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NCT04128384 Clinical Trial

Infranodal Conduction Time During TAVR as Predictor of HAVB

Left Bundle-Branch Block Clinical Trial

— HOM-TAVI  

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04128384
Other study ID # HOM-TAVI
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date June 21, 2018
Est. completion date January 31, 2023

Study information
Verified date October 2019
Source University Hospital, Saarland
Contact Christian Ukena, MD
Phone 004968411615912
Email christian.ukena@uks.eu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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) .

Recruitment information / eligibility
Status Recruiting
Enrollment 200
Est. completion date January 31, 2023
Est. primary completion date December 31, 2021
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

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the quadripolar diagnostic catheter used as temporary pacemaker wire (5F, Woven, Boston Scientific) during TAVR was retracted from the apex and positioned at the His bundle to measure HV- and AH-intervals.

Locations
Country Name City State
Germany Universitätsklinikum des Saarlandes Homburg Saarland

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Saarland

Country where clinical trial is conducted

Germany, 

References & Publications (3)

Gaede L, Kim WK, Liebetrau C, Dörr O, Sperzel J, Blumenstein J, Berkowitsch A, Walther T, Hamm C, Elsässer A, Nef H, Möllmann 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. — View Citation

Nazif TM, Williams MR, Hahn RT, Kapadia S, Babaliaros V, Rodés-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. — View Citation

Urena M, Mok M, Serra V, Dumont E, Nombela-Franco L, DeLarochellière R, Doyle D, Igual A, Larose E, Amat-Santos I, Côté M, Cuéllar H, Pibarot P, de Jaegere P, Philippon F, Garcia del Blanco B, Rodés-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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary High-degree AV block Occurence of high-degree AV block necessitating a pacemaker implantation during follow up 24 months
Primary Persistence of left bundle-branch block Persistence of new onset left bundle branch-block following TAVR procedure 24 months
Secondary Differences between implanted valve types on ifranodal conduction 24 months
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