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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00947310
Recruitment Status : Completed
First Posted : July 28, 2009
Results First Posted : April 18, 2013
Last Update Posted : August 8, 2018
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation

Tracking Information
First Submitted Date  ICMJE July 27, 2009
First Posted Date  ICMJE July 28, 2009
Results First Submitted Date  ICMJE March 4, 2013
Results First Posted Date  ICMJE April 18, 2013
Last Update Posted Date August 8, 2018
Study Start Date  ICMJE September 2009
Actual Primary Completion Date August 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 4, 2013)
Inappropriate ICD Therapy [ Time Frame: Average of 1.4 years follow-up ]
First occurance of inappropriate therapy (either anti-tachycardia pacing or shock)
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 4, 2013)
  • All-cause Mortality [ Time Frame: Average 1.4 years of follow-up ]
  • Syncope [ Time Frame: Average of 1.4 years follow-up ]
    First episode of syncope
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Multicenter Automatic Defibrillator Implantation Trial - Reduce Inappropriate Therapy
Official Title  ICMJE IDE-Exempt: Multicenter Automatic Defibrillator Implantation Trial - Reduce Inappropriate Therapy
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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Primary Prevention of Sudden Cardiac Arrest
Intervention  ICMJE
  • Device: Standard ICD programming
    Standard ICD programming
  • Device: High rate cutoff
    Programming of a high rate cutoff
  • Device: Long delay
    Programming of a prolonged delay
Study Arms  ICMJE
  • Experimental: A
    Standard ICD Programming
    Intervention: Device: Standard ICD programming
  • Experimental: B
    High rate cutoff
    Intervention: Device: High rate cutoff
  • Experimental: C
    Long ICD duration delay
    Intervention: Device: Long delay
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 28, 2009)
1500
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE December 2012
Actual Primary Completion Date August 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00947310
Other Study ID Numbers  ICMJE MADIT-RIT
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Boston Scientific Corporation
Study Sponsor  ICMJE Boston Scientific Corporation
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Arthur J Moss, MD University of Rochester
PRS Account Boston Scientific Corporation
Verification Date March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP