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 @ 12:11 PM
Ignite Modification Date:
2025-12-24 @ 12:11 PM
NCT ID:
NCT00323661
Eligibility Criteria:
Inclusion Criteria:
* Patients with a CYLOS pacemaker (implantation within the last 3 to 6 weeks)
* Closed Loop Stimulation mode activated since pre-hospital discharge
* Patients with chronotropic incompetence according to physician's judgment
* Maximum sinus rate \< 100 beats per minute (bpm) OR percentage of atrial pacing ≥ 25%
* Patients suitable for rate-adaptive pacing for at least 2 years
* Patient informed consent
Exclusion Criteria:
* Age under 55
* Pregnant and breast-feeding women
* Patients who are already enrolled in another study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
55 Years
Study:
NCT00323661
Study Brief:
Protocol Section:
NCT00323661