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

NCT ID: NCT06599008

Last Updated: 2024-09-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

250 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-10-05

Study Completion Date

2025-05-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Incidence of Junctional Rhythm

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Clermont-Ferrand

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Centre Hospitalier Universitaire de Clermont-Ferrand

Clermont-Ferrand, , France

Site Status

CHU clermont-Ferrand

Clermont-Ferrand, , France

Site Status

Countries

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France

Central Contacts

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Lise Laclautre

Role: CONTACT

+33 473 754 963

Facility Contacts

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Lise Laclautre

Role: primary

0033473754963

Other Identifiers

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2024-A01132-45

Identifier Type: OTHER

Identifier Source: secondary_id

24.03051.000665

Identifier Type: OTHER

Identifier Source: secondary_id

RNI 2024 MASSOULLIE

Identifier Type: -

Identifier Source: org_study_id

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