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 @ 4:57 AM
Ignite Modification Date:
2025-12-25 @ 4:57 AM
NCT ID:
NCT02222818
Eligibility Criteria:
Inclusion Criteria:
* Subject is willing to sign and date the study patient Informed Consent form.
* Subject is at least 18 years of age (or older, if required by local law).
* Subject is expected to remain available after enrollment to complete follow-up visits in both arms of the study
* Subject has had a Medtronic Viva or Brava CRT-D device implanted at least 30 days prior to enrollment.
* Subject has history of AF burden, of at least 6 days of at least 4 hours of AF over any 4 week period within the last 90 days as documented in device diagnostic data OR if subject has no atrial lead (therefore no device diagnostic data) but clinical evidence of high AF burden.
* Subject has demonstrated history of being able to complete Left Ventricular Capture Management (LVCM) documented in device data.
* Subject has a documented % V pacing during AF of less than or equal to 97% within 90 days prior to enrollment or within 10 days after enrollment.
Exclusion Criteria:
* Subject has undergone AV node ablation for treatment of AF.
* Subject has complete or 3rd degree AV block.
* Subject has had an MI within 30 days.
* Subject has medical conditions that limit study participation (per physician discretion).
* Subject is enrolled in one or more concurrent studies that could confound the study results as determined by Medtronic.
* Subject has a limited life expectancy for non-cardiac causes that would not allow completion of the study.
* Subject is pregnant (in the US, all women of child-bearing potential must undergo a pregnancy test within seven days prior to CRTee download).
* Subject meets the exclusion criteria required by local law.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02222818
Study Brief:
Protocol Section:
NCT02222818