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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

Tracking Information
First Submitted Date January 4, 2016
First Posted Date January 20, 2016
Last Update Posted Date January 20, 2016
Study Start Date January 2016
Estimated Primary Completion Date July 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 14, 2016)
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.
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: January 14, 2016)
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 ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title HV Electrophysiology Study In Transcatheter Aortic Valve Implantation Patients
Official Title HV Electrophysiology Study In Transcatheter Aortic Valve Implantation Patients
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.

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 Type Observational
Study Design Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population All patients undergoing implantation of a TAVI device in the Maastricht University Medical Center.
Condition
  • Left Bundle Branch Block
  • Transcatheter Aortic Valve Replacement
  • Transcatheter Aortic Valve Implantation
Intervention Other: HV measurement
Electrophysiology (EP) study during the TAVI procedure
Other Names:
  • Electrophysiology study
  • His-catheter
  • His catheter
  • EP study
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: January 14, 2016)
100
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2017
Estimated Primary Completion Date July 2017   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number NCT02659137
Other Study ID Numbers 152042
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Maastricht University Medical Center
Study Sponsor Maastricht University Medical Center
Collaborators Maastricht University
Investigators Not Provided
PRS Account Maastricht University Medical Center
Verification Date January 2016