Multicenter Automatic Defibrillator Implantation Trial with Subcutaneous Implantable Cardioverter Defibrillator (S-ICD)

Recruitment & Eligibility

Status: Withdrawn

Sex: Not specified

Target Recruitment: 90

Inclusion Criteria

* Age * 65 years on date of consent
* Diabetes mellitus treated with oral hypoglycemic agents, non-insulin injectable and/or insulin for the past 3calendar months or longer prior to consent date
* LV ejection fraction (LVEF) of 36-50% documented by imaging (preferably by MRI or echocardiographic methods), within 12 calendar months before consent date and at least 3 calendar months after most recent MI, PCI or CABG
* One or more clinically documented, enzyme-positive myocardial infarctions, more than 3 calendar months prior to consent date*.
o If enzyme information and clinical documentation is not available, there must be a clear evidence of prior silent myocardial infarction identified as either new pathologic Q waves on ECG or imaging documentation of an infarcted area (left ventricular angiography/ nuclear scan/ MRI)*
* MI qualification based on the Universal Definition of MI1
* Qualifying 12-lead ECG within 6 calendar months before consent date and at least 3 calendar months after most recent MI, PCI or CABG
* The qualifying ECG can be sinus rhythm or atrial fibrillation (patients with persistent or permanent atrial fibrillation should have a controlled ventricular response <100 bpm on consent date)
*QRS duration on the qualifying ECG >90 msec
* Passing S-ICD Screening ECG performed per applicable user*s manual on or after the consent date that identifies one or more qualifying S-ICD sensing vectors

Exclusion Criteria

* Ejection fraction >50% or <36% within 12 calendar months prior to consent date and at least 3 calendar months after the most recent MI, PCI or CABG
* Existing guideline based indication for an ICD, pacemaker, CRT, or CRT-D therapy
* Existing or previously implanted ICD, CRT, CRT-D, or pacemaker device system
* Active infection at the time of consent
* Contraindication for S-ICD implantation according to the S-ICD pulse generator (PG) User*s Manual
* Hemodialysis and/or peritoneal dialysis at the time of enrollment
* New York Heart Association Class IV in the past 3 calendar months prior to or at the time of consent date
* Coronary artery bypass graft surgery or percutaneous coronary intervention (balloon and/or stent angioplasty) within 3 calendar months prior to the consent date
* Enzyme-positive myocardial infarction or silent myocardial infarction diagnosed within 3 calendar months prior to the consent date
* Unstable angina with need for outpatient treatment or hospitalization (change/addition of anti-anginal medication and/or coronary revascularization), within 3 calendar months prior to the consent date
* Angiographic evidence of coronary disease in a patient that is a candidate for coronary revascularization and is likely to undergo CABG or PCI in the next 3 calendar months
* High risk for arterial embolism (e.g. presence of mobile left ventricular
* thrombus)
* Hemodynamically significant congenital heart disease, aortic valvular heart disease, or amyloid heart disease
* Baseline body mass index > 45 kg/m2
* On a heart transplant list or likely to undergo heart transplant within one calendar year
* Presence of any other disease, other than the subject*s cardiac disease, that in the opinion of the investigator is likely to significantly reduce the patient*s likelihood of survival for the duration of the trial (e.g. cancer, liver failure).
* Unwillingness or inability to cooperate with the protocol
* Resides at such a distance from the enrolling site so travel to follow-up visits would be unusually difficult
* Reversible causes of heart disease (e.g. viral myocarditis or tachycardia induced cardiomyopathy)
* Participation in other clinical trials (observational registries are allowed with approval from the CDC)
* Does not anticipate residing in the vicinity of the enrolling site for the duration of the trial
* Unwillingness to sign the consent for participation

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary endpoint is all-cause mortality.<br /><br><br /><br>The primary objective is to test the hypothesis that post-MI diabetic patients<br /><br>with relatively preserved ejection fraction of 36-50% will have a survival<br /><br>benefit from a subcutaneous implantable cardioverter defibrillator (S-ICD).</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The secondary objective of the study is to evaluate the effects of the S-ICD on<br /><br>all-cause mortality in various subgroups and on sudden cardiac death.</p><br>