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 @ 6:55 PM
Ignite Modification Date:
2025-12-24 @ 6:55 PM
NCT ID:
NCT01528657
Eligibility Criteria:
Inclusion Criteria:
* Patients over 18 years of age;
* Patient has proven informed consent;
* Subject with indication of dual chamber pacemaker due to Sinus Node Dysfunction;
* Subjects with a dual chamber pacemaker already implanted within six months from enrollment, provided that ventricular pacing percentage ≤ 40% and with the right ventricular lead in the apical position;
* Stable medical situation;
* Stable geographical situation;
Exclusion Criteria:
* Permanent or paroxysmal AV block ≥ II;
* Permanent Atrial fibrillation/Atrial flutter;
* Device Replacement;
* Patient with a poor echocardiographic window;
* Patient already implanted with the right ventricular lead not in the apical position;
* Subjects with a dual chamber pacemaker, implanted later than six months;
* Subjects with a dual chamber pacemaker with ventricular pacing percentage ≥ 40%;
* Contraindication for DDD(R)-ADI(R) or DDD(R) pacing modes;
* VpS or IRSplus algorithm contraindications;
* Age \< 18 years;
* Life expectancy \< 12 months;
* Cardiac surgery planned within the FU period;
* Participation to another clinical investigation;
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01528657
Study Brief:
Protocol Section:
NCT01528657