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Not yet recruiting NCT07631988

The ShortCut Post-Market Study

— Observational Aortic Stenosis Treated With TAVI

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Transfemoral catheter designed to split the bioprosthetic aortic valve leaflets prior to TAVR.
Who it may be relevant to
Registry conditions: Aortic Stenosis Treated With TAVI. Basic parameters: from 22 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Prospective, Multicenter, Non-Randomized, Single-Arm, Post-Market Study of the ShortCut™ (The ShortCut PMS)

Overview

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.

Interventions

  • Device Transfemoral 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.

Primary outcome measures

  • Primary Safety Assessment [Time frame: At discharge or 7 days post-procedure, whichever occurs first]
  • Primary Effectiveness Assessment [Time frame: Immediately after TAVR procedure]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • 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.
  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Study design

Observational model
Cohort

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07631988 · CLN-0003581

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