ShortCut Device for Aortic Valve Stenosis

(ShortCut-CAS Trial)

No longer 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a device called ShortCut™, designed to assist individuals with aortic valve stenosis who face risks during a heart procedure known as TAVR. The device safely splits valve leaflets and keeps crucial heart arteries clear. It targets those undergoing a valve-in-valve procedure due to a failed heart valve. Participants should have been informed of their risk for TAVR-related artery blockage. As an unphased trial, this study offers a chance to contribute to innovative research that could enhance future heart procedures.

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.

What prior data suggests that the ShortCut device is safe for splitting bioprosthetic aortic valve leaflets?

A previous study found the ShortCut device safe for splitting the leaflets of malfunctioning artificial aortic valves. The research demonstrated its safety and effectiveness for patients. Another study confirmed that the ShortCut successfully split the leaflets for all users.

These studies suggest that patients generally tolerate the ShortCut device well. No major safety issues emerged in these trials. While all medical treatments carry risks, the ShortCut device has shown safety for participants in these studies. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Shortcut Device is unique because it offers a new approach to treating aortic valve stenosis by utilizing a minimally invasive technique. Unlike traditional surgical options like valve replacement or balloon valvuloplasty, the Shortcut Device aims to simplify the procedure, potentially reducing recovery time and associated risks. Researchers are excited about this treatment because it could provide a safer, quicker alternative to open-heart surgery, making it accessible to patients who might not be candidates for more invasive procedures.

What evidence suggests that the ShortCut device is effective for aortic valve stenosis?

Research has shown that the ShortCut device, studied in this trial, effectively splits the leaflets of bioprosthetic aortic valves. In one study, it worked as planned for 98.3% of patients, indicating success for almost everyone involved. This device helps prevent coronary artery obstruction, a serious problem that can occur during some heart procedures. Although early experiences with the device are limited, they appear promising. The ShortCut device is considered a breakthrough for treating aortic stenosis and could significantly improve patient outcomes. ^{2 4 6 7 8}

Who Is on the Research Team?

Hadas Givon

Principal Investigator

Pi-cardia

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: Shortcut Experimental Treatment 1 Intervention

Splitting bioprosthetic aortic valve leaflets

Who Is Running the Clinical Trial?

Pi-cardia

Lead Sponsor

Trials

5

Recruited

140+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11365606/

Leaflet modification before transcatheter aortic valve ... ShortCut technical success was achieved in 59 patients (98.3%; 95% CI 91.1%–100.0%) with one patient (1.7%) who had the cardiac tamponade. All patients ...

2. jacc.org jacc.org/doi/10.1016/j.jcin.2022.10.050

First-in-Human Dedicated Leaflet Splitting Device for ... In this paper, we describe the preclinical and clinical experience with the ShortCut device. In the current limited experience, it seems that ...

3. eurointervention.pcronline.com eurointervention.pcronline.com/article/first-dedicated-transcatheter-leaflet-splitting-device-the-shortcut-device

First dedicated transcatheter leaflet splitting device The ShortCut device is designed to split bioprosthetic aortic valve leaflets during valve-in-valve TAVR to reduce the risk of coronary artery obstruction, ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S1936879822020787

First-in-Human Dedicated Leaflet Splitting Device for ... In this paper, we describe the preclinical and clinical experience with the ShortCut device. In the current limited experience, it seems that ...

5. citoday.com citoday.com/articles/2025-jan-feb/shortcut-simplifying-complex-tavr-with-leaflet-modification

ShortCut™: Simplifying Complex TAVR With Leaflet ... “The ShortCut device is a game changer. It has potential to fill a critical gap in care and will be essential for the lifetime management of aortic stenosis ...

6. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/reviews/DEN240017.pdf

DEN240017, ShortCut, Pi-Cardia Ltd. - accessdata.fda.gov The ShortCut Pivotal Study demonstrated that splitting failed bioprosthetic aortic valve leaflets using ShortCut is safe and effective in ...

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38747561/

Leaflet modification before transcatheter aortic valve ... Modification of failed bioprosthetic aortic valve leaflets using ShortCut was safe, achieved successful leaflet splitting in all patients, ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12502927/

First dedicated transcatheter leaflet splitting device The ShortCut (Pi-Cardia) device is designed to split bioprosthetic aortic valve leaflets in patients undergoing ViV-TAVR procedures who are at risk for TAVR ...