HV Electrophysiology Study In Transcatheter Aortic Valve Implantation Patients

Transcatheter Aortic Valve Replacement Clinical Trial

— HESITATE  

Official title:

HV Electrophysiology Study In Transcatheter Aortic Valve Implantation Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02659137
• Other study ID #: 152042
• Status: Recruiting
• Phase: N/A
• First received: January 4, 2016
• Last updated: January 14, 2016
• Start date: January 2016
• Est. completion date: December 2017

Study information

• Verified date: January 2016
• Source: Maastricht University Medical Center
• Contact: Thomas Poels, MD
• Phone: +31 43 38 75070
• Email: thomas.poels[@]mumc.nl
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)Netherlands: Clinical Trial Center Maastricht (CTCM)
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Bundle-Branch Block
• Left Bundle Branch Block
• Transcatheter Aortic Valve Implantation
• Transcatheter Aortic Valve Replacement

Intervention

Other:
• HV measurement
Electrophysiology (EP) study during the TAVI procedure

Locations

Country	Name	City	State
Netherlands	Maastricht University Medical Center	Maastricht

Sponsors (2)

Lead Sponsor	Collaborator
Maastricht University Medical Center	Maastricht University

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Secondary	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	No