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 @ 12:32 AM
Ignite Modification Date:
2025-12-25 @ 12:32 AM
NCT ID:
NCT00148967
Eligibility Criteria:
Inclusion Criteria:
* Patients who meet VITALITY™AVT® ICD indications
* Patients who sign and date a Patient Informed Consent prior to device implant
* Patients who remain in the clinical care of the enrolling physician
Exclusion Criteria:
* Patients with current indication for CRT-D
* Patients who previously had a pacemaker, ICD or CRT-D
* Patients with chronic AF
* Patients whose life expectancy is \<12 months due to other medical conditions
* Patients who are expected to receive a heart transplant during the duration of the study
* Patients with epicardial pacing leads
* Patients who have CABG, PCI, cardiac or other arrhythmia surgery planned but not yet performed
* Patients with or who are likely to receive a tricuspid or other valve prosthesis
* Patients who are currently enrolled in another investigational study that would directly impact the treatment or outcome of the current study
* Patients who are younger than 18 years of age
* Patients who are pregnant
* Patients who are mentally incompetent and cannot give Patient Informed Consent or participate in the study
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00148967
Study Brief:
Protocol Section:
NCT00148967