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:
2025-12-26 @ 12:15 PM
Ignite Modification Date:
2025-12-26 @ 12:15 PM
NCT ID:
NCT00787800
Eligibility Criteria:
Inclusion Criteria:
* Candidates for ICD for primary prevention according to American Heart Association/American College of Cardiology (AHA/ACC) guidelines who have a clinical indication for ICD implantation for ventricular arrhythmia or sudden death prevention.
* The ability to understand the scope of the study, provide written informed consent, and a willingness to complete all study visits and associated procedures.
Exclusion Criteria:
* Pregnant women
* Age \<18 years old
* Inability to provide consent
* On a heart transplant waiting list
* Life expectancy \<1 year
* Indication for pacing
* Atrioventricular (AV) node ablation
* Permanent atrial fibrillation or atrial flutter
* Indication for cardiac resynchronization
* Preexisting, separate pacemaker pulse generator that won't be explanted
* Intra-aortic balloon pump or other device
* Inotropic drug (not digitalis) necessary for hemodynamic support
* Chronic serious bacterial infection
* Inability to receive pectoral non-thoracotomy lead ICD
* Inability to program device according to protocol
* History of Out of Hospital Cardiac Arrest (OHCA) or sustained Ventricular Tachycardia as an indication for ICD (secondary prevention indication)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
90 Years
Study:
NCT00787800
Study Brief:
Protocol Section:
NCT00787800