Aortic StenosisTAVIWOPNCT04350658
TAVR Without Predilatation
An observational study of Aortic Stenosis, run by University Hospital, Montpellier at 1 site in France.
Trial summary
The procedure is performed via transfemoral or transcaprotid access; Patients were confirmed to be eligible for TAVR by a multidisciplinary heart team including at least an interventional cardiologist, a cardiothoracic surgeon and an anesthetist. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Stenosis
- What is being tested?
- Transcatheter aortic valve implantation required for symptomatic aortic stenosis
- Type of treatment
- Surgery or procedure
- How many people
- 138 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jun 2020to 1 Apr 2022
- 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 comers patients undergoing TAVR using transfemoral or transcaorotid approaches
Who may be able to join
- patients undergoing TAVR via transfemoral or rascoarotid access
Who cannot join
- others access (subclavian, apical, transaortic)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility and Safety of TAVI Without Predilatation: an Observational All Comers Study
The procedure is performed via transfemoral or transcaprotid access; Patients were confirmed to be eligible for TAVR by a multidisciplinary heart team including at least an interventional cardiologist, a cardiothoracic surgeon and an anesthetist. All TAVR implantation procedures were performed with the Edwards SAPIEN 3 THV or the MEDTRONIC CoreValve EVOLUT . For all patients, both vascular access and aortic valve were evaluated before the procedure by multislice computerized tomographic angiography (MSCT) of the entire aorta using vascular windows settings. The prosthesis and the vascular access were left to the discretion of the operating team. Transfemoral access was the first choice when possible. All TAVR procedures were performed in the same hybrid room (in Montpellier University Hospital), Most TAVR were performed under sedation or general anesthesia using mild low profile 14-16 French delivery systems and using percutaneous or surgical vascular access.
- Conditions
- Aortic Stenosis
- Being tested
- Transcatheter aortic valve implantation required for symptomatic aortic stenosis
- Keywords
- TAVR, Balloon prediltation, success of crossing the valve, direct implanation
- 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 implantation required for symptomatic aortic stenosisProcedure or surgery
The procedure is performed via transfemoral or transcarotid access; Patients were confirmed to be eligible for TAVR by a multidisciplinary heart team including at least an interventional cardiologist, a cardiothoracic surgeon and an anesthetist. All TAVR implantation procedures were performed with the Edwards SAPIEN 3 THV or the MEDTRONIC CoreValve EVOLUT . For all patients, both vascular access and aortic valve were evaluated before the procedure by multislice computerized tomographic angiography (MSCT) of the entire aorta using vascular windows settings. The prosthesis and the vascular access were left to the discretion of the operating team. Transfemoral access was the first choice when possible. All TAVR procedures were performed in the same hybrid room (in Montpellier University Hospital), Most TAVR were performed under sedation or general anesthesia using mild low profile 14-16 French delivery systems and using percutaneous or surgical vascular access.
| Study group | Role | What they receive |
|---|---|---|
| TAVR | all comers study including all transfemoral or transcarotid TAVR procédures. direct implantation is the default strategy usually used in our enter as in may centers Receives: Procedure: Transcatheter aortic valve implantation required for symptomatic aortic stenosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
success of the direct implantation
success of the direct implantation defined as failure of crossing with the THV after 3 attemps and absence of complication related to the direct crossing
Measured: 1 day
Secondary outcomes (3)
Indidence of post dilatation
Indidence of post dilatation
Measured: 1 day
Underexpansion of the Edwards SAPIEN 3 THV
Underexpansion of the Edwards SAPIEN 3 THV
Measured: 1 day
risks factors of failure of crossing
risks factors of failure of crossing : femoral vs carotid access, type of THV , vascular tortuosities, biscuipid valve, calcification, tight stenosis, horizontal aorta, small annulus
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2020
- Study start1 Jun 2020
- Primary completion1 Jul 2021
- Study completion1 Apr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 138 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Florence Leclercq, MD, PhD, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04350658
- Sponsor's protocol ID
- RECHMPL20_0204
- Acronym
- TAVIWOP
- Status last verified
- Nov 2021
- First submitted
- 15 Apr 2020
- Last updated
- 11 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: NC
Study at a glance
From the registry record, last updated by the sponsor on 11 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Safety of TAVI Without Predilatation: an Observational All Comers Study
