Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:13 PM
Ignite Modification Date:
2025-12-24 @ 7:13 PM
NCT ID:
NCT01845103
Eligibility Criteria:
Inclusion Criteria:
* Class IV angina (according to Canadian Cardiovascular Society Angina Scale)
* Ejection Fraction \> 30%
* Patients with regions of myocardium in the distal two-thirds of the left ventricle with reversible ischemia and who are not eligible for direct coronary revascularization (e.g., CABG or PTCA).
* Patients amenable to thoracoscopic TMR.
Exclusion Criteria:
* Age less than18-years
* Pregnant or nursing mothers
* Unable to undergo a surgical procedure or general anesthesia
* Hepatic disease, renal failure, cancer or major infection
* Severely unstable angina (un-weanable from intravenous anti-anginals for 48- hours)
* Patients with mechanical/prosthetic heart valves
* Myocardial ischemia limited to the right ventricular wall
* Q-Wave myocardial infarction within three (3) weeks prior to the procedure
* Non Q-Wave myocardial infarction within two (2) weeks prior to the procedure
* Requires anticoagulation medications or has other hemorrhagic propensity
* Severe arrhythmia within one week prior to the procedure
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01845103
Study Brief:
Protocol Section:
NCT01845103