Clinical trial NCT04128384: Infranodal Conduction Time During TAVR as Predictor of HAVB
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Severe Aortic Valve Stenosis
High-degree AV Block
Left Bundle-Branch Block
Keywords: Transcatheter valve replacement
Infranodal conduction time
High-degree AV block
Left Bundle-Branch Block
Lead sponsor: University Hospital, Saarland
Sponsor class: OTHER
First posted: 2019-10-16
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief 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) .


Eligibility criteria: 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

Primary outcomes:
measure: High-degree AV block
timeFrame: 24 months
measure: Persistence of left bundle-branch block
timeFrame: 24 months
Secondary outcomes:
measure: Differences between implanted valve types on ifranodal conduction
timeFrame: 24 months
Other outcomes:
Locations:
city: Homburg
country: Germany
facility: Universitätsklinikum des Saarlandes
state: Saarland
Study officials:
affiliation: Universitätsklinikum des Saarlandes, Homburg/Saar, Germany
name: Christian Ukena, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.