Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06599008
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-12
Brief Title:
Evaluate the Incidence of Junctional Rhythms Occurring During Post-procedure TAVI Hospitalization
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Incidence and Pronostic of Junctional Rhythm After TAVI Implantation
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
JUNCTAVI
Brief Summary:
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
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:
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None