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

U

University Hospital, Clermont-Ferrand

Status

Not yet enrolling

Conditions

Incidence of Junctional Rhythm

Study type

Observational

Funder types

Other

Identifiers

NCT06599008
RNI 2024 MASSOULLIE
2024-A01132-45 (Other Identifier)
24.03051.000665 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

250 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial contacts and locations

2

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Central trial contact

Lise Laclautre

Data sourced from clinicaltrials.gov

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