The ShortCut Post-Market Study

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.

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Key information

Conditions

Aortic Stenosis Treated With TAVI

Age range

22 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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.

Treatment and study plan

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.

Primary outcomes

Primary Safety Assessment

Time frame: At discharge or 7 days post-procedure, whichever occurs first
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
Primary Effectiveness Assessment

Time frame: Immediately after TAVR procedure

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.

Sponsors and collaborators

Lead sponsor

Pi-cardia

Industry

Registry information

Official study title

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

Acronym: ShortCut PMS

Important dates

Study start: 2026
Primary completion: 2027
Study completion: 2027
First posted: Jun 8, 2026
Registry last updated: Jun 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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