MADIT-CRT: Multicenter Automatic Defibrillator Implantation With Cardiac Resynchronization Therapy
NCT ID: NCT00180271
Last Updated: 2018-12-19
Study Results
Results available
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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Recruitment Status
COMPLETED
Clinical Phase
NA
Total Enrollment
1820 participants
Study Classification
INTERVENTIONAL
Study Start Date
2004-12-31
Study Completion Date
2010-09-30
Brief Summary
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The MADIT-CRT trial is designed to determine if combined implantable cardiac defibrillator (ICD)-cardiac resynchronization therapy (CRT-D) will reduce the risk of mortality and heart failure (HF) events by approximately 25%, in subjects who are in New York Heart Association (NYHA) functional Class II with non-ischemic or ischemic cardiomyopathy and subjects who are in NYHA functional Class I with ischemic cardiomyopathy, left ventricular dysfunction (ejection fraction \[EF\] \< or = 0.30), and prolonged intraventricular conduction (QRS duration \> or = 130 ms).
Detailed Description
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In this study, subjects will be randomized to CRT-D or ICD-only. Randomization will be stratified by clinical center and ischemic status. Approximately 60% of the subjects will be randomly assigned to receive a CRT-D with biventricular pacing, and 40% will receive an ICD only. Optimal pharmacological therapy for heart failure will be required in both treatment arms. Length of follow-up for each subject will depend on the date of entry into the study, since all subjects will be followed to a common study termination date.
Conditions
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Tachycardia
Congestive Heart Failure
Keywords
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Defibrillator
Cardiac Resynchronization Therapy
MADIT
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
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CRT-D
CRT-D: Cardiac resynchronization therapy with defibrillation.
Group Type
EXPERIMENTAL
Cardiac resynchronization therapy with defibrillation
Intervention Type
DEVICE
Boston Scientific Corporation Market Released Cardiac Resynchronization therapy with defibrillation
ICD
ICD: Implantable cardioverter defibrillator
Group Type
ACTIVE_COMPARATOR
Implantable Cardioverter Defibrillator (ICD)
Intervention Type
DEVICE
Boston Scientific Corporation Market Released Implantable Cardioverter Defibrillator
Interventions
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Cardiac resynchronization therapy with defibrillation
Boston Scientific Corporation Market Released Cardiac Resynchronization therapy with defibrillation
Intervention Type
DEVICE
Implantable Cardioverter Defibrillator (ICD)
Boston Scientific Corporation Market Released Implantable Cardioverter Defibrillator
Intervention Type
DEVICE
Eligibility Criteria
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Inclusion Criteria
* Ischemic heart disease defined as:
* NYHA Class I or II for the past 3 calendar months prior to, and at the time of, enrollment;
* one or more clinically documented (Q wave or enzyme positive) prior myocardial infarctions, but not within 3 calendar months of enrollment; and/or
* one or more prior coronary artery bypass graft surgeries or percutaneous coronary interventions (balloon and/or stent angioplasty) but not within 3 calendar months of enrollment.
OR
* Non-ischemic heart disease including dilated cardiomyopathy characterized by a low ejection fraction and increased ventricular volume, with ventricular compliance that is normal or increased
* NYHA Class II for the past 3 calendar months prior to, and at the time of, enrollment
AND all of the following:
* Stable optimal pharmacologic therapy.
* An ejection fraction \< or = 0.30 by angiographic, radionuclide, or echocardiographic methods within one year prior to enrollment and measured during the enrollment echocardiogram obtained within 14 days prior to randomization to confirm eligibility (recommended)
* Resting QRS duration \> or = 130 ms on print-out of a current electrocardiogram (ECG) obtained within 14 days prior to randomization.
* Sinus rhythm by ECG (including right bundle branch block \[RBBB\] and first degree heart block with PR \< 250 ms.)
* Men and women 21 years of age or older (no upper-age cut off)
* NYHA Class I or II for the past 3 calendar months prior to, and at the time of, enrollment;
* one or more clinically documented (Q wave or enzyme positive) prior myocardial infarctions, but not within 3 calendar months of enrollment; and/or
* one or more prior coronary artery bypass graft surgeries or percutaneous coronary interventions (balloon and/or stent angioplasty) but not within 3 calendar months of enrollment.
OR
* Non-ischemic heart disease including dilated cardiomyopathy characterized by a low ejection fraction and increased ventricular volume, with ventricular compliance that is normal or increased
* NYHA Class II for the past 3 calendar months prior to, and at the time of, enrollment
AND all of the following:
* Stable optimal pharmacologic therapy.
