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

ConditionsTranscatheter Aortic Valve Implantation Physiological Pacing Right Ventricular Pacing AV Block Preserved Left Ventricular Systolic Function

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorHospital Clinic of Barcelona

About this trial

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 criteria

Qualifiers

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.

Disqualifiers

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).

Trial design

Treatments tested in this trial

Conduction system pacing
Right ventricular pacing

Treatment groups

48 Participants

are divided into 2 treatment groups

Locations

Hospital Clínic de Barcelona08036, Barcelona Spain

Sponsors and collaborators

Hospital Clinic of Barcelona

Lead sponsor

Source ClinicalTrials.gov