N/A N=20 Other

EasyCrossTM Device-Self-centering Catheter

Transcatheter Aortic Valve Replacement (TAVR)

Bottom Line

View on ClinicalTrials.gov: NCT06412354 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Apr 2026

Primary outcome: Primary: Number of Participants With AE /SAE Linked or no Linked With the EasyCross Device — 0 Participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: EasyCross™ first-in human (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Vivheart s.r.l.
Primary completion: Jul 2024

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	—	—

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

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

View full record on ClinicalTrials.gov →

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.