EasyCrossTM Device-Self-centering Catheter

Transcatheter Aortic Valve Replacement (TAVR) Clinical Trial

— VIV-FIH  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06412354
• Other study ID #: CIP01
• Status: Recruiting
• Phase: N/A
• Start date: February 12, 2024
• Est. completion date: June 2024

Study information

• Verified date: May 2024
• Source: Vivheart s.r.l.
• Contact: Marco ANcona, Dr.
• Phone: 02 2643 7338
• Email: ancona.marco[@]hsr.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. completion date: June 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Transcatheter Aortic Valve Replacement (TAVR)

Intervention

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.

Locations

Country	Name	City	State
Italy	San Raffaele Scientific Institute	Milan

Sponsors (1)

Lead Sponsor	Collaborator
Vivheart s.r.l.

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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