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 @ 2:47 AM
Ignite Modification Date:
2025-12-25 @ 2:47 AM
NCT ID:
NCT04068233
Eligibility Criteria:
Inclusion Criteria:
* Patient is able and willing to give informed consent and is above the age of 18.
* Patient is implanted with a dual chamber pacemaker system for at least 6 weeks.
* Patient is in sinus rhythm on the day of recruitment.
* Patient has a ventricular pacing rate exceeding 90%.
* Upon initial device interrogation, parameters are within normal ranges.
* Calculated battery life is more than 1 year.
Exclusion Criteria:
* Patient is not in sinus rhythm on the day of echo examination.
* Intrinsic ventricular activation on the day of echo examination.
* Relevant shunt on the atrial, ventricular or pulmonary level.
* Moderate or severe heart valve dysfunction (stenosis or regurgitation).
* Presence of other medical devices that may interact with the pacemaker system.
* Women who are pregnant or breast feeding.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
99 Years
Study:
NCT04068233
Study Brief:
Protocol Section:
NCT04068233