Multicenter Automatic Defibrillator Implantation Trial - Reduce Inappropriate Therapy

NCT00947310 | Completed Results DMC

• 1 other identifier: MADIT-RIT
• Study Type: interventional
• Target: 1,500
• Locations: 1 country
• Sites: 1

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.

Conditions

Primary Prevention of Sudden Cardiac Arrest

Keywords

Inappropriate therapy; ICD therapy; Primary prevention

Outcome Measures

Primary Outcomes (1)

• Inappropriate ICD Therapy

  First occurance of inappropriate therapy (either anti-tachycardia pacing or shock)

  Average of 1.4 years follow-up

Secondary Outcomes (2)

• All-cause Mortality

  Average 1.4 years of follow-up

• Syncope

  Average of 1.4 years follow-up

Study Arms (3)

A

EXPERIMENTAL

Standard ICD Programming

Device: Standard ICD programming

B

EXPERIMENTAL

High rate cutoff

Device: High rate cutoff

C

EXPERIMENTAL

Long ICD duration delay

Device: Long delay

Interventions

Standard ICD programming DEVICE

Standard ICD programming

A

High rate cutoff DEVICE

Programming of a high rate cutoff

B

Long delay DEVICE

Programming of a prolonged delay

C

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boston Scientific Corporation: lead

Study Sites (1)

University of Rochester (Multiple Facilities Participating World Wide)

Rochester, New York, 14642, United States

Location

Related Publications (12)

• 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.

  PMID: 22816536 BACKGROUND

• 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.

  PMID: 31765809 DERIVED

• 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.

  PMID: 29978932 DERIVED

• 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.

  PMID: 26743237 DERIVED

• 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.

  PMID: 26001510 DERIVED

• 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.

  PMID: 25917337 DERIVED

• 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.

  PMID: 25745075 DERIVED

• 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.

  PMID: 25546486 DERIVED

• 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.

  PMID: 25136077 DERIVED

• 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.

  PMID: 24201303 DERIVED

• 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.

  PMID: 23881862 DERIVED

• 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.

  PMID: 23131066 DERIVED

Results Point of Contact

• Title: Dr. Arthur J. Moss
• Organization: University of Rochester, Heart Research Follow-up Program

arthur.moss@heart.rochester.edu

585-275-5391

Study Officials

• Arthur J Moss, MD

  University of Rochester

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 27, 2009
• First Posted: July 28, 2009
• Study Start: September 1, 2009
• Primary Completion: August 1, 2012
• Study Completion: December 1, 2012
• Last Updated: August 8, 2018
• Results First Posted: April 18, 2013

Record last verified: 2013-03

Locations

US (1)