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:
2025-12-25 @ 4:12 AM
Ignite Modification Date:
2025-12-25 @ 4:12 AM
NCT ID:
NCT00157820
Eligibility Criteria:
Inclusion Criteria:
* Meet the Class I implantation criteria for single chamber implantable cardioverter defibrillator according to the guidelines (ACC/AHA).
Exclusion Criteria:
* Permanent atrial fibrillation
* Patients without structural heart disease
* Patient meets implantation criteria for dual-chamber pacing (symptomatic sinus node disease, all 2nd Atrio-Ventricular (AV) block \[except asymptomatic Mobitz I\] and all 3rd degree AV block ).
* Patient with previous system implanted (ICD or pacemaker).
* Patients with biventricular stimulation or re-synchronization.
* Patient has a mechanical right heart valve.
* Patient has medical conditions that would preclude the testing required by the protocol, or limit study participation.
* Patient is unwilling or unable to cooperate or give written informed consent, or the patient is a minor and legal guardians refuse to give informed consent.
* Patient is or will be inaccessible for follow-up at the study center.
* Patients who are enrolled or planning to enroll in other clinical trials during the clinical study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
100 Years
Study:
NCT00157820
Study Brief:
Protocol Section:
NCT00157820