* An ejection fraction \< or = 0.30 by angiographic, radionuclide, or echocardiographic methods within one year prior to enrollment and measured during the enrollment echocardiogram obtained within 14 days prior to randomization to confirm eligibility (recommended)
* Resting QRS duration \> or = 130 ms on print-out of a current electrocardiogram (ECG) obtained within 14 days prior to randomization.
* Sinus rhythm by ECG (including right bundle branch block \[RBBB\] and first degree heart block with PR \< 250 ms.)
* Men and women 21 years of age or older (no upper-age cut off)
Exclusion Criteria
* Existing indication for CRT
* Subjects with an implanted pacemaker
* Subjects with an existing ICD or CRT device
* Subjects in NYHA Class I with non-ischemic cardiomyopathy
* Subjects in NYHA Class III or IV in the past 3 calendar months prior to, or at the time of, enrollment
* Coronary artery bypass graft surgery or percutaneous coronary intervention (balloon and/or stent angioplasty) within the past 3 calendar months prior to enrollment
* Enzyme-positive myocardial infarction within the past 3 calendar months prior to enrollment
* Subjects with angiographic evidence of coronary disease who are candidates for coronary revascularization and are likely to undergo coronary artery bypass graft surgery or percutaneous coronary intervention in the foreseeable future
* Subjects with second or third degree heart block
* Subjects with irreversible brain damage from preexisting cerebral disease
* Women who are pregnant or plan to become pregnant during the course of the trial. Women of childbearing potential must have a negative pregnancy test within 7 days prior to enrollment.
* Reversible non-ischemic cardiomyopathy such as acute viral myocarditis or discontinuation of alcohol in alcohol-induced heart disease
* Subjects with chronic atrial fibrillation within one month prior to enrollment
* Presence of any disease, other than the subject's cardiac disease, associated with a reduced likelihood of survival for the duration of the trial, e.g., cancer, uremia (blood urea nitrogen \[BUN\] \> 70 mg/dl or creatinine \> 3.0 mg/dl), liver failure, etc.
* Subjects participating in any other clinical trials
* Subjects unwilling or unable to cooperate with the protocol
* Subjects who live at such a distance from the clinic that travel for follow-up visits would be unusually difficult
* Subjects who do not anticipate being residents of the area for the scheduled duration of the trial
* Subjects unwilling to sign the consent for participation
* Subjects with an implanted pacemaker
* Subjects with an existing ICD or CRT device
* Subjects in NYHA Class I with non-ischemic cardiomyopathy
* Subjects in NYHA Class III or IV in the past 3 calendar months prior to, or at the time of, enrollment
* Coronary artery bypass graft surgery or percutaneous coronary intervention (balloon and/or stent angioplasty) within the past 3 calendar months prior to enrollment
* Enzyme-positive myocardial infarction within the past 3 calendar months prior to enrollment
* Subjects with angiographic evidence of coronary disease who are candidates for coronary revascularization and are likely to undergo coronary artery bypass graft surgery or percutaneous coronary intervention in the foreseeable future
* Subjects with second or third degree heart block
* Subjects with irreversible brain damage from preexisting cerebral disease
* Women who are pregnant or plan to become pregnant during the course of the trial. Women of childbearing potential must have a negative pregnancy test within 7 days prior to enrollment.
* Reversible non-ischemic cardiomyopathy such as acute viral myocarditis or discontinuation of alcohol in alcohol-induced heart disease
* Subjects with chronic atrial fibrillation within one month prior to enrollment
* Presence of any disease, other than the subject's cardiac disease, associated with a reduced likelihood of survival for the duration of the trial, e.g., cancer, uremia (blood urea nitrogen \[BUN\] \> 70 mg/dl or creatinine \> 3.0 mg/dl), liver failure, etc.
* Subjects participating in any other clinical trials
* Subjects unwilling or unable to cooperate with the protocol
* Subjects who live at such a distance from the clinic that travel for follow-up visits would be unusually difficult
* Subjects who do not anticipate being residents of the area for the scheduled duration of the trial
* Subjects unwilling to sign the consent for participation
Minimum Eligible Age
21 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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University of Rochester
OTHER
Sponsor Role
collaborator
Boston Scientific Corporation
INDUSTRY
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Arthur J Moss, MD
Role: PRINCIPAL_INVESTIGATOR
University of Rochester, NY
Locations
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Multiple locations in the US and international
Rochester, New York, United States
Site Status
Countries
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United States
References
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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
Goldenberg I, Younis A, Aktas MK, McNitt S, Zareba W, Kutyifa V. Competing risk analysis of ventricular arrhythmia events in heart failure patients with moderately compromised renal dysfunction. Europace. 2020 Sep 1;22(9):1384-1390. doi: 10.1093/europace/euaa146.
