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

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)

Study Overview

• Status: Recruiting
• Conditions: Trans-catheter Aortic Valve Implantation

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 Type: Observational
• Enrollment (Estimated): 419

Contacts and Locations

• Study Contact: Name: Florence LECLERCQ, MD; Phone Number: +33467336212; Email: f-leclercq@chu-montpellier.fr

Study Locations

• France
  • Occitanie
    • Montpellier, Occitanie, France, 34295
      • Recruiting
      • University hopsital
      • Principal Investigator: FLORENCE LECLERCQ, MD, PhD
      • Contact: FLORENCE LECLERCQ, MD, PhD; Phone Number: 0681055297; Email: f-leclercq@chu-montpellier.fr
      • Contact: Email: f-leclercq@chu-montpellier.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

patients with indication of femoral TAVR for aortic stenosis after heart team decision

Description

Inclusion Criteria:

• all patients elligible for TAVR witn a self expandable device

Exclusion Criteria:

• femoral access not suitable
• valve in valve procedures

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Device success according to VARC 3 criteria	1 month follow up

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier

Study record dates

Study Major Dates

• Study Start (Actual): February 10, 2026
• Primary Completion (Estimated): February 15, 2028
• Study Completion (Estimated): March 1, 2028

Study Registration Dates

• First Submitted: March 26, 2026
• First Submitted That Met QC Criteria: March 26, 2026
• First Posted (Actual): April 1, 2026

Study Record Updates

• Last Update Posted (Actual): April 1, 2026
• Last Update Submitted That Met QC Criteria: March 26, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: hemodynamics; self expandable devices; intra annular design; supra annular design; procedural success
• Other Study ID Numbers: 2025-12-397

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No