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Completed

NCT Number: NCT06412354

EasyCrossTM Device-Self-centering Catheter

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

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Key information

Conditions

Transcatheter Aortic Valve Replacement (TAVR)

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

San Raffaele Scientific Institute

Milan, 20132, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

EasyCross™ first-in human

Device

At T0 the patient will undergo the TAVR procedure including the investigational procedure with the VIVHEART EasyCross™ catheter.

The interventional cardiologist will introduce the VIVHEART EasyCross™ catheter through the femoral artery with a percutaneous access according to the clinical practice through a vascular introducer on an already positioned guidewire. An operator in the procedure room will start a chronometer at this point to measure the investigational device crossing procedure duration.

The VIVHEART EasyCross™ catheter will be progressed into the aorta and up to the aortic valve.

At that time the external part of the VIVHEART EasyCross™ catheter will be opened to allow the self-centering of the catheter on the aortic valve. The guidewire will be introduced and once having crossed the valve the VIVHEART EasyCross™ catheter will be retracted by the physician and removed from the patient's body.

Primary outcomes

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

    Time frame: Day of procedure; 1 week; 4 week

    The primary endpoint is the safety of VIVHEART EasyCross™ catheter, in term of adverse events (AE) and serious adverse events (SAE). Occurrence of any AE will be recorded, in particular the following AE will be coded and investigated as adverse events of special interest (AESI):

    • Intra-operative death,
    • Any intra-operative complication due to device malfunction,
    • Any embolization event,
    • Any allergic reaction.

Secondary outcomes

  1. Time (in Minutes) Spent to Crossing the Valve Witn EasyCross Device

    Time frame: after procedure

    The secondary endpoints will evaluate the performances of the VIVHEART

    EasyCross™ catheter in terms of:

    • Investigational device crossing procedure duration, assesmed in minutes starting by introduction of Easycross catheter to crossing the valve.

Sponsors and collaborators

Lead sponsor

Vivheart s.r.l.

Industry

Registry information

Official study title

VIVHEART Transcatheter Aortic Valve Replacement (TAVR) Self-centering Catheter First-in-human Feasibility Trial (VIV-FIH)

Acronym: VIV-FIH

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
May 14, 2024
Registry last updated
Apr 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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