Multicenter Automatic Defibrillator Implantation Trial - Reduce Inappropriate Therapy (MADIT-RIT)

July 12, 2018 updated by: Boston Scientific Corporation

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

1500

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Rochester, New York, United States, 14642
        • University of Rochester (Multiple Facilities Participating World Wide)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A
Standard ICD Programming
Device: Standard ICD programming
Standard ICD programming
Experimental: B
High rate cutoff
Device: High rate cutoff
Programming of a high rate cutoff
Experimental: C
Long ICD duration delay
Device: Long delay
Programming of a prolonged delay

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Inappropriate ICD Therapy
Time Frame: Average of 1.4 years follow-up
First occurance of inappropriate therapy (either anti-tachycardia pacing or shock)
Average of 1.4 years follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
All-cause Mortality
Time Frame: Average 1.4 years of follow-up
Average 1.4 years of follow-up
Syncope
Time Frame: Average of 1.4 years follow-up
First episode of syncope
Average of 1.4 years follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boston Scientific Corporation

Investigators

  • Principal Investigator: Arthur J Moss, MD, University of Rochester

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2009

Primary Completion (Actual)

August 1, 2012

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

July 27, 2009

First Submitted That Met QC Criteria

July 27, 2009

First Posted (Estimate)

July 28, 2009

Study Record Updates

Last Update Posted (Actual)

August 8, 2018

Last Update Submitted That Met QC Criteria

July 12, 2018

Last Verified

March 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MADIT-RIT

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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