ShortCut Device for Aortic Valve Stenosis

(ShortCut CAS Trial)

Recruiting at 4 trial locations

Overseen By Merav Gat

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Pi-cardia

Disqualifiers: Carotid disease, Recent CVA, MI, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: Intra-procedure

50 Participants Needed

Trial Summary

What is the purpose of this trial?

A Prospective, Multicenter, Non-Randomized, Single-Arm, Open-Label Continued Access Study of the ShortCut™ device (The ShortCut™ CAS). The continued access study will be used to collect additional safety and effectiveness data of the ShortCut™ device for splitting bioprosthetic aortic valve leaflets, and to demonstrate coronary artery ostia patency following leaflet split, in patients who are at risk for TAVR-induced coronary artery ostium obstruction following a ViV procedure.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Eligibility Criteria

This trial is for patients needing aortic valve replacement who are at risk of coronary artery blockage from a valve-in-valve (ViV) procedure. Specific eligibility details aren't provided, but typically participants must meet certain health standards and not have conditions that could interfere with the study.

Inclusion Criteria

Patient is at risk for TAVR-induced coronary artery ostium obstruction.

Written informed consent to participate in the study obtained from the subject or subject's legal representative, according to local regulations, prior to initiation of any study mandated procedure.

I am scheduled for a valve-in-valve procedure due to a failed heart valve replacement.

Exclusion Criteria

LVEF < 30%.

I have not had a heart attack in the last 6 weeks.

I do not have a severe infection or sepsis.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo the ShortCut™ procedure for splitting bioprosthetic aortic valve leaflets

Intra-procedure

Follow-up

Participants are monitored for safety and effectiveness after the procedure

90 days

Open-label extension (optional)

Participants may opt into continued access to the ShortCut™ device for long-term data collection

Treatment Details

Interventions

• Shortcut

Trial Overview The ShortCut™ device is being tested in this non-randomized, single-arm study. It's designed to split bioprosthetic aortic valve leaflets to prevent blockage of coronary arteries during ViV procedures in patients requiring aortic valve replacement.

Participant Groups

Group I: Shortcut Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Pi-cardia

Lead Sponsor

Trials

5

Recruited

140+