Trial Outcomes & Findings for The ShortCut™ Study Protocol (NCT NCT04952909)

NCT ID: NCT04952909

Last Updated: 2025-02-03

Results Overview

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 60 participants
• Primary outcome timeframe: Discharge or at 7 days post-procedure, whichever occurs first
• Results posted on: 2025-02-03

Participant Flow

Subjects were enrolled at 22 clinical sites from January 2022 to September 2023.

66 subjects were found eligible per protocol. 60 subjects were treated with the device (started), after 6 subjects dropped out prior to treatment.

Participant milestones

Measure	ShortCut™ ShortCut™: Splitting bioprosthetic aortic valve leaflets
Overall Study STARTED	60
Overall Study 30 Days Follow up	58
Overall Study 90 Days Follow up	57
Overall Study COMPLETED	57
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Measure	ShortCut™ ShortCut™: Splitting bioprosthetic aortic valve leaflets
Overall Study Death	3

Baseline Characteristics

The ShortCut™ Study Protocol

Baseline characteristics by cohort

Measure	ShortCut™ n=60 Participants ShortCut™: Splitting bioprosthetic aortic valve leaflets
Age, Continuous	77.0 Years STANDARD_DEVIATION 9.6 • n=5 Participants
Sex: Female, Male Female	42 Participants n=5 Participants
Sex: Female, Male Male	18 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	46 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	13 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	42 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	16 Participants n=5 Participants
Surgical risk Extremely high	6 Participants n=5 Participants
Surgical risk HIgh	54 Participants n=5 Participants
Coronary artery disease	26 Participants n=5 Participants
Renal impairment Severe	20 Participants n=5 Participants
Renal impairment Moderate	24 Participants n=5 Participants
Renal impairment None/mild	16 Participants n=5 Participants
Prior coronary artery bypass grafting	13 Participants n=5 Participants
Prior stroke	7 Participants n=5 Participants
Failed Valve Type Surgical Aortic Valve Replacement (SAVR)	58 Participants n=5 Participants
Failed Valve Type Transcatheter Aortic Valve Replacement (TAVR)	2 Participants n=5 Participants
Aortic valve disease Aortic Stenosis (AS)	35 Participants n=5 Participants
Aortic valve disease Aortic Regurgitation (AR)	7 Participants n=5 Participants
Aortic valve disease Mixed failure (both Aortic Stenosis and Aortic Regurgitation)	18 Participants n=5 Participants

PRIMARY outcome

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

Outcome measures

Measure	ShortCut™ n=60 Participants ShortCut™: Splitting bioprosthetic aortic valve leaflets
(Number of Patients With) ShortCut™ Device- and/or ShortCut™ Procedure-related Mortality and All Cause Stroke All-cause mortality	0 Participants
(Number of Patients With) ShortCut™ Device- and/or ShortCut™ Procedure-related Mortality and All Cause Stroke All-cause stroke	1 Participants
(Number of Patients With) ShortCut™ Device- and/or ShortCut™ Procedure-related Mortality and All Cause Stroke No ShortCut™ device- and/or ShortCut™ procedure-related mortality and all cause stroke	59 Participants

PRIMARY outcome

Timeframe: Intra-procedure

Assessed by echo and/or angiography

Outcome measures

Measure	ShortCut™ n=60 Participants ShortCut™: Splitting bioprosthetic aortic valve leaflets
(Number of Patients With) Leaflet Splitting Success Using the ShortCut™ Device	60 Participants

SECONDARY outcome

Timeframe: 30 days post procedure

(VARC-3) The Valve Academic Research Consortium (VARC) is intended to (i) identify appropriate clinical endpoints and (ii) standardize definitions of these endpoints for transcatheter and surgical aortic valve clinical trials.

VARC-3 provides an update of the most appropriate clinical endpoint definitions to be used in the conduct of transcatheter and surgical aortic valve clinical research.

Outcome measures

Measure	ShortCut™ n=60 Participants ShortCut™: Splitting bioprosthetic aortic valve leaflets
(Number of Patients With) All-cause Mortality All-cause mortality	2 Participants
(Number of Patients With) All-cause Mortality Cardiovascular mortality	0 Participants
(Number of Patients With) All-cause Mortality No all-cause mortality	58 Participants

SECONDARY outcome

Timeframe: 30 days post procedure

(VARC-3) The Valve Academic Research Consortium (VARC) is intended to (i) identify appropriate clinical endpoints and (ii) standardize definitions of these endpoints for transcatheter and surgical aortic valve clinical trials. VARC-3 provides an update of the most appropriate clinical endpoint definitions to be used in the conduct of transcatheter and surgical aortic valve clinical research.

