CompletedNot Applicable

EasyCrossTM Device-Self-centering Catheter

Italy20 participantsStarted 2024-02-12

Plain-language 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

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of Participants With AE /SAE Linked or no Linked With the EasyCross Device

Timeframe: Day of procedure; 1 week; 4 week

Trial details

NCT IDNCT06412354

SponsorVivheart s.r.l.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-07-15

Results submitted2025-11-14

View on ClinicalTrials.gov More Transcatheter Aortic Valve Replacement (TAVR) trials