Coronary SyndromeDIRECTAVILONGNCT05140317
5 Years Follow up of the SAPIEN 3 Valve From the DIRECTAVI Trial
An observational study of Coronary Syndrome and Hemodynamic Instability, run by University Hospital, Montpellier at 1 site in France.
Trial summary
A strategy of Transcatheter Aortic Valve Replacement (TAVR) without balloon predilatation has shown to be feasible in routine in observational studies and in two recent randomized trial including the DIRECTAVI trial. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Syndrome, Hemodynamic Instability
- What is being tested?
- Transcatheter heart valve implantation with or withour predilatatation
- Type of treatment
- Surgery or procedure
- How many people
- 236 participants
- Where
- 1 siteFrance
- Study dates
- 1 May 2021to 1 Aug 2023
- 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
- No healthy volunteers
- Adult, Older adult
Study population: All patients included in the DIRECTAVI trial
Who may be able to join
- Older than 18 years old.
- patients included in the DIRECTAVI trial
Who cannot join
- Patients not living in France
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 5 Years Hemodynamic and Clinical Follow-up of the SAPIEN 3 Transcatheter Heart Valve According to the Implantation Strategy: Insight From the Randomized DIRECTAVI Trial
A strategy of Transcatheter Aortic Valve Replacement (TAVR) without balloon predilatation has shown to be feasible in routine in observational studies and in two recent randomized trial including the DIRECTAVI trial. Whether the initial implantation strategy may impact the long-term trans catheter heart valve (THV) performances and patient outcomes remains unknown to date. The Investigators therefore aimed to evaluate the 5-years impact of the implantation strategy on THV hemodynamic performances and clinical outcomes in patients included in the DIRECTAVI trial.
Read the detailed description
All patients (n=236) included in the DIRECTAVI randomized trial conducted between May 2016 to May 2018 will be prospectively assessed for up to 5 years follow-up . The DIRECTAVI prospective, randomized, single-center, open-label trial, demonstrated the non-inferiority of a "direct TAVR" strategy using the third-generation balloon-expandable Edwards SAPIEN 3 device (Edwards Lifesciences, Irvine, CA, USA)
A systematic echographic follow-up will be performed in all patients enrolled in the DIRECTAVI trial at the longest follow -up obtained after TAVR between 2021 and 2022. Clinical follow-up will be obtained with a brief patient clinical questionnaire or by phone by patients' cardiologist.
Serial Echographic follow-up will be obtained by patients' cardiologist except for the latest follow-up echocardiography (primary end point) performed in the reference center at Montpellier University hospital by two experienced cardiologists specialized in valvular echography to avoid inter operator variability.
- Conditions
- Coronary Syndrome, Hemodynamic Instability
- Being tested
- Transcatheter heart valve implantation with or withour predilatatation
- Keywords
- patients included in the directavi trial, TAVR Hemodynamic performances long term follow up
- Medical subject headings
- Angina, Unstable
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcatheter heart valve implantation with or withour predilatatationProcedure or surgery
long term up to 5 years echographic and clinical follow up
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | The direct stargegy group included patients with implanation of the THV without predilatation The reference group included patients with direct implanation of tne THV withour predilaation Receives: Procedure: Transcatheter heart valve implantation with or withour predilatatation | |
| Group 2 | the echographists were blinded regarding the groups of the patients Receives: Procedure: Transcatheter heart valve implantation with or withour predilatatation |
What is being measured
The primary outcome is the main question the study is designed to answer.
the incidence of patients without THV dysfunction
the incidence of patients without THV dysfunction according to the implantation strategy group (direct implantation vs ballon predilatation) at the latest follow-up available (up to 5 years)
Measured: up to 5 years
the incidence of patients without correct hemodynamic performance
the incidence of patients without correct hemodynamic performance according to the implantation strategy group (direct implantation vs ballon predilatation) at the latest follow-up available (up to 5 years)
Measured: up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2021
- Study start1 May 2021
- Primary completion1 Aug 2023
- Study completion1 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary SyndromeStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 236 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Florence Leclercq, PU PH, Study director, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05140317
- Sponsor's protocol ID
- RECHMPL21_0342
- Acronym
- DIRECTAVILONG
- Status last verified
- Jan 2024
- First submitted
- 10 Nov 2021
- Last updated
- 17 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: NC
Publications
Jammoul N, Dupasquier V, Akodad M, Meunier PA, Moulis L, Soltani S, Macia JC, Robert P, Schmutz L, Steinecker M, Piot C, Targosz F, Benkemoun H, Lattuca B, Roubille F, Cayla G, Leclercq F. Long-term follow-up of balloon-expandable valves according to the implantation strategy: insight from the DIRECTAVI trial. Am Heart J. 2024 Apr;270:13-22. doi: 10.1016/j.ahj.2024.01.005. Epub 2024 Jan 20.