Outcome measures

Measure	ShortCut™ n=60 Participants ShortCut™: Splitting bioprosthetic aortic valve leaflets
(Number of Patients With) All-cause Stroke Fatal stroke	0 Participants
(Number of Patients With) All-cause Stroke Stroke with disability	1 Participants
(Number of Patients With) All-cause Stroke Stroke without disability	0 Participants
(Number of Patients With) All-cause Stroke No all-cause stroke	59 Participants

SECONDARY outcome

Timeframe: 30 days post procedure

(VARC-3) The Valve Academic Research Consortium (VARC) is intended to (i) identify appropriate clinical endpoints and (ii) standardize definitions of these endpoints for transcatheter and surgical aortic valve clinical trials. VARC-3 provides an update of the most appropriate clinical endpoint definitions to be used in the conduct of transcatheter and surgical aortic valve clinical research.

Outcome measures

Measure	ShortCut™ n=60 Participants ShortCut™: Splitting bioprosthetic aortic valve leaflets
(Number of Patients With) Coronary Obstruction	3 Participants

SECONDARY outcome

Timeframe: 30 days post procedure

(VARC-3) The Valve Academic Research Consortium (VARC) is intended to (i) identify appropriate clinical endpoints and (ii) standardize definitions of these endpoints for transcatheter and surgical aortic valve clinical trials. VARC-3 provides an update of the most appropriate clinical endpoint definitions to be used in the conduct of transcatheter and surgical aortic valve clinical research.

Outcome measures

Measure	ShortCut™ n=60 Participants ShortCut™: Splitting bioprosthetic aortic valve leaflets
(Number of Patients With) Myocardial Infarction With New Evidence of Coronary Artery Obstruction Requiring Intervention	2 Participants

SECONDARY outcome

Timeframe: 30 days post procedure

(VARC-3) The Valve Academic Research Consortium (VARC) is intended to (i) identify appropriate clinical endpoints and (ii) standardize definitions of these endpoints for transcatheter and surgical aortic valve clinical trials. VARC-3 provides an update of the most appropriate clinical endpoint definitions to be used in the conduct of transcatheter and surgical aortic valve clinical research.

Outcome measures

Measure	ShortCut™ n=60 Participants ShortCut™: Splitting bioprosthetic aortic valve leaflets
(Number of Patients With) Major Vascular Complications	0 Participants

SECONDARY outcome

Timeframe: 30 days post procedure

(VARC-3) The Valve Academic Research Consortium (VARC) is intended to (i) identify appropriate clinical endpoints and (ii) standardize definitions of these endpoints for transcatheter and surgical aortic valve clinical trials. VARC-3 provides an update of the most appropriate clinical endpoint definitions to be used in the conduct of transcatheter and surgical aortic valve clinical research.

Outcome measures

Measure	ShortCut™ n=60 Participants ShortCut™: Splitting bioprosthetic aortic valve leaflets
(Number of Patients With) Cardiac Tamponade	1 Participants

SECONDARY outcome

Timeframe: 30 days post procedure

(Acute kidney injury stage 3-4 per VARC-3)

The Valve Academic Research Consortium (VARC) is intended to (i) identify appropriate clinical endpoints and (ii) standardize definitions of these endpoints for transcatheter and surgical aortic valve clinical trials. VARC-3 provides an update of the most appropriate clinical endpoint definitions to be used in the conduct of transcatheter and surgical aortic valve clinical research.

• Acute kidney injury stage 3:

• Increase in serum creatinine >300% (>3.0 X increase) within 7 days compared with baseline
• Serum creatinine ≥4.0 mg/dL (≥354 mmol/L) with an acute increase of ≥0.5 mg/dL (≥44 mmol/L)
• Acute kidney injury stage 4:

• AKI requiring new temporary or permanent renal replacement therapy

No differentiation was made between the stages when assessing the outcome.

Outcome measures

Measure	ShortCut™ n=60 Participants ShortCut™: Splitting bioprosthetic aortic valve leaflets
(Number of Patients With) Acute Kidney Injury	2 Participants

SECONDARY outcome

Timeframe: 30 days post procedure

(VARC-3) The Valve Academic Research Consortium (VARC) is intended to (i) identify appropriate clinical endpoints and (ii) standardize definitions of these endpoints for transcatheter and surgical aortic valve clinical trials. VARC-3 provides an update of the most appropriate clinical endpoint definitions to be used in the conduct of transcatheter and surgical aortic valve clinical research.

