The ShortCut™ Continued Access Study Protocol (ShortCut-CAS)

Pi-cardia

Status: Completed

Conditions: Aortic Stenosis; Valve-in-valve Procedures; Coronary; Obstruction

Treatments: Device: Shortcut

Study type: Interventional

Funder types: Industry

Identifiers

NCT06211296

S01-CLN-023

Details and patient eligibility

About

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

Full description

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.

Enrollment: 8 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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8 participants in 1 patient group

Shortcut

Experimental group

Description:

Splitting bioprosthetic aortic valve leaflets

Treatment:

Device: Shortcut