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Infranodal Conduction Time During TAVR as Predictor of HAVB

NCT04128384 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2019-10-22

No results posted yet for this study

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) .

Conditions

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

Interventions

DIAGNOSTIC_TEST

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the quadripolar diagnostic catheter used as temporary pacemaker wire (5F, Woven, Boston Scientific) during TAVR was retracted from the apex and positioned at the His bundle to measure HV- and AH-intervals.

Sponsors & Collaborators

  • University Hospital, Saarland

    lead OTHER

Principal Investigators

  • Christian Ukena, MD · Universitätsklinikum des Saarlandes, Homburg/Saar, Germany

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-06-21
Primary Completion
2021-12-31
Completion
2023-01-31
FDA Device
Yes

Countries

  • Germany

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04128384 on ClinicalTrials.gov