A Prospective, Multicenter, Non-Randomized, Single-Arm, Open-Label Clinical Study to Demonstrate the Safety and Effectiveness of the ShortCut™ Device (The ShortCut™ Study)

Pi-cardia23 sites in 5 countries60 target enrollmentJanuary 21, 2022

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Not specified
Sponsor: Pi-cardia
Enrollment: 60
Locations: 23
Primary Endpoint: (Number of Patients With) ShortCut™ Device- and/or ShortCut™ Procedure-related Mortality and All Cause Stroke
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

January 21, 2022

End Date

December 31, 2023

Last Updated

last year

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Pi-cardia

Responsible Party

Sponsor

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.

Outcomes

Primary Outcomes

(Number of Patients With) ShortCut™ Device- and/or ShortCut™ Procedure-related Mortality and All Cause Stroke

Time Frame: Discharge or at 7 days post-procedure, whichever occurs first

(Number of Patients With) Leaflet Splitting Success Using the ShortCut™ Device

Time Frame: Intra-procedure

Assessed by echo and/or angiography

Secondary Outcomes

(Number of Patients With) All-cause Mortality(30 days post procedure)
(Number of Patients With) All-cause Stroke(30 days post procedure)
(Number of Patients With) Coronary Obstruction(30 days post procedure)
(Number of Patients With) Myocardial Infarction With New Evidence of Coronary Artery Obstruction Requiring Intervention(30 days post procedure)
(Number of Patients With) Major Vascular Complications(30 days post procedure)
(Number of Patients With) Cardiac Tamponade(30 days post procedure)
(Number of Patients With) Acute Kidney Injury(30 days post procedure)
(Number of Patients With) Access-related Type 3-4 Bleeding(30 days post procedure)
(Number of Patients With) Freedom From Coronary Artery Ostia Obstruction Related to the Intervened Leaflet(30 days post index procedure)
(Number of Patients With) Freedom From Coronary Artery Intervention Related to the Intervened Leaflet(30 days post index procedure)
(Number of Patients With) ShortCut™ Technical Success(At exit from procedure room)