HV Electrophysiology Study In Transcatheter Aortic Valve Implantation Patients (HESITATE)

Maastricht University Medical Centre (MUMC) logo

Maastricht University Medical Centre (MUMC)

Status

Unknown

Conditions

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

Treatments

Other: HV measurement

Study type

Observational

Funder types

Other

Identifiers

NCT02659137
152042

Details and patient eligibility

About

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.

Full description

A prospective, single center, non-randomized pilot study in which patients will undergo an electrophysiology (EP) study during the TAVI procedure. All patients eligible for inclusion will undergo an electrophysiology (EP) study during the TAVI procedure. For the purpose of EP measurements, a His-catheter will be placed at the beginning of the procedure and remain in the same location until the end of the procedure. Continuous HV measurements will be collected, together with a continuous surface ECG, during the entire TAVI procedure. The different steps in TAVI procedure will be registered. During the study, patients will undergo regular electrocardiographic examinations at the outpatient clinic (before implantation, after implantation, before discharge and after 6 weeks, 6 and 12 months post-implantation). These are part of the standard healthcare after the TAVI procedure. The research protocol has been approved by the ethical committee (METC).

Enrollment

100 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • All patients must provide written informed consent

Exclusion criteria

  • Pre-existent LBBB
  • Pre-existent sick sinus syndrome
  • Pre-existent high-degree atrioventricular block
  • Pre-existent permanent pacemaker
  • Patients unable to provide written informed consent

Trial contacts and locations

1

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Central trial contact

Vincent Ommen van, MD, PhD; Thomas Poels, MD

Data sourced from clinicaltrials.gov

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