Valve-in-valve ProceduresShortCut-CASNCT06211296
The ShortCut™ Continued Access Study Protocol
A study testing Shortcut in people with Valve-in-valve Procedures and Aortic Stenosis, run by Pi-cardia at 4 sites in United States.
Trial summary
A Prospective, Multicenter, Non-Randomized, Single-Arm, Open-Label Continued Access Study of the ShortCut™ device (The ShortCut™ CAS). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Valve-in-valve Procedures, Aortic Stenosis, Coronary; Obstruction
- What is being tested?
- Shortcut
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 4 sitesUnited States
- Study dates
- 3 Jul 2024to 12 May 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient is planned to undergo a percutaneous valve-in-valve procedure for an approved ViV indication due to a failed bioprosthetic valve.
- Patient is at risk for TAVR-induced coronary artery ostium obstruction.
- 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.
Who cannot join
- 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.
- 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.
- CVA or TIA ≤ 6 months prior to index procedure.
- History of a myocardial infarction (MI) ≤ 6 weeks prior to index procedure.
- Hemodynamic or respiratory instability requiring inotropic support, mechanical ventilation or mechanical heart assistance.
- LVEF < 30%.
Show all 9Show fewer
- Ongoing severe infection or sepsis.
- 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 locations and contacts
4 sites in 1 country.
United States4 sites
Morristown Medical Center
Morristown, New Jersey, 07960
Columbia University Medical Center /NYPH
New York, New York, 10032
Los Robles Regional Medical Center
Thousand Oaks, California, 91360
UPMC Pinnacle
Wormleysburg, Pennsylvania, 17043
About this study
Official title: A Prospective, Multicenter, Non-Randomized, Single-Arm, Open-Label Continued Access Study of the ShortCut™ Device (The ShortCut™ CAS).
A Prospective, Multicenter, Non-Randomized, Single-Arm, Open-Label Continued Access Study of the ShortCut™ device (The ShortCut™ CAS).
Read the detailed 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.
- Being tested
- Shortcut
- Keywords
- TAVI, Pi-Cardia, TAVR, ViV, continued access, Shortcut
- Medical subject headings
- Aortic Valve Stenosis, Bites and Stings
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ShortcutDevice
Splitting bioprosthetic aortic valve leaflets
| Study group | Role | What they receive |
|---|---|---|
| Shortcut | Experimental | Splitting bioprosthetic aortic valve leaflets Receives: Device: Shortcut |
What is being measured
The primary outcome is the main question the study is designed to answer.
ShortCut™ Device- and/or ShortCut™ Procedure-related: Mortality, Stroke
Primary safety endpoint, ShortCut™ device- and/or ShortCut™ procedure-related: Mortality, Stroke
Measured: discharge or at 7 days post-procedure, whichever occurs first
Number of Participants With Leaflet Splitting Success Using the Shortcut Device, Assessed by Echo and/or Angiography
Primary effectiveness endpoint, Leaflet splitting success using the Shortcut Device, assessed by echo and/or angiography
Measured: Intra-procedure
Secondary outcomes (11)
Rate of All Cause Mortality, Per VARC 3
Secondary safety endpoint, Rate of all cause mortality, per VARC 3
Measured: 30 days post procedure
Rate of All-cause Stroke, Per VARC-3
Secondary safety endpoint, Rate of all-cause stroke, per VARC-3
Measured: 30 days post procedure
Rate of Coronary Obstruction Per VARC-3
Secondary safety endpoint, Rate of coronary obstruction per VARC-3
Measured: 30 days post procedure
Rate of MI With New Evidence of Coronary Artery Obstruction Requiring Intervention Per VARC-3
Secondary safety endpoint, Rate of MI with new evidence of coronary artery obstruction requiring intervention per VARC-3
Measured: 30 days post procedure
-Rate of Major Vascular Complications Per VARC-3
Secondary safety endpoint, -Rate of major vascular complications per VARC-3
Measured: 30 days post procedure
Rate of Cardiac Temponade Per VARC-3
Secondary safety endpoint, Rate of cardiac temponade per VARC-3
Measured: 30 days post procedure
Rate of Acute Kidney Injury Per VARC-3
Secondary safety endpoint, Rate of Acute Kidney Injury per VARC-3
Measured: 30 days post procedure
Access-related Type 3-4 Bleeding Per VARC-3
Secondary safety endpoint, Access-related type 3-4 bleeding per VARC-3
Measured: 30 days post procedure
Rate of Freedom From Coronary Artery Intervention Related to the Intervened Leaflet
Secondary effectiveness endpoint, Rate of freedom from coronary artery intervention related to the intervened leaflet
Measured: 30 days post procedure
Rate of Freedom From Coronary Artery Ostia Obstruction Related to the Intervened Leaflet
Secondary effectiveness endpoint, Rate of freedom from coronary artery ostia obstruction related to the intervened leaflet
Measured: 30 days post procedure
Shortcut Technical Success
Technical success endpoint, Shortcut technical success - Successful access, delivery, and retrieval of the ShortCut™ device.
