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Predictive Value of Pre-TAVI Infrahissian Conduction Time in the Occurrence of Complete Atrioventricular Block (TAVHIS)

G

GCS Ramsay Santé pour l'Enseignement et la Recherche

Status

Terminated

Conditions

Aortic Stenosis, Severe

Treatments

Procedure: Transcatheter Aortic Valve Implantation

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT05714579
2022-A02274-39

Details and patient eligibility

About

The purpose of the study is implantation of a Pacemaker at 30 days for occurrence of a high-grade conduction disorder per- or post-procedure (yes/no)

Full description

The main objective is to assess the predictive value of the pre-TAVI infrahelic conduction time interval (infraheal conduction time measured before percutaneous aortic valve implantation) on the risk of Pacemaker implantation at 30 days post-TAVI, in patients with right bundle branch block prior to surgery.

The aim of the study is to identify a pre-interventional marker of the risk of rhythmological complication after the TAVI procedure (Transcatheter Aortic Valve Implantation), in order to better anticipate it.

This is an interventional, prospective, longitudinal (follow-up: 12 months), multicenter (4 centers) study.

Enrollment

35 patients

Sex

All

Ages

65+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patient suffering from severe aortic stenosis, eligible for a TAVI procedure (Transcatheter Aortic Valve Implantation) ;
  • Patient presenting with complete right bundle branch block during the pre-TAVI electrocardiogram, with QRS interval ≥ 120 ms (depolarization of the ventricles);
  • Patient able to understand the information related to the study, to read the information leaflet and agreeing to participate in the study. ;
  • Patient having signed a consent.

Exclusion criteria

  • Contraindication to Transcatheter Aortic Valve Implantation ;
  • Patient under guardianship or curatorship, or under a regime of deprivation of liberty;
  • Patient participating in another clinical trial, or in a period of exclusion from another clinical trial;
  • Patient not benefiting from a social security scheme.

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

35 participants in 1 patient group

severe aortic stenosis with complete right bundle branch block
Experimental group
Description:
patients with aortic stenosis undergoing a Transcatheter Aortic Valve Implantation procedure
Treatment:
Procedure: Transcatheter Aortic Valve Implantation

Trial contacts and locations

1

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Central trial contact

Oualid ZOUAGHI, MD

Data sourced from clinicaltrials.gov

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