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 @ 2:16 AM
Ignite Modification Date:
2025-12-25 @ 2:16 AM
NCT ID:
NCT00711360
Eligibility Criteria:
Inclusion Criteria:
* Patient eligible for 1-, 2- or 3-chamber ICD implantation according to current guidelines or patient already implanted with a Lumax 540 device or successor
* NYHA-class II to IV
* LVEF lower or equal to 35%
* Patient accepts Home Monitoring concept and has sufficient GSM/GPRS net coverage
* Increased risk for HF-related hospitalization according to pre-defined criteria
* Patient information
* Informed consent
Exclusion Criteria:
* Age \< 18 years
* Contraindication for ICD implantation
* Post HTX or actively listed for HTX
* Cardiac surgery within the previous 3 months or planned at time of inclusion
* Acute coronary syndrome within the previous 3 months
* Chronic renal dialysis
* Pregnant or breast-feeding women
* Limited contractual capability
* Participation in another study
* Anticipated non-compliance with the follow-up scheme
* Life expectancy not longer than 1.5 years due to a non-cardiac disease
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00711360
Study Brief:
Protocol Section:
NCT00711360