Reference Type
DERIVED
Younis A, Goldenberg M, Kutyifa V, Polonsky B, Mcnitt S, Zareba W, Golovchiner G, Aktas MK, Barsheshet A. Applicability of the MADIT-CRT Response Score for Prediction of Long-Term Clinical and Arrhythmic Events by QRS Morphology. Circ Arrhythm Electrophysiol. 2020 Sep;13(9):e008499. doi: 10.1161/CIRCEP.120.008499. Epub 2020 Jul 23. No abstract available.
Reference Type
DERIVED
Vidula H, Lee E, McNitt S, Polonsky B, Aktas M, Rosero S, Younis A, Solomon SD, Zareba W, Kutyifa V, Goldenberg I. Cardiac Resynchronization Therapy and Risk of Recurrent Hospitalizations in Patients Without Left Bundle Branch Block: The Long-Term Multicenter Automatic Defibrillator Implantation Trial With Cardiac Resynchronization Therapy. Circ Heart Fail. 2020 Jul;13(7):e006925. doi: 10.1161/CIRCHEARTFAILURE.120.006925. Epub 2020 Jul 1.
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DERIVED
Biton Y, Daimee UA, Baman JR, Kutyifa V, McNitt S, Polonsky B, Zareba W, Goldenberg I. Prognostic Importance of Defibrillator-Appropriate Shocks and Antitachycardia Pacing in Patients With Mild Heart Failure. J Am Heart Assoc. 2019 Mar 19;8(6):e010346. doi: 10.1161/JAHA.118.010346.
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DERIVED
Kutyifa V, Vermilye K, Solomon SD, McNitt S, Moss AJ, Daimee UA. Long-term outcomes of cardiac resynchronization therapy by left ventricular ejection fraction. Eur J Heart Fail. 2019 Mar;21(3):360-369. doi: 10.1002/ejhf.1357. Epub 2018 Dec 28.
Reference Type
DERIVED
Baturova MA, Kutyifa V, McNitt S, Polonsky B, Solomon S, Carlson J, Zareba W, Platonov PG. Usefulness of Electrocardiographic Left Atrial Abnormality to Predict Response to Cardiac Resynchronization Therapy in Patients With Mild Heart Failure and Left Bundle Branch Block (a Multicenter Automatic Defibrillator Implantation Trial with Cardiac Resynchronization Therapy Substudy). Am J Cardiol. 2018 Jul 15;122(2):268-274. doi: 10.1016/j.amjcard.2018.03.364. Epub 2018 Apr 11.
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DERIVED
Ozlu MF, Barsheshet A, Moss AJ, Goldenberg I, Kutyifa V, Biton Y, McNitt S, Zareba W, Aktas MK. Time Dependence of Ventricular Tachyarrhythmias After Myocardial Infarction: A MADIT-CRT Substudy. JACC Clin Electrophysiol. 2016 Oct;2(5):565-573. doi: 10.1016/j.jacep.2016.04.010. Epub 2016 Jun 22.
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DERIVED
Jame S, Kutyifa V, Polonsky B, McNitt S, Al-Ahmad A, Moss AJ, Zareba W, Wang PJ. Predictive value of device-derived activity level for short-term outcomes in MADIT-CRT. Heart Rhythm. 2017 Jul;14(7):1081-1086. doi: 10.1016/j.hrthm.2017.03.032. Epub 2017 Mar 25.
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DERIVED
Biering-Sorensen T, Knappe D, Pouleur AC, Claggett B, Wang PJ, Moss AJ, Solomon SD, Kutyifa V. Regional Longitudinal Deformation Improves Prediction of Ventricular Tachyarrhythmias in Patients With Heart Failure With Reduced Ejection Fraction: A MADIT-CRT Substudy (Multicenter Automatic Defibrillator Implantation Trial-Cardiac Resynchronization Therapy). Circ Cardiovasc Imaging. 2017 Jan;10(1):e005096. doi: 10.1161/CIRCIMAGING.116.005096.
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DERIVED
Mathias A, Moss AJ, McNitt S, Zareba W, Goldenberg I, Solomon SD, Kutyifa V. Clinical Implications of Complete Left-Sided Reverse Remodeling With Cardiac Resynchronization Therapy: A MADIT-CRT Substudy. J Am Coll Cardiol. 2016 Sep 20;68(12):1268-76. doi: 10.1016/j.jacc.2016.06.051.
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DERIVED
Jame S, Kutyifa V, Aktas MK, McNitt S, Polonsky B, Al-Ahmad A, Zareba W, Moss A, Wang PJ. Bipolar left ventricular pacing is associated with significant reduction in heart failure or death in CRT-D patients with LBBB. Heart Rhythm. 2016 Jul;13(7):1468-74. doi: 10.1016/j.hrthm.2016.03.009. Epub 2016 Mar 4.
