Trial Outcomes & Findings for The ShortCut™ Continued Access Study Protocol (NCT NCT06211296)

NCT ID: NCT06211296

Last Updated: 2025-11-17

Results Overview

Primary safety endpoint, ShortCut™ device- and/or ShortCut™ procedure-related: Mortality, Stroke

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 8 participants
• Primary outcome timeframe: discharge or at 7 days post-procedure, whichever occurs first
• Results posted on: 2025-11-17

Participant Flow

Participant milestones

Measure	Shortcut Shortcut: Splitting bioprosthetic aortic valve leaflets
Overall Study STARTED	8
Overall Study 30 Days Follow up	8
Overall Study 90 Days Follow up	8
Overall Study COMPLETED	8
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The ShortCut™ Continued Access Study Protocol

Baseline characteristics by cohort

Measure	Shortcut n=8 Participants Shortcut: Splitting bioprosthetic aortic valve leaflets
Age, Continuous	80.6 years STANDARD_DEVIATION 9.2 • n=202 Participants
Sex: Female, Male Female	5 Participants n=202 Participants
Sex: Female, Male Male	3 Participants n=202 Participants
Race/Ethnicity, Customized White	7 participants n=202 Participants
Race/Ethnicity, Customized Unknown	1 participants n=202 Participants
Region of Enrollment United States	8 Participants n=202 Participants
STS score	10.3 units on a scale STANDARD_DEVIATION 12.3 • n=202 Participants

PRIMARY outcome

Timeframe: discharge or at 7 days post-procedure, whichever occurs first

Primary safety endpoint, ShortCut™ device- and/or ShortCut™ procedure-related: Mortality, Stroke

Outcome measures

Measure	Shortcut n=8 Participants Shortcut: Splitting bioprosthetic aortic valve leaflets
ShortCut™ Device- and/or ShortCut™ Procedure-related: Mortality, Stroke	0 Participants

PRIMARY outcome

Timeframe: Intra-procedure

Primary effectiveness endpoint, Leaflet splitting success using the Shortcut Device, assessed by echo and/or angiography

Outcome measures

Measure	Shortcut n=8 Participants Shortcut: Splitting bioprosthetic aortic valve leaflets
Number of Participants With Leaflet Splitting Success Using the Shortcut Device, Assessed by Echo and/or Angiography	8 Participants

SECONDARY outcome

Timeframe: 30 days post procedure

Secondary safety endpoint, Rate of all cause mortality, per VARC 3

Outcome measures

Measure	Shortcut n=8 Participants Shortcut: Splitting bioprosthetic aortic valve leaflets
Rate of All Cause Mortality, Per VARC 3	0 Participants

SECONDARY outcome

Timeframe: 30 days post procedure

Secondary safety endpoint, Rate of all-cause stroke, per VARC-3

Outcome measures

Measure	Shortcut n=8 Participants Shortcut: Splitting bioprosthetic aortic valve leaflets
Rate of All-cause Stroke, Per VARC-3	0 Participants

SECONDARY outcome

Timeframe: 30 days post procedure

Secondary safety endpoint, Rate of coronary obstruction per VARC-3

Outcome measures

Measure	Shortcut n=8 Participants Shortcut: Splitting bioprosthetic aortic valve leaflets
Rate of Coronary Obstruction Per VARC-3	0 Participants

SECONDARY outcome

Timeframe: 30 days post procedure

Secondary safety endpoint, Rate of MI with new evidence of coronary artery obstruction requiring intervention per VARC-3

Outcome measures

Measure	Shortcut n=8 Participants Shortcut: Splitting bioprosthetic aortic valve leaflets
Rate of MI With New Evidence of Coronary Artery Obstruction Requiring Intervention Per VARC-3	0 Participants

SECONDARY outcome

Timeframe: 30 days post procedure

Secondary safety endpoint, -Rate of major vascular complications per VARC-3

Outcome measures

Measure	Shortcut n=8 Participants Shortcut: Splitting bioprosthetic aortic valve leaflets
-Rate of Major Vascular Complications Per VARC-3	0 Participants

