An interventional study of EasyCross™ first-in human in Transcatheter Aortic Valve Replacement (TAVR), sponsored by Vivheart s.r.l.. Completed at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-22.
Sponsored by Vivheart s.r.l. · Not applicable, Interventional, and Other
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
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.
This is the only study on the registry with Vivheart s.r.l. as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Number of Participants With AE /SAE Linked or no Linked With the EasyCross Device
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.
Time frame: Day of procedure; 1 week; 4 week
Time (in Minutes) Spent to Crossing the Valve Witn 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.
Time frame: after procedure
| Milestone | VIV-FIH |
|---|---|
| Started | 20 |
| Completed | 20 |
| Not completed | 0 |
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.
| Participants | VIV-FIH |
|---|---|
| Number of Participants With AE /SAE Linked or no Linked With the EasyCross Device | 0 |
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.
Results for this outcome have not been posted.
Collected over 1 month. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| VIV-FIH | 0/20 (0%) | 0/20 (0%) | 2/20 (10%) |
| Event | VIV-FIH |
|---|---|
| AEGeneral disorders | 0/20 |
| Event | VIV-FIH |
|---|---|
| AEGeneral disorders | 2/20 |
| Age, Categorical(Participants) | VIV-FIH |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 0 |
| >=65 years | 20 |
| Age, Continuous(years) | VIV-FIH |
|---|---|
| Median | 82 (72 to 89) |
| Sex: Female, Male(Participants) | VIV-FIH |
|---|---|
| Female | 12 |
| Male | 8 |
| Race and Ethnicity Not Collected(Participants) | VIV-FIH |
|---|
| Diabetes(Participants) | VIV-FIH |
|---|---|
| Number | 4 |
| Peripheral vascular disease(Participants) | VIV-FIH |
|---|---|
| Count of participants | 9 |
| Chronic Kidney Disease(participants) | VIV-FIH |
|---|---|
| Number | 4 |
| Previous Percutaneous Coronary Intervention(PCI)(Participants) | VIV-FIH |
|---|---|
| Count of participants | 3 |
10 further baseline measures are reported on the registry.
Documents are hosted by the registry — open the source record to download them.
This study is completed, as verified in May 2024. You cannot join it, but the record below documents what was studied.
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