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DERIVED
Biton Y, Kutyifa V, Cygankiewicz I, Goldenberg I, Klein H, McNitt S, Polonsky B, Ruwald AC, Ruwald MH, Moss AJ, Zareba W. Relation of QRS Duration to Clinical Benefit of Cardiac Resynchronization Therapy in Mild Heart Failure Patients Without Left Bundle Branch Block: The Multicenter Automatic Defibrillator Implantation Trial with Cardiac Resynchronization Therapy Substudy. Circ Heart Fail. 2016 Feb;9(2):e002667. doi: 10.1161/CIRCHEARTFAILURE.115.002667.
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DERIVED
Biton Y, Goldenberg I, Kutyifa V, Baman JR, Solomon S, Moss AJ, Szepietowska B, McNitt S, Polonsky B, Zareba W, Barsheshet A. Relative Wall Thickness and the Risk for Ventricular Tachyarrhythmias in Patients With Left Ventricular Dysfunction. J Am Coll Cardiol. 2016 Jan 26;67(3):303-12. doi: 10.1016/j.jacc.2015.10.076.
Reference Type
DERIVED
Medina A, Moss AJ, McNitt S, Zareba W, Wang PJ, Goldenberg I. Brain natriuretic peptide and the risk of ventricular tachyarrhythmias in mildly symptomatic heart failure patients enrolled in MADIT-CRT. Heart Rhythm. 2016 Apr;13(4):852-9. doi: 10.1016/j.hrthm.2015.12.024. Epub 2015 Dec 25.
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DERIVED
Biton Y, Goldenberg I, Kutyifa V, Zareba W, Szepietowska B, Mcnitt S, Polonsky B, Barsheshet A, Moss AJ. Effects of Statins on First and Recurrent Supraventricular Arrhythmias in Patients With Mild Heart Failure (from the Multicenter Automatic Defibrillator Implantation Trial With Cardiac Resynchronization Therapy). Am J Cardiol. 2015 Dec 15;116(12):1869-74. doi: 10.1016/j.amjcard.2015.09.027. Epub 2015 Oct 8.
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DERIVED
Biton Y, Kutyifa V, Zareba W, Klein HU, Solomon SD, McNitt S, Polonsky B, Moss AJ, Goldenberg I. Long-term outcome with cardiac resynchronization therapy in mild heart failure patients with left bundle branch block from US and Europe MADIT-CRT. Heart Fail Rev. 2015 Sep;20(5):535-43. doi: 10.1007/s10741-015-9499-2.
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DERIVED
Biton Y, Moss AJ, Kutyifa V, Mathias A, Sherazi S, Zareba W, McNitt S, Polonsky B, Barsheshet A, Brown MW, Goldenberg I. Inverse Relationship of Blood Pressure to Long-Term Outcomes and Benefit of Cardiac Resynchronization Therapy in Patients With Mild Heart Failure: A Multicenter Automatic Defibrillator Implantation Trial With Cardiac Resynchronization Therapy Long-Term Follow-Up Substudy. Circ Heart Fail. 2015 Sep;8(5):921-6. doi: 10.1161/CIRCHEARTFAILURE.115.002208. Epub 2015 Jul 15.
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DERIVED
Kutyifa V, Moss AJ, Solomon SD, McNitt S, Aktas MK, Barsheshet A, Merkely B, Zareba W, Goldenberg I. Reduced risk of life-threatening ventricular tachyarrhythmias with cardiac resynchronization therapy: relationship to left ventricular ejection fraction. Eur J Heart Fail. 2015 Sep;17(9):971-8. doi: 10.1002/ejhf.311. Epub 2015 Jul 14.
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DERIVED
Biton Y, Zareba W, Goldenberg I, Klein H, McNitt S, Polonsky B, Moss AJ, Kutyifa V; MADIT-CRT Executive Committee. Sex Differences in Long-Term Outcomes With Cardiac Resynchronization Therapy in Mild Heart Failure Patients With Left Bundle Branch Block. J Am Heart Assoc. 2015 Jun 29;4(7):e002013. doi: 10.1161/JAHA.115.002013.
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DERIVED
Perkiomaki JS, Ruwald AC, Kutyifa V, Ruwald MH, Mcnitt S, Polonsky B, Goldstein RE, Haigney MC, Krone RJ, Zareba W, Moss AJ; MADIT-CRT Investigators. Risk factors and the effect of cardiac resynchronization therapy on cardiac and non-cardiac mortality in MADIT-CRT. Europace. 2015 Dec;17(12):1816-22. doi: 10.1093/europace/euv201. Epub 2015 Jun 11.
