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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-A01132-45 | Other Identifier | ANSM : Agence Nationale de Sécurité du Médicament et des Produits de Santé | |
| 24.03051.000665 | Other Identifier | CPP: Comité de Protection des Personnes Ile de France III |
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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.
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.
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| Measure | Description | Time Frame |
|---|---|---|
| The occurrence of junctional rhythm during hospitalization after 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. | 30 days post TAVI procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Describe the prognosis of the occurrence of a junctional rhythm during hospitalization following a TAVI procedure. | Need for pacemaker implantation between D0 and D30, following the TAVI procedure. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lise Laclautre | Contact | +33 473 754 963 | promo_interne_drci@chu-clermontferrand.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier Universitaire de Clermont-Ferrand | Clermont-Ferrand | 63000 | France | |||
| CHU clermont-Ferrand |
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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. |
| 30 days post TAVI procedure |
| Clermont-Ferrand |
| France |
|