Trans-catheter Aortic Valve ImplantationNEOVALVENCT07506382
Comparative Observational Study of Supra-annular Versus Intra-annular Self-expanding Aortic Valves in Routine Clinical Practice
An observational study of Trans-catheter Aortic Valve Implantation, run by University Hospital, Montpellier at 1 site in France.
Trial summary
We proposed to compare in an observational study procedural success at one month (VARC 3 criteria) and clinical and echographic follow-up at 6 months between 2 self expandable devices in TAVR : the supra annular Evolut device (Medtronic) vs the intra anular NAVITOR device (Abott) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Trans-catheter Aortic Valve Implantation
- How many people
- 419 participants
- Where
- 1 siteFrance
- Study dates
- 10 Feb 2026to Mar 2028
- How long will I take part?
- 36 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: patients with indication of femoral TAVR for aortic stenosis after heart team decision
Who may be able to join
- all patients elligible for TAVR witn a self expandable device
Who cannot join
- femoral access not suitable
- valve in valve procedures
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
University hopsital
Montpellier, Occitanie, 34295
FLORENCE LECLERCQ, MD, PhD, 0681055297, f-leclercq@chu-montpellier.fr
f-leclercq@chu-montpellier.fr
About this study
We proposed to compare in an observational study procedural success at one month (VARC 3 criteria) and clinical and echographic follow-up at 6 months between 2 self expandable devices in TAVR : the supra annular Evolut device (Medtronic) vs the intra anular NAVITOR device (Abott)
Read the detailed description
Compared with balloon-expandable valves, self-expandable supra annular devices (Mertronic Evolut) offer superior post-procedural hemodynamics in TAVR and are, therefore, expected to play a growing role in clinical practice particularly in small aortic anatomies . However, the relatively long stent frame of self-expandable valves posed challenges for coronary access after implantation and PPI rates remain higher, despite lower implantation height with the cusp overlap technique The Navitor valves (Abbott Structural Valve) is a new generation intra-annular self-expandable device with tall stent frame but larger stent cells and shorter outer skirt which may be more favorable for future coronary access than the Evolut FX valves, particularly in patients with lower coronary heights . The Navitor platform showed satisfying data in tricuspid anatomy, providing intra-annular leaflets, an innovative sealing cuff, and repositionability .However this platform showed a high rate of PPI that could be related to the need for lower implantation to stabilize the device (first generation) Considering the lack of specific data regarding the compared performance of the 2 plateforms including latest generation devices, we aimed to evaluate procedural success, clinical and hemodynamic results, and conductive disorders between the 2 platforms in an observational real life study
- Conditions
- Trans-catheter Aortic Valve Implantation
- Keywords
- self expandable devices, intra annular design, supra annular design, procedural success, hemodynamics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| patients with indication of TAVR - supra annular design device | TAVR with self expandable supra annular design device (EVOLUT) | |
| patients with indication of TAVR - intra annular design device | TAVR with self expandable intra annular design device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Device success according to VARC 3 criteria
Measured: 1 month follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2026
- Study start10 Feb 2026
- Primary completion15 Feb 2028 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Trans-catheter Aortic Valve ImplantationStudies 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
- 419 participants (estimated)
- Target duration
- 36 Months
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07506382
- Sponsor's protocol ID
- 2025-12-397
- Acronym
- NEOVALVE
- Status last verified
- Mar 2026
- First submitted
- 26 Mar 2026
- Last updated
- 1 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Observational Study of Supra-annular Versus Intra-annular Self-expanding Aortic Valves in Routine Clinical Practice
- ClinicalTrials.gov ID
- NCT07506382
- Acronym / sponsor ID
- NEOVALVE / 2025-12-397
- Conditions
- Trans-catheter Aortic Valve Implantation
- Keywords
- self expandable devices, intra annular design, supra annular design, procedural success, hemodynamics
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 419 participants (estimated)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 10 Feb 2026 (actual)
- Primary completion
- 15 Feb 2028 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 1 Apr 2026 (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.
We proposed to compare in an observational study procedural success at one month (VARC 3 criteria) and clinical and echographic follow-up at 6 months between 2 self expandable devices in TAVR : the supra annular Evolut device (Medtronic) vs the intra anular NAVITOR device (Abott)
Detailed description
Compared with balloon-expandable valves, self-expandable supra annular devices (Mertronic Evolut) offer superior post-procedural hemodynamics in TAVR and are, therefore, expected to play a growing role in clinical practice particularly in small aortic anatomies . However, the relatively long stent frame of self-expandable valves posed challenges for coronary access after implantation and PPI rates remain higher, despite lower implantation height with the cusp overlap technique The Navitor valves (Abbott Structural Valve) is a new generation intra-annular self-expandable device with tall stent frame but larger stent cells and shorter outer skirt which may be more favorable for future coronary access than the Evolut FX valves, particularly in patients with lower coronary heights . The Navitor platform showed satisfying data in tricuspid anatomy, providing intra-annular leaflets, an innovative sealing cuff, and repositionability .However this platform showed a high rate of PPI that could be related to the need for lower implantation to stabilize the device (first generation) Considering the lack of specific data regarding the compared performance of the 2 plateforms including latest generation devices, we aimed to evaluate procedural success, clinical and hemodynamic results, and conductive disorders between the 2 platforms in an observational real life study
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 36 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients with indication of TAVR - supra annular design device | – | –TAVR with self expandable supra annular design device (EVOLUT) |
| patients with indication of TAVR - intra annular design device | – | –TAVR with self expandable intra annular design device |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with indication of femoral TAVR for aortic stenosis after heart team decision
Key inclusion criteria (1 listed)
- all patients elligible for TAVR witn a self expandable device
Key exclusion criteria (2 listed)
- femoral access not suitable
- valve in valve procedures
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Device success according to VARC 3 criteria
Time frame: 1 month follow up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2026.
- Individual participant dataSharing planned: Yes
Related trials for Trans-catheter Aortic Valve Implantation
RecruitingObservational study
Impact of Trans-catheter Aortic Valve Implantation on Renal Function
Aortic Valve Stenosis, Chronic Kidney Diseases
RecruitingObservational study
Pre-Emptive LAVA-ECMO for Complex High-Risk TAVR
Severe Aortic Stenosis, Cardiogenic Shock
Not yet recruiting
Optimization of Commissural Alignment During Transcatheter Aortic Valve Implantation With Evolut FX+
Aortic Stenosis, Trans-catheter Aortic Valve Implantation
Not yet recruiting
CAN3T - Canadian TAVI Triage Tool
Aortic Stenosis
RecruitingObservational study
Functional and Quality of Life Improvement Following Transcatheter Heart Valve Implantation
Trans Catheter Aortic Valve, Aortic Stenosis
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.
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 Trans-catheter Aortic Valve Implantation, 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 2 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: looking for participants now, as of the sponsor's last update on 1 Apr 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Florence LECLERCQ, MD (+33467336212, f-leclercq@chu-montpellier.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Device success according to VARC 3 criteria (time frame: 1 month follow up). 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 1 Apr 2026.