The ShortCut™ Continued Access Study Protocol

A Prospective, Multicenter, Non-Randomized, Single-Arm, Open-Label Continued Access Study of the ShortCut™ Device (The ShortCut™ CAS).

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06211296

Acronym

ShortCut-CAS

Enrollment

Registered

2024-01-18

Start date

2024-07-03

Completion date

2025-05-12

Last updated

2026-06-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aortic Stenosis, Coronary; Obstruction, Valve-in-valve Procedures

Keywords

TAVI, Pi-Cardia, TAVR, ViV, continued access, Shortcut

Brief summary

A Prospective, Multicenter, Non-Randomized, Single-Arm, Open-Label Continued Access Study of the ShortCut™ device (The ShortCut™ CAS).

Detailed description

The continued access study will be used to collect additional safety and effectiveness data of the ShortCut™ device for splitting bioprosthetic aortic valve leaflets, and to demonstrate coronary artery ostia patency following leaflet split, in patients who are at risk for TAVR-induced coronary artery ostium obstruction following a ViV procedure.

Interventions

DEVICEShortcut

Splitting bioprosthetic aortic valve leaflets

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Patient is planned to undergo a percutaneous valve-in-valve procedure for an approved ViV indication due to a failed bioprosthetic valve. 2. Patient is at risk for TAVR-induced coronary artery ostium obstruction. 3. Written informed consent to participate in the study obtained from the subject or subject's legal representative, according to local regulations, prior to initiation of any study mandated procedure.

Exclusion criteria

1. An excessive aortic valve leaflet Calcium morphology, such as diffuse massive calcification at the targeted leaflet for splitting or anatomy not suitable for the use of the ShortCut™ device, as determined by the CT measurements. 2. Carotid or vertebral artery disease that, in the opinion of the local Heart Team, should be treated; or treatment of carotid stenosis ≤ 1 month prior to index procedure. 3. CVA or TIA ≤ 6 months prior to index procedure. 4. History of a myocardial infarction (MI) ≤ 6 weeks prior to index procedure. 5. Hemodynamic or respiratory instability requiring inotropic support, mechanical ventilation or mechanical heart assistance. 6. LVEF \< 30%. 7. Ongoing severe infection or sepsis. 8. Patient has renal insufficiency or is on chronic dialysis. 8\. Need for emergency surgery for any reason. 9. Life expectancy is less than 1 year.

Design outcomes

Primary

Measure	Time frame	Description
ShortCut™ Device- and/or ShortCut™ Procedure-related: Mortality, Stroke	discharge or at 7 days post-procedure, whichever occurs first	Primary safety endpoint, ShortCut™ device- and/or ShortCut™ procedure-related: Mortality, Stroke
Number of Participants With Leaflet Splitting Success Using the Shortcut Device, Assessed by Echo and/or Angiography	Intra-procedure	Primary effectiveness endpoint, Leaflet splitting success using the Shortcut Device, assessed by echo and/or angiography

Secondary

Measure	Time frame	Description
Rate of All Cause Mortality, Per VARC 3	30 days post procedure	Secondary safety endpoint, Rate of all cause mortality, per VARC 3
Rate of All-cause Stroke, Per VARC-3	30 days post procedure	Secondary safety endpoint, Rate of all-cause stroke, per VARC-3
Rate of Coronary Obstruction Per VARC-3	30 days post procedure	Secondary safety endpoint, Rate of coronary obstruction per VARC-3
Rate of MI With New Evidence of Coronary Artery Obstruction Requiring Intervention Per VARC-3	30 days post procedure	Secondary safety endpoint, Rate of MI with new evidence of coronary artery obstruction requiring intervention per VARC-3
-Rate of Major Vascular Complications Per VARC-3	30 days post procedure	Secondary safety endpoint, -Rate of major vascular complications per VARC-3
Rate of Cardiac Temponade Per VARC-3	30 days post procedure	Secondary safety endpoint, Rate of cardiac temponade per VARC-3
Rate of Acute Kidney Injury Per VARC-3	30 days post procedure	Secondary safety endpoint, Rate of Acute Kidney Injury per VARC-3
Access-related Type 3-4 Bleeding Per VARC-3	30 days post procedure	Secondary safety endpoint, Access-related type 3-4 bleeding per VARC-3
Rate of Freedom From Coronary Artery Intervention Related to the Intervened Leaflet	30 days post procedure	Secondary effectiveness endpoint, 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	Secondary effectiveness endpoint, Rate of freedom from coronary artery ostia obstruction related to the intervened leaflet
Shortcut Technical Success	At exit from procedure room, immediately after the procedure	Technical success endpoint, Shortcut technical success - Successful access, delivery, and retrieval of the ShortCut™ device.

Countries

United States

Contacts

STUDY_DIRECTORHadas Givon

Pi-cardia

Participant flow

Participants by arm

Arm	Count
Shortcut Shortcut: Splitting bioprosthetic aortic valve leaflets	8
Total	8

Baseline characteristics

Characteristic	Shortcut
Age, Continuous	80.6 years STANDARD_DEVIATION 9.2
Race/Ethnicity, Customized Unknown	1 participants
Race/Ethnicity, Customized White	7 participants
Region of Enrollment United States	8 Participants
Sex: Female, Male Female	5 Participants
Sex: Female, Male Male	3