NCT Number: NCT06599008
Evaluate the Incidence of Junctional Rhythms Occurring During Post-procedure TAVI Hospitalization.
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.
Trial opening soon.
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Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Observational
Primary location
CHU clermont-Ferrand, Clermont-Ferrand, France
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Primary outcomes
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The occurrence of junctional rhythm during hospitalization after TAVI procedure.
Time frame: 30 days post 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.
Secondary outcomes
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Describe the prognosis of the occurrence of a junctional rhythm during hospitalization following a TAVI procedure.
Time frame: 30 days post TAVI procedure
Need for pacemaker implantation between D0 and D30, following the TAVI procedure.
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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
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.
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
University Hospital, Clermont-Ferrand
Other
Registry information
Official study title
Incidence and Pronostic of Junctional Rhythm After TAVI Implantation
Acronym: JUNCTAVI
Important dates
- Study start
- 2024
- Primary completion
- 2025
- Study completion
- 2025
- First posted
- Sep 19, 2024
- Registry last updated
- Sep 19, 2024
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.