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

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ClinicalTrials.gov Identifier: NCT04128384
Recruitment Status : Recruiting
First Posted : October 16, 2019
Last Update Posted : October 22, 2019
Sponsor:
Information provided by (Responsible Party):
Christian Ukena, University Hospital, Saarland

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 Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
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 : June 21, 2018
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : January 31, 2023


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the quadripolar diagnostic catheter used as temporary pacemaker wire (5F, Woven, Boston Scientific) during TAVR was retracted from the apex and positioned at the His bundle to measure HV- and AH-intervals.




Primary Outcome Measures :
  1. High-degree AV block [ Time Frame: 24 months ]
    Occurence of high-degree AV block necessitating a pacemaker implantation during follow up

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


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04128384


Contacts
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Contact: Christian Ukena, MD 004968411615912 christian.ukena@uks.eu
Contact: Valerie Pavlicek, MD 004968411615912 valerie.pavlicek@uks.eu

Locations
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Germany
Universitätsklinikum des Saarlandes Recruiting
Homburg, Saarland, Germany, 66421
Contact: Christian Ukena, MD    004968411615912    christian.ukena@uks.eu   
Contact: Valerie Pavlicek, MD    004968411615912    valerie.pavlicek@uks.eu   
Sponsors and Collaborators
University Hospital, Saarland
Investigators
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Principal Investigator: Christian Ukena, MD Universitätsklinikum des Saarlandes, Homburg/Saar, Germany

Publications:
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Responsible Party: Christian Ukena, Principal Investigator, University Hospital, Saarland
ClinicalTrials.gov Identifier: NCT04128384    
Other Study ID Numbers: HOM-TAVI
First Posted: October 16, 2019    Key Record Dates
Last Update Posted: October 22, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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, University Hospital, Saarland:
Transcatheter valve replacement
Infranodal conduction time
High-degree AV block
Left Bundle-Branch Block
Additional relevant MeSH terms:
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Aortic Valve Stenosis
Bundle-Branch Block
Heart Block
Atrioventricular Block
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction
Arrhythmias, Cardiac
Cardiac Conduction System Disease
Pathologic Processes