Evaluate the Incidence of Junctional Rhythms Occurring During Post-procedure TAVI Hospitalization.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Incidence of Junctional Rhythm. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Incidence and Pronostic of Junctional Rhythm After TAVI Implantation
Overview
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.
Primary outcome measures
- The occurrence of junctional rhythm during hospitalization after TAVI procedure. [Time frame: 30 days post TAVI procedure]
Secondary outcome measures (2)
- Describe the prognosis of the occurrence of a junctional rhythm during hospitalization following a TAVI procedure. [Time frame: 30 days post 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. [Time frame: 30 days post 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
France · 2 centers
- Centre Hospitalier Universitaire de Clermont-Ferrand — Clermont-Ferrand
- CHU clermont-Ferrand — Clermont-Ferrand
Identifiers
NCT: NCT06599008 · RNI 2024 MASSOULLIE · 2024-A01132-45 · 24.03051.000665