Multizentrische Studie zur Implantation eines automatisierten Defibrillators: Subkutaner implantierbarer Kardioverter-Defibrillator (MADIT S-ICD)

Device: Subcutaneous Implantable Cardioverter Defibrillator

Gender: All
Maximum age: N/A
Minimum age: 65 Years

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 3 calendar 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 Myocardial Infarction (MI), percutaneous coronary
intervention (PCI) or coronary artery bypass graft (CABG).

- One or more clinically documented, enzyme-positive myocardial infarctions, more than 3
calendar months prior to consent date*. (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)
Note: MI qualification based on the Universal Definition of MI)

- 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 implantable cardioverter defibrillator
(ICD), pacemaker, cardiac resynchronization therapy device (CRT), or cardiac
resynchronization therapy device with defibrillator (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