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 @ 3:39 AM
Ignite Modification Date:
2025-12-25 @ 3:39 AM
NCT ID:
NCT02362802
Eligibility Criteria:
Inclusion Criteria:
* All patients for de-novo implantation of a transvenous ICD (single chamber, dual chamber or cardiac resynchronization tehrapy) with left pectoral device position and planned apical location of the right ventricular defibrillation electrode.
Exclusion Criteria:
* Resuscitation, cardiac surgical procedure, acute coronary syndrome, acute myocardial infarction, coronary revascularisation, cardioversion or ablation during the past 4 weeks, if baseline high-sensitive Troponin T is elevated
* Known stenosis of coronary vessels with indication for coronary intervention or operative revascularisation
* Intracardiac thrombus or general contraindication against ventricular burst stimulation or intraoperative ICD-testing
* Atypical lead implantation with indication for defibrillation threshold testing by induction of ventricular fibrillation
* Right sided implantation of ICD
* Planned electrical cardioversion
* Lead explantation or -extraction during procedure
* Redo procedure (except of additional implantation of a right ventricular ICD lead)
* Present temporary pacemaker electrode
* ASA \>= IV or NYHA IV
* Cardiogenic shock
* Pulmonary embolism, cerebrovascular insult or dialysis in the past 4 weeks
* Lack of consent of patient
* Minority of patient
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02362802
Study Brief:
Protocol Section:
NCT02362802