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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation
ClinicalTrials.gov Identifier:
NCT00947310
First received: July 27, 2009
Last updated: March 4, 2013
Last verified: March 2013
  Purpose

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.


Condition Intervention Phase
Primary Prevention of Sudden Cardiac Arrest
Device: Standard ICD programming
Device: High rate cutoff
Device: Long delay
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: IDE-Exempt: Multicenter Automatic Defibrillator Implantation Trial - Reduce Inappropriate Therapy

Resource links provided by NLM:


Further study details as provided by Boston Scientific Corporation:

Primary Outcome Measures:
  • Inappropriate ICD Therapy [ Time Frame: Average of 1.4 years follow-up ] [ Designated as safety issue: No ]
    First occurance of inappropriate therapy (either anti-tachycardia pacing or shock)


Secondary Outcome Measures:
  • All-cause Mortality [ Time Frame: Average 1.4 years of follow-up ] [ Designated as safety issue: Yes ]
  • Syncope [ Time Frame: Average of 1.4 years follow-up ] [ Designated as safety issue: Yes ]
    First episode of syncope


Enrollment: 1500
Study Start Date: September 2009
Study Completion Date: December 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00947310

Locations
United States, New York
University of Rochester (Multiple Facilities Participating World Wide)
Rochester, New York, United States, 14642
Sponsors and Collaborators
Boston Scientific Corporation
Investigators
Principal Investigator: Arthur J Moss, MD University of Rochester
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT00947310     History of Changes
Other Study ID Numbers: MADIT-RIT
Study First Received: July 27, 2009
Results First Received: March 4, 2013
Last Updated: March 4, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Boston Scientific Corporation:
Inappropriate therapy
ICD therapy
Primary prevention

Additional relevant MeSH terms:
Heart Arrest
Death, Sudden, Cardiac
Heart Diseases
Cardiovascular Diseases
Death, Sudden
Death
Pathologic Processes

ClinicalTrials.gov processed this record on August 26, 2014