EasyCrossTM Device-Self-centering Catheter (VIV-FIH)

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

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

Study Overview

• Status: Recruiting
• Conditions: Transcatheter Aortic Valve Replacement (TAVR)
• Intervention / Treatment: Device: EasyCross™ first-in human

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 25
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Marco ANcona, Dr.; Phone Number: 02 2643 7338; Email: ancona.marco@hsr.it
• Study Contact Backup: Name: Elisabetta Messaggio; Phone Number: +39 02 2643 7338

Study Locations

• Italy
  • Milan, Italy, 20132
    • Recruiting
    • San Raffaele Scientific Institute
    • Contact: Marco Ancona, Dr.; Phone Number: +39 02 2643 7338; Email: ancona.marco@hsr.it
    • Contact: Elisabetta Messaggio; Phone Number: +39 02 2643 7338; Email: messaggio.elisabetta@hsr.it
    • Principal Investigator: Marco Ancona, Dr.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: VIV-FIH; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Performances of the EasyCross™ device	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.	during procedure
Performances of the EasyCross™ device	The other Secondary Ouycome Measures that will be evaluate the performances of the VIVHEART EasyCross™ catheter, will be: - the assesment by the PI the correct placement of valvular device	during procedure

Collaborators and Investigators

• Sponsor: Vivheart s.r.l.

Study record dates

Study Major Dates

• Study Start (Actual): February 12, 2024
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): June 1, 2024

Study Registration Dates

• First Submitted: April 30, 2024
• First Submitted That Met QC Criteria: May 8, 2024
• First Posted (Actual): May 14, 2024

Study Record Updates

• Last Update Posted (Actual): May 14, 2024
• Last Update Submitted That Met QC Criteria: May 8, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: CIP01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No