Trial Outcomes & Findings for EasyCrossTM Device-Self-centering Catheter (NCT NCT06412354)
NCT ID: NCT06412354
Last Updated: 2026-04-22
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
20 participants
Primary outcome timeframe
Day of procedure; 1 week; 4 week
Results posted on
2026-04-22
Participant Flow
Participant milestones
| Measure |
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.
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|---|---|
|
Overall Study
STARTED
|
20
|
|
Overall Study
COMPLETED
|
20
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
VIV-FIH
n=20 Participants
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.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=20 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=20 Participants
|
|
Age, Categorical
>=65 years
|
20 Participants
n=20 Participants
|
|
Age, Continuous
|
82 years
n=20 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=20 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=20 Participants
|
|
Diabetes
|
4 Participants
n=20 Participants
|
|
Peripheral vascular disease
|
9 Participants
n=20 Participants
|
|
Chronic Kidney Disease
|
4 participants
n=20 Participants
|
|
Previous Percutaneous Coronary Intervention(PCI)
|
3 Participants
n=20 Participants
|
|
Previous Coronary Artery bypass graft (CABG)
|
0 Participants
n=20 Participants
|
|
Previous Surgical Aortic Valve Replacement (SAVR)
|
6 Participants
n=20 Participants
|
|
Previous TAVR
|
1 Participants
n=20 Participants
|
|
Previous Ictus
|
2 Participants
n=20 Participants
|
|
Previous pulmonary embolism
|
0 Participants
n=20 Participants
|
|
Cardiovascular disease
|
14 Participants
n=20 Participants
|
|
Neurological disease
|
0 Participants
n=20 Participants
|
|
Lung diseases
|
0 Participants
n=20 Participants
|
|
Previous lower limb fracture
|
0 Participants
n=20 Participants
|
PRIMARY outcome
Timeframe: Day of procedure; 1 week; 4 weekThe 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.
Outcome measures
| Measure |
VIV-FIH
n=20 Participants
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.
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|---|---|
|
Number of Participants With AE /SAE Linked or no Linked With the EasyCross Device
|
0 Participants
|
SECONDARY outcome
Timeframe: after procedureThe 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.
Outcome measures
Outcome data not reported
Adverse Events
VIV-FIH
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
VIV-FIH
n=20 participants at risk
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.
|
|---|---|
|
General disorders
AE
|
0.00%
0/20 • 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.
|
Other adverse events
| Measure |
VIV-FIH
n=20 participants at risk
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.
|
|---|---|
|
General disorders
AE
|
10.0%
2/20 • 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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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place