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 @ 11:53 PM
Ignite Modification Date:
2025-12-24 @ 11:53 PM
NCT ID:
NCT00927251
Eligibility Criteria:
Inclusion Criteria:
* Cardiac Resynchronization Therapy (CRT)/Cardiac Resynchronization Therapy-Defibrillator (CRT-D) indications according to the European Society of Cardiology/American College of Cardiology/American Heart Association (ESC/ACC/AHA) guidelines
* On optimal medical treatment according to investigator opinion
* Indicated for implantable cardioverter defibrillator (ICD) if CRT-D is implanted
* Patient consent
* Geographically stable
Exclusion Criteria:
* Left Ventricular (LV) lead implant attempt in last 30 days
* Unstable angina or acute myocardial infarction (MI) in past 30 days
* Coronary artery bypass graft (CABG) or percutaneous transluminal coronary angioplasty (PTCA) in past 90 days
* Contraindicated for transvenous pacing
* Heart transplant
* Contraindicated for less than 1 milligram (mg) dexamethasone acetate
* Enrolled or intends to participate in concurrent drug and/or device study which would confound results
* Life expectancy shorter than duration of the study
* Exclusion criteria required by local law
* Unable to tolerate urgent thoracotomy
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT00927251
Study Brief:
Protocol Section:
NCT00927251