Aortic Stenosis, SevereTAVHISNCT05714579
Predictive Value of Pre-TAVI Infrahissian Conduction Time in the Occurrence of Complete Atrioventricular Block
A study testing Transcatheter Aortic Valve Implantation in people with Aortic Stenosis, Severe, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 1 site in France.
Trial summary
The purpose of the study is implantation of a Pacemaker at 30 days for occurrence of a high-grade conduction disorder per- or post-procedure (yes/no) Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Aortic Stenosis, Severe
- What is being tested?
- Transcatheter Aortic Valve Implantation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteFrance
- Study dates
- 30 May 2023to 20 Nov 2024
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Patient suffering from severe aortic stenosis, eligible for a TAVI procedure (Transcatheter Aortic Valve Implantation) ;
- Patient presenting with complete right bundle branch block during the pre-TAVI electrocardiogram, with QRS interval ≥ 120 ms (depolarization of the ventricles);
- Patient able to understand the information related to the study, to read the information leaflet and agreeing to participate in the study. ;
- Patient having signed a consent.
Who cannot join
- Contraindication to Transcatheter Aortic Valve Implantation ;
- Patient under guardianship or curatorship, or under a regime of deprivation of liberty;
- Patient participating in another clinical trial, or in a period of exclusion from another clinical trial;
- Patient not benefiting from a social security scheme.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Predictive Value of Pre-Transcatheter Aortic Valve Implantation (TAVI) Infrahissian Conduction Time in the Occurrence of Complete Atrioventricular Block in Patients With Preoperative Right Bundle Branch Block
The purpose of the study is implantation of a Pacemaker at 30 days for occurrence of a high-grade conduction disorder per- or post-procedure (yes/no)
Read the detailed description
The main objective is to assess the predictive value of the pre-TAVI infrahelic conduction time interval (infraheal conduction time measured before percutaneous aortic valve implantation) on the risk of Pacemaker implantation at 30 days post-TAVI, in patients with right bundle branch block prior to surgery.
The aim of the study is to identify a pre-interventional marker of the risk of rhythmological complication after the TAVI procedure (Transcatheter Aortic Valve Implantation), in order to better anticipate it.
This is an interventional, prospective, longitudinal (follow-up: 12 months), multicenter (4 centers) study.
- Conditions
- Aortic Stenosis, Severe
- Being tested
- Transcatheter Aortic Valve Implantation
- Medical subject headings
- Aortic Valve Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcatheter Aortic Valve ImplantationProcedure or surgery
The TAVI procedure is performed transfemorally under local anesthesia most often, or more rarely under general anesthesia via the subclavian or transaortic route. Identification is carried out under fluoroscopy in the cardiac catheterization room. The crossing of the aortic valve allows the establishment of a guide at the bottom of the left ventricle. Aortic valve predilation can be performed. The tightness of the device is checked by an aortography. Sometimes, post-dilation of the implanted bioprosthesis proves necessary, particularly in the event of under-deployment or significant para-prosthetic leakage.
The duration of the intervention is approximately 1 hour.
| Study group | Role | What they receive |
|---|---|---|
| severe aortic stenosis with complete right bundle branch block | Experimental | patients with aortic stenosis undergoing a Transcatheter Aortic Valve Implantation procedure Receives: Procedure: Transcatheter Aortic Valve Implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Implantation of a Pacemaker at 30 days
Implantation of a Pacemaker at 30 days for occurrence of a high-grade conduction disorder per- or post-procedure (yes/no)
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2023
- Study start30 May 2023
- Primary completion20 Nov 2024
- Study completion20 Nov 2024
Why it stopped: The sponsor, in consultation with the coordinating investigator, had decided to stop enrolment prematurely because the enrolment rate would not have made it possible to reach the target of 142 patients without increasing the duration of the study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic Stenosis, SevereStudies of the same condition, open and under way.
- More trials run by GCS Ramsay Santé pour l'Enseignement et la RechercheThe sponsor's other registered studies.
- 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
- 35 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Euraxi Pharma
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05714579
- Sponsor's protocol ID
- 2022-A02274-39
- Acronym
- TAVHIS
- Status last verified
- Mar 2025
- First submitted
- 27 Jan 2023
- Last updated
- 25 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Value of Pre-Transcatheter Aortic Valve Implantation (TAVI) Infrahissian Conduction Time in the Occurrence of Complete Atrioventricular Block in Patients With Preoperative Right Bundle Branch Block
- ClinicalTrials.gov ID
- NCT05714579
- Acronym / sponsor ID
- TAVHIS / 2022-A02274-39
- Conditions
- Aortic Stenosis, Severe
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The sponsor, in consultation with the coordinating investigator, had decided to stop enrolment prematurely because the enrolment rate would not have made it possible to reach the target of 142 patients without increasing the duration of the study
- Enrolment
- 35 participants (actual)
- Lead sponsor
- GCS Ramsay Santé pour l'Enseignement et la RechercheUniversity, hospital or other
- Collaborators
- Euraxi Pharma
- Study start
- 30 May 2023 (actual)
- Primary completion
- 20 Nov 2024 (actual)
- Study completion
- 20 Nov 2024 (actual)
- First posted
- 6 Feb 2023 (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.
The purpose of the study is implantation of a Pacemaker at 30 days for occurrence of a high-grade conduction disorder per- or post-procedure (yes/no)
Detailed description
The main objective is to assess the predictive value of the pre-TAVI infrahelic conduction time interval (infraheal conduction time measured before percutaneous aortic valve implantation) on the risk of Pacemaker implantation at 30 days post-TAVI, in patients with right bundle branch block prior to surgery.
The aim of the study is to identify a pre-interventional marker of the risk of rhythmological complication after the TAVI procedure (Transcatheter Aortic Valve Implantation), in order to better anticipate it.
This is an interventional, prospective, longitudinal (follow-up: 12 months), multicenter (4 centers) study.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| severe aortic stenosis with complete right bundle branch block | Experimental | Procedure: Transcatheter Aortic Valve Implantationpatients with aortic stenosis undergoing a Transcatheter Aortic Valve Implantation procedure |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Patient suffering from severe aortic stenosis, eligible for a TAVI procedure (Transcatheter Aortic Valve Implantation) ;
- Patient presenting with complete right bundle branch block during the pre-TAVI electrocardiogram, with QRS interval ≥ 120 ms (depolarization of the ventricles);
- Patient able to understand the information related to the study, to read the information leaflet and agreeing to participate in the study. ;
- Patient having signed a consent.
Key exclusion criteria (4 listed)
- Contraindication to Transcatheter Aortic Valve Implantation ;
- Patient under guardianship or curatorship, or under a regime of deprivation of liberty;
- Patient participating in another clinical trial, or in a period of exclusion from another clinical trial;
- Patient not benefiting from a social security scheme.
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 |
|---|---|---|
| Transcatheter Aortic Valve ImplantationThe TAVI procedure is performed transfemorally under local anesthesia most often, or more rarely under general anesthesia via the subclavian or transaortic route. Identification is carried out under fluoroscopy in the cardiac catheterization room. The crossing of the aortic valve allows the establishment of a guide at the bottom of the left ventricle. Aortic valve predilation can be performed. The tightness of the device is checked by an aortography. Sometimes, post-dilation of the implanted bioprosthesis proves necessary, particularly in the event of under-deployment or significant para-prosthetic leakage. The duration of the intervention is approximately 1 hour. | Procedure or surgery | severe aortic stenosis with complete right bundle branch block |
Primary outcome
Implantation of a Pacemaker at 30 days
Time frame: 30 days
Implantation of a Pacemaker at 30 days for occurrence of a high-grade conduction disorder per- or post-procedure (yes/no)
Results and safety
The study was stopped early (reason given: The sponsor, in consultation with the coordinating investigator, had decided to stop enrolment prematurely because the enrolment rate would not have made it possible to reach the target of 142 patients without increasing the duration of the study). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2025.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcatheter Aortic Valve Implantation in people with Aortic Stenosis, Severe, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 1 site in France.
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 4 inclusion and 4 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: stopped early, as of the sponsor's last update on 25 Mar 2025. 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 France. 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?
The study was stopped early (reason given: The sponsor, in consultation with the coordinating investigator, had decided to stop enrolment prematurely because the enrolment rate would not have made it possible to reach the target of 142 patients without increasing the duration of the study). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Implantation of a Pacemaker at 30 days (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Mar 2025.