RecruitingNot Applicable

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

Spain48 participantsStarted 2023-11-30

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Clinical combined endpoint: survival; and improvement > 1 point in NYHA class or > 25% increase in the distance covered in the 6-minute walking test.

Timeframe: 12 months

Trial details

NCT IDNCT06197503

SponsorHospital Clinic of Barcelona

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-12-15

Contact for this trial

Lluís Mont, MD, PhD

93 2271778 Ext. 2094 lmont@clinic.cat

View on ClinicalTrials.gov More Transcatheter Aortic Valve Implantation trials