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The ShortCut Post-Market Study (ShortCut PMS)

3 juni 2026 bijgewerkt door: Pi-cardia

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:

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.
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.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Aortastenose behandeld met TAVI

Interventie / Behandeling

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

Studietype

Observationeel

Inschrijving (Geschat)

150

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

Volwassen
Oudere volwassene

Accepteert gezonde vrijwilligers

NVT

Bemonsteringsmethode

Niet-waarschijnlijkheidssteekproef

Studie Bevolking

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

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat	Maatregel Beschrijving	Tijdsspanne
Primary Safety Assessment Tijdsspanne: 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	At discharge or 7 days post-procedure, whichever occurs first
Primary Effectiveness Assessment Tijdsspanne: 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.	Immediately after TAVR procedure

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Pi-cardia

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

1 juni 2026

Primaire voltooiing (Geschat)

1 juli 2027

Studie voltooiing (Geschat)

1 september 2027

Studieregistratiedata

Eerst ingediend

12 mei 2026

Eerst ingediend dat voldeed aan de QC-criteria

3 juni 2026

Eerst geplaatst (Werkelijk)

8 juni 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)