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Procedure

ShortCut Device for Aortic Valve Stenosis (ShortCut CAS Trial)

N/A
Waitlist Available
Research Sponsored by Pi-cardia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patient is planned to undergo a percutaneous valve-in-valve procedure for an approved ViV indication due to a failed bioprosthetic valve.
Be older than 18 years old
Must not have
History of a myocardial infarction (MI) ≤ 6 weeks prior to index procedure.
Ongoing severe infection or sepsis.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 90 days post procedure
Awards & highlights
No Placebo-Only Group

Summary

This trial is being conducted to gather more information about the safety and effectiveness of the ShortCut™ device. This device is used to split bioprosthetic aortic valve leaflets and ensure that the

Who is the study for?
This trial is for patients needing aortic valve replacement who are at risk of coronary artery blockage from a valve-in-valve (ViV) procedure. Specific eligibility details aren't provided, but typically participants must meet certain health standards and not have conditions that could interfere with the study.
What is being tested?
The ShortCut™ device is being tested in this non-randomized, single-arm study. It's designed to split bioprosthetic aortic valve leaflets to prevent blockage of coronary arteries during ViV procedures in patients requiring aortic valve replacement.
What are the potential side effects?
While specific side effects are not listed, generally such interventions may include risks like bleeding, infection, damage to nearby heart structures, irregular heartbeats or other complications related to heart procedures.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am scheduled for a valve-in-valve procedure due to a failed heart valve replacement.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have not had a heart attack in the last 6 weeks.
Select...
I do not have a severe infection or sepsis.
Select...
I have kidney problems or am on long-term dialysis.
Select...
I require emergency surgery.
Select...
I need help with breathing or heart function.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~intra-procedure
This trial's timeline: 3 weeks for screening, Varies for treatment, and intra-procedure for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Leaflet splitting success using the Shortcut Device, assessed by echo and/or angiography
ShortCut™ device- and/or ShortCut™ procedure-related: Mortality, Stroke
Secondary study objectives
-Rate of major vascular complications per VARC-3
Access-related type 3-4 bleeding per VARC-3
Rate of Acute Kidney Injury per VARC-3
+7 more
Other study objectives
Rate of MI with new evidence of coronary artery obstruction requiring intervention per VARC-3
Rate of all cause mortality per VARC-3
Rate of stroke per VARC-3

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: ShortcutExperimental Treatment1 Intervention

Find a Location

Who is running the clinical trial?

Pi-cardiaLead Sponsor
4 Previous Clinical Trials
160 Total Patients Enrolled
~19 spots leftby Apr 2025
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