Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06211296
Other study ID # S01-CLN-023
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Recruiting NCT04310046 - Optimal Timing of Transcatheter Aortic Valve Implantation and Percutaneous Coronary Intervention - The TAVI PCI Trial N/A
Completed NCT03332745 - Mechanism of Decompensation Evaluation - Aortic Stenosis
Recruiting NCT06008080 - Post-Market Clinical Follow Up Study With Navitor Valve
Recruiting NCT06055751 - Long Term Evaluation of Cardiac Arrhythmias After Transcatheter Aortic Valve Implantation -The LOCATE Registry
Active, not recruiting NCT04815785 - Safety and Efficacy of TaurusOne® Transcatheter Aortic Valve System in Patients With Severe Calcific Aortic Stenosis N/A
Terminated NCT02202434 - Safety and Efficacy Study of Lotus Valve for Transcatheter Aortic Valve Replacement N/A
Recruiting NCT03029026 - The Role of Occult Cardiac Amyloid in the Elderly With Aortic Stenosis.
Active, not recruiting NCT02903420 - A Clinical Trial of Transcatheter Aortic Valves in Dialysis Patients (Japan) N/A
Completed NCT02629328 - CardioCel Tri-leaflet Repair Study N/A
Completed NCT02306226 - Symetis ACURATE Neo™ Valve Implantation SAVI TF Registry
Withdrawn NCT01648309 - Neuropsychological Testing in Patients Undergoing Transvascular Aortic Valve Implantation N/A
Completed NCT01676727 - ADVANCE Direct Aortic Study
Completed NCT01422044 - Risk Prediction in Aortic Stenosis N/A
Withdrawn NCT00774657 - Ventricular Remodeling In Patients With Aortic Stenosis Assessed Echocardiography N/A
Terminated NCT00535899 - Speckle Tracking Imaging in Patients With Low Ejection Fraction Aortic Stenosis (SPArKLE-AS) N/A
Terminated NCT05070130 - OpSens PRIME CLASS
Completed NCT03314857 - China XT: Safety and Effectiveness of Edwards Lifesciences SAPIEN XT THV in the Chinese Population N/A
Completed NCT04157920 - Impact of Predilatation Between Self-expanding Valves N/A
Enrolling by invitation NCT06212050 - Feasibility, Safety, and Effectiveness of the ACURATE neo2 Transcatheter Heart Valve for Severe Bicuspid Aortic Stenosis
Recruiting NCT05893082 - Multicenter Feasibility Trial of the F2 Filter and Delivery System for Embolic Protection During TAVR N/A