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NCT Number: NCT07506382

Comparative Observational Study of Supra-annular Versus Intra-annular Self-expanding Aortic Valves in Routine Clinical Practice

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)

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University hopsital

Montpellier, Occitanie, 34295, France

Location status: Recruiting

Location contact

FLORENCE LECLERCQ, MD, PhD

CONTACT

[email protected]

0681055297

FLORENCE LECLERCQ, MD, PhD

PRINCIPAL_INVESTIGATOR

CONTACT

[email protected]

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • all patients elligible for TAVR witn a self expandable device

Exclusion criteria

  • femoral access not suitable
  • valve in valve procedures

Treatment and study plan

Primary outcomes

  1. Device success according to VARC 3 criteria

    Time frame: 1 month follow up

Study contacts

Contact information is provided by the study sponsor or research team.

Florence LECLERCQ, MD

CONTACT

[email protected]

+33467336212

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Registry information

Acronym: NEOVALVE

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Apr 1, 2026
Registry last updated
Apr 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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