NL-OMON45670撤回不适用
Multicenter Automatic Defibrillator Implantation Trial with Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) - MADIT S-ICD
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 90
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •* 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
排除标准
- •* 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
研究者
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