EasyCrossTM Device-Self-centering Catheter
- Conditions
- Transcatheter Aortic Valve Replacement (TAVR)
- Interventions
- Device: EasyCross™ first-in human
- Registration Number
- NCT06412354
- Lead Sponsor
- Vivheart s.r.l.
- 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
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 25
- 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.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description VIV-FIH EasyCross™ first-in human 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").
- Primary Outcome Measures
Name Time Method Number of Participants with AE /SAE linked or no linked with the EasyCross device 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 Outcome Measures
Name Time Method Time (in minutes) spent to crossing the valve witn EasyCross device during 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.
Trial Locations
- Locations (1)
San Raffaele Scientific Institute
🇮🇹Milan, Italy