Measured: At exit from procedure room, immediately after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2024
- Study start3 Jul 2024
- Primary completion12 May 2025
- Study completion12 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Valve-in-valve ProceduresStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pi-cardia
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hadas Givon, Study director, Pi-cardia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06211296
- Sponsor's protocol ID
- S01-CLN-023
- Acronym
- ShortCut-CAS
- Status last verified
- May 2026
- First submitted
- 8 Jan 2024
- Last updated
- 12 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Non-Randomized, Single-Arm, Open-Label Continued Access Study of the ShortCut™ Device (The ShortCut™ CAS).
- ClinicalTrials.gov ID
- NCT06211296
- Acronym / sponsor ID
- ShortCut-CAS / S01-CLN-023
- Keywords
- TAVI, Pi-Cardia, TAVR, ViV, continued access, Shortcut
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Pi-cardiaIndustry (pharma, biotech, devices)
- Study start
- 3 Jul 2024 (actual)
- Primary completion
- 12 May 2025 (actual)
- Study completion
- 12 May 2025 (actual)
- First posted
- 18 Jan 2024 (actual)
- Results
- Posted 17 Nov 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A Prospective, Multicenter, Non-Randomized, Single-Arm, Open-Label Continued Access Study of the ShortCut™ device (The ShortCut™ CAS).
Detailed 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Shortcut | Experimental | Device: ShortcutSplitting bioprosthetic aortic valve leaflets |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patient is planned to undergo a percutaneous valve-in-valve procedure for an approved ViV indication due to a failed bioprosthetic valve.
- Patient is at risk for TAVR-induced coronary artery ostium obstruction.
- 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.
Key exclusion criteria (9 listed)
- 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.
- 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.
- CVA or TIA ≤ 6 months prior to index procedure.
- History of a myocardial infarction (MI) ≤ 6 weeks prior to index procedure.
- Hemodynamic or respiratory instability requiring inotropic support, mechanical ventilation or mechanical heart assistance.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ShortcutSplitting bioprosthetic aortic valve leaflets | Device | Shortcut |
Primary outcome
ShortCut™ Device- and/or ShortCut™ Procedure-related: Mortality, Stroke
Time frame: discharge or at 7 days post-procedure, whichever occurs first
Primary safety endpoint, ShortCut™ device- and/or ShortCut™ procedure-related: Mortality, Stroke
Number of Participants With Leaflet Splitting Success Using the Shortcut Device, Assessed by Echo and/or Angiography
Time frame: Intra-procedure
Primary effectiveness endpoint, Leaflet splitting success using the Shortcut Device, assessed by echo and/or angiography
11 secondary outcomes
Rate of All Cause Mortality, Per VARC 3
Time frame: 30 days post procedure
Rate of All-cause Stroke, Per VARC-3
Time frame: 30 days post procedure
Rate of Coronary Obstruction Per VARC-3
Time frame: 30 days post procedure
Rate of MI With New Evidence of Coronary Artery Obstruction Requiring Intervention Per VARC-3
Time frame: 30 days post procedure
-Rate of Major Vascular Complications Per VARC-3
Time frame: 30 days post procedure
Rate of Cardiac Temponade Per VARC-3
Time frame: 30 days post procedure
Rate of Acute Kidney Injury Per VARC-3
Time frame: 30 days post procedure
Access-related Type 3-4 Bleeding Per VARC-3
Time frame: 30 days post procedure
Rate of Freedom From Coronary Artery Intervention Related to the Intervened Leaflet
Time frame: 30 days post procedure
Rate of Freedom From Coronary Artery Ostia Obstruction Related to the Intervened Leaflet
Time frame: 30 days post procedure
Shortcut Technical Success
Time frame: At exit from procedure room, immediately after the procedure
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hadas Givon study director
Pi-cardia
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Shortcut in people with Valve-in-valve Procedures and Aortic Stenosis, run by Pi-cardia at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Nov 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ShortCut™ Device- and/or ShortCut™ Procedure-related: Mortality, Stroke (time frame: discharge or at 7 days post-procedure, whichever occurs first). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2026.