Infranodal Conduction Time During TAVR as Predictor of HAVB (HOM-TAVI)

University Hospital, Saarland

Status: Unknown

Conditions: Severe Aortic Valve Stenosis; Left Bundle-Branch Block; High-degree AV Block

Treatments: Diagnostic Test: Limited electrophysiologic study including measurements of HV- and AH-intervals pre- and post-TAVR

Study type: Interventional

Funder types: Other

Identifiers

NCT04128384

HOM-TAVI

Details and patient eligibility

About

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) .

Enrollment: 200 estimated patients

Sex: All

Volunteers: No 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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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200 participants in 1 patient group

EPS arm

Other group

Description:

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

Treatment:

Diagnostic Test: Limited electrophysiologic study including measurements of HV- and AH-intervals pre- and post-TAVR