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 @ 5:05 AM
Ignite Modification Date:
2025-12-25 @ 5:05 AM
NCT ID:
NCT01282918
Eligibility Criteria:
Inclusion Criteria:
* Indication for implantation of a single chamber ICD, dual chamber ICD and CRT-D therapy according to the ACC/AHA/ESC 2006 guidelines for management of patients with ventricular arrhythmias and the prevention of sudden cardiac death and the 2010 focused update of ESC guidelines on device therapy in heart failure (Class I recommendations)
* Primary or secondary prophylaxis
* First ICD implantation with no pre/existing or previous ICD therapy or ICD system
* The patient is willing and able to comply with the clinical investigation plan
* Patient has signed informed consent
Exclusion Criteria:
* Age ≤ 18 years
* ARVC or hypertrophic cardiomyopathy
* VF due to acute ischemia or other potentially reversible causes
* Actively listed for a transplant
* Unable or unwilling to participate in the study
* Unavailable for required follow-ups and study procedures
* Participating in another clinical study other than a registry or observational/non-interventional study
* Anticipated right sided implantation of ICD generator
* Malignant condition with a life expectancy less than the duration of the study
* Pregnant and breast-feeding women
* Terminal renal insufficiency
* Persistent AF without pre-operative TEE (Transesophageal echocardiography)
* Persistent AF with left atrial thrombus diagnosed by TEE
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01282918
Study Brief:
Protocol Section:
NCT01282918