N/A
Completed N=8
The ShortCut™ Continued Access Study Protocol
Valve-in-valve Procedures · Aortic Stenosis · Coronary; Obstruction
Source: ClinicalTrials.gov NCT06211296 ↗
Enrolled (actual)
8
Serious AEs
37.5%
Results posted
Nov 2025
Primary outcomePrimary: ShortCut™ Device- and/or ShortCut™ Procedure-related: Mortality, Stroke — 0 Participants
Summary
A Prospective, Multicenter, Non-Randomized, Single-Arm, Open-Label Continued Access Study of the ShortCut™ device (The ShortCut™ CAS).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY ShortCut™ Device- and/or ShortCut™ Procedure-related: Mortality, Stroke |
— | — |
| PRIMARY Number of Participants With Leaflet Splitting Success Using the Shortcut Device, Assessed by Echo and/or Angiography |
8 | — |
| SECONDARY Rate of All Cause Mortality, Per VARC 3 |
— | — |
| SECONDARY Rate of All-cause Stroke, Per VARC-3 |
— | — |
| SECONDARY Rate of Coronary Obstruction Per VARC-3 |
— | — |
| SECONDARY Rate of MI With New Evidence of Coronary Artery Obstruction Requiring Intervention Per VARC-3 |
— | — |
| SECONDARY -Rate of Major Vascular Complications Per VARC-3 |
— | — |
| SECONDARY Rate of Cardiac Temponade Per VARC-3 |
— | — |
| SECONDARY Rate of Acute Kidney Injury Per VARC-3 |
— | — |
| SECONDARY Access-related Type 3-4 Bleeding Per VARC-3 |
— | — |
| SECONDARY Rate of Freedom From Coronary Artery Intervention Related to the Intervened Leaflet |
8 | — |
| SECONDARY Rate of Freedom From Coronary Artery Ostia Obstruction Related to the Intervened Leaflet |
8 | — |
| SECONDARY Shortcut Technical Success |
7 | — |
Eligibility Criteria
Inclusion Criteria
- Patient is planned to undergo a percutaneous valve-in-valve procedure for an approved ViV indication due to a failed bioprosthetic valve.
- 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.
Exclusion Criteria
- An excessive aortic valve leaflet Calcium morphology, such as diffuse massive calcification at the targeted leaflet for splitting or anatomy not suitable for the use of the ShortCut™ device, as determined by the CT measurements.
- Carotid or vertebral artery disease that, in the opinion of the local Heart Team, should be treated; or treatment of carotid stenosis ≤ 1 month prior to index procedure.
- CVA or TIA ≤ 6 months prior to index procedure.
- History of a myocardial infarction (MI) ≤ 6 weeks prior to index procedure.
- Hemodynamic or respiratory instability requiring inotropic support, mechanical ventilation or mechanical heart assistance.
- LVEF < 30%.
- Ongoing severe infection or sepsis.
- Patient has renal insufficiency or is on chronic dialysis.
- Need for emergency surgery for any reason. 9. Life expectancy is less than 1 year.
Data sourced from ClinicalTrials.gov (NCT06211296). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.