• Type 3 bleeding:

• Overt bleeding causing hypovolemic shock or severe hypotension (systolic blood pressure <90 mmHg lasting >30 min and not responding to volume resuscitation) or requiring vasopressors or surgery (BARC 3b)
• Overt bleeding requiring reoperation, surgical exploration, or reintervention for the purpose of controlling bleeding (BARC 3b, BARC 4)
• Overt bleeding requiring a transfusion of ≥5 units of whole blood/red blood cells (BARC 3a)
• Overt bleeding associated with a hemoglobin drop ≥5 g/dL (≥3.1 mmol/L) (BARC 3b)
• Type 4 bleeding:

• Overt bleeding leading

Outcome measures

Measure	ShortCut™ n=60 Participants ShortCut™: Splitting bioprosthetic aortic valve leaflets
(Number of Patients With) Access-related Type 3-4 Bleeding	0 Participants

SECONDARY outcome

Timeframe: 30 days post index procedure

Outcome measures

Measure	ShortCut™ n=60 Participants ShortCut™: Splitting bioprosthetic aortic valve leaflets
(Number of Patients With) Freedom From Coronary Artery Ostia Obstruction Related to the Intervened Leaflet	57 Participants

SECONDARY outcome

Timeframe: 30 days post index procedure

Outcome measures

Measure	ShortCut™ n=60 Participants ShortCut™: Splitting bioprosthetic aortic valve leaflets
(Number of Patients With) Freedom From Coronary Artery Intervention Related to the Intervened Leaflet	56 Participants

SECONDARY outcome

Timeframe: At exit from procedure room

Technical success is defined as a composite of the following:

• Successful access, delivery, and retrieval of the ShortCut™ device
• Freedom from ShortCut™ device- and/or ShortCut™ procedure-related mortality
• Freedom from ShortCut™ device- and/or ShortCut™ procedure-related: Surgery or intervention, Major vascular or access-related complications, Cardiac structural complication.

Outcome measures

Measure	ShortCut™ n=60 Participants ShortCut™: Splitting bioprosthetic aortic valve leaflets
(Number of Patients With) ShortCut™ Technical Success	59 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 90 days post procedure

(VARC-3) The Valve Academic Research Consortium (VARC) is intended to (i) identify appropriate clinical endpoints and (ii) standardize definitions of these endpoints for transcatheter and surgical aortic valve clinical trials. VARC-3 provides an update of the most appropriate clinical endpoint definitions to be used in the conduct of transcatheter and surgical aortic valve clinical research.

Outcome measures

Measure	ShortCut™ n=60 Participants ShortCut™: Splitting bioprosthetic aortic valve leaflets
(Number of Patients With) All-cause Mortality	3 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 90 days post procedure

(VARC-3) The Valve Academic Research Consortium (VARC) is intended to (i) identify appropriate clinical endpoints and (ii) standardize definitions of these endpoints for transcatheter and surgical aortic valve clinical trials. VARC-3 provides an update of the most appropriate clinical endpoint definitions to be used in the conduct of transcatheter and surgical aortic valve clinical research.

Outcome measures

Measure	ShortCut™ n=60 Participants ShortCut™: Splitting bioprosthetic aortic valve leaflets
(Number of Patients With) Stroke	1 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 90 days post procedure

(VARC-3) The Valve Academic Research Consortium (VARC) is intended to (i) identify appropriate clinical endpoints and (ii) standardize definitions of these endpoints for transcatheter and surgical aortic valve clinical trials. VARC-3 provides an update of the most appropriate clinical endpoint definitions to be used in the conduct of transcatheter and surgical aortic valve clinical research.

Outcome measures

Measure	ShortCut™ n=60 Participants ShortCut™: Splitting bioprosthetic aortic valve leaflets
(Number of Patients With) Myocardial Infarction With New Evidence of Coronary Artery Obstruction Requiring Intervention	2 Participants

Adverse Events

ShortCut™

Serious events: 13 serious events

Other events: 5 other events

Deaths: 3 deaths

Serious adverse events

Measure	ShortCut™ n=60 participants at risk ShortCut™: Splitting bioprosthetic aortic valve leaflets
Nervous system disorders All-cause stroke	1.7% 1/60 • Number of events 1 • Adverse Events (AEs) reported from point of index procedure until 90 days post procedure
Cardiac disorders Coronary obstruction	5.0% 3/60 • Number of events 3 • Adverse Events (AEs) reported from point of index procedure until 90 days post procedure
Cardiac disorders Myocardial Infarction with new evidence of coronary artery obstruction requiring intervention	3.3% 2/60 • Number of events 2 • Adverse Events (AEs) reported from point of index procedure until 90 days post procedure
Cardiac disorders Cardiac tamponade	1.7% 1/60 • Number of events 1 • Adverse Events (AEs) reported from point of index procedure until 90 days post procedure
Renal and urinary disorders Acute kidney injury stage 3-4	3.3% 2/60 • Number of events 2 • Adverse Events (AEs) reported from point of index procedure until 90 days post procedure
Cardiac disorders Permanent pacemaker	10.0% 6/60 • Number of events 6 • Adverse Events (AEs) reported from point of index procedure until 90 days post procedure

Other adverse events

Measure	ShortCut™ n=60 participants at risk ShortCut™: Splitting bioprosthetic aortic valve leaflets
Cardiac disorders Left Bundle Branch Block (LBBB)	8.3% 5/60 • Number of events 6 • Adverse Events (AEs) reported from point of index procedure until 90 days post procedure

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

Restriction type: GT60