PubMed 38253304
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 5 Years Hemodynamic and Clinical Follow-up of the SAPIEN 3 Transcatheter Heart Valve According to the Implantation Strategy: Insight From the Randomized DIRECTAVI Trial
- ClinicalTrials.gov ID
- NCT05140317
- Acronym / sponsor ID
- DIRECTAVILONG / RECHMPL21_0342
- Conditions
- Coronary Syndrome, Hemodynamic Instability
- Keywords
- patients included in the directavi trial, TAVR Hemodynamic performances long term follow up
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 236 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 1 May 2021 (actual)
- Primary completion
- 1 Aug 2023 (actual)
- Study completion
- 1 Aug 2023 (actual)
- First posted
- 1 Dec 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.
A strategy of Transcatheter Aortic Valve Replacement (TAVR) without balloon predilatation has shown to be feasible in routine in observational studies and in two recent randomized trial including the DIRECTAVI trial. Whether the initial implantation strategy may impact the long-term trans catheter heart valve (THV) performances and patient outcomes remains unknown to date. The Investigators therefore aimed to evaluate the 5-years impact of the implantation strategy on THV hemodynamic performances and clinical outcomes in patients included in the DIRECTAVI trial.
Detailed description
All patients (n=236) included in the DIRECTAVI randomized trial conducted between May 2016 to May 2018 will be prospectively assessed for up to 5 years follow-up . The DIRECTAVI prospective, randomized, single-center, open-label trial, demonstrated the non-inferiority of a "direct TAVR" strategy using the third-generation balloon-expandable Edwards SAPIEN 3 device (Edwards Lifesciences, Irvine, CA, USA)
A systematic echographic follow-up will be performed in all patients enrolled in the DIRECTAVI trial at the longest follow -up obtained after TAVR between 2021 and 2022. Clinical follow-up will be obtained with a brief patient clinical questionnaire or by phone by patients' cardiologist.
Serial Echographic follow-up will be obtained by patients' cardiologist except for the latest follow-up echocardiography (primary end point) performed in the reference center at Montpellier University hospital by two experienced cardiologists specialized in valvular echography to avoid inter operator variability.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Procedure: Transcatheter heart valve implantation with or withour predilatatationThe direct stargegy group included patients with implanation of the THV without predilatation The reference group included patients with direct implanation of tne THV withour predilaation |
| Group 2 | – | Procedure: Transcatheter heart valve implantation with or withour predilatatationthe echographists were blinded regarding the groups of the patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients included in the DIRECTAVI trial
Key inclusion criteria (2 listed)
- Older than 18 years old.
- patients included in the DIRECTAVI trial
Key exclusion criteria (1 listed)
- Patients not living in France
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 heart valve implantation with or withour predilatatationlong term up to 5 years echographic and clinical follow up | Procedure or surgery | Group 1, Group 2 |
Primary outcome
the incidence of patients without THV dysfunction
Time frame: up to 5 years
the incidence of patients without THV dysfunction according to the implantation strategy group (direct implantation vs ballon predilatation) at the latest follow-up available (up to 5 years)
the incidence of patients without correct hemodynamic performance
Time frame: up to 5 years
the incidence of patients without correct hemodynamic performance according to the implantation strategy group (direct implantation vs ballon predilatation) at the latest follow-up available (up to 5 years)
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 17 Jan 2024.
- Derived from this study: PubMed 38253304Jammoul N, Dupasquier V, Akodad M, Meunier PA, Moulis L, Soltani S, Macia JC, Robert P, Schmutz L, Steinecker M, Piot C, Targosz F, Benkemoun H, Lattuca B, Roubille F, Cayla G, Leclercq F. Long-term follow-up of balloon-expandable valves according to the implantation strategy: insight from the DIRECTAVI trial. Am Heart J. 2024 Apr;270:13-22. doi: 10.1016/j.ahj.2024.01.005. Epub 2024 Jan 20.
- Individual participant dataSharing planned: Undecided. NC
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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.
Florence Leclercq, PU PH study director
University Hospital, Montpellier
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 Coronary Syndrome and Hemodynamic Instability, run by University Hospital, Montpellier 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 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: finished, as of the sponsor's last update on 17 Jan 2024. 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?
the incidence of patients without THV dysfunction (time frame: up to 5 years). 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 NCT05140317, which also lists 1 linked publication.
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 17 Jan 2024; AzTrials last refreshed its copy on 8 Nov 2026.