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DERIVED
Daimee UA, Moss AJ, Biton Y, Solomon SD, Klein HU, McNitt S, Polonsky B, Zareba W, Goldenberg I, Kutyifa V. Long-Term Outcomes With Cardiac Resynchronization Therapy in Patients With Mild Heart Failure With Moderate Renal Dysfunction. Circ Heart Fail. 2015 Jul;8(4):725-32. doi: 10.1161/CIRCHEARTFAILURE.115.002082. Epub 2015 Jun 2.
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DERIVED
Lee AY, Moss AJ, Ruwald MH, Kutyifa V, McNitt S, Polonsky B, Zareba W, Ruwald AC. Temporal Influence of Heart Failure Hospitalizations Prior to Implantable Cardioverter Defibrillator or Cardiac Resynchronization Therapy With Defibrillator on Subsequent Outcome in Mild Heart Failure Patients (from MADIT-CRT). Am J Cardiol. 2015 May 15;115(10):1423-7. doi: 10.1016/j.amjcard.2015.02.029. Epub 2015 Feb 18.
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DERIVED
Aktas MK, Goldenberg I, Moss AJ, Huang DT, Kutyifa V, Wang PJ, Brenyo A, McNitt S, Zareba W, Barsheshet A. Comparison of age (<75 Years versus >/=75 Years) to risk of ventricular tachyarrhythmias and implantable cardioverter defibrillator shocks (from the Multicenter Automatic Defibrillator Implantation Trial With Cardiac Resynchronization Therapy). Am J Cardiol. 2014 Dec 15;114(12):1855-60. doi: 10.1016/j.amjcard.2014.09.026. Epub 2014 Sep 28.
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Ruwald MH, Moss AJ, Zareba W, Jons C, Ruwald AC, McNitt S, Polonsky B, Kutyifa V. Circadian distribution of ventricular tachyarrhythmias and association with mortality in the MADIT-CRT trial. J Cardiovasc Electrophysiol. 2015 Mar;26(3):291-9. doi: 10.1111/jce.12592. Epub 2015 Jan 5.
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DERIVED
Ruwald MH, Solomon SD, Foster E, Kutyifa V, Ruwald AC, Sherazi S, McNitt S, Jons C, Moss AJ, Zareba W. Left ventricular ejection fraction normalization in cardiac resynchronization therapy and risk of ventricular arrhythmias and clinical outcomes: results from the Multicenter Automatic Defibrillator Implantation Trial With Cardiac Resynchronization Therapy (MADIT-CRT) trial. Circulation. 2014 Dec 23;130(25):2278-86. doi: 10.1161/CIRCULATIONAHA.114.011283. Epub 2014 Oct 9.
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Ruwald MH, Mittal S, Ruwald AC, Aktas MK, Daubert JP, McNitt S, Al-Ahmad A, Jons C, Kutyifa V, Steinberg JS, Wang P, Moss AJ, Zareba W. Association between frequency of atrial and ventricular ectopic beats and biventricular pacing percentage and outcomes in patients with cardiac resynchronization therapy. J Am Coll Cardiol. 2014 Sep 9;64(10):971-81. doi: 10.1016/j.jacc.2014.06.1177.
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DERIVED
Ruwald AC, Kutyifa V, Ruwald MH, Solomon S, Daubert JP, Jons C, Brenyo A, McNitt S, Do D, Tanabe K, Al-Ahmad A, Wang P, Moss AJ, Zareba W. The association between biventricular pacing and cardiac resynchronization therapy-defibrillator efficacy when compared with implantable cardioverter defibrillator on outcomes and reverse remodelling. Eur Heart J. 2015 Feb 14;36(7):440-8. doi: 10.1093/eurheartj/ehu294. Epub 2014 Aug 11.
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Kutyifa V, Stockburger M, Daubert JP, Holmqvist F, Olshansky B, Schuger C, Klein H, Goldenberg I, Brenyo A, McNitt S, Merkely B, Zareba W, Moss AJ. PR interval identifies clinical response in patients with non-left bundle branch block: a Multicenter Automatic Defibrillator Implantation Trial-Cardiac Resynchronization Therapy substudy. Circ Arrhythm Electrophysiol. 2014 Aug;7(4):645-51. doi: 10.1161/CIRCEP.113.001299. Epub 2014 Jun 24.
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Brenyo A, Barsheshet A, Kutyifa V, Ruwald AC, Rao M, Zareba W, Pouleur AC, Knappe D, Solomon SD, McNitt S, Huang DT, Moss AJ, Goldenberg I. Predictors of spontaneous reverse remodeling in mild heart failure patients with left ventricular dysfunction. Circ Heart Fail. 2014 Jul;7(4):565-72. doi: 10.1161/CIRCHEARTFAILURE.113.000929. Epub 2014 Apr 30.
