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:
2025-12-24 @ 2:20 PM
Ignite Modification Date:
2025-12-24 @ 2:20 PM
NCT ID:
NCT01930695
Eligibility Criteria:
Inclusion Criteria:
* CRT-D indication according to current ESC guidelines (NYHA III/IV; QRS≥120ms; LVEF≤35%; Expected survival ≥ 1 year; need for pacing because of slow ventricular rate or pacemaker dependency as a result of AV nodal ablation or ventricular rate ≤60bpm at rest and ≤90bpm on exercise)
* Permanent atrial fibrillation
* Patients planned to be implanted with BIOTRONIK Lumax 640/740 HF-T
* Patients planned to be implanted with BIOTRONIK LinoxSmart S DX right ventricular lead (or successors)
* Patient eligible for programming of DX functionality according to the physicians' decision
* Patient is willing and able to comply with the CIP and provided written informed consent
* Patient accepts Home Monitoring® concept and has sufficient GSM/GPRS coverage
Exclusion Criteria:
* Patients with any contraindication to CRT-D therapy
* Patients listed for heart transplantation
* Life expectancy less than 12 months
* Pregnant or breast-feeding women
* Patients under the age of 18
* Patients with limited contractual capability
* Participation in any other clinical study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01930695
Study Brief:
Protocol Section:
NCT01930695