EasyCrossTM Device-Self-centering Catheter

NCT06412354 | Completed Results

• 1 other identifier: CIP01
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Transcatheter Aortic Valve Replacement (TAVR)

Outcome Measures

Primary Outcomes (1)

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

  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.

  Day of procedure; 1 week; 4 week

Secondary Outcomes (1)

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

  after procedure

Study Arms (1)

VIV-FIH

EXPERIMENTAL

The VIVHEART EasyCross™ fist-in human (VIV-FIH) study is a single center, prospective, open-label, non-randomized, single-group assignment, first-in-human feasibility trial of the VIVHEART EasyCross™ catheter used according to the indication of use. The experimental part of the trial which differs from the traditional TAVR procedure is the use of the self-centering catheter from its insertion in an artery and up to its removal from the patient body (henceforth "investigational procedure").

Device: EasyCross™ first-in human

Interventions

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.

VIV-FIH

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Vivheart s.r.l.: lead

Study Sites (1)

San Raffaele Scientific Institute

Milan, 20132, Italy

Location

Results Point of Contact

• Title: Dr. Marco Ancona
• Organization: IRCCS San Raffaele

ancona.marco@hsr.it

+39 02 26437331

Study Officials

• Marco Ancona, Dr.

  IRCCS San Raffaele

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The VIVHEART EasyCross™ fist-in human (VIV-FIH) study is a singlecenter, prospective, open-label, non-randomized, single-group assignment, first-in-human feasibility trial of the VIVHEART EasyCross™ catheter used according to the indication of use. The experimental part of the trial which differs from the traditional TAVR procedure is the use of the self-centering catheter from its insertion in an artery and up to its removal from the patient body (henceforth "investigational procedure").

Study Record Dates

• First Submitted: April 30, 2024
• First Posted: May 14, 2024
• Study Start: February 12, 2024
• Primary Completion: July 15, 2024
• Study Completion: July 15, 2024
• Last Updated: April 22, 2026
• Results First Posted: April 22, 2026

Record last verified: 2024-05

Locations

IT (1)