MedTrace Logo

HV Electrophysiology Study In Transcatheter Aortic Valve Implantation Patients

NCT02659137 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2016-01-20

No results posted yet for this study

Summary

TAVI induced LBBB is a complication that occurs between 7 and 65 % of the cases, numbers that differ considerably between devices. There is an increased risk of progression to total AV-block at follow-up, with the risk of brady-arrhythmic death.

The aim of the study is to elucidate the anatomical location of the conduction pathology of a TAVI induced LBBB. This could impact valve design and placement and thereby reduce the number of new LBBB induced by TAVI in the future. Furthermore, finding predictors for progression to a high degree AV block in the follow-up (and thus an indication for permanent pacemaker) could improve management of post-operative conduction abnormalities and prevent the risk of brady-arrhythmic death.

Conditions

  • Left Bundle Branch Block
  • Transcatheter Aortic Valve Replacement
  • Transcatheter Aortic Valve Implantation

Interventions

OTHER

HV measurement

Electrophysiology (EP) study during the TAVI procedure

Sponsors & Collaborators

  • Maastricht University

    collaborator OTHER

  • Maastricht University Medical Center

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-01-31
Primary Completion
2017-07-31
Completion
2017-12-31

Countries

  • Netherlands

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 NCT02659137 on ClinicalTrials.gov