NCT07506382

Brief 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)

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
419

participants targeted

Target at P75+ for all trials

Timeline
23mo left

Started Feb 2026

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress9%
Feb 2026Mar 2028

Study Start

First participant enrolled

February 10, 2026

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 26, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 1, 2026

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2028

Expected
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2028

Last Updated

April 1, 2026

Status Verified

March 1, 2026

Enrollment Period

2 years

First QC Date

March 26, 2026

Last Update Submit

March 26, 2026

Conditions

Trans-catheter Aortic Valve Implantation

Keywords

self expandable devicesintra annular designsupra annular designprocedural successhemodynamics

Outcome Measures

Primary Outcomes (1)

  • Device success according to VARC 3 criteria

    1 month follow up

Study Arms (2)

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • all patients elligible for TAVR witn a self expandable device

You may not qualify if:

  • femoral access not suitable
  • valve in valve procedures

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University hopsital

Montpellier, Occitanie, 34295, France

RECRUITING

Central Study Contacts

Florence LECLERCQ, MD

CONTACT

+33467336212f-leclercq@chu-montpellier.fr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
36 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 26, 2026

First Posted

April 1, 2026

Study Start

February 10, 2026

Primary Completion (Estimated)

February 15, 2028

Study Completion (Estimated)

March 1, 2028

Last Updated

April 1, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will share

Locations

FR(1)