, HHSC, MHI, VCAT and Mazankowski Alberta Heart Institute.
The primary outcome is mortality (all cause). The primary analysis will compare the CRT-D and ICD groups for time to mortality. The survival experience (time-to-event) in each of the two groups will be analyzed using Kaplan-Meier product limit estimates and the nonparametric log-rank test. The hazard ratio (HR) and associated 95% CI will be calculated. In addition, the Cox proportional hazards model will be used to assess the consistency of the therapy group effect on this outcome taking the randomization stratification factors (clinical center, atrial rhythm (atrial fibrillation or flutter or sinus-atrial pacing), and a planned implantation of a single- or dual-chamber ICD)); as well, the Cox proportional hazards model analysis will be conducted as a sensitivity analysis to assess the therapy group effect on mortality while accounting for important baseline characteristics (any variable with a p value of less than 0.10 at baseline). Underlying assumptions for these statistical procedures will be assessed; in particular, the proportional hazard's assumption will be assessed using graphical (i.e., visual inspection of the log-negative-log plot) and numerical tests (i.e., test of the interaction term group x time). Should this assumption fail, a stratified Cox model will be fitted in order to correct for non-proportional hazards or, if ineffective, time-dependent variables will be introduced. In addition, chi-square tests will be used to compare the Kaplan-Meier (actuarial) rate of event-free survival at 10 years. The ITT population will be used.
The secondary outcome is the composite outcome of ventricular assist device implant (LVAD) or heart transplant or mortality (all cause). The primary analysis will compare the CRT-d and ICD groups for this composite outcome. For this analysis, the time-to-event analysis for Study Questions 1 will be followed. In addition, chi-square tests will be used to compare the Kaplan-Meier (actuarial) rate of event-free survival at 10 years. Also, the event rates for the composite outcome will be calculated for each therapy group and the relative risk (RR) and 95% CI calculated.
Secondary analysis - As a sensitivity analysis, the analysis for the primary and secondary questions 1 and will be repeated for the PP population.
Subgroup analysis - Subgroup analyses based on patient characteristics will be undertaken, primarily for sensitivity analyses to assess the robustness of the results, as well as for exploratory purposes for hypothesis generation. In particular, planned subgroups include: age (\<65, ≥65), sex (male, female), NYHA Class (I, II), ischemic heart disease (\<150, ≥150) paced QRS, LV ejection fraction, atrial rhythm (permanent Afib/flutter, sinus or atrial paced). The interaction of the therapy and subgroup will be included in the models.
Conditions
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Heart Failure, Congestive
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
QUADRUPLE
Participants
Caregivers
Investigators
Outcome Assessors
Study Groups
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1. Optimal Medical therapy plus ICD
Group Type
ACTIVE_COMPARATOR
Optimal Medical Therapy plus ICD
Intervention Type
DEVICE
ICD vs CRT/ICD
2. Optimal Medical Therapy plus CRT/ICD
Group Type
ACTIVE_COMPARATOR
Optimal Medical Therapy plus CRT/ICD
Intervention Type
DEVICE
ICD vs CRT/ICD
Interventions
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Optimal Medical Therapy plus ICD
ICD vs CRT/ICD
Intervention Type
DEVICE
Optimal Medical Therapy plus CRT/ICD
ICD vs CRT/ICD
Intervention Type
DEVICE
Eligibility Criteria
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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.
* 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.
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
* 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
* 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
* 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
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Canadian Institutes of Health Research (CIHR)
OTHER_GOV
Sponsor Role
collaborator
Medtronic
INDUSTRY
Sponsor Role
collaborator
Ottawa Heart Institute Research Corporation
OTHER
Sponsor Role
lead
Responsible Party
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Anthony Tang
Principal Investigator
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Anthony Tang, MD
Role: PRINCIPAL_INVESTIGATOR
Ottawa Heart Institute Research Corporation
George Wells, PhD
Role: PRINCIPAL_INVESTIGATOR
Ottawa Heart Institute Research Corporation
Locations
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Royal Adelaide Hospital
Adelaide, , Australia
Site Status
Sir Charles Gairdner Hospital
Perth, , Australia
Site Status
University Ziekenhuis
Leuven, , Belgium
Site Status
University of Calgary/Foothill Hospital
Calgary, Alberta, Canada
Site Status
Alberta Heart Institute
Edmonton, Alberta, Canada
Site Status
St. Paul's Hospital
Vancouver, British Columbia, Canada
Site Status
Victoria Cardiac Arrhythmia Trials
Victoria, British Columbia, Canada
Site Status
NB Heart Centre Research Initiative
Saint John, New Brunswick, Canada
Site Status
Memorial Hospital
St. John's, Newfoundland and Labrador, Canada
Site Status
Queen Elizabeth II
Halifax, Nova Scotia, Canada
Site Status
Hamilton Health Sciences Centre
Hamilton, Ontario, Canada
Site Status
Kingston General Hospital
Kingston, Ontario, Canada
Site Status
St. Mary's Hospital
Kitchener, Ontario, Canada
Site Status
London Health Sciences Centre
London, Ontario, Canada
Site Status
Southlake Regional Health Care
Newmarket, Ontario, Canada
Site Status
University of Ottawa Heart Institute
Ottawa, Ontario, Canada
Site Status
Sunnybrook Hospital
Toronto, Ontario, Canada
Site Status
St. Michael's Hospital
Toronto, Ontario, Canada
Site Status
UHN Toronto General
Toronto, Ontario, Canada
Site Status
Montreal Heart Institute
Montreal, Quebec, Canada
Site Status
CHUM Hopital Notre Dame
Montreal, Quebec, Canada
Site Status
McGill University Health Centre
Montreal, Quebec, Canada
Site Status
Hopital du Sacre Coeur de Montreal
Montreal, Quebec, Canada
Site Status
Laval Hospital
Québec, Quebec, Canada
Site Status
CHUS Centre Hospitalier Universitaire de Sherbrooke
Sherbrooke, Quebec, Canada
Site Status
Skejby University Hospital
Aarhus, , Denmark
Site Status
Zentralklinik
Bad Berka, , Germany
Site Status
J.W. Goethe University
Frankfurt, , Germany
Site Status
University of Giessen
Giessen, , Germany
Site Status
Ludwigshafen
Ludwigshafen, , Germany
Site Status
University of Mainz
Mainz, , Germany
Site Status
Isala Klinieken
Zwolle, , Netherlands
Site Status
Ege University
Izmir, , Turkey (Türkiye)
Site Status
Countries
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Australia
Belgium
Canada
Denmark
Germany
Netherlands
Turkey (Türkiye)
References
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Sapp JL, Sivakumaran S, Redpath CJ, Khan H, Parkash R, Exner DV, Healey JS, Thibault B, Sterns LD, Lam NHN, Manlucu J, Mokhtar A, Sumner G, McKinlay S, Kimber S, Mondesert B, Talajic M, Rouleau J, McCarron CE, Wells G, Tang ASL; RAFT Long-Term Study Team. Long-Term Outcomes of Resynchronization-Defibrillation for Heart Failure. N Engl J Med. 2024 Jan 18;390(3):212-220. doi: 10.1056/NEJMoa2304542.
