N/A
Completed N=20
EasyCrossTM Device-Self-centering Catheter
Transcatheter Aortic Valve Replacement (TAVR)
Source: ClinicalTrials.gov NCT06412354 ↗
Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Apr 2026
Primary outcomePrimary: Number of Participants With AE /SAE Linked or no Linked With the EasyCross Device — 0 Participants
Summary
VIVHEART EasyCross™ is a self-centering device for inserting a guidewire through a heart valve. It consists in a temporary catheter inserted into an artery with a terminal part able to expand a distal structure with 6 arms ("basket") to allow distancing of the catheter from the vessels walls and thus facilitating the passage of the guide wire through the aortic valve. The device is expected to reduce the attempts and the time needed to cross the valve and improves the safety of TAVR procedure
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With AE /SAE Linked or no Linked With the EasyCross Device |
— | — |
| SECONDARY Time (in Minutes) Spent to Crossing the Valve Witn EasyCross Device |
— | — |
Eligibility Criteria
Inclusion Criteria
- Age: ≥18 years old
- Candidate to TAVR of a native valve, recrossing and balloon postdilation of a prosthetic aortic valve, or a valve-in-valve aortic valve replacement.
- Willingness to undergo follow-up visits.
- Ability to understand scope, content and risks of the study, and provide informed consent to participation.
Exclusion Criteria
- Contraindications for endovascular procedures
- Pregnancy or breastfeeding females at screening and at time of investigational procedure
- Hemodynamically unstable or other clinical conditions increasing the risk of transcatheter valve procedure failure
- Needing emergent procedure
- Allergies to components of the device
- Allergies to drugs or contrast material that may be used during the investigational procedure and all the TAVR procedure
- Participation in another clinical trial
Data sourced from ClinicalTrials.gov (NCT06412354). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.