Transcatheter Aortic Valve ImplantationPhysiological PacingRight Ventricular PacingAV BlockPreserved Left Ventricular Systolic Function
Investigational drug(s) / intervention(s)
Conduction system pacingRight ventricular pacing
Conduction system pacing: Left bundle branch pacing or His bundle branch pacing
Right ventricular pacing: Conventional pacing
Study summary
Single-center randomized trial in patients with pacing indication (AV block) after TAVI (transfemoral aortic valve implantation) and LVEF\> 50%, that aims to study the percentage of patients who improve at 12 months in a combined clinical endpoint.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* Successful implantation of TAVI according to VARC-3 criteria.
* Indication of cardiac pacing due to AV block according to ESC Guidelines.
* LVEF\> 50%.
* The patient must indicate their acceptance to participate in the study by signing an informed consent document.
Exclusion Criteria:
* Ventricular dysfunction: LVEF \<50%.
* Transapical TAVI.
* Participating currently in a clinical investigation that includes an active treatment.
* Patients with left bundle branch block but without indication of pacing (AV block).
* Life expectancy \<12 months.
Primary outcome measure(s)
Clinical combined endpoint: survival; and improvement > 1 point in NYHA class or > 25% increase in the distance covered in the 6-minute walking test. — 12 months Determine the percentage of patients who improve at 12 months on a clinical combined endpoint: survival; and improvement \> 1 point in NYHA class or \> 25% increase in the distance covered in the 6-minute walking test.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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