Multicenter Automatic Defibrillator Implantation Trial - Reduce Inappropriate Therapy

Primary Prevention of Sudden Cardiac Arrest Clinical Trial

— MADIT-RIT  

Official title:

IDE-Exempt: Multicenter Automatic Defibrillator Implantation Trial - Reduce Inappropriate Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00947310
• Other study ID #: MADIT-RIT
• Status: Completed
• Phase: N/A
• Start date: September 2009
• Est. completion date: December 2012

Study information

• Verified date: March 2013
• Source: Boston Scientific Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1500
• Est. completion date: December 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Death, Sudden, Cardiac
• Heart Arrest
• Primary Prevention of Sudden Cardiac Arrest

Intervention

Device:
• Standard ICD programming
Standard ICD programming
• High rate cutoff
Programming of a high rate cutoff
• Long delay
Programming of a prolonged delay

Locations

Country	Name	City	State
United States	University of Rochester (Multiple Facilities Participating World Wide)	Rochester	New York

Sponsors (1)

Lead Sponsor	Collaborator
Boston Scientific Corporation

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Inappropriate ICD Therapy	First occurance of inappropriate therapy (either anti-tachycardia pacing or shock)	Average of 1.4 years follow-up
Secondary	All-cause Mortality		Average 1.4 years of follow-up
Secondary	Syncope	First episode of syncope	Average of 1.4 years follow-up