The ShortCut Post-Market Study

NCT07631988 | Not Yet Recruiting FDA Device

• 1 other identifier: CLN-0003581
• Study Type: observational
• Target: 150
• Locations: 0 countries
• Sites: N/A

Brief Summary

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. 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. 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.

Conditions

Aortic Stenosis Treated With TAVI

Outcome Measures

Primary Outcomes (2)

• 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

Interventions

Transfemoral catheter designed to split the bioprosthetic aortic valve leaflets prior to TAVR DEVICE

A transfemoral catheter designed to split the bioprosthetic aortic valve leaflets prior to TAVR, to reduce the risk of coronary obstruction and coronary access compromise and enable a valve-in-valve procedure.

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• Any contraindication as specified in the approved device label.
• An excessive aortic valve leaflet calcium morphology, as determined by CT assessment.
• Anatomy that is not suitable for the use of the ShortCut, as determined by CT assessment.
• 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.
• Cerebrovascular Accident (CVA) or Transient Ischemic Attack (TIA) ≤ 6 months prior to index procedure or severe neurological disability, as determined by the investigator.
• Myocardial infarction (MI) ≤ 6 weeks prior to index procedure.
• Hemodynamic or respiratory instability.
• Left ventricle ejection fraction \< 30%.
• Ongoing severe infection, sepsis or endocarditis.
• Patient has renal insufficiency (GFR \< 30 ml/min or serum creatinine \> 2.5 mg/dL), or on chronic dialysis.
• Need for emergency surgery for any reason.
• Life expectancy is less than 1 year.

Sponsors & Collaborators

• Pi-cardia: lead

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2026
• First Posted: June 8, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: June 8, 2026

Record last verified: 2026-06