EasyCrossTM Device-Self-centering Catheter

Last updated: September 20, 2024
Sponsor: Vivheart s.r.l.
Overall Status: Completed

Phase

N/A

Condition

Cardiac Surgery

Open Heart Surgery

Treatment

EasyCross™ first-in human

Clinical Study ID

NCT06412354
CIP01
  • Ages > 18
  • All Genders

Study 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

Inclusion Criteria:

  • Age: ≥18 years old

  • Candidate to TAVR of a native valve, recrossing and balloon postdilation of aprosthetic 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 informedconsent to participation.

Exclusion

Exclusion Criteria:

  • Contraindications for endovascular procedures

  • Pregnancy or breastfeeding females at screening and at time of investigationalprocedure

  • Hemodynamically unstable or other clinical conditions increasing the risk oftranscatheter valve procedure failure

  • Needing emergent procedure

  • Allergies to components of the device

  • Allergies to drugs or contrast material that may be used during the investigationalprocedure and all the TAVR procedure

  • Participation in another clinical trial

Study Design

Total Participants: 20
Treatment Group(s): 1
Primary Treatment: EasyCross™ first-in human
Phase:
Study Start date:
February 12, 2024
Estimated Completion Date:
July 15, 2024

Study Description

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.

EasyCross™ device is a catheter is intended to allow a rapid and safe centering of a heart valve in order to direct and introduce a guidewire through it. The intended purpose is the use of the device during percutaneous TAVR procedures, including TAVR of a native valve, recrossing and balloon post-dilation of a prosthetic aortic valve, or a valve-in-valve aortic valve replacement within the scope of the CE mark.

The VIVHEART EasyCross™ device is intended for patients candidate to TAVR of a native valve, recrossing and balloon post-dilation of a prosthetic aortic valve, or a valve-in-valve aortic valve replacement. The suitability of the patient is to be verified case by case by the specialized physician, by means of proper physical examination and instrumental evaluation, according to clinical practice.

Connect with a study center

  • San Raffaele Scientific Institute

    Milan, 20132
    Italy

    Site Not Available

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