- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04128384
Infranodal Conduction Time During TAVR as Predictor of HAVB (HOM-TAVI)
October 19, 2019 updated by: Christian Ukena, University Hospital, Saarland
Changes in Infranodal Conduction Times and New Onset Left Bundle Branch Block: Possible Predictors for High-grade AV Block Following Transcatheter Aortic Valve Replacement
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) .
Study Overview
Status
Unknown
Study Type
Interventional
Enrollment (Anticipated)
200
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Christian Ukena, MD
- Phone Number: 004968411615912
- Email: christian.ukena@uks.eu
Study Contact Backup
- Name: Valerie Pavlicek, MD
- Phone Number: 004968411615912
- Email: valerie.pavlicek@uks.eu
Study Locations
-
-
Saarland
-
Homburg, Saarland, Germany, 66421
- Recruiting
- Universitätsklinikum des Saarlandes
-
Contact:
- Christian Ukena, MD
- Phone Number: 004968411615912
- Email: christian.ukena@uks.eu
-
Contact:
- Valerie Pavlicek, MD
- Phone Number: 004968411615912
- Email: valerie.pavlicek@uks.eu
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: EPS arm
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
High-degree AV block
Time Frame: 24 months
|
Occurence of high-degree AV block necessitating a pacemaker implantation during follow up
|
24 months
|
Persistence of left bundle-branch block
Time Frame: 24 months
|
Persistence of new onset left bundle branch-block following TAVR procedure
|
24 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Differences between implanted valve types on ifranodal conduction
Time Frame: 24 months
|
24 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Christian Ukena, MD, Universitätsklinikum des Saarlandes, Homburg/Saar, Germany
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 21, 2018
Primary Completion (Anticipated)
December 31, 2021
Study Completion (Anticipated)
January 31, 2023
Study Registration Dates
First Submitted
October 12, 2019
First Submitted That Met QC Criteria
October 12, 2019
First Posted (Actual)
October 16, 2019
Study Record Updates
Last Update Posted (Actual)
October 22, 2019
Last Update Submitted That Met QC Criteria
October 19, 2019
Last Verified
October 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HOM-TAVI
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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