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

Primary Purpose

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

Status
Unknown status
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Limited electrophysiologic study including measurements of HV- and AH-intervals pre- and post-TAVR
Sponsored by
University Hospital, Saarland
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Severe Aortic Valve Stenosis focused on measuring Transcatheter valve replacement, Infranodal conduction time, High-degree AV block, Left Bundle-Branch Block

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Universitätsklinikum des SaarlandesRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

EPS arm

Arm Description

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

Outcomes

Primary Outcome Measures

High-degree AV block
Occurence of high-degree AV block necessitating a pacemaker implantation during follow up
Persistence of left bundle-branch block
Persistence of new onset left bundle branch-block following TAVR procedure

Secondary Outcome Measures

Differences between implanted valve types on ifranodal conduction

Full Information

First Posted
October 12, 2019
Last Updated
October 19, 2019
Sponsor
University Hospital, Saarland
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1. Study Identification

Unique Protocol Identification Number
NCT04128384
Brief Title
Infranodal Conduction Time During TAVR as Predictor of HAVB
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Unknown status
Study Start Date
June 21, 2018 (Actual)
Primary Completion Date
December 31, 2021 (Anticipated)
Study Completion Date
January 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital, Saarland

4. Oversight

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
Data Monitoring Committee
No

5. 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) .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
EPS arm
Arm Type
Other
Arm Description
Limited electrophysiologic study including measurements of HV- and AH-intervals pre- and post-TAVR
Intervention Type
Diagnostic Test
Intervention Name(s)
Limited electrophysiologic study including measurements of HV- and AH-intervals pre- and post-TAVR
Intervention Description
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.
Primary Outcome Measure Information:
Title
High-degree AV block
Description
Occurence of high-degree AV block necessitating a pacemaker implantation during follow up
Time Frame
24 months
Title
Persistence of left bundle-branch block
Description
Persistence of new onset left bundle branch-block following TAVR procedure
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Differences between implanted valve types on ifranodal conduction
Time Frame
24 months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Indication for TAVR according to current guidelines Written informed consent Exclusion Criteria: 1. Pre-existent intracardiac device as pacemaker, implanted cardioverter defibrillator or CRT-P/CRT-D device
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Christian Ukena, MD
Phone
004968411615912
Email
christian.ukena@uks.eu
First Name & Middle Initial & Last Name or Official Title & Degree
Valerie Pavlicek, MD
Phone
004968411615912
Email
valerie.pavlicek@uks.eu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christian Ukena, MD
Organizational Affiliation
Universitätsklinikum des Saarlandes, Homburg/Saar, Germany
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universitätsklinikum des Saarlandes
City
Homburg
State/Province
Saarland
ZIP/Postal Code
66421
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christian Ukena, MD
Phone
004968411615912
Email
christian.ukena@uks.eu
First Name & Middle Initial & Last Name & Degree
Valerie Pavlicek, MD
Phone
004968411615912
Email
valerie.pavlicek@uks.eu

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28963581
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.
Results Reference
background
PubMed Identifier
24179072
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.
Results Reference
background
PubMed Identifier
23040577
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.
Results Reference
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Infranodal Conduction Time During TAVR as Predictor of HAVB

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