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

• Sponsor: University Hospital, Saarland (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04128384
• Collaborator: (none)
• Enrollment: 200
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 55.4
• Patients Per Site Per Month: 3.6

Study Details

Study Description

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) .

Condition or Disease	Intervention/Treatment	Phase
Severe Aortic Valve Stenosis; High-degree AV Block; Left Bundle-Branch Block	Diagnostic Test: Limited electrophysiologic study including measurements of HV- and AH-intervals pre- and post-TAVR	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 200 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• 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
• Actual Study Start Date: Jun 21, 2018
• Anticipated Primary Completion Date: Dec 31, 2021
• Anticipated Study Completion Date: Jan 31, 2023

Arms and Interventions

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the quadripolar diagnostic catheter used as temporary pacemaker wire (5F, Woven, Boston Scientific) during TAVR was retracted from the apex and positioned at the His bundle to measure HV- and AH-intervals.

Outcome Measures

Primary Outcome Measures

1. High-degree AV block [24 months]

   Occurence of high-degree AV block necessitating a pacemaker implantation during follow up

2. Persistence of left bundle-branch block [24 months]

   Persistence of new onset left bundle branch-block following TAVR procedure

Secondary Outcome Measures

1. Differences between implanted valve types on ifranodal conduction [24 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Universitätsklinikum des Saarlandes	Homburg	Saarland	Germany	66421

Sponsors and Collaborators

• University Hospital, Saarland

Investigators

• Principal Investigator: Christian Ukena, MD, Universitätsklinikum des Saarlandes, Homburg/Saar, Germany

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• 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.
• 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.

• Responsible Party: Christian Ukena, Principal Investigator, University Hospital, Saarland
• ClinicalTrials.gov Identifier: NCT04128384
• Other Study ID Numbers: HOM-TAVI
• First Posted: Oct 16, 2019
• Last Update Posted: Oct 22, 2019
• Last Verified: Oct 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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
• Keywords provided by Christian Ukena, Principal Investigator, University Hospital, Saarland: Transcatheter valve replacement; Infranodal conduction time; High-degree AV block; Left Bundle-Branch Block
• Additional relevant MeSH terms: Aortic Valve Stenosis; Bundle-Branch Block; Heart Block; Atrioventricular Block

Study Results

No Results Posted as of Oct 22, 2019