NCT04128384: HOM-TAVI

Infranodal Conduction Time During TAVR as Predictor of HAVB

Status unknown NA Last updated 22 October 2019

What this trial tests

NA trial testing Limited electrophysiologic study including measurements of HV- and AH-intervals pre- and post-TAVR in Severe Aortic Valve Stenosis in 200 participants. Status unknown.

Timeline

21 June 2018

Primary endpoint
31 December 2021

31 January 2023

Quick facts

Lead sponsor	University Hospital, Saarland
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	diagnostic
Enrollment	200
Start date	21 June 2018
Primary completion	31 December 2021
Estimated completion	31 January 2023
Sites	1 location across Germany

Drugs / interventions tested

• Limited electrophysiologic study including measurements of HV- and AH-intervals pre- and post-TAVR

Conditions studied

• Severe Aortic Valve Stenosis — all drugs for Severe Aortic Valve Stenosis →
• High-degree AV Block — all drugs for High-degree AV Block →
• Left Bundle-Branch Block — all drugs for Left Bundle-Branch Block →

Sponsor

University Hospital, Saarland

Who can join

Eligibility, any sex, with Severe Aortic Valve Stenosis or High-degree AV Block. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Consecutive patients with high grade aortic stenosis undergoing transcatheter aortic valve replacement (TAVR) with a self-expanding valve (Medtronic CoreValve Evolut R® or Edwards Sapien S3®) without pre-existing pacemaker devices are eligible for inclusion. During the TAVR procedure, an electrophysiologic study including measurements of infranodal conduction times (HV-interval before and after valve implantation) will be performed. Electrocardiograms before TAVR, before discharge, after 30 days and after 12 months will be analyzed regarding new onset LBB and the occurrence of high-degree AV block (HAVB) .

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Unmet Needs in TAVR: Conduction Disturbances and Management of Coronary Artery Disease.
   Auffret V, Ridard C, Salerno N, Sorrentino S. · · 2022 · cited 7× · PMID 36362484 · DOI 10.3390/jcm11216256
2. Prediction of conduction disturbances in patients undergoing transcatheter aortic valve replacement.
   Pavlicek V, Mahfoud F, Bubel K, Fries P, et al · · 2023 · cited 6× · PMID 36680617 · DOI 10.1007/s00392-023-02160-0