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Goldenberg I, Kutyifa V, Klein HU, Cannom DS, Brown MW, Dan A, Daubert JP, Estes NA 3rd, Foster E, Greenberg H, Kautzner J, Klempfner R, Kuniss M, Merkely B, Pfeffer MA, Quesada A, Viskin S, McNitt S, Polonsky B, Ghanem A, Solomon SD, Wilber D, Zareba W, Moss AJ. Survival with cardiac-resynchronization therapy in mild heart failure. N Engl J Med. 2014 May 1;370(18):1694-701. doi: 10.1056/NEJMoa1401426. Epub 2014 Mar 30.
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Ge Y, Ruwald AC, Kutyifa V, McNitt S, Polonsky S, Klein H, Goldenberg I, Solomon SD, Foster E, Zareba W, Moss AJ. A metric for evaluating the cardiac response to resynchronization therapy. Am J Cardiol. 2014 Apr 15;113(8):1371-7. doi: 10.1016/j.amjcard.2014.01.410. Epub 2014 Jan 31.
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Slyngstad T, Huth Ruwald AC, Kutyifa V, McNitt S, Polonsky B, Solomon SD, Foster E, Goldenberg I, Wang PJ, Klein H, Zareba W, Moss AJ. Cardiac resynchronization therapy is associated with reductions in left atrial volume and inappropriate implantable cardioverter-defibrillator therapy in MADIT-CRT. Heart Rhythm. 2014 Jun;11(6):1001-7. doi: 10.1016/j.hrthm.2014.01.033. Epub 2014 Feb 4.
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Kuperstein R, Goldenberg I, Moss AJ, Solomon S, Bourgoun M, Shah A, McNitt S, Zareba W, Klempfner R. Left atrial volume and the benefit of cardiac resynchronization therapy in the MADIT-CRT trial. Circ Heart Fail. 2014 Jan;7(1):154-60. doi: 10.1161/CIRCHEARTFAILURE.113.000748. Epub 2013 Dec 17.
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Ruwald AC, Pietrasik G, Goldenberg I, Kutyifa V, Daubert JP, Ruwald MH, Jons C, McNitt S, Wang P, Zareba W, Moss AJ. The effect of intermittent atrial tachyarrhythmia on heart failure or death in cardiac resynchronization therapy with defibrillator versus implantable cardioverter-defibrillator patients: a MADIT-CRT substudy (Multicenter Automatic Defibrillator Implantation Trial With Cardiac Resynchronization Therapy). J Am Coll Cardiol. 2014 Apr 1;63(12):1190-1197. doi: 10.1016/j.jacc.2013.10.074. Epub 2013 Dec 11.
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Sood N, Ruwald AC, Solomon S, Daubert JP, McNitt S, Polonsky B, Jons C, Clyne CA, Zareba W, Moss AJ. Association between myocardial substrate, implantable cardioverter defibrillator shocks and mortality in MADIT-CRT. Eur Heart J. 2014 Jan;35(2):106-15. doi: 10.1093/eurheartj/eht451. Epub 2013 Oct 31.
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Brenyo A, Barsheshet A, Rao M, Huang DT, Zareba W, McNitt S, Hall WJ, Peterson DR, Solomon SD, Moss AJ, Goldenberg I. Brain natriuretic peptide and cardiac resynchronization therapy in patients with mildly symptomatic heart failure. Circ Heart Fail. 2013 Sep 1;6(5):998-1004. doi: 10.1161/CIRCHEARTFAILURE.112.000174. Epub 2013 Jun 25.
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Ruwald MH, Abu-Zeitone A, Jons C, Ruwald AC, McNitt S, Kutyifa V, Zareba W, Moss AJ. Impact of carvedilol and metoprolol on inappropriate implantable cardioverter-defibrillator therapy: the MADIT-CRT trial (Multicenter Automatic Defibrillator Implantation With Cardiac Resynchronization Therapy). J Am Coll Cardiol. 2013 Oct 8;62(15):1343-50. doi: 10.1016/j.jacc.2013.03.087. Epub 2013 Jun 13.
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Kutyifa V, Pouleur AC, Knappe D, Al-Ahmad A, Gibinski M, Wang PJ, McNitt S, Merkely B, Goldenberg I, Solomon SD, Moss AJ, Zareba W. Dyssynchrony and the risk of ventricular arrhythmias. JACC Cardiovasc Imaging. 2013 Apr;6(4):432-44. doi: 10.1016/j.jcmg.2012.12.008.
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DERIVED
Ruwald MH, Ruwald AC, Jons C, Alexis J, McNitt S, Zareba W, Moss AJ. Effect of metoprolol versus carvedilol on outcomes in MADIT-CRT (multicenter automatic defibrillator implantation trial with cardiac resynchronization therapy). J Am Coll Cardiol. 2013 Apr 9;61(14):1518-26. doi: 10.1016/j.jacc.2013.01.020.
