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RecruitingNot ApplicableNCT06197503

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

Ranodmized Study of Physiological vs Right Ventricular Pacing in Patients With Normal Ventricular Function Post TAVI (PHYSTAVI II)

Sponsor

Hospital Clinic of Barcelona

Enrollment

48 participants

Start Date

Nov 30, 2023

Study Type

INTERVENTIONAL

Conditions

Right Ventricular PacingAV BlockTranscatheter Aortic Valve ImplantationPhysiological PacingPreserved Left Ventricular Systolic Function

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

Min Age: 18 Years

Inclusion Criteria4

  • 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 Criteria5

  • 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.
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Interventions

PROCEDUREConduction system pacing

Left bundle branch pacing or His bundle branch pacing

PROCEDURERight ventricular pacing

Conventional pacing

Locations(1)

Hospital Clínic de Barcelona

Barcelona, Spain

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NCT06197503

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