HV Electrophysiology Study In Transcatheter Aortic Valve Implantation Patients

NCT02659137 | Unknown DMC

• 1 other identifier: 152042
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Left Bundle Branch Block; Transcatheter Aortic Valve Replacement; Transcatheter Aortic Valve Implantation

Keywords

LBBB; TAVI

Outcome Measures

Primary Outcomes (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.

  Evaluate the location of a LBBB.

  2 hours (from beginning to the end of TAVI procedure)

Secondary Outcomes (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).

  at 1 day before TAVI procure, at 1 hour after TAVI procedure, at discharge, at 6 weeks, at 6 months, at 12 months

Interventions

HV measurement OTHER

Electrophysiology (EP) study during the TAVI procedure

Also known as: Electrophysiology study, His-catheter, His catheter, EP study

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• All patients must provide written informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Maastricht University Medical Center: lead
• Maastricht University: collaborator

Study Sites (1)

Maastricht University Medical Center

Maastricht, 6229 HX, Netherlands

RECRUITING

MeSH Terms

Conditions

Bundle-Branch Block

Condition Hierarchy (Ancestors)

Heart Block; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Thomas Poels, MD

CONTACT

+31 43 38 75070; thomas.poels@mumc.nl

Vincent Ommen van, MD, PhD

CONTACT

+31 43 38 75070; v.van.ommen@mumc.nl

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 4, 2016
• First Posted: January 20, 2016
• Study Start: January 1, 2016
• Primary Completion: July 1, 2017
• Study Completion: December 1, 2017
• Last Updated: January 20, 2016

Record last verified: 2016-01

Locations

NL (1)