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Not yet recruitingNCT07631988ShortCut PMSUpdated Jun 8, 2026

The ShortCut Post-Market Study

An observational study in Aortic Stenosis Treated With TAVI, sponsored by Pi-cardia. Not yet recruiting. Open to participants aged 22 Years and older. Per ClinicalTrials.gov, last updated 2026-06-08.

Sponsored by Pi-cardia · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
150
Ages
22 Years and older
Sex
All
01

Study 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. 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:

  1. 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.
  2. 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.

02

Conditions studied

  • Aortic Stenosis Treated With TAVI
03

In context

Lead sponsor

Pi-cardia is the lead sponsor of 5 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
22 Years and older
Sexes eligible
All
Sampling method
Non-probability sample

Study population

Patients ≥22 years old that plan to undergo a ViV TAVR procedure at risk for coronary obstruction.

Inclusion criteria

  1. Male or female ≥ 22 years of age.
  2. Subject is planned to undergo a ViV TAVR procedure with the ShortCut, according to its labeling.
  3. Preprocedural evidence for risk for coronary occlusion during ViV TAVR in bioprosthetic valve failure.
  4. Written informed consent to participate in the study obtained from the subject or subject's legal representative, according to local regulations

Exclusion criteria

Exclusion Criteria:

  1. Any contraindication as specified in the approved device label.
  2. An excessive aortic valve leaflet calcium morphology, as determined by CT assessment.
  3. Anatomy that is not suitable for the use of the ShortCut, as determined by CT assessment.
  4. 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.
  5. Cerebrovascular Accident (CVA) or Transient Ischemic Attack (TIA) ≤ 6 months prior to index procedure or severe neurological disability, as determined by the investigator.
  6. Myocardial infarction (MI) ≤ 6 weeks prior to index procedure.
  7. Hemodynamic or respiratory instability.
  8. Left ventricle ejection fraction \< 30%.
  9. Ongoing severe infection, sepsis or endocarditis.
  10. Patient has renal insufficiency (GFR \< 30 ml/min or serum creatinine > 2.5 mg/dL), or on chronic dialysis.
  11. Need for emergency surgery for any reason.
  12. Life expectancy is less than 1 year.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
150 participants (estimated)
Patient registry
No

Interventions

  • DeviceTransfemoral catheter designed to split the bioprosthetic aortic valve leaflets prior to TAVR

    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.

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: At discharge or 7 days post-procedure, whichever occurs first

  2. 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.

    Time frame: Immediately after TAVR procedure

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 8, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07631988
Lead sponsor
Pi-cardia
Responsible party
Sponsor
First posted
Jun 8, 2026
Start date
Jun 2026 (estimated)
Primary completion
Jul 2027 (estimated)
Completion
Sep 2027 (estimated)
Last update
Jun 8, 2026

Oversight

FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.

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Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

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