The ShortCut™ Study Protocol

Pi-cardia

Status

Completed

Conditions

Risk of Coronary Obstruction Following Transcatheter Aortic Valve Replacement (TAVR) Procedure

Treatments

Device: ShortCut™

Study type

Interventional

Funder types

Industry

Identifiers

NCT04952909

S01-CLN-002

Details and patient eligibility

About

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.

Enrollment

60 patients

Sex

All

Ages

18 to 100 years old

Volunteers

No Healthy Volunteers

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.