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

Not yet recruiting

• Conditions: Incidence of Junctional Rhythm

• Registration Number: NCT06599008
• Lead Sponsor: University Hospital, Clermont-Ferrand

Brief 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.

Study Timeline

• Status Verified: 2024-09
• Study First Submitted: 2024-09-12
• Study First Submitted QC: 2024-09-12
• Last Update Submitted: 2024-09-12
• Study First Posted: 2024-09-19
• Last Update Posted: 2024-09-19
• Study Start: 2024-10-05
• Primary Completion: 2025-05-01
• Study Completion: 2025-05-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 250

Inclusion Criteria

• Major patients who have undergone or are undergoing a TAVI procedure (since 01/12/2023) and who present a junctional rhythm.

Exclusion Criteria

• Minor patients
• Patients already implanted with a pacemaker
• Atrial fibrillation
• Pregnant women.
• Patients under guardianship or legal protection
• Patients deprived of liberty
• Patients refusing to participate in the study

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The occurrence of junctional rhythm during hospitalization after TAVI procedure.	30 days post TAVI procedure	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.

Secondary Outcome Measures

Name	Time	Method
Describe the prognosis of the occurrence of a junctional rhythm during hospitalization following a TAVI procedure.	30 days post TAVI procedure	Need for pacemaker implantation between D0 and D30, following the TAVI procedure.
Investigate the association between the presence of a junctional rhythm following TAVI procedure and all-cause or cardiovascular mortality, rehospitalization, and heart failure.	30 days post TAVI procedure	Assessment of the prognosis of junctional rhythms: collection of all-cause mortality, cardiovascular mortality, presence of syncope, conduction disorder on Holter ECG, rehospitalizations, occurrence of heart failure at day 30 post TAVI.

Trial Locations

Locations (2)

Centre Hospitalier Universitaire de Clermont-Ferrand; 🇫🇷 Clermont-Ferrand, France

CHU clermont-Ferrand; 🇫🇷 clermont-Ferrand, France