Clinical trial NCT06599008: Evaluate the Incidence of Junctional Rhythms Occurring During Post-procedure TAVI Hospitalization.
Official title: Incidence and Pronostic of Junctional Rhythm After TAVI Implantation
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Incidence of Junctional Rhythm
Keywords: Transcatheter Aortic Valve Implantation
Junctional rhythm
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: The occurrence of junctional rhythm during hospitalization after TAVI procedure.
timeFrame: 30 days post TAVI procedure
Secondary outcomes:
measure: Describe the prognosis of the occurrence of a junctional rhythm during hospitalization following a TAVI procedure.
timeFrame: 30 days post TAVI procedure
measure: Investigate the association between the presence of a junctional rhythm following TAVI procedure and all-cause or cardiovascular mortality, rehospitalization, and heart failure.
timeFrame: 30 days post TAVI procedure
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: Centre Hospitalier Universitaire de Clermont-Ferrand
city: clermont-Ferrand
country: France
facility: CHU clermont-Ferrand
Study officials:
References: