Conduction DisturbanceSTIM TAVI MSNCT04906837
Pre TAVI Membranous Septum Measurement Predicts High Grade Iatrioventricular Conduction Disorders in Patients With Specific Pacemaker Implanted After TAVI. The STIM TAVI-MS Study
An observational study of Conduction Disturbance and Trans Aortic Valve Implantation (TAVI), run by Association de Recherche en Cardiologie des Alpes at 1 site in France.
Trial summary
Conduction disturbances are a major complication of TAVI. There is no predictor of post-TAVI conduction disorder. The study of the membranous septum on the pre-TAVI scanner and the valve implantation height are promising and little studied data on the occurrence of post-TAVI conduction disorders. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Conduction Disturbance, Trans Aortic Valve Implantation (TAVI)
- What is being tested?
- Trans aortic valve implantation
- How many people
- 197 participants
- Where
- 1 siteFrance
- Study dates
- 20 Jun 2020to 26 Feb 2021
- Phase
- Observational
- 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 18 years and older
- All sexes
- Adult, Older adult
Study population: Patients included in the STIM TAVI study with full follow-up (not excluded from STIM TAVI for lack of data)
Who may be able to join
- 18 years old
- Patients included in the STIM TAVI study with full follow-up (not excluded from STIM TAVI for lack of data)
- Patients who did not object to the use of CT and angiography data
Who cannot join
- Oral opposition to participate
Trial locations and contacts
1 site in 1 country.
About this study
Conduction disturbances are a major complication of TAVI. There is no predictor of post-TAVI conduction disorder. The study of the membranous septum on the pre-TAVI scanner and the valve implantation height are promising and little studied data on the occurrence of post-TAVI conduction disorders.
Read the detailed description
After being developed for the treatment of aortic stenosis in inoperable patients, trans aortic valve implantation (TAVI) techniques and devices have gradually improved, and its use can now be considered in low-risk populations. . However, the need for pacemaker implantation after TAVI remains one of the most common complications, and this issue needs to be addressed before further expanding the TAVI indications.
Implantation of PM after TAVI is associated with increased morbidity and mortality, and there are no formal predictors of these conduction disturbances. Some studies suggest that the existence of preoperative conduction disturbances (eg, right bundle branch block or 1st degree AVB) are associated with greater PM implantation or greater reliance on ventricular pacing.
Other studies have focused on anatomical measurements such as the height of the membranous septum obtained on the pre TAVI scanner, calcifications of the aortic ring and the depth of the valve implantation obtained on the angiography of the TAVI procedure. . The depth of valve implantation in relation to the height of the membranous septum would be a predictor of conduction disorders and PM implantation post TAVI.
Anatomically, the left branch of the bundle of HIS originates approximately 6 mm below the aortic annulus. Implantation of TAVI can affect the conduction tissues and lead to conduction abnormalities where the penetrating portion of the HIS emerges on the surface of the LV flushing chamber. The farther away the emerging part of the HIS is from the ring, the less likely it is that an implant will encroach on it, and impair conduction.
Because the emerging part of the bundle of His is "sandwiched" between the membranous septum and the posterior crest of the muscular septum, the lower end of the membranous septum provides an anatomical landmark for the left ventricular exit point of the bundle of His, with the length of the membranous septum equivalent to the distance aortic ring - bundle of HIS.
The STIM TAVI study showed that 30% of patients implanted with a post-TAVI pacemaker did not have high-grade AVB beyond 7 days post-implantation. Patients with early AVB (D1-D7) were at high risk of developing late AVB. The study did not identify a population at low risk of late-onset AVB, nor any pre-TAVI clinical or paraclinical criteria predictive of post-TAVI AVB.
The study of the anatomy of the membranous septum and the height of implantation of the aortic prosthesis in the STIM TAVI population would make it possible to analyze new predictive criteria for late AVB (after D7).
- Being tested
- Trans aortic valve implantation
- Keywords
- membranous septum, valve implantation height, predictive factors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trans aortic valve implantationDiagnostic test
Measurement of the membranous septum on the pre TAVI scanner and the valve implantation height
What is being measured
The primary outcome is the main question the study is designed to answer.
