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 @ 9:20 PM
Ignite Modification Date:
2025-12-24 @ 9:20 PM
NCT ID:
NCT03624504
Eligibility Criteria:
Inclusion Criteria:
1. Subjects who have a Class I or II indication for implantation of a single chamber ventricular pacemaker according to ACC/AHA/HRS 2008 guidelines and China guideline.
2. Subjects who are willing to participate in study through consent and willing to undergo study specific required procedures with expectancy of geographically stable for follow up duration.
3. Subjects who are at least 18 years of age.
Exclusion Criteria:
1. Subject has an existing or prior pacemaker, ICD or CRT device implant.
2. Subject has unstable angina pectoris or has had an acute myocardial infarction (AMI) in the 30 days prior to eligibility assessment.
3. Subjects with current implantation of neurostimulator or any other chronically implanted device which uses current in the body. Note that a temporary pacing wire is allowed.
4. Subjects with a mechanical tricuspid valve, implanted vena cava filter, or left ventricular assist device (LVAD).
5. Subjects who are morbidly obese and physician believes telemetry communication of ≤5 inches (12.5 cm) could not be obtained with programmer head.
6. Subjects whose femoral venous anatomy is unable to accommodate a 23 French introducer sheath or implant on the right side of the heart (for example, due to obstructions or severe tortuosity) in the opinion of the implanter.
7. Subjects who are considered as unable to tolerate an urgent sternotomy.
8. Subjects with a known intolerance to Nickel-Titanium (Nitinol) Alloy.
9. Subjects for whom a single dose of 1.0mg dexamethasone acetate may be contraindicated.
10. Subjects with a life expectancy of less than 12-months.
11. Subjects who are currently enrolled or planning to participate in a potentially confounding drug or device trial during the course of this study. Co-enrollment in concurrent trials is only allowed when document pre-approval is obtained from the Medtronic study manager.
12. Pregnant women or breastfeeding women, or women of child bearing potential and who are not on a reliable form of birth regulation method or abstinence.
13. Subjects with exclusion criteria required by local law (age or other).
14. Subjects with medical condition which precludes patient from participation in the opinion of the Investigator.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03624504
Study Brief:
Protocol Section:
NCT03624504