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

Launched by HOSPITAL CLINIC OF BARCELONA · Jan 8, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at two different types of heart pacing—physiological pacing and right ventricular pacing—in patients who have had a successful heart valve replacement called Transcatheter Aortic Valve Implantation (TAVI) and need a pacemaker due to a condition called AV block. The goal is to see which type of pacing helps patients feel better and improves their heart health after 12 months. The study is currently recruiting participants who are between 65 and 74 years old, have good heart function (specifically, a left ventricular ejection fraction greater than 50%), and have agreed to take part by signing consent.

To be eligible for this study, patients must have successfully undergone TAVI and need pacing due to AV block. However, those with significant heart function issues or a life expectancy of less than 12 months will not qualify. Participants can expect regular follow-ups to monitor their health and progress over the year. This trial is important as it aims to find out which pacing method is better for improving the quality of life for patients after TAVI.

Gender

ALL

Eligibility criteria

• 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.