The ShortCut™ Continued Access Study Protocol

Aortic Stenosis Clinical Trial

— ShortCut CAS  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06211296
• Other study ID #: S01-CLN-023
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 2024
• Est. completion date: September 2025

Study information

• Verified date: January 2024
• Source: Pi-cardia
• Contact: Merav Gat
• Phone: 224-217-3238
• Email: Merav[@]pi-cardia.net
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

The continued access study will be used to collect additional safety and effectiveness data of the ShortCut™ device for splitting bioprosthetic aortic valve leaflets, and to demonstrate coronary artery ostia patency following leaflet split, in patients who are at risk for TAVR-induced coronary artery ostium obstruction following a ViV procedure.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: September 2025
• Est. primary completion date: April 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Patient is planned to undergo a percutaneous valve-in-valve procedure for an approved ViV indication due to a failed bioprosthetic valve.

2. Patient is at risk for TAVR-induced coronary artery ostium obstruction.

3. 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:

1. 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.

2. 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.

3. CVA or TIA = 6 months prior to index procedure.

4. History of a myocardial infarction (MI) = 6 weeks prior to index procedure.

5. Hemodynamic or respiratory instability requiring inotropic support, mechanical ventilation or mechanical heart assistance.

6. LVEF < 30%.

7. Ongoing severe infection or sepsis.

8. Patient has renal insufficiency or is on chronic dialysis.

8. Need for emergency surgery for any reason. 9. Life expectancy is less than 1 year.

Related Conditions & MeSH terms

• Aortic Stenosis
• Aortic Valve Stenosis

Intervention

Device:
• Shortcut
Splitting bioprosthetic aortic valve leaflets

Locations

Country	Name	City	State
United States	Morristown Medical Center	Morristown	New Jersey
United States	Columbia University Medical Center /NYPH	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Pi-cardia

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Rate of all cause mortality per VARC-3	Tertiary Safety Endpoint	90 days post procedure
Other	Rate of stroke per VARC-3	Tertiary Safety Endpoint	90 days post procedure
Other	Rate of MI with new evidence of coronary artery obstruction requiring intervention per VARC-3	Tertiary Safety Endpoint	90 days post procedure
Primary	ShortCut™ device- and/or ShortCut™ procedure-related: Mortality, Stroke	Primary safety endpoint	discharge or at 7 days post-procedure, whichever occurs first
Primary	Leaflet splitting success using the Shortcut Device, assessed by echo and/or angiography	Primary effectiveness endpoint	Intra-procedure
Secondary	Rate of all cause mortality, per VARC 3	Secondary safety endpoint	30 days post procedure
Secondary	Rate of all-cause stroke, per VARC-3	Secondary safety endpoint	30 days post procedure
Secondary	Rate of coronary obstruction per VARC-3	Secondary safety endpoint	30 days post procedure
Secondary	Rate of MI with new evidence of coronary artery obstruction requiring intervention per VARC-3	Secondary safety endpoint	30 days post procedure
Secondary	-Rate of major vascular complications per VARC-3	Secondary safety endpoint	30 days post procedure
Secondary	Rate of cardiac temponade per VARC-3	Secondary safety endpoint	30 days post procedure
Secondary	Rate of Acute Kidney Injury per VARC-3	Secondary safety endpoint	30 days post procedure
Secondary	Access-related type 3-4 bleeding per VARC-3	Primary safety endpoint	30 days post procedure
Secondary	Rate of freedom from coronary artery intervention related to the intervened leaflet	Secondary effectiveness endpoint	30 days post procedure
Secondary	Rate of freedom from coronary artery ostia obstruction related to the intervened leaflet	Secondary effectiveness endpoint	30 days post procedure
Secondary	Shortcut technical success	Technical success endpoint	At exit from procedure room