VIVHEART Transcatheter Aortic Valve Replacement (TAVR) Self-centering Catheter First-in-human Feasibility Trial (VIV-FIH)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 20
- Locations
- 2
- Primary Endpoint
- Number of Participants with AE /SAE linked or no linked with the EasyCross device
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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").
Intervention: EasyCross™ first-in human (Device)
Outcomes
Primary Outcomes
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.
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
- Time (in minutes) spent to crossing the valve witn EasyCross device(during procedure)
- Time (in Minutes) Spent to Crossing the Valve Witn EasyCross Device(after procedure)