Infranodal Conduction Time During TAVR as Predictor of HAVB (HOM-TAVI)

Changes in Infranodal Conduction Times and New Onset Left Bundle Branch Block: Possible Predictors for High-grade AV Block Following Transcatheter Aortic Valve Replacement

Consecutive patients with high grade aortic stenosis undergoing transcatheter aortic valve replacement (TAVR) with a self-expanding valve (Medtronic CoreValve Evolut R® or Edwards Sapien S3®) without pre-existing pacemaker devices are eligible for inclusion. During the TAVR procedure, an electrophysiologic study including measurements of infranodal conduction times (HV-interval before and after valve implantation) will be performed. Electrocardiograms before TAVR, before discharge, after 30 days and after 12 months will be analyzed regarding new onset LBB and the occurrence of high-degree AV block (HAVB) .

Study Overview

• Status: Unknown
• Conditions: Left Bundle-Branch Block; Severe Aortic Valve Stenosis; High-degree AV Block
• Intervention / Treatment: Diagnostic test: Limited electrophysiologic study including measurements of HV- and AH-intervals pre- and post-TAVR

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Christian Ukena, MD; Phone Number: 004968411615912; Email: christian.ukena@uks.eu
• Study Contact Backup: Name: Valerie Pavlicek, MD; Phone Number: 004968411615912; Email: valerie.pavlicek@uks.eu

Study Locations

• Germany
  • Saarland
    • Homburg, Saarland, Germany, 66421
      • Recruiting
      • Universitätsklinikum des Saarlandes
      • Contact: Christian Ukena, MD; Phone Number: 004968411615912; Email: christian.ukena@uks.eu
      • Contact: Valerie Pavlicek, MD; Phone Number: 004968411615912; Email: valerie.pavlicek@uks.eu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Indication for TAVR according to current guidelines
2. Written informed consent

Exclusion Criteria:

1. Pre-existent intracardiac device as pacemaker, implanted cardioverter defibrillator or CRT-P/CRT-D device

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: EPS arm; Limited electrophysiologic study including measurements of HV- and AH-intervals pre- and post-TAVR	Diagnostic test: Limited electrophysiologic study including measurements of HV- and AH-intervals pre- and post-TAVR; For the purpose of obtaining intracardiac measurements, the quadripolar diagnostic catheter used as temporary pacemaker wire (5F, Woven, Boston Scientific) during TAVR was retracted from the apex and positioned at the His bundle to measure HV- and AH-intervals.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
High-degree AV block	Occurence of high-degree AV block necessitating a pacemaker implantation during follow up	24 months
Persistence of left bundle-branch block	Persistence of new onset left bundle branch-block following TAVR procedure	24 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Differences between implanted valve types on ifranodal conduction	24 months

Collaborators and Investigators

• Sponsor: University Hospital, Saarland
• Investigators: Principal Investigator: Christian Ukena, MD, Universitätsklinikum des Saarlandes, Homburg/Saar, Germany

Publications and helpful links

General Publications

• Urena M, Mok M, Serra V, Dumont E, Nombela-Franco L, DeLarochelliere R, Doyle D, Igual A, Larose E, Amat-Santos I, Cote M, Cuellar H, Pibarot P, de Jaegere P, Philippon F, Garcia del Blanco B, Rodes-Cabau J. Predictive factors and long-term clinical consequences of persistent left bundle branch block following transcatheter aortic valve implantation with a balloon-expandable valve. J Am Coll Cardiol. 2012 Oct 30;60(18):1743-52. doi: 10.1016/j.jacc.2012.07.035. Epub 2012 Oct 3.
• Gaede L, Kim WK, Liebetrau C, Dorr O, Sperzel J, Blumenstein J, Berkowitsch A, Walther T, Hamm C, Elsasser A, Nef H, Mollmann H. Pacemaker implantation after TAVI: predictors of AV block persistence. Clin Res Cardiol. 2018 Jan;107(1):60-69. doi: 10.1007/s00392-017-1158-2. Epub 2017 Sep 29.
• Nazif TM, Williams MR, Hahn RT, Kapadia S, Babaliaros V, Rodes-Cabau J, Szeto WY, Jilaihawi H, Fearon WF, Dvir D, Dewey TM, Makkar RR, Xu K, Dizon JM, Smith CR, Leon MB, Kodali SK. Clinical implications of new-onset left bundle branch block after transcatheter aortic valve replacement: analysis of the PARTNER experience. Eur Heart J. 2014 Jun 21;35(24):1599-607. doi: 10.1093/eurheartj/eht376. Epub 2013 Oct 30.

Study record dates

Study Major Dates

• Study Start (Actual): June 21, 2018
• Primary Completion (Anticipated): December 31, 2021
• Study Completion (Anticipated): January 31, 2023

Study Registration Dates

• First Submitted: October 12, 2019
• First Submitted That Met QC Criteria: October 12, 2019
• First Posted (Actual): October 16, 2019

Study Record Updates

• Last Update Posted (Actual): October 22, 2019
• Last Update Submitted That Met QC Criteria: October 19, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Keywords: Left Bundle-Branch Block; Transcatheter valve replacement; Infranodal conduction time; High-degree AV block
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Aortic Valve Disease; Heart Valve Diseases; Ventricular Outflow Obstruction; Cardiac Conduction System Disease; Aortic Valve Stenosis; Bundle-Branch Block; Heart Block; Atrioventricular Block
• Other Study ID Numbers: HOM-TAVI

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes