Infranodal Conduction Time During TAVR as Predictor of HAVB

Not Applicable

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

• Registration Number: NCT04128384
• Lead Sponsor: University Hospital, Saarland

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) .

Detailed Description

Not available

Study Timeline

• Study Start: 2018-06-21
• Status Verified: 2019-10
• Study First Submitted: 2019-10-12
• Study First Submitted QC: 2019-10-12
• Study First Posted: 2019-10-16
• Last Update Submitted: 2019-10-19
• Last Update Posted: 2019-10-22
• Primary Completion: 2021-12-31
• Study Completion: 2023-01-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Differences between implanted valve types on ifranodal conduction	24 months

Trial Locations

Locations (1)

Universitätsklinikum des Saarlandes; 🇩🇪 Homburg, Saarland, Germany