One late high-grade AVB
Presence of at least one late high-grade AVB episode
Measured: between day 7 to one year
Secondary outcomes (2)
CT and angiographic measurements,
Feasibility of CT and angiographic measurements,
Measured: one year
intra and inter observer variability
intra and inter observer variability.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2021
- Study start20 Jun 2020
- Primary completion26 Feb 2021
- Study completion26 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Conduction DisturbanceStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 197 participants (actual)
Sponsor and investigators
- Lead sponsor
- Association de Recherche en Cardiologie des Alpes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04906837
- Sponsor's protocol ID
- AlpinARC
- Acronym
- STIM TAVI MS
- Status last verified
- May 2021
- First submitted
- 25 May 2021
- Last updated
- 28 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pre TAVI Membranous Septum Measurement Predicts High Grade Iatrioventricular Conduction Disorders in Patients With Specific Pacemaker Implanted After TAVI. The STIM TAVI-MS Study
- ClinicalTrials.gov ID
- NCT04906837
- Acronym / sponsor ID
- STIM TAVI MS / AlpinARC
- Keywords
- membranous septum, valve implantation height, predictive factors
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 197 participants (actual)
- Lead sponsor
- Association de Recherche en Cardiologie des AlpesUniversity, hospital or other
- Study start
- 20 Jun 2020 (actual)
- Primary completion
- 26 Feb 2021 (actual)
- Study completion
- 26 Feb 2021 (actual)
- First posted
- 28 May 2021 (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.
Conduction disturbances are a major complication of TAVI. There is no predictor of post-TAVI conduction disorder. The study of the membranous septum on the pre-TAVI scanner and the valve implantation height are promising and little studied data on the occurrence of post-TAVI conduction disorders.
Detailed description
After being developed for the treatment of aortic stenosis in inoperable patients, trans aortic valve implantation (TAVI) techniques and devices have gradually improved, and its use can now be considered in low-risk populations. . However, the need for pacemaker implantation after TAVI remains one of the most common complications, and this issue needs to be addressed before further expanding the TAVI indications.
Implantation of PM after TAVI is associated with increased morbidity and mortality, and there are no formal predictors of these conduction disturbances. Some studies suggest that the existence of preoperative conduction disturbances (eg, right bundle branch block or 1st degree AVB) are associated with greater PM implantation or greater reliance on ventricular pacing.
Other studies have focused on anatomical measurements such as the height of the membranous septum obtained on the pre TAVI scanner, calcifications of the aortic ring and the depth of the valve implantation obtained on the angiography of the TAVI procedure. . The depth of valve implantation in relation to the height of the membranous septum would be a predictor of conduction disorders and PM implantation post TAVI.
Anatomically, the left branch of the bundle of HIS originates approximately 6 mm below the aortic annulus. Implantation of TAVI can affect the conduction tissues and lead to conduction abnormalities where the penetrating portion of the HIS emerges on the surface of the LV flushing chamber. The farther away the emerging part of the HIS is from the ring, the less likely it is that an implant will encroach on it, and impair conduction.
Because the emerging part of the bundle of His is "sandwiched" between the membranous septum and the posterior crest of the muscular septum, the lower end of the membranous septum provides an anatomical landmark for the left ventricular exit point of the bundle of His, with the length of the membranous septum equivalent to the distance aortic ring - bundle of HIS.
The STIM TAVI study showed that 30% of patients implanted with a post-TAVI pacemaker did not have high-grade AVB beyond 7 days post-implantation. Patients with early AVB (D1-D7) were at high risk of developing late AVB. The study did not identify a population at low risk of late-onset AVB, nor any pre-TAVI clinical or paraclinical criteria predictive of post-TAVI AVB.
The study of the anatomy of the membranous septum and the height of implantation of the aortic prosthesis in the STIM TAVI population would make it possible to analyze new predictive criteria for late AVB (after D7).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients included in the STIM TAVI study with full follow-up (not excluded from STIM TAVI for lack of data)
Key inclusion criteria (3 listed)
- 18 years old
- Patients included in the STIM TAVI study with full follow-up (not excluded from STIM TAVI for lack of data)
- Patients who did not object to the use of CT and angiography data
Key exclusion criteria (1 listed)
- Oral opposition to participate
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 |
|---|---|---|
| Trans aortic valve implantationMeasurement of the membranous septum on the pre TAVI scanner and the valve implantation height | Diagnostic test | – |
Primary outcome
One late high-grade AVB
Time frame: between day 7 to one year
Presence of at least one late high-grade AVB episode
2 secondary outcomes
CT and angiographic measurements,
Time frame: one year
intra and inter observer variability
Time frame: one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2021.
- Individual participant dataSharing planned: Undecided
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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?
An observational study of Conduction Disturbance and Trans Aortic Valve Implantation (TAVI), run by Association de Recherche en Cardiologie des Alpes 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 3 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: finished, as of the sponsor's last update on 28 May 2021. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
One late high-grade AVB (time frame: between day 7 to one year). 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 28 May 2021.