SECONDARY outcome

Timeframe: 30 days post procedure

Secondary safety endpoint, Rate of cardiac temponade per VARC-3

Outcome measures

Measure	Shortcut n=8 Participants Shortcut: Splitting bioprosthetic aortic valve leaflets
Rate of Cardiac Temponade Per VARC-3	0 Participants

SECONDARY outcome

Timeframe: 30 days post procedure

Secondary safety endpoint, Rate of Acute Kidney Injury per VARC-3

Outcome measures

Measure	Shortcut n=8 Participants Shortcut: Splitting bioprosthetic aortic valve leaflets
Rate of Acute Kidney Injury Per VARC-3	0 Participants

SECONDARY outcome

Timeframe: 30 days post procedure

Secondary safety endpoint, Access-related type 3-4 bleeding per VARC-3

Outcome measures

Measure	Shortcut n=8 Participants Shortcut: Splitting bioprosthetic aortic valve leaflets
Access-related Type 3-4 Bleeding Per VARC-3	0 Participants

SECONDARY outcome

Timeframe: 30 days post procedure

Secondary effectiveness endpoint, Rate of freedom from coronary artery intervention related to the intervened leaflet

Outcome measures

Measure	Shortcut n=8 Participants Shortcut: Splitting bioprosthetic aortic valve leaflets
Rate of Freedom From Coronary Artery Intervention Related to the Intervened Leaflet	8 Participants

SECONDARY outcome

Timeframe: 30 days post procedure

Secondary effectiveness endpoint, Rate of freedom from coronary artery ostia obstruction related to the intervened leaflet

Outcome measures

Measure	Shortcut n=8 Participants Shortcut: Splitting bioprosthetic aortic valve leaflets
Rate of Freedom From Coronary Artery Ostia Obstruction Related to the Intervened Leaflet	8 Participants

SECONDARY outcome

Timeframe: At exit from procedure room, immediately after the procedure

Technical success endpoint, Shortcut technical success - Successful access, delivery, and retrieval of the ShortCut™ device.

Outcome measures

Measure	Shortcut n=8 Participants Shortcut: Splitting bioprosthetic aortic valve leaflets
Shortcut Technical Success	7 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 90 days post procedure

Tertiary Safety Endpoint, Rate of all cause mortality per VARC-3

Outcome measures

Measure	Shortcut n=8 Participants Shortcut: Splitting bioprosthetic aortic valve leaflets
Rate of All Cause Mortality Per VARC-3	0 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 90 days post procedure

Tertiary Safety Endpoint, Rate of stroke per VARC-3

Outcome measures

Measure	Shortcut n=8 Participants Shortcut: Splitting bioprosthetic aortic valve leaflets
Rate of Stroke Per VARC-3	0 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 90 days post procedure

Tertiary Safety Endpoint, Rate of MI with new evidence of coronary artery obstruction requiring intervention per VARC-3

Outcome measures

Measure	Shortcut n=8 Participants Shortcut: Splitting bioprosthetic aortic valve leaflets
Rate of MI With New Evidence of Coronary Artery Obstruction Requiring Intervention Per VARC-3	0 Participants

Adverse Events

Shortcut

Serious events: 3 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Shortcut n=8 participants at risk Shortcut: Splitting bioprosthetic aortic valve leaflets
Cardiac disorders Bradycardia	12.5% 1/8 • Number of events 1 • Adverse Events (AEs) reported from point of index procedure until 90 days post procedure
Cardiac disorders Cardiac standstill	12.5% 1/8 • Number of events 1 • Adverse Events (AEs) reported from point of index procedure until 90 days post procedure
Cardiac disorders Hypertension	12.5% 1/8 • Number of events 1 • Adverse Events (AEs) reported from point of index procedure until 90 days post procedure

Other adverse events

Adverse event data not reported

Additional Information

Hadas Givon, VP CA/RA

Pi-Cardia

Phone: +972-8-9484800

Email: hadas@pi-cardia.net

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place