Clinical trial NCT00947310: Multicenter Automatic Defibrillator Implantation Trial - Reduce Inappropriate Therapy
Official title: IDE-Exempt: Multicenter Automatic Defibrillator Implantation Trial - Reduce Inappropriate Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Primary Prevention of Sudden Cardiac Arrest
Keywords: Inappropriate therapy
ICD therapy
Primary prevention
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2009-07-28
Enrollment: 1500
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will assess the impact of higher rate cutoffs and longer delays than standard programming on inappropriate therapy in primary prevention ICD and CRT-D patients.

Detailed description: The purpose of the MADIT-RIT trial is to compare the time to first inappropriate therapy using high rate cutoff and/or long delay in primary prevention patients receiving an ICD or CRT-D device compared to standard programming.

Eligibility criteria: Inclusion Criteria:

* Primary prevention patient with ischemic or non-ischemic heart disease who meets current guidelines for dual-chamber ICD or CRT-D device therapy
* Patient in sinus rhythm
* Patient on stable optimal pharmacologic therapy for the cardiac condition or who has developed a recent ICD indication that necessitates ICD therapy concurrent with the optimization of pharmacologic therapy
* Patient ≥ 21 years of age, or legal representative, willing and capable of giving informed consent

Exclusion Criteria:

* Patient with an implanted pacemaker or CRT-P
* Patient with existing ICD or CRT-D device components
* Patient with a history of VT or VF
* Patient with permanent or chronic AF, or cardioversion for AF, within the past three calendar months before enrollment
* Patient with coronary artery bypass graft surgery or percutaneous coronary intervention within the past three calendar months prior to enrollment
* Patient with enzyme-positive myocardial infarction within the past three calendar months prior to enrollment
* Patient 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
* Patient with second or third degree heart block
* Patient in NYHA Class IV
* Patient who is pregnant or plans to become pregnant during the course of the trial
* Patient with irreversible brain damage from preexisting cerebral disease
* Patient with presence of any disease, other than the patient's cardiac disease, associated with a reduced likelihood of survival for the duration of the trial, e.g., cancer, uremia, liver failure, etc.
* Patient with chronic renal disease with BUN ≥ 50mg/dl or creatinine ≥ 2.5 mg/dl
* Patient participating in any other clinical trial
* Patient unwilling or unable to cooperate with the protocol
* Patient who lives at such a distance from the clinic that travel for follow-up visits would be unusually difficult
* Patient who does not anticipate being a resident of the area for the scheduled duration of the trial
* Patient unwilling to sign the consent for participation
* Patient whose physician does not allow participation

