Infranodal Conduction Time During TAVR as Predictor of HAVB

Study Overview
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Brief Summary
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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) .

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

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

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Indication for TAVR according to current guidelines Written informed consent Exclusion Criteria: 1. Pre-existent intracardiac device as pacemaker, implanted cardioverter defibrillator or CRT-P/CRT-D device
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: EPS arm<br>Limited electrophysiologic study including measurements of HV- and AH-intervals pre- and post-TAVR | Diagnostic Test: Limited electrophysiologic study including measurements of HV- and AH-intervals pre- and post-TAVR<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Differences between implanted valve types on ifranodal conduction |  | 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Transcatheter valve replacement, Infranodal conduction time, High-degree AV block, Left Bundle-Branch Block