TachycardiaMADIT-CRTNCT00180271
MADIT-CRT: Multicenter Automatic Defibrillator Implantation With Cardiac Resynchronization Therapy
A study testing Cardiac resynchronization therapy with defibrillation and Implantable Cardioverter Defibrillator (ICD) in people with Tachycardia and Congestive Heart Failure, run by Boston Scientific Corporation at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Tachycardia, Congestive Heart Failure
- What is being tested?
- Cardiac resynchronization therapy with defibrillation and Implantable Cardioverter Defibrillator (ICD)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,820 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2004to Sep 2010
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 13Show fewer
- 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)
Who cannot join
- 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
Show all 19Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Multiple locations in the US and international
Rochester, New York, 14642
About this study
Official title: Multicenter Automatic Defibrillator Implantation Trial With Cardiac Resynchronization Therapy
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).
Read the detailed description
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
- Tachycardia, Congestive Heart Failure
- Being tested
- Cardiac resynchronization therapy with defibrillation, Implantable Cardioverter Defibrillator (ICD)
- Keywords
- Defibrillator, Cardiac Resynchronization Therapy, MADIT
- Medical subject headings
- Tachycardia, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac resynchronization therapy with defibrillationDevice
Boston Scientific Corporation Market Released Cardiac Resynchronization therapy with defibrillation
Implantable Cardioverter Defibrillator (ICD)Device
Boston Scientific Corporation Market Released Implantable Cardioverter Defibrillator
| Study group | Role | What they receive |
|---|---|---|
| CRT-D | Experimental | CRT-D: Cardiac resynchronization therapy with defibrillation. Receives: Device: Cardiac resynchronization therapy with defibrillation |
| ICD | Active comparator | ICD: Implantable cardioverter defibrillator Receives: Device: Implantable Cardioverter Defibrillator (ICD) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality From Any Cause or First Heart Failure (HF) Event
MADIT-CRT was an event-driven trial in which patients were monitored for all-cause mortality and HF events. An HF event was defined as either hospitalization for symptoms and/or signs consistent with congestive HF and:
- administration of intravenous decongestive therapy that does not involve formal in-patient hospital admission, regardless of the setting (i.e. in an emergency room setting, in the physician's office, etc.), or
- administration of an augmented HF regimen with oral or intravenous medications during an in-hospital stay.
Measured: Outcome measured at average follow-up duration of 2.4 years.
Secondary outcomes (1)
Recurrent Heart Failure Events
The MADIT-CRT secondary outcome evaluated the effects of CRT-D, relative to ICD, on the recurrence of heart failure events over the full study period An HF event was defined as either hospitalization for symptoms and/or signs consistent with congestive HF and:
- administration of intravenous decongestive therapy that does not involve formal in-patient hospital admission, regardless of the setting (i.e. in an emergency room setting, in the physician's office, etc.), or
- administration of an augmented HF regimen with oral or intravenous medications during an in-hospital stay.
Measured: Time of event, DSMB review
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startDec 2004
- Primary completionJun 2009
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (59)Papers the sponsor has linked to this study.
- Other trials for TachycardiaStudies of the same condition, open and under way.
- More trials run by Boston Scientific CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,820 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Rochester
- Responsible party
- Sponsor
- Investigators
- Arthur J Moss, MD, Principal investigator, University of Rochester, NY
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00180271
- Sponsor's protocol ID
- Clinicals0003
- Other IDs
- MADIT-CRT
- Acronym
- MADIT-CRT
- Status last verified
- Nov 2018
- First submitted
- 9 Sep 2005
- Last updated
- 19 Dec 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Thomas S, McNitt S, Polonsky B, Alexis JD, Bisognano JD, Goldenberg I, Kutyifa V. Effects of Cardiac Resynchronization Therapy on Cardiovascular and Noncardiovascular Hospitalization: A MADIT-CRT Long-Term Follow-Up. J Am Heart Assoc. 2026 Mar 17;15(6):e019880. doi: 10.1161/JAHA.120.019880. Epub 2026 Feb 27.
PubMed 41757453Fudim 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.
