CompletedNot Applicable

EasyCrossTM Device-Self-centering Catheter

Italy20 participantsStarted 2024-02-12

Plain-language 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

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Number of Participants With AE /SAE Linked or no Linked With the EasyCross Device

Timeframe: Day of procedure; 1 week; 4 week

Trial details

NCT IDNCT06412354

SponsorVivheart s.r.l.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-07-15

Results submitted2025-11-14