NCT06599008

Evaluate the Incidence of Junctional Rhythms Occurring During Post-procedure TAVI Hospitalization.

Incidence and Pronostic of Junctional Rhythm After TAVI Implantation

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 250 (estimated)
• Sponsor: University Hospital, Clermont-Ferrand · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Transcatheter Aortic Valve Implantation (TAVI) aims to treat patients with symptomatic narrowing of the aorta by implanting an aortic bioprosthesis. This technique, which is currently highly developed, can lead to the appearance of cardiac conduction disorders following implantation, and in particular the presence of a junctional rhythm. Junctional rhythms are tachycardias involving a circuit between the atria and the ventricles (junction between the two compartments atrium and ventricle). The goal of this observational study is to describe the incidence and pronostic of this rhythm disorder (junctional rhythm) following the TAVI procedure.

Detailed description

Monocentric observational study including all patients implanted with aortic bioprosthesis \[undergoing Transcatheter Aortic Valve Implantation (TAVI)\] at Clermont-Ferrand University Hospital, between December 1st, 2023 and March 1st, 2025. Telemetric monitoring and daily electrocardiograms were used to identify junctional rhythms. The primary endpoint was pacemaker (PM) implantation between day 0 and day 30 after TAVI. Patients with a junctional rhythm at the time of hospitalization were recalled to find out whether they had benefited from PM implantation within 30 days after the TAVI procedure.

Conditions

• Incidence of Junctional Rhythm

Timeline

• Start date: 2024-10-05
• Primary completion: 2025-05-01
• Completion: 2025-05-01
• First posted: 2024-09-19
• Last updated: 2024-09-19

Locations

2 sites across 1 country: France