Primary outcomes:
measure: Inappropriate ICD Therapy
timeFrame: Average of 1.4 years follow-up
Secondary outcomes:
measure: All-cause Mortality
timeFrame: Average 1.4 years of follow-up
measure: Syncope
timeFrame: Average of 1.4 years follow-up
Other outcomes:
Locations:
city: Rochester
country: United States
facility: University of Rochester (Multiple Facilities Participating World Wide)
state: New York
Study officials:
affiliation: University of Rochester
name: Arthur J Moss, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Schuger C, Daubert JP, Brown MW, Cannom D, Estes NA 3rd, Hall WJ, Kayser T, Klein H, Olshansky B, Power KA, Wilber D, Zareba W, Moss AJ. Multicenter automatic defibrillator implantation trial: reduce inappropriate therapy (MADIT-RIT): background, rationale, and clinical protocol. Ann Noninvasive Electrocardiol. 2012 Jul;17(3):176-85. doi: 10.1111/j.1542-474X.2012.00531.x.
citation: Younis A, Heist EK, McNitt S, Aktas MK, Rosero S, Goldenberg I, Kutyifa V. Predictors and outcomes of atrial tachyarrhythmia among patients with implantable defibrillators. Heart Rhythm. 2020 Apr;17(4):553-559. doi: 10.1016/j.hrthm.2019.11.024. Epub 2019 Nov 22.
citation: Jackson LR 2nd, Thomas KL, Polonsky B, Zareba W, Lahiri M, Saba S, McNitt S, Schuger C, Daubert JP, Moss AJ, Kutyifa V. Effectiveness of high rate and delayed detection ICD programming by race: A MADIT-RIT substudy. J Cardiovasc Electrophysiol. 2018 Oct;29(10):1418-1424. doi: 10.1111/jce.13693. Epub 2018 Jul 24.
citation: Kutyifa V, Daubert JP, Schuger C, Goldenberg I, Klein H, Aktas MK, McNitt S, Stockburger M, Merkely B, Zareba W, Moss AJ. Novel ICD Programming and Inappropriate ICD Therapy in CRT-D Versus ICD Patients: A MADIT-RIT Sub-Study. Circ Arrhythm Electrophysiol. 2016 Jan;9(1):e001965. doi: 10.1161/CIRCEP.114.001965.
citation: Kutyifa V, Daubert JP, Olshansky B, Huang DT, Zhang C, Ruwald AC, McNitt S, Zareba W, Moss AJ, Schuger C. Characterization and predictors of first and subsequent inappropriate ICD therapy by heart rate ranges: Result of the MADIT-RIT efficacy analysis. Heart Rhythm. 2015 Sep;12(9):2030-7. doi: 10.1016/j.hrthm.2015.05.021. Epub 2015 May 19.
citation: Kutyifa V, Moss AJ, Schuger C, McNitt S, Polonsky B, Ruwald AH, Ruwald MH, Daubert JP, Zareba W. Reduction in Inappropriate ICD Therapy in MADIT-RIT Patients Without History of Atrial Tachyarrhythmia. J Cardiovasc Electrophysiol. 2015 Aug;26(8):879-884. doi: 10.1111/jce.12692. Epub 2015 Jun 15.
citation: Stockburger M, Moss AJ, Olshansky B, Klein H, McNitt S, Schuger C, Daubert JP, Goldenberg I, Ruwald AC, Merkely B, Zareba W, Kutyifa V. Time-dependent risk reduction of ventricular tachyarrhythmias in cardiac resynchronization therapy patients: a MADIT-RIT sub-study. Europace. 2015 Jul;17(7):1085-91. doi: 10.1093/europace/euv008. Epub 2015 Mar 4.
citation: Sedlacek K, Ruwald AC, Kutyifa V, McNitt S, Thomsen PEB, Klein H, Stockburger M, Wichterle D, Merkely B, DE LA Concha JF, Swissa M, Zareba W, Moss AJ, Kautzner J, Ruwald MH; MADIT-RIT Investigators. The effect of ICD programming on inappropriate and appropriate ICD Therapies in ischemic and nonischemic cardiomyopathy: the MADIT-RIT trial. J Cardiovasc Electrophysiol. 2015 Apr;26(4):424-433. doi: 10.1111/jce.12605. Epub 2015 Feb 11.
citation: Ruwald AC, Schuger C, Moss AJ, Kutyifa V, Olshansky B, Greenberg H, Cannom DS, Estes NA, Ruwald MH, Huang DT, Klein H, McNitt S, Beck CA, Goldstein R, Brown MW, Kautzner J, Shoda M, Wilber D, Zareba W, Daubert JP. Mortality reduction in relation to implantable cardioverter defibrillator programming in the Multicenter Automatic Defibrillator Implantation Trial-Reduce Inappropriate Therapy (MADIT-RIT). Circ Arrhythm Electrophysiol. 2014 Oct;7(5):785-92. doi: 10.1161/CIRCEP.114.001623. Epub 2014 Aug 18.
citation: Ruwald MH, Okumura K, Kimura T, Aonuma K, Shoda M, Kutyifa V, Ruwald AC, McNitt S, Zareba W, Moss AJ. Syncope in high-risk cardiomyopathy patients with implantable defibrillators: frequency, risk factors, mechanisms, and association with mortality: results from the multicenter automatic defibrillator implantation trial-reduce inappropriate therapy (MADIT-RIT) study. Circulation. 2014 Feb 4;129(5):545-52. doi: 10.1161/CIRCULATIONAHA.113.004196. Epub 2013 Nov 7.
citation: Ruwald MH, Zareba W, Jons C, Zhang C, Ruwald AC, Olshansky B, McNitt S, Bloch Thomsen PE, Shoda M, Merkely B, Moss AJ, Kutyifa V. Influence of diabetes mellitus on inappropriate and appropriate implantable cardioverter-defibrillator therapy and mortality in the Multicenter Automatic Defibrillator Implantation Trial-Reduce Inappropriate Therapy (MADIT-RIT) Trial. Circulation. 2013 Aug 13;128(7):694-701. doi: 10.1161/CIRCULATIONAHA.113.002472. Epub 2013 Jul 23.
citation: Moss AJ, Schuger C, Beck CA, Brown MW, Cannom DS, Daubert JP, Estes NA 3rd, Greenberg H, Hall WJ, Huang DT, Kautzner J, Klein H, McNitt S, Olshansky B, Shoda M, Wilber D, Zareba W; MADIT-RIT Trial Investigators. Reduction in inappropriate therapy and mortality through ICD programming. N Engl J Med. 2012 Dec 13;367(24):2275-83. doi: 10.1056/NEJMoa1211107. Epub 2012 Nov 6.