Aortic Stenosis Treated With TAVIShortCut PMSNCT07631988
The ShortCut Post-Market Study
An observational study of Aortic Stenosis Treated With TAVI, run by Pi-cardia.
Trial summary
This is a post-market, prospective, multicenter, single-arm post market study sponsored by Pi-Cardia Ltd. The ShortCut is indicated for use as a splitting device of bioprosthetic aortic valve leaflets to facilitate valve-in-valve procedures for subjects at risk for coronary obstruction. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Aortic Stenosis Treated With TAVI
- What is being tested?
- Transfemoral catheter designed to split the bioprosthetic aortic valve leaflets prior to TAVR
- Type of treatment
- Medical device
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- Jun 2026to Sep 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 22 years and older
- All sexes
- Adult, Older adult
Study population: Patients ≥22 years old that plan to undergo a ViV TAVR procedure at risk for coronary obstruction.
Who may be able to join
- Male or female ≥ 22 years of age.
- Subject is planned to undergo a ViV TAVR procedure with the ShortCut, according to its labeling.
- Preprocedural evidence for risk for coronary occlusion during ViV TAVR in bioprosthetic valve failure.
- Written informed consent to participate in the study obtained from the subject or subject's legal representative, according to local regulations
Who cannot join
- Any contraindication as specified in the approved device label.
- An excessive aortic valve leaflet calcium morphology, as determined by CT assessment.
- Anatomy that is not suitable for the use of the ShortCut, as determined by CT assessment.
- 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, as determined by the investigator.
- Myocardial infarction (MI) ≤ 6 weeks prior to index procedure.
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- Hemodynamic or respiratory instability.
- Left ventricle ejection fraction < 30%.
- Ongoing severe infection, sepsis or endocarditis.
- Patient has renal insufficiency (GFR < 30 ml/min or serum creatinine > 2.5 mg/dL), or on chronic dialysis.
- Need for emergency surgery for any reason.
- Life expectancy is less than 1 year.
About this study
Official title: A Prospective, Multicenter, Non-Randomized, Single-Arm, Post-Market Study of the ShortCut™ (The ShortCut PMS)
This is a post-market, prospective, multicenter, single-arm post market study sponsored by Pi-Cardia Ltd. The ShortCut is indicated for use as a splitting device of bioprosthetic aortic valve leaflets to facilitate valve-in-valve procedures for subjects at risk for coronary obstruction. The ShortCut has been cleared by FDA under DEN240017, and this study is a post-market evaluation of the ShortCut per the FDA cleared indications for use.
The objectives of the study are:
Read more
- To collect real-world data on the use of ShortCut to split bioprosthetic aortic valve leaflets prior to TAVR in subjects at risk for coronary obstruction.
- To collect real-world data on coronary patency following ShortCut and ViV TAVR procedures in subjects who are at risk for coronary artery ostium obstruction.
Data will be collected, where available, from the subjects' medical records at the following time-points: baseline, index procedure, pre-discharge, and 30 days post-procedure.
- Conditions
- Aortic Stenosis Treated With TAVI
- Being tested
- Transfemoral catheter designed to split the bioprosthetic aortic valve leaflets prior to TAVR
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transfemoral catheter designed to split the bioprosthetic aortic valve leaflets prior to TAVRDevice
A transfemoral catheter designed to split the bioprosthetic aortic valve leaflets prior to TAVR, to reduce the risk of coronary obstruction and coronary access compromise and enable a valve-in-valve procedure.
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Safety Assessment
Each of the following ShortCut- and/or ShortCut procedure-related adverse events at initial cardiac hospitalization discharge or 7 days post-procedure, whichever occurs first, as assessed by the Clinical Events Committee (CEC):
- Cardiovascular Mortality
- All Stroke
Measured: At discharge or 7 days post-procedure, whichever occurs first
Primary Effectiveness Assessment
Rate of coronary patency of the coronary ostium adjacent to the treated leaflet by contrast aortography after TAVR implantation as assessed by a core lab.
Measured: Immediately after TAVR procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2026
- Study startJun 2026 (estimated)
- Primary completionJul 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic Stenosis Treated With TAVIStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pi-cardia
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07631988
- Sponsor's protocol ID
- CLN-0003581
- Acronym
- ShortCut PMS
- Status last verified
- Jun 2026
- First submitted
- 12 May 2026
- Last updated
- 8 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Non-Randomized, Single-Arm, Post-Market Study of the ShortCut™ (The ShortCut PMS)
- ClinicalTrials.gov ID
- NCT07631988
- Acronym / sponsor ID
- ShortCut PMS / CLN-0003581
- Conditions
- Aortic Stenosis Treated With TAVI
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Pi-cardiaIndustry (pharma, biotech, devices)
- Study start
- Jun 2026 (estimated)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 8 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a post-market, prospective, multicenter, single-arm post market study sponsored by Pi-Cardia Ltd. The ShortCut is indicated for use as a splitting device of bioprosthetic aortic valve leaflets to facilitate valve-in-valve procedures for subjects at risk for coronary obstruction. The ShortCut has been cleared by FDA under DEN240017, and this study is a post-market evaluation of the ShortCut per the FDA cleared indications for use.
The objectives of the study are:
- To collect real-world data on the use of ShortCut to split bioprosthetic aortic valve leaflets prior to TAVR in subjects at risk for coronary obstruction.
- To collect real-world data on coronary patency following ShortCut and ViV TAVR procedures in subjects who are at risk for coronary artery ostium obstruction.
Data will be collected, where available, from the subjects' medical records at the following time-points: baseline, index procedure, pre-discharge, and 30 days post-procedure.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients ≥22 years old that plan to undergo a ViV TAVR procedure at risk for coronary obstruction.
Key inclusion criteria (4 listed)
- Male or female ≥ 22 years of age.
- Subject is planned to undergo a ViV TAVR procedure with the ShortCut, according to its labeling.
- Preprocedural evidence for risk for coronary occlusion during ViV TAVR in bioprosthetic valve failure.
- Written informed consent to participate in the study obtained from the subject or subject's legal representative, according to local regulations
Key exclusion criteria (12 listed)
- Any contraindication as specified in the approved device label.
- An excessive aortic valve leaflet calcium morphology, as determined by CT assessment.
- Anatomy that is not suitable for the use of the ShortCut, as determined by CT assessment.
- 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, as determined by the investigator.
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 |
|---|---|---|
| Transfemoral catheter designed to split the bioprosthetic aortic valve leaflets prior to TAVRA transfemoral catheter designed to split the bioprosthetic aortic valve leaflets prior to TAVR, to reduce the risk of coronary obstruction and coronary access compromise and enable a valve-in-valve procedure. | Device | – |
Primary outcome
Primary Safety Assessment
Time frame: At discharge or 7 days post-procedure, whichever occurs first
Each of the following ShortCut- and/or ShortCut procedure-related adverse events at initial cardiac hospitalization discharge or 7 days post-procedure, whichever occurs first, as assessed by the Clinical Events Committee (CEC): * Cardiovascular Mortality * All Stroke
Primary Effectiveness Assessment
Time frame: Immediately after TAVR procedure
Rate of coronary patency of the coronary ostium adjacent to the treated leaflet by contrast aortography after TAVR implantation as assessed by a core lab.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Aortic Stenosis Treated With TAVI, run by Pi-cardia.
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 4 inclusion and 12 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: opening soon, as of the sponsor's last update on 8 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
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?
Primary Safety Assessment (time frame: At discharge or 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 8 Jun 2026.