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 @ 12:31 AM
Ignite Modification Date:
2025-12-25 @ 12:31 AM
NCT ID:
NCT01039467
Eligibility Criteria:
Inclusion Criteria:
* Signed and dated study informed consent
* Class I or Class IIa pacemaker indication
* Geographically stable and available for follow-up at the center for the length of the study
* Age greater than 18
* To be implanted with Adapta dual chamber pacemaker
Exclusion Criteria:
* Unwillingness or inability to give written informed consent to participate in the Study
* Patient with a previously implanted pacemaker/Implantable Cardioverter-Defibrillator (ICD)/Cardiac Resynchronization Therapy (CRT) device
* Life expectancy of less than one year
* Patient has a mechanical tricuspid heart valve
* Medical conditions that preclude the testing requirement by the protocol or limit study participation
* Patient has persistent 3rd degree atrioventricular (AV) block
* Patient has persistent atrial fibrillation (AF)
* Patient has neurogenic syncope
* Patient has carotid sinus syndrome
* Patient has hypertrophic obstructive cardiomyopathy
* Inclusion in another clinical trial or study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01039467
Study Brief:
Protocol Section:
NCT01039467