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

Incidence and Pronostic of Junctional Rhythm After TAVI Implantation

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Incidence of Junctional Rhythm

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 Type: Observational
• Enrollment (Estimated): 250

Contacts and Locations

• Study Contact: Name: Lise LACLAUTRE; Phone Number: +33 473 754 963; Email: promo_interne_drci@chu-clermontferrand.fr

Study Locations

• France
  • Clermont-Ferrand, France, 63000
    • Centre Hospitalier Universitaire de Clermont-Ferrand
  • clermont-Ferrand, France
    • CHU Clermont-Ferrand
    • Contact: Lise Laclautre; Phone Number: 0033473754963; Email: promo_interne_drci@chu-clermontferrand.fr
    • Principal Investigator: Grégoire MASSOULLIE

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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.	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

Collaborators and Investigators

• Sponsor: University Hospital, Clermont-Ferrand

Study record dates

Study Major Dates

• Study Start (Estimated): October 5, 2024
• Primary Completion (Estimated): May 1, 2025
• Study Completion (Estimated): May 1, 2025

Study Registration Dates

• First Submitted: September 12, 2024
• First Submitted That Met QC Criteria: September 12, 2024
• First Posted (Estimated): September 19, 2024

Study Record Updates

• Last Update Posted (Estimated): September 19, 2024
• Last Update Submitted That Met QC Criteria: September 12, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: Transcatheter Aortic Valve Implantation; Junctional rhythm
• Other Study ID Numbers: RNI 2024 MASSOULLIE; 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)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No