New tool may prevent artery blockage during heart valve replacement
NCT ID NCT07631988
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looks at a device called ShortCut that splits old heart valve leaflets before placing a new valve inside it. The goal is to keep the arteries open and prevent blockages. About 150 people with aortic stenosis who are at risk for this complication will take part. Researchers will check safety and how well the device works up to 30 days after the procedure.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 150 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jun 2026
An estimate. Start dates often move.
- Expected to finish
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Sep 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Patients ≥22 years old that plan to undergo a ViV TAVR procedure at risk for coronary obstruction.
- Ages
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22 years and older
- Sex
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Anyone
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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: 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
More trials for these conditions
Other studies related to the condition(s) this trial covers.