Clinical trial NCT06211296: The ShortCut™ Continued Access Study Protocol
Official title: A Prospective, Multicenter, Non-Randomized, Single-Arm, Open-Label Continued Access Study of the ShortCut™ Device (The ShortCut™ CAS).
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Valve-in-valve Procedures
Aortic Stenosis
Coronary; Obstruction
Keywords: TAVI
Pi-Cardia
TAVR
ViV
continued access
Shortcut
Lead sponsor: Pi-cardia
Sponsor class: INDUSTRY
First posted: 2024-01-18
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: ShortCut™ device- and/or ShortCut™ procedure-related: Mortality, Stroke
timeFrame: discharge or at 7 days post-procedure, whichever occurs first
measure: Leaflet splitting success using the Shortcut Device, assessed by echo and/or angiography
timeFrame: Intra-procedure
Secondary outcomes:
measure: Rate of all cause mortality, per VARC 3
timeFrame: 30 days post procedure
measure: Rate of all-cause stroke, per VARC-3
timeFrame: 30 days post procedure
measure: Rate of coronary obstruction per VARC-3
timeFrame: 30 days post procedure
measure: Rate of MI with new evidence of coronary artery obstruction requiring intervention per VARC-3
timeFrame: 30 days post procedure
measure: -Rate of major vascular complications per VARC-3
timeFrame: 30 days post procedure
measure: Rate of cardiac temponade per VARC-3
timeFrame: 30 days post procedure
measure: Rate of Acute Kidney Injury per VARC-3
timeFrame: 30 days post procedure
measure: Access-related type 3-4 bleeding per VARC-3
timeFrame: 30 days post procedure
measure: Rate of freedom from coronary artery intervention related to the intervened leaflet
timeFrame: 30 days post procedure
measure: Rate of freedom from coronary artery ostia obstruction related to the intervened leaflet
timeFrame: 30 days post procedure
measure: Shortcut technical success
timeFrame: At exit from procedure room
Other outcomes:
measure: Rate of all cause mortality per VARC-3
timeFrame: 90 days post procedure
measure: Rate of stroke per VARC-3
timeFrame: 90 days post procedure
measure: Rate of MI with new evidence of coronary artery obstruction requiring intervention per VARC-3
timeFrame: 90 days post procedure
Locations:
city: Thousand Oaks
country: United States
facility: Los Robles Regional Medical Center
state: California
city: Morristown
country: United States
facility: Morristown Medical Center
state: New Jersey
city: New York
country: United States
facility: Columbia University Medical Center /NYPH
state: New York
city: Wormleysburg
country: United States
facility: UPMC Pinnacle
state: Pennsylvania
Study officials:
References: