Multicenter Automatic Defibrillator Implantation Trial - Reduce Inappropriate Therapy

Phase 4

• Conditions: Primary Prevention of Sudden Cardiac Arrest that is limited to the approved Japanese ICD or CRT-D indications

• Registration Number: JPRN-UMIN000003056
• Lead Sponsor: niversity of Rochester

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-01-19
• Study Completion: 2012-09-01
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 1500

Inclusion Criteria

Not provided

Exclusion Criteria

1)Patient with an implanted pacemaker or CRT-P 2)Patient with existing ICD or CRT-D device components 3)Patient with a history of spontaneous sustained VT or VF 4)Patient with permanent or chronic AF, or cardioversion for AF, within the past three calendar months before enrollment 5)Patient with coronary artery bypass graft surgery or percutaneous coronary intervention within the past three calendar months prior to enrollment 6)Patient with enzyme-positive myocardial infarction within the past three calendar months prior to enrollment 7)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 8)Patient with second or third degree heart block 9)Patient in NYHA Class IV 10)Patient who is pregnant or plans to become pregnant during the course of the trial 11)Patient with irreversible brain damage from p reexisting cerebral disease 12)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. 13)Patient with chronic renal disease with BUN >50mg/dl or creatinine >2.5 mg/dl 14)Patient participating in any other clinical trial 15)Patient unwilling or unable to cooperate with the protocol 16)Patient who lives at such a distance from the clinic that travel for follow-up visits would be unusually difficult 17)Patient who does not anticipate being a resident of the area for the scheduled duration of the trial 18)Patient unwilling to sign the consent for participation 19)Patient whose physician does not allow participation

Study & Design

• Study Type: Interventional
• Study Design: Not specified