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DERIVED
Kutyifa V, Kloppe A, Zareba W, Solomon SD, McNitt S, Polonsky S, Barsheshet A, Merkely B, Lemke B, Nagy VK, Moss AJ, Goldenberg I. The influence of left ventricular ejection fraction on the effectiveness of cardiac resynchronization therapy: MADIT-CRT (Multicenter Automatic Defibrillator Implantation Trial With Cardiac Resynchronization Therapy). J Am Coll Cardiol. 2013 Mar 5;61(9):936-44. doi: 10.1016/j.jacc.2012.11.051.
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DERIVED
Brenyo A, Rao M, Barsheshet A, Cannom D, Quesada A, McNitt S, Huang DT, Moss AJ, Zareba W. QRS axis and the benefit of cardiac resynchronization therapy in patients with mildly symptomatic heart failure enrolled in MADIT-CRT. J Cardiovasc Electrophysiol. 2013 Apr;24(4):442-8. doi: 10.1111/jce.12057. Epub 2012 Dec 17.
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DERIVED
Goldstein RE, Haigney MC, Krone RJ, McNitt S, Zareba W, Moss AJ. Differing effects of cardiac resynchronization therapy on long-term mortality in patient subgroups of MADIT-CRT defined by baseline conduction and 1-year post-treatment left ventricular remodeling. Heart Rhythm. 2013 Mar;10(3):366-73. doi: 10.1016/j.hrthm.2012.11.020. Epub 2012 Nov 24.
Reference Type
DERIVED
Ouellet G, Huang DT, Moss AJ, Hall WJ, Barsheshet A, McNitt S, Klein H, Zareba W, Goldenberg I. Effect of cardiac resynchronization therapy on the risk of first and recurrent ventricular tachyarrhythmic events in MADIT-CRT. J Am Coll Cardiol. 2012 Oct 30;60(18):1809-16. doi: 10.1016/j.jacc.2012.05.057. Epub 2012 Oct 3.
Reference Type
DERIVED
Hsu JC, Solomon SD, Bourgoun M, McNitt S, Goldenberg I, Klein H, Moss AJ, Foster E; MADIT-CRT Executive Committee. Predictors of super-response to cardiac resynchronization therapy and associated improvement in clinical outcome: the MADIT-CRT (multicenter automatic defibrillator implantation trial with cardiac resynchronization therapy) study. J Am Coll Cardiol. 2012 Jun 19;59(25):2366-73. doi: 10.1016/j.jacc.2012.01.065.
Reference Type
DERIVED
Brenyo A, Link MS, Barsheshet A, Moss AJ, Zareba W, Wang PJ, McNitt S, Huang D, Foster E, Estes M 3rd, Solomon SD, Goldenberg I. Cardiac resynchronization therapy reduces left atrial volume and the risk of atrial tachyarrhythmias in MADIT-CRT (Multicenter Automatic Defibrillator Implantation Trial with Cardiac Resynchronization Therapy). J Am Coll Cardiol. 2011 Oct 11;58(16):1682-9. doi: 10.1016/j.jacc.2011.07.020.
Reference Type
DERIVED
Goldenberg I, Moss AJ, Hall WJ, Foster E, Goldberger JJ, Santucci P, Shinn T, Solomon S, Steinberg JS, Wilber D, Barsheshet A, McNitt S, Zareba W, Klein H; MADIT-CRT Executive Committee. Predictors of response to cardiac resynchronization therapy in the Multicenter Automatic Defibrillator Implantation Trial with Cardiac Resynchronization Therapy (MADIT-CRT). Circulation. 2011 Oct 4;124(14):1527-36. doi: 10.1161/CIRCULATIONAHA.110.014324. Epub 2011 Sep 6.
Reference Type
DERIVED
Goldenberg I, Hall WJ, Beck CA, Moss AJ, Barsheshet A, McNitt S, Polonsky S, Brown MW, Zareba W. Reduction of the risk of recurring heart failure events with cardiac resynchronization therapy: MADIT-CRT (Multicenter Automatic Defibrillator Implantation Trial With Cardiac Resynchronization Therapy). J Am Coll Cardiol. 2011 Aug 9;58(7):729-37. doi: 10.1016/j.jacc.2011.04.024.
Reference Type
DERIVED
Barsheshet A, Wang PJ, Moss AJ, Solomon SD, Al-Ahmad A, McNitt S, Foster E, Huang DT, Klein HU, Zareba W, Eldar M, Goldenberg I. Reverse remodeling and the risk of ventricular tachyarrhythmias in the MADIT-CRT (Multicenter Automatic Defibrillator Implantation Trial-Cardiac Resynchronization Therapy). J Am Coll Cardiol. 2011 Jun 14;57(24):2416-23. doi: 10.1016/j.jacc.2010.12.041.
