NCT02659137

HV Electrophysiology Study In Transcatheter Aortic Valve Implantation Patients

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: Maastricht University Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Detailed 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).

Conditions

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

Interventions

Type	Name	Description
OTHER	HV measurement	Electrophysiology (EP) study during the TAVI procedure

Timeline

• Start date: 2016-01-01
• Primary completion: 2017-07-01
• Completion: 2017-12-01
• First posted: 2016-01-20
• Last updated: 2016-01-20

Locations

1 site across 1 country: Netherlands