Transcatheter Aortic Valve Replacement (TAVR)
Conditions
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.
Interventions
DEVICEEasyCross™ 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.
Sponsors
Vivheart s.r.l.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Intervention model description
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").
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Time (in Minutes) Spent to Crossing the Valve Witn EasyCross Device | after 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. |
Countries
Italy
Contacts
PRINCIPAL_INVESTIGATORMarco Ancona, Dr.
IRCCS San Raffaele
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 20 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Age, Continuous | 82 years |
| Cardiovascular disease | 14 Participants |
| Chronic Kidney Disease | 4 participants |
| Diabetes | 4 Participants |
| Lung diseases | 0 Participants |
| Neurological disease | 0 Participants |
| Peripheral vascular disease | 9 Participants |
| Previous Coronary Artery bypass graft (CABG) | 0 Participants |
| Previous Ictus | 2 Participants |
| Previous lower limb fracture | 0 Participants |
| Previous Percutaneous Coronary Intervention(PCI) | 3 Participants |
| Previous pulmonary embolism | 0 Participants |
| Previous Surgical Aortic Valve Replacement (SAVR) | 6 Participants |
| Previous TAVR | 1 Participants |
| Sex: Female, Male Female | 12 Participants |
| Sex: Female, Male Male | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 20 |
| other Total, other adverse events | 2 / 20 |
| serious Total, serious adverse events | 0 / 20 |
Outcome results
None listed