HV Electrophysiology Study In Transcatheter Aortic Valve Implantation Patients (HESITATE)
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|ClinicalTrials.gov Identifier: NCT02659137|
Recruitment Status : Unknown
Verified January 2016 by Maastricht University Medical Center.
Recruitment status was: Recruiting
First Posted : January 20, 2016
Last Update Posted : January 20, 2016
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.
|Condition or disease||Intervention/treatment|
|Left Bundle Branch Block Transcatheter Aortic Valve Replacement Transcatheter Aortic Valve Implantation||Other: HV measurement|
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).
|Study Type :||Observational|
|Estimated Enrollment :||100 participants|
|Official Title:||HV Electrophysiology Study In Transcatheter Aortic Valve Implantation Patients|
|Study Start Date :||January 2016|
|Estimated Primary Completion Date :||July 2017|
|Estimated Study Completion Date :||December 2017|
- Other: HV measurement
Electrophysiology (EP) study during the TAVI procedureOther Names:
- Electrophysiology study
- His catheter
- EP study
- Presence of a conduction disturbance in the His-bundle on occurence of a left bundle branch block on surface electrocardiogram by registering the HV-time in milli-seconds during the TAVI procedure. [ Time Frame: 2 hours (from beginning to the end of TAVI procedure) ]Evaluate the location of a LBBB.
- Persistency and/or progression of a TAVI induced LBBB by registering the presence of a LBBB or a high degree AV block (second degree AV block or complete AV block) on surface electrocardiogram (ECG). [ Time Frame: at 1 day before TAVI procure, at 1 hour after TAVI procedure, at discharge, at 6 weeks, at 6 months, at 12 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02659137
|Contact: Thomas Poels, MD||+31 43 38 email@example.com|
|Contact: Vincent Ommen van, MD, PhD||+31 43 38 firstname.lastname@example.org|