CompletedNot Applicable

The ShortCut™ Continued Access Study Protocol

United States8 participantsStarted 2024-07-03

Plain-language summary

A Prospective, Multicenter, Non-Randomized, Single-Arm, Open-Label Continued Access Study of the ShortCut™ device (The ShortCut™ CAS).

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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.

✕. 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.

ShortCut™ Device- and/or ShortCut™ Procedure-related: Mortality, Stroke

Timeframe: discharge or at 7 days post-procedure, whichever occurs first

Number of Participants With Leaflet Splitting Success Using the Shortcut Device, Assessed by Echo and/or Angiography

Timeframe: Intra-procedure

NCT IDNCT06211296

SponsorPi-cardia

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-05-12

Results submitted2025-09-28

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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.

✕. 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.