Reference Type
DERIVED
Fudim M, Dalgaard F, Friedman DJ, Abraham WT, Cleland JGF, Curtis AB, Gold MR, Kutyifa V, Linde C, Ali-Ahmed F, Tang A, Olivas-Martinez A, Inoue LYT, Al-Khatib SM, Sanders GD. Comorbidities and clinical response to cardiac resynchronization therapy: Patient-level meta-analysis from eight clinical trials. Eur J Heart Fail. 2024 Apr;26(4):1039-1046. doi: 10.1002/ejhf.3029. Epub 2023 Sep 15.
Reference Type
DERIVED
Friedman DJ, Al-Khatib SM, Dalgaard F, Fudim M, Abraham WT, Cleland JGF, Curtis AB, Gold MR, Kutyifa V, Linde C, Tang AS, Ali-Ahmed F, Olivas-Martinez A, Inoue LYT, Sanders GD. Cardiac Resynchronization Therapy Improves Outcomes in Patients With Intraventricular Conduction Delay But Not Right Bundle Branch Block: A Patient-Level Meta-Analysis of Randomized Controlled Trials. Circulation. 2023 Mar 7;147(10):812-823. doi: 10.1161/CIRCULATIONAHA.122.062124. Epub 2023 Jan 26.
Reference Type
DERIVED
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.
Reference Type
DERIVED
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.
Reference Type
DERIVED
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.
Reference Type
DERIVED
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.
Reference Type
DERIVED
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.
Reference Type
DERIVED
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.
Reference Type
DERIVED
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.
Reference Type
DERIVED
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.
Reference Type
DERIVED
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.
Reference Type
DERIVED
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.
Reference Type
DERIVED
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.
Reference Type
DERIVED
Other Identifiers
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FRN 63208
Identifier Type: -
Identifier Source: secondary_id
FRN 63208
Identifier Type: -
Identifier Source: org_study_id
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NA
Comparison of Medical Therapy, Pacing and Defibrillation in Heart Failure
NCT00180258
COMPLETED
PHASE2/PHASE3
Adaptive Cardiac Resynchronization Therapy Study
NCT00980057
COMPLETED
NA
Pacing for Heart Failure With Preserved Ejection Fraction
NCT01045291
COMPLETED
NA
Dual-Site LV Pacing in CRT Non Responders: Multicenter Randomized Trial
NCT01059175
COMPLETED
NA
Predicting Response to Cardiac Resynchronization Therapy in Heart Failure
NCT00359372
COMPLETED
REsynchronization reVErses Remodeling in Systolic Left vEntricular Dysfunction (REVERSE)
NCT00271154
COMPLETED
NA
Assessment of Ventricular Arrhythmia Risk After CRT-D Replacement for Patients With Primary Prevention Indication
NCT02323503
COMPLETED
Optimal Cardiac Resynchronization Therapy Pacing Rate
NCT02258061
COMPLETED
EARLY_PHASE1
PARTNERS HF: Program to Access and Review Trending Information and Evaluate Correlation to Symptoms in Patients With Heart Failure
NCT00279955
COMPLETED
Home Monitoring in Cardiac Resynchronisation Therapy
NCT00376116
COMPLETED
Stimulus Intensity in Left Ventricular Leads
NCT01060449
COMPLETED
NA
REsynchronization Comparison In LBBB and Normal or Mildly Reduced VENTricular Function With CRT (REINVENT-CRT)
NCT05652218
ACTIVE_NOT_RECRUITING
NA
Safety and Efficacy of Automatic Testing Feature in New ICDs and CRT-Ds
NCT00746356
COMPLETED
NA
Optimal Programming to Improve Mechanical Indices, Symptoms and Exercise in Cardiac Resynchronization Therapy.
NCT00489177
COMPLETED
PHASE4
Safety and Effectiveness of Cardiac Resynchronization Therapy With Defibrillation
NCT00387803
COMPLETED
PHASE2/PHASE3
Cutaneous Heart Sounds Data Collection During Cardiac Resynchronization Therapy (CRT) Optimization Study
NCT01609985
COMPLETED
CARE-HF Long Term Follow-up
NCT00318357
COMPLETED