- ClinicalTrials.gov ID
- NCT04350658
- Acronym / sponsor ID
- TAVIWOP / RECHMPL20_0204
- Conditions
- Aortic Stenosis
- Keywords
- TAVR, Balloon prediltation, success of crossing the valve, direct implanation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 138 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 1 Jul 2021 (actual)
- Study completion
- 1 Apr 2022 (estimated)
- First posted
- 17 Apr 2020 (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 procedure is performed via transfemoral or transcaprotid access; Patients were confirmed to be eligible for TAVR by a multidisciplinary heart team including at least an interventional cardiologist, a cardiothoracic surgeon and an anesthetist. All TAVR implantation procedures were performed with the Edwards SAPIEN 3 THV or the MEDTRONIC CoreValve EVOLUT . For all patients, both vascular access and aortic valve were evaluated before the procedure by multislice computerized tomographic angiography (MSCT) of the entire aorta using vascular windows settings. The prosthesis and the vascular access were left to the discretion of the operating team. Transfemoral access was the first choice when possible. All TAVR procedures were performed in the same hybrid room (in Montpellier University Hospital), Most TAVR were performed under sedation or general anesthesia using mild low profile 14-16 French delivery systems and using percutaneous or surgical vascular access.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TAVR | – | Procedure: Transcatheter aortic valve implantation required for symptomatic aortic stenosisall comers study including all transfemoral or transcarotid TAVR procédures. direct implantation is the default strategy usually used in our enter as in may centers |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- all comers patients undergoing TAVR using transfemoral or transcaorotid approaches
Key inclusion criteria (1 listed)
- patients undergoing TAVR via transfemoral or rascoarotid access
Key exclusion criteria (1 listed)
- others access (subclavian, apical, transaortic)
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 implantation required for symptomatic aortic stenosisThe procedure is performed via transfemoral or transcarotid access; Patients were confirmed to be eligible for TAVR by a multidisciplinary heart team including at least an interventional cardiologist, a cardiothoracic surgeon and an anesthetist. All TAVR implantation procedures were performed with the Edwards SAPIEN 3 THV or the MEDTRONIC CoreValve EVOLUT . For all patients, both vascular access and aortic valve were evaluated before the procedure by multislice computerized tomographic angiography (MSCT) of the entire aorta using vascular windows settings. The prosthesis and the vascular access were left to the discretion of the operating team. Transfemoral access was the first choice when possible. All TAVR procedures were performed in the same hybrid room (in Montpellier University Hospital), Most TAVR were performed under sedation or general anesthesia using mild low profile 14-16 French delivery systems and using percutaneous or surgical vascular access. | Procedure or surgery | TAVR |
Primary outcome
success of the direct implantation
Time frame: 1 day
success of the direct implantation defined as failure of crossing with the THV after 3 attemps and absence of complication related to the direct crossing
3 secondary outcomes
Indidence of post dilatation
Time frame: 1 day
Underexpansion of the Edwards SAPIEN 3 THV
Time frame: 1 day
risks factors of failure of crossing
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Nov 2021.
- Individual participant dataSharing planned: Undecided. NC
Related trials for Aortic Stenosis
Not yet recruiting
NHLBI SESAME (SEptal Scoring Along Midline Endocardium) Multi-Center Prospective Study Using Improvised Off-Label Devices
Hypertrophic Cardiomyopathy, Left Ventricular Outflow Obstruction
Not yet recruiting
Exercise and Diet Supplements for Older Patients Undergoing TAVI: the IRON-TAVI Trial
Aortic Stenosis Disease, Aortic Stenosis Symptomatic
Not yet recruiting
Human Experimental Models of Pain (HEMP)
Acute Pain
Not yet recruitingPhase 4
Application of TAVI at Experienced Interventional Cardiac Centers Without On-site Cardiac Surgery (ATLAS Study)
Aortic Stenosis, Severe Aortic Stenosis
Active, not recruiting
Early Valve Replacement Guided by Biomarkers of LV Decompensation in Asymptomatic Patients With Severe AS
Aortic Valve Stenosis, Hypertrophy, Left Ventricular
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, MD, PhD principal investigator
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 Aortic Stenosis, 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 1 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 11 Nov 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?
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?
success of the direct implantation (time frame: 1 day). 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 11 Nov 2021.