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 @ 7:13 PM
Ignite Modification Date:
2025-12-24 @ 7:13 PM
NCT ID:
NCT03631303
Eligibility Criteria:
Inclusion Criteria:
* Implanted with a dual-chamber device
* For ICD patients: a LVEF ≤35%, measured recently
* For Pacemaker patients: a LVEF \> 50% measured both recently
* A device follow-up of at least one year must be available
* Optimal (stable) medical therapy
* Sinus rhythm
Exclusion Criteria:
* Age \<18 or incapacitated adult
* Unknown left ventricular function prior to device implantation
* Patients unwilling to participate
* Documented atrial fibrillation
* Second or third degree atrioventricular (AV) conduction disorders;
* Patients with a cardiac resynchronization therapy (CRT-D) or one-chamber device
* Hypertrophic cardiomyopathy
* Conditions with insufficient blood flow to the fingers, e.g. M. Raynaud or conditions with extreme vasoconstriction
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03631303
Study Brief:
Protocol Section:
NCT03631303