PubMed 37671601Friedman 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.
PubMed 36700426Goldenberg 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.
PubMed 32875313Younis 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.
PubMed 32701367Vidula 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.
PubMed 32605387Biton 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.
PubMed 30857452Kutyifa 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.
PubMed 30592353Baturova 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.
PubMed 29861050Ozlu 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.
PubMed 29759576Jame 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.
PubMed 28347835Biering-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.
PubMed 28003221Mathias 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.
PubMed 27634117Jame 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.
PubMed 26961303Biton 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.
PubMed 26823498
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Automatic Defibrillator Implantation Trial With Cardiac Resynchronization Therapy
- ClinicalTrials.gov ID
- NCT00180271
- Acronym / sponsor ID
- MADIT-CRT / Clinicals0003
- Conditions
- Tachycardia, Congestive Heart Failure
- Keywords
- Defibrillator, Cardiac Resynchronization Therapy, MADIT
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,820 participants (actual)
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- Collaborators
- University of Rochester
- Study start
- Dec 2004
- Primary completion
- Jun 2009 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 16 Sep 2005 (estimated)
- Results
- Posted 2 Jun 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CRT-D | Experimental | Device: Cardiac resynchronization therapy with defibrillationCRT-D: Cardiac resynchronization therapy with defibrillation. |
| ICD | Active comparator | Device: Implantable Cardioverter Defibrillator (ICD)ICD: Implantable cardioverter defibrillator |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Ischemic heart disease defined as:
- 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
- Stable optimal pharmacologic therapy.
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cardiac resynchronization therapy with defibrillationBoston Scientific Corporation Market Released Cardiac Resynchronization therapy with defibrillation | Device | CRT-D |
| Implantable Cardioverter Defibrillator (ICD)Boston Scientific Corporation Market Released Implantable Cardioverter Defibrillator | Device | ICD |
Primary outcome
Mortality From Any Cause or First Heart Failure (HF) Event
Time frame: Outcome measured at average follow-up duration of 2.4 years.
MADIT-CRT was an event-driven trial in which patients were monitored for all-cause mortality and HF events. An HF event was defined as either hospitalization for symptoms and/or signs consistent with congestive HF and: 1. administration of intravenous decongestive therapy that does not involve formal in-patient hospital admission, regardless of the setting (i.e. in an emergency room setting, in the physician's office, etc.), or 2. administration of an augmented HF regimen with oral or intravenous medications during an in-hospital stay.
1 secondary outcome
Recurrent Heart Failure Events
Time frame: Time of event, DSMB review
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41757453Thomas S, McNitt S, Polonsky B, Alexis JD, Bisognano JD, Goldenberg I, Kutyifa V. Effects of Cardiac Resynchronization Therapy on Cardiovascular and Noncardiovascular Hospitalization: A MADIT-CRT Long-Term Follow-Up. J Am Heart Assoc. 2026 Mar 17;15(6):e019880. doi: 10.1161/JAHA.120.019880. Epub 2026 Feb 27.
- Derived from this study: PubMed 37671601Fudim 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.
- Derived from this study: PubMed 36700426Friedman 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.
- Derived from this study: PubMed 32875313Goldenberg 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.
- Derived from this study: PubMed 32701367Younis 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.
- Derived from this study: PubMed 32605387Vidula 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.
- Derived from this study: PubMed 30857452Biton 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.
- Derived from this study: PubMed 30592353Kutyifa 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.
- Derived from this study: PubMed 29861050Baturova 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.
- Derived from this study: PubMed 29759576Ozlu 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.
- Derived from this study: PubMed 28347835Jame 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.
- Derived from this study: PubMed 28003221Biering-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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arthur J Moss, MD principal investigator
University of Rochester, NY
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cardiac resynchronization therapy with defibrillation and Implantable Cardioverter Defibrillator (ICD) in people with Tachycardia and Congestive Heart Failure, run by Boston Scientific Corporation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Jun 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality From Any Cause or First Heart Failure (HF) Event (time frame: Outcome measured at average follow-up duration of 2.4 years.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00180271, which also lists 59 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2018.