Infranodal Conduction Time During TAVR as Predictor of HAVB

Changes in Infranodal Conduction Times and New Onset Left Bundle Branch Block: Possible Predictors for High-grade AV Block Following Transcatheter Aortic Valve Replacement

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04128384

Acronym

HOM-TAVI

Enrollment

200

Registered

2019-10-16

Start date

2018-06-21

Completion date

2023-01-31

Last updated

2019-10-22

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

Conditions

High-degree AV Block, Left Bundle-Branch Block, Severe Aortic Valve Stenosis

Keywords

Transcatheter valve replacement, Infranodal conduction time, High-degree AV block, Left Bundle-Branch Block

Brief summary

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) .

Interventions

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

For the purpose of obtaining intracardiac measurements, the quadripolar diagnostic catheter used as temporary pacemaker wire (5F, Woven, Boston Scientific) during TAVR was retracted from the apex and positioned at the His bundle to measure HV- and AH-intervals.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion criteria

1. Indication for TAVR according to current guidelines 2. Written informed consent

Exclusion criteria

1\. Pre-existent intracardiac device as pacemaker, implanted cardioverter defibrillator or CRT-P/CRT-D device

Design outcomes

Primary

Measure	Time frame	Description
High-degree AV block	24 months	Occurence of high-degree AV block necessitating a pacemaker implantation during follow up
Persistence of left bundle-branch block	24 months	Persistence of new onset left bundle branch-block following TAVR procedure

Secondary

Measure	Time frame
Differences between implanted valve types on ifranodal conduction	24 months

Countries

Germany

Contacts

Primary ContactChristian Ukena, MD

christian.ukena@uks.eu004968411615912

Backup ContactValerie Pavlicek, MD

valerie.pavlicek@uks.eu004968411615912

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 12, 2026