N/A
Completed N=60
The ShortCut™ Study Protocol
Risk of Coronary Obstruction Following Transcatheter Aortic Valve Replacement (TAVR) Procedure
Source: ClinicalTrials.gov NCT04952909 ↗
Enrolled (actual)
60
Serious AEs
21.7%
Results posted
Feb 2025
Primary outcomePrimary: (Number of Patients With) ShortCut™ Device- and/or ShortCut™ Procedure-related Mortality and All Cause Stroke — 0; 1; 59 Participants
Summary
A Prospective, Multicenter, Non-Randomized, Single-Arm, Open-Label Clinical Study to Demonstrate the Safety and Effectiveness of the ShortCut™ device for splitting bioprosthetic aortic valve leaflets in patients who are presented for a valve-in-valve (ViV) transcatheter aortic valve replacement (TAVR) procedure for an approved ViV indication, and who are at risk for TAVR-induced coronary artery ostium obstruction.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY (Number of Patients With) ShortCut™ Device- and/or ShortCut™ Procedure-related Mortality and All Cause Stroke |
0; 1; 59 | — |
| PRIMARY (Number of Patients With) Leaflet Splitting Success Using the ShortCut™ Device |
60 | — |
| SECONDARY (Number of Patients With) All-cause Mortality |
3 | — |
| SECONDARY (Number of Patients With) All-cause Stroke |
0; 1; 0; 59 | — |
| SECONDARY (Number of Patients With) Coronary Obstruction |
3 | — |
| SECONDARY (Number of Patients With) Myocardial Infarction With New Evidence of Coronary Artery Obstruction Requiring Intervention |
2 | — |
| SECONDARY (Number of Patients With) Major Vascular Complications |
— | — |
| SECONDARY (Number of Patients With) Cardiac Tamponade |
1 | — |
| SECONDARY (Number of Patients With) Acute Kidney Injury |
2 | — |
| SECONDARY (Number of Patients With) Access-related Type 3-4 Bleeding |
— | — |
| SECONDARY (Number of Patients With) Freedom From Coronary Artery Ostia Obstruction Related to the Intervened Leaflet |
57 | — |
| SECONDARY (Number of Patients With) Freedom From Coronary Artery Intervention Related to the Intervened Leaflet |
56 | — |
| SECONDARY (Number of Patients With) ShortCut™ Technical Success |
59 | — |
Eligibility Criteria
Inclusion Criteria
- Patient is planned to undergo a percutaneous valve-in-valve procedure for an approved valve-in-valve indication due to a failed bioprosthetic valve.
- 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 or anatomy not suitable for the use of the ShortCut™ device.
- 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.
- Myocardial infarction (MI) ≤ 6 weeks prior to index procedure.
- Hemodynamic or respiratory instability.
- Left ventricle ejection fraction < 30%.
- Ongoing severe infection, sepsis or endocarditis.
- Renal insufficiency
- Need for emergency surgery for any reason.
- Life expectancy is less than 1 year.
Data sourced from ClinicalTrials.gov (NCT04952909). 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.