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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
Sponsor:
Collaborator:
Maastricht University
Information provided by (Responsible Party):
Maastricht University Medical Center

Study Description
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Brief 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.


Condition or disease Intervention/treatment
Left Bundle Branch Block Transcatheter Aortic Valve Replacement Transcatheter Aortic Valve Implantation Other: HV measurement

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).

Study Design
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Study Type : Observational
Estimated Enrollment : 100 participants
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Intervention Details:
  • Other: HV measurement
    Electrophysiology (EP) study during the TAVI procedure
    Other Names:
    • Electrophysiology study
    • His-catheter
    • His catheter
    • EP study

Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
All patients undergoing implantation of a TAVI device in the Maastricht University Medical Center.
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: Thomas Poels, MD +31 43 38 75070 thomas.poels@mumc.nl
Contact: Vincent Ommen van, MD, PhD +31 43 38 75070 v.van.ommen@mumc.nl

Locations
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Netherlands
Maastricht University Medical Center Recruiting
Maastricht, Netherlands, 6229 HX
Contact: Thomas Poels, MD    +31 (0)43 38 75070    thomas.poels@mumc.nl   
Contact: Vincent Ommen van, MD, PhD    +31 (0)43 38 75070    v.van.ommen@mumc.nl   
Sponsors and Collaborators
Maastricht University Medical Center
Maastricht University
More Information
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Responsible Party: Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT02659137    
Other Study ID Numbers: 152042
First Posted: January 20, 2016    Key Record Dates
Last Update Posted: January 20, 2016
Last Verified: January 2016
Keywords provided by Maastricht University Medical Center:
LBBB
TAVI
Additional relevant MeSH terms:
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Bundle-Branch Block
Heart Block
Arrhythmias, Cardiac
Heart Diseases
 Cardiovascular Diseases
Cardiac Conduction System Disease
Pathologic Processes