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 @ 11:44 PM
Ignite Modification Date:
2025-12-24 @ 11:44 PM
NCT ID:
NCT06055751
Eligibility Criteria:
Inclusion Criteria:
* Patients \> 18 years of age with severe aortic stenosis that undergo TAVI for severe aortic stenosis that develop any one of the following conduction system abnormalities on the immediate post procedural or post operative ECG and have undergone ILR implantation for long-term monitoring of these conditions:
* New left bundle branch block (QRS \>120ms)
* New first degree AV block (PR\>200ms) or worsening of pre-existing first-degree AV block by \>30ms
* New right bundle branch block (QRS\>120ms)
* Intra-procedural 2:1 or higher-grade AV block with spontaneous improvement within 24 hours
Exclusion Criteria:
* Patients with high grade or complete AV block post TAVI needing urgent pacemakers
* Patient with existing cardiac implantable electronic devices (CIEDs)
* Patients having a particular medical condition that dictates that they cannot tolerate subcutaneous, chronically-inserted device
* Patient is currently pregnant as evidenced by urine positive Beta-HCG. (Urine Beta human chorionic gonadotropin (HCG) will be checked in all females of the reproductive age group).
* Patients not willing to sign the consent, lacks the capacity to sign the consent or revoke the consent after signing will be excluded
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06055751
Study Brief:
Protocol Section:
NCT06055751