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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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
Maastricht University
Information provided by (Responsible Party):
Maastricht University Medical Center

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).

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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

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

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 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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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.

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

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 identifier (NCT number): NCT02659137

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Contact: Thomas Poels, MD +31 43 38 75070
Contact: Vincent Ommen van, MD, PhD +31 43 38 75070

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Maastricht University Medical Center Recruiting
Maastricht, Netherlands, 6229 HX
Contact: Thomas Poels, MD    +31 (0)43 38 75070   
Contact: Vincent Ommen van, MD, PhD    +31 (0)43 38 75070   
Sponsors and Collaborators
Maastricht University Medical Center
Maastricht University
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Responsible Party: Maastricht University Medical Center 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:
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