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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VIV-FIH | Experimental | 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"). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EasyCross™ first-in human | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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):
| Day of procedure; 1 week; 4 week |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | after procedure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marco Ancona, Dr. | IRCCS San Raffaele | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| San Raffaele Scientific Institute | Milan | 20132 | Italy |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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"). 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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"). 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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):
| Posted | Count of Participants | Participants | Day of procedure; 1 week; 4 week |
|
1 month
Five SAEs occurred: three pacemaker implantations for post-TAVR conduction disturbances, one gastrointestinal bleeding (VARC type 3) requiring transfusion and hospitalization, and one head trauma causing prolonged stay. Two AEs were reported: a VARC type 1 bleeding and a Prostar closure failure needing a femoral stent. All events were procedure-related and not attributed to the VIVHEART EasyCross™ device.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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"). 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| AE | General disorders | Non-systematic Assessment | One patient had a VARC(Valve Academic Research ) type 1 bleeding event, necessitating one blood transfusion |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| AE | General disorders | Non-systematic Assessment | One patient had prolonged hospitalization due to head trauma |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Marco Ancona | IRCCS San Raffaele | +39 02 26437331 | ancona.marco@hsr.it |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 14, 2023 | Mar 31, 2026 | Prot_000.pdf |
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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").
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| Participants |
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| Age, Continuous | Median | Full Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Diabetes | Number | Participants |
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| Peripheral vascular disease | Count of Participants | Participants |
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| Chronic Kidney Disease | Number | participants |
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| Previous Percutaneous Coronary Intervention(PCI) | Count of Participants | Participants |
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| Previous Coronary Artery bypass graft (CABG) | Count of Participants | Participants |
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| Previous Surgical Aortic Valve Replacement (SAVR) | Count of Participants | Participants |
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| Previous TAVR | Count of Participants | Participants |
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| Previous Ictus | Count of Participants | Participants |
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| Previous pulmonary embolism | Count of Participants | Participants |
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| Cardiovascular disease | Count of Participants | Participants |
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| Neurological disease | Count of Participants | Participants |
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| Lung diseases | Count of Participants | Participants |
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| Previous lower limb fracture | Count of Participants | Participants |
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| Lung diseases | Count of Participants | Participants |
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| Secondary | 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. | Not Posted | Sep 2026 | after procedure | Participants |
| 0 |
| 20 |
| 0 |
| 20 |
| 2 |
| 20 |
|
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