Severe Aortic Valve StenosisHOM-TAVINCT04128384
Infranodal Conduction Time During TAVR as Predictor of HAVB
A study testing Limited electrophysiologic study including measurements of HV- and AH-intervals pre- and post-TAVR in people with Severe Aortic Valve Stenosis and High-degree AV Block, run by University Hospital, Saarland at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Severe Aortic Valve Stenosis, High-degree AV Block, Left Bundle-Branch Block
- What is being tested?
- Limited electrophysiologic study including measurements of HV- and AH-intervals pre- and post-TAVR
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteGermany
- Study dates
- 21 Jun 2018to 31 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Indication for TAVR according to current guidelines
- Written informed consent
Who cannot join
- 1. Pre-existent intracardiac device as pacemaker, implanted cardioverter defibrillator or CRT-P/CRT-D device
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Universitätsklinikum des Saarlandes
Homburg, Saarland, 66421
Christian Ukena, MD, 004968411615912, christian.ukena@uks.eu
Valerie Pavlicek, MD, 004968411615912, valerie.pavlicek@uks.eu
About this study
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
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) .
- Being tested
- Limited electrophysiologic study including measurements of HV- and AH-intervals pre- and post-TAVR
- Keywords
- Transcatheter valve replacement, Infranodal conduction time, High-degree AV block, Left Bundle-Branch Block
- Medical subject headings
- Aortic Valve Stenosis, Bundle-Branch Block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Limited electrophysiologic study including measurements of HV- and AH-intervals pre- and post-TAVRDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| EPS arm | Other | Limited electrophysiologic study including measurements of HV- and AH-intervals pre- and post-TAVR Receives: Diagnostic Test: Limited electrophysiologic study including measurements of HV- and AH-intervals pre- and post-TAVR |
What is being measured
The primary outcome is the main question the study is designed to answer.
High-degree AV block
Occurence of high-degree AV block necessitating a pacemaker implantation during follow up
Measured: 24 months
Persistence of left bundle-branch block
Persistence of new onset left bundle branch-block following TAVR procedure
Measured: 24 months
Secondary outcomes (1)
Differences between implanted valve types on ifranodal conduction
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2019
- Study start21 Jun 2018
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Jan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Severe Aortic Valve StenosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Saarland
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christian Ukena, University Hospital, Saarland
- Investigators
- Christian Ukena, MD, Principal investigator, Universitätsklinikum des Saarlandes, Homburg/Saar, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04128384
- Sponsor's protocol ID
- HOM-TAVI
- Acronym
- HOM-TAVI
- Status last verified
- Oct 2019
- First submitted
- 12 Oct 2019
- Last updated
- 22 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 28963581Nazif 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.
PubMed 24179072Urena 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.
PubMed 23040577Pavlicek 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.
PubMed 36680617
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04128384
- Acronym / sponsor ID
- HOM-TAVI / HOM-TAVI
- Keywords
- Transcatheter valve replacement, Infranodal conduction time, High-degree AV block, Left Bundle-Branch Block
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University Hospital, SaarlandUniversity, hospital or other
- Study start
- 21 Jun 2018 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Jan 2023 (estimated)
- First posted
- 16 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EPS arm | Other | Diagnostic Test: Limited electrophysiologic study including measurements of HV- and AH-intervals pre- and post-TAVRLimited electrophysiologic study including measurements of HV- and AH-intervals pre- and post-TAVR |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Indication for TAVR according to current guidelines
- Written informed consent
Key exclusion criteria (1 listed)
- 1. Pre-existent intracardiac device as pacemaker, implanted cardioverter defibrillator or CRT-P/CRT-D device
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Limited electrophysiologic study including measurements of HV- and AH-intervals pre- and post-TAVRFor 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. | Diagnostic test | EPS arm |
Primary outcome
High-degree AV block
Time frame: 24 months
Occurence of high-degree AV block necessitating a pacemaker implantation during follow up
Persistence of left bundle-branch block
Time frame: 24 months
Persistence of new onset left bundle branch-block following TAVR procedure
1 secondary outcome
Differences between implanted valve types on ifranodal conduction
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2019.
- Background: PubMed 28963581Gaede 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.
- Background: PubMed 24179072Nazif 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.
- Background: PubMed 23040577Urena 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.
- Derived from this study: PubMed 36680617Pavlicek 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christian Ukena, MD principal investigator
Universitätsklinikum des Saarlandes, Homburg/Saar, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Limited electrophysiologic study including measurements of HV- and AH-intervals pre- and post-TAVR in people with Severe Aortic Valve Stenosis and High-degree AV Block, run by University Hospital, Saarland at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Christian Ukena, MD (004968411615912, christian.ukena@uks.eu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
High-degree AV block (time frame: 24 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04128384, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2019.