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

Predictive Value of Pre-Transcatheter Aortic Valve Implantation (TAVI) Infrahissian Conduction Time in the Occurrence of Complete Atrioventricular Block in Patients With Preoperative Right Bundle Branch Block

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05714579

Acronym

TAVHIS

Enrollment

Registered

2023-02-06

Start date

2023-05-30

Completion date

2024-11-20

Last updated

2025-03-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aortic Stenosis, Severe

Brief summary

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)

Detailed 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.

Interventions

PROCEDURETranscatheter Aortic Valve Implantation

The TAVI procedure is performed transfemorally under local anesthesia most often, or more rarely under general anesthesia via the subclavian or transaortic route. Identification is carried out under fluoroscopy in the cardiac catheterization room. The crossing of the aortic valve allows the establishment of a guide at the bottom of the left ventricle. Aortic valve predilation can be performed. The tightness of the device is checked by an aortography. Sometimes, post-dilation of the implanted bioprosthesis proves necessary, particularly in the event of under-deployment or significant para-prosthetic leakage. The duration of the intervention is approximately 1 hour.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

65 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
Implantation of a Pacemaker at 30 days	30 days	Implantation of a Pacemaker at 30 days for occurrence of a high-grade conduction disorder per- or post-procedure (yes/no)

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026