ShortCut™ for Risk of Coronary Obstruction After Transcatheter Aortic Valve Replacement (TAVR) Procedure

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Risk of Coronary Obstruction After Transcatheter Aortic Valve Replacement (TAVR) ProcedureShortCut™ - Device
Eligibility
18 - 100
All Sexes
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Study Summary

A Prospective, Multicenter, Non-Randomized, Single-Arm, Open-Label Clinical Study to Demonstrate the Safety and Effectiveness of the ShortCut™ device for splitting bioprosthetic aortic valve leaflets in patients who are presented for a valve-in-valve transcatheter aortic valve replacement (TAVR) procedure, and who are at risk for TAVR-induced coronary artery ostium obstruction.

Treatment Effectiveness

Effectiveness Progress

1 of 3

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1
Single
1
General
1
Twelve TMVR Implant

Study Objectives

4 Primary · 9 Secondary · Reporting Duration: 90 days post procedure

Day 30
Rate of freedom from coronary artery intervention related to the intervened leaflet
Rate of freedom from coronary artery ostia obstruction related to the intervened leaflet
30 days post procedure
Rate of access-related type 3-4 bleeding
Rate of acute kidney injury
Rate of all-cause stroke
Rate of cardiac tamponade
Rate of coronary obstruction
Rate of major vascular complications
90 days post procedure
Adverse events
Rate of all-cause mortality
Rate of myocardial infarction with new evidence of coronary artery obstruction requiring intervention
Rate of stroke
At exit from procedure room
ShortCut™ technical success
Day 7
ShortCut™ device- and/or ShortCut™ procedure-related mortality and all cause stroke
Intra-procedure
Leaflet splitting success using the ShortCut™ device
ShortCut™ device and/or ShortCut™ procedure-related serious adverse events
Successful leaflet splitting

Trial Safety

Safety Progress

1 of 3

Similar Trials

1
Single
1
General
1
Twelve TMVR Implant

Trial Design

1 Treatment Group

ShortCut™
1 of 1

Experimental Treatment

70 Total Participants · 1 Treatment Group

Primary Treatment: ShortCut™ · No Placebo Group · N/A

ShortCut™
Device
Experimental Group · 1 Intervention: ShortCut™ · Intervention Types: Device

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 90 days post procedure

Who is running the clinical trial?

Pi-cardiaLead Sponsor
3 Previous Clinical Trials
110 Total Patients Enrolled

Eligibility Criteria

Age 18 - 100 · All Participants · 2 Total Inclusion Criteria

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References

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