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Randomized Study of Physiological vs Right Ventricular Pacing in Patients With Normal Ventricular Function Post TAVI

RECRUITINGN/ASponsored by Hospital Clinic of Barcelona
Actively Recruiting
PhaseN/A
SponsorHospital Clinic of Barcelona
Started2023-11-30
Est. completion2025-12
Eligibility
Age18 Years+
Healthy vol.Accepted
View on ClinicalTrials.gov →

NCT06197503

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

Age: 18 Years+Healthy volunteers accepted
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.

Conditions6

AV BlockHeart DiseasePhysiological PacingPreserved Left Ventricular Systolic FunctionRight Ventricular PacingTranscatheter Aortic Valve Implantation

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