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

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.

Study Overview

• Status: Unknown
• Conditions: Transcatheter Aortic Valve Replacement; Transcatheter Aortic Valve Implantation; Left Bundle Branch Block
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

• Study Contact: Name: Thomas Poels, MD; Phone Number: +31 43 38 75070; Email: thomas.poels@mumc.nl
• Study Contact Backup: Name: Vincent Ommen van, MD, PhD; Phone Number: +31 43 38 75070; Email: v.van.ommen@mumc.nl

Study Locations

• Netherlands
  • Maastricht, Netherlands, 6229 HX
    • Recruiting
    • Maastricht University Medical Center
    • Contact: Thomas Poels, MD; Phone Number: +31 (0)43 38 75070; Email: thomas.poels@mumc.nl
    • Contact: Vincent Ommen van, MD, PhD; Phone Number: +31 (0)43 38 75070; Email: v.van.ommen@mumc.nl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

All patients undergoing implantation of a TAVI device in the Maastricht University Medical Center.

Description

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

Study Plan

How is the study designed?

Design Details

• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Evaluate the location of a LBBB.	2 hours (from beginning to the end of TAVI procedure)

Secondary Outcome Measures

Outcome Measure	Time Frame
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).	at 1 day before TAVI procure, at 1 hour after TAVI procedure, at discharge, at 6 weeks, at 6 months, at 12 months

Collaborators and Investigators

• Sponsor: Maastricht University Medical Center
• Collaborators: Maastricht University

Study record dates

Study Major Dates

• Study Start: January 1, 2016
• Primary Completion (Anticipated): July 1, 2017
• Study Completion (Anticipated): December 1, 2017

Study Registration Dates

• First Submitted: January 4, 2016
• First Submitted That Met QC Criteria: January 14, 2016
• First Posted (Estimate): January 20, 2016

Study Record Updates

• Last Update Posted (Estimate): January 20, 2016
• Last Update Submitted That Met QC Criteria: January 14, 2016
• Last Verified: January 1, 2016

More Information

Terms related to this study

• Keywords: TAVI; LBBB
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Cardiac Conduction System Disease; Heart Block; Bundle-Branch Block
• Other Study ID Numbers: 152042