The ShortCut Post-Market Study (ShortCut PMS)

A Prospective, Multicenter, Non-Randomized, Single-Arm, Post-Market Study of the ShortCut™ (The ShortCut PMS)

This is a post-market, prospective, multicenter, single-arm post market study sponsored by Pi-Cardia Ltd. The ShortCut is indicated for use as a splitting device of bioprosthetic aortic valve leaflets to facilitate valve-in-valve procedures for subjects at risk for coronary obstruction. The ShortCut has been cleared by FDA under DEN240017, and this study is a post-market evaluation of the ShortCut per the FDA cleared indications for use.

The objectives of the study are:

1. To collect real-world data on the use of ShortCut to split bioprosthetic aortic valve leaflets prior to TAVR in subjects at risk for coronary obstruction.
2. To collect real-world data on coronary patency following ShortCut and ViV TAVR procedures in subjects who are at risk for coronary artery ostium obstruction.

Data will be collected, where available, from the subjects' medical records at the following time-points: baseline, index procedure, pre-discharge, and 30 days post-procedure.

Study Overview

• Status: Not yet recruiting
• Conditions: Aortic Stenosis Treated With TAVI
• Intervention / Treatment: Device: Transfemoral catheter designed to split the bioprosthetic aortic valve leaflets prior to TAVR

• Study Type: Observational
• Enrollment (Estimated): 150

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Patients ≥22 years old that plan to undergo a ViV TAVR procedure at risk for coronary obstruction.

Description

Inclusion Criteria:

1. Male or female ≥ 22 years of age.
2. Subject is planned to undergo a ViV TAVR procedure with the ShortCut, according to its labeling.
3. Preprocedural evidence for risk for coronary occlusion during ViV TAVR in bioprosthetic valve failure.
4. Written informed consent to participate in the study obtained from the subject or subject's legal representative, according to local regulations

Exclusion Criteria:

1. Any contraindication as specified in the approved device label.
2. An excessive aortic valve leaflet calcium morphology, as determined by CT assessment.
3. Anatomy that is not suitable for the use of the ShortCut, as determined by CT assessment.
4. Coronary, carotid or vertebral artery disease that, in the opinion of the local Heart Team, should be treated; or treatment of such disease ≤ 1 month prior to index procedure.
5. Cerebrovascular Accident (CVA) or Transient Ischemic Attack (TIA) ≤ 6 months prior to index procedure or severe neurological disability, as determined by the investigator.
6. Myocardial infarction (MI) ≤ 6 weeks prior to index procedure.
7. Hemodynamic or respiratory instability.
8. Left ventricle ejection fraction < 30%.
9. Ongoing severe infection, sepsis or endocarditis.
10. Patient has renal insufficiency (GFR < 30 ml/min or serum creatinine > 2.5 mg/dL), or on chronic dialysis.
11. Need for emergency surgery for any reason.
12. Life expectancy is less than 1 year.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary Safety Assessment	Each of the following ShortCut- and/or ShortCut procedure-related adverse events at initial cardiac hospitalization discharge or 7 days post-procedure, whichever occurs first, as assessed by the Clinical Events Committee (CEC): Cardiovascular Mortality; All Stroke	At discharge or 7 days post-procedure, whichever occurs first
Primary Effectiveness Assessment	Rate of coronary patency of the coronary ostium adjacent to the treated leaflet by contrast aortography after TAVR implantation as assessed by a core lab.	Immediately after TAVR procedure

Collaborators and Investigators

• Sponsor: Pi-cardia

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): September 1, 2027

Study Registration Dates

• First Submitted: May 12, 2026
• First Submitted That Met QC Criteria: June 3, 2026
• First Posted (Actual): June 8, 2026

Study Record Updates

• Last Update Posted (Actual): June 8, 2026
• Last Update Submitted That Met QC Criteria: June 3, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: CLN-0003581

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No