Reference Type
DERIVED
Knappe D, Pouleur AC, Shah AM, Cheng S, Uno H, Hall WJ, Bourgoun M, Foster E, Zareba W, Goldenberg I, McNitt S, Pfeffer MA, Moss AJ, Solomon SD; Multicenter Automatic Defibrillator Implantation Trial-Cardiac Resynchronization Therapy Investigators. Dyssynchrony, contractile function, and response to cardiac resynchronization therapy. Circ Heart Fail. 2011 Jul;4(4):433-40. doi: 10.1161/CIRCHEARTFAILURE.111.962902. Epub 2011 May 22.
Reference Type
DERIVED
Singh JP, Klein HU, Huang DT, Reek S, Kuniss M, Quesada A, Barsheshet A, Cannom D, Goldenberg I, McNitt S, Daubert JP, Zareba W, Moss AJ. Left ventricular lead position and clinical outcome in the multicenter automatic defibrillator implantation trial-cardiac resynchronization therapy (MADIT-CRT) trial. Circulation. 2011 Mar 22;123(11):1159-66. doi: 10.1161/CIRCULATIONAHA.110.000646. Epub 2011 Mar 7.
Reference Type
DERIVED
Zareba W, Klein H, Cygankiewicz I, Hall WJ, McNitt S, Brown M, Cannom D, Daubert JP, Eldar M, Gold MR, Goldberger JJ, Goldenberg I, Lichstein E, Pitschner H, Rashtian M, Solomon S, Viskin S, Wang P, Moss AJ; MADIT-CRT Investigators. Effectiveness of Cardiac Resynchronization Therapy by QRS Morphology in the Multicenter Automatic Defibrillator Implantation Trial-Cardiac Resynchronization Therapy (MADIT-CRT). Circulation. 2011 Mar 15;123(10):1061-72. doi: 10.1161/CIRCULATIONAHA.110.960898. Epub 2011 Feb 28.
Reference Type
DERIVED
Martin DT, McNitt S, Nesto RW, Rutter MK, Moss AJ. Cardiac resynchronization therapy reduces the risk of cardiac events in patients with diabetes enrolled in the multicenter automatic defibrillator implantation trial with cardiac resynchronization therapy (MADIT-CRT). Circ Heart Fail. 2011 May;4(3):332-8. doi: 10.1161/CIRCHEARTFAILURE.110.959510. Epub 2011 Feb 24.
Reference Type
DERIVED
Arshad A, Moss AJ, Foster E, Padeletti L, Barsheshet A, Goldenberg I, Greenberg H, Hall WJ, McNitt S, Zareba W, Solomon S, Steinberg JS; MADIT-CRT Executive Committee. Cardiac resynchronization therapy is more effective in women than in men: the MADIT-CRT (Multicenter Automatic Defibrillator Implantation Trial with Cardiac Resynchronization Therapy) trial. J Am Coll Cardiol. 2011 Feb 15;57(7):813-20. doi: 10.1016/j.jacc.2010.06.061.
Reference Type
DERIVED
Solomon SD, Foster E, Bourgoun M, Shah A, Viloria E, Brown MW, Hall WJ, Pfeffer MA, Moss AJ; MADIT-CRT Investigators. Effect of cardiac resynchronization therapy on reverse remodeling and relation to outcome: multicenter automatic defibrillator implantation trial: cardiac resynchronization therapy. Circulation. 2010 Sep 7;122(10):985-92. doi: 10.1161/CIRCULATIONAHA.110.955039. Epub 2010 Aug 23.
Reference Type
DERIVED
Barsheshet A, Goldenberg I, Narins CR, Moss AJ, McNitt S, Wang PJ, Huang DT, Hall WJ, Zareba W, Eldar M, Guetta V. Time dependence of life-threatening ventricular tachyarrhythmias after coronary revascularization in MADIT-CRT. Heart Rhythm. 2010 Oct;7(10):1421-7. doi: 10.1016/j.hrthm.2010.07.005. Epub 2010 Jul 8.
Reference Type
DERIVED
Moss AJ, Hall WJ, Cannom DS, Klein H, Brown MW, Daubert JP, Estes NA 3rd, Foster E, Greenberg H, Higgins SL, Pfeffer MA, Solomon SD, Wilber D, Zareba W; MADIT-CRT Trial Investigators. Cardiac-resynchronization therapy for the prevention of heart-failure events. N Engl J Med. 2009 Oct 1;361(14):1329-38. doi: 10.1056/NEJMoa0906431. Epub 2009 Sep 1.
Reference Type
DERIVED
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
MADIT-CRT
Identifier Type: -
Identifier Source: secondary_id
Clinicals0003
Identifier Type: -
Identifier Source: org_study_id