Infranodal Conduction Time During TAVR as Predictor of HAVB

NCT ID: NCT04128384

Last Updated: 2019-10-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-21

Study Completion Date

2023-01-31

Brief Summary

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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) .

Detailed Description

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Conditions

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Severe Aortic Valve Stenosis High-degree AV Block Left Bundle-Branch Block

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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EPS arm

Limited electrophysiologic study including measurements of HV- and AH-intervals pre- and post-TAVR

Group Type OTHER

Limited electrophysiologic study including measurements of HV- and AH-intervals pre- and post-TAVR

Intervention Type DIAGNOSTIC_TEST

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the quadripolar diagnostic catheter used as temporary pacemaker wire (5F, Woven, Boston Scientific) during TAVR was retracted from the apex and positioned at the His bundle to measure HV- and AH-intervals.

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Saarland

OTHER

Sponsor Role lead

Responsible Party

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Christian Ukena

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Christian Ukena, MD

Role: PRINCIPAL_INVESTIGATOR

Universitätsklinikum des Saarlandes, Homburg/Saar, Germany

Locations

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Universitätsklinikum des Saarlandes

Homburg, Saarland, Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Christian Ukena, MD

Role: CONTACT

004968411615912

Valerie Pavlicek, MD

Role: CONTACT

004968411615912

Facility Contacts

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Christian Ukena, MD

Role: primary

004968411615912

Valerie Pavlicek, MD

Role: backup

004968411615912

References

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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.

Reference Type BACKGROUND
PMID: 28963581 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24179072 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23040577 (View on PubMed)

Pavlicek V, Mahfoud F, Bubel K, Fries P, Ewen S, Bohm M, Scheller B, Ukena C. Prediction of conduction disturbances in patients undergoing transcatheter aortic valve replacement. Clin Res Cardiol. 2023 May;112(5):677-690. doi: 10.1007/s00392-023-02160-0. Epub 2023 Jan 21.

Reference Type DERIVED
PMID: 36680617 (View on PubMed)

Other Identifiers

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HOM-TAVI

Identifier Type: -

Identifier Source: org_study_id

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