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:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-26 @ 3:18 PM
NCT ID:
NCT07434193
Eligibility Criteria:
Inclusion Criteria:
* Age over 18 years
* Successful and complication-free TAVI implantation for significant aortic stenosis
* Signed informed consent after detailed patient information
* New-onset LBBB wider than 130 ms after TAVI, persisting at the time of planned discharge (assessed postoperatively on or after day 5)(21)
* Mildly reduced left ventricular systolic function on echocardiography at the planned time of discharge (at the earliest on postoperative day 5), with EF between 35% and 55%
Exclusion Criteria:
* Pre-existing right bundle branch block, or prior pacemaker/ICD implantation associated with significant (\>20%) ventricular pacing
* Progression of LBBB during hospitalization to a degree indicating pacemaker implantation (e.g., Mobitz II or third-degree AV block, alternating bundle branch block) before the planned discharge date
* Concomitant severe valvular disease of other valves (mitral, pulmonary, or tricuspid)
* Severe infection and/or septic state
* TAVI-associated stroke
* More than moderate paravalvular leak of the TAVI valve on postoperative echocardiography
* EF \< 35% or \> 55% on echocardiography performed at the planned time of discharge
* GOLD stage IV COPD
* Chronic renal failure requiring regular dialysis
* Concurrent participation in another clinical trial
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07434193
Study Brief:
Protocol Section:
NCT07434193