Loading clinical trials...

Multicenter Automatic Defibrillator Implantation Trial - Reduce Inappropriate Therapy | Clinical Trials | Clareo Health

COMPLETEDNA

Multicenter Automatic Defibrillator Implantation Trial - Reduce Inappropriate Therapy

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

NCT00947310•Boston Scientific Corporation

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

Age

21 - No limit years

Sex

ALL

Healthy Volunteers

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
+9 more criteria

Locations (1)

University of Rochester (Multiple Facilities Participating World Wide)

Rochester, New York, United States

Key Dates

Start Date

September 1, 2009

Primary Completion Date

August 1, 2012

Completion Date

December 1, 2012

Last Updated

August 8, 2018

Enrollment

1,500

ACTUAL participants

Conditions

Primary Prevention of Sudden Cardiac Arrest

Interventions

Standard ICD programming

DEVICE

High rate cutoff

DEVICE

Long delay

DEVICE

Longitudinal Surveillance Study of the 4-SITE Lead/Header System

NCT01596595

Primary Prevention of Sudden Cardiac ArrestSecondary Prevention of Sudden Cardiac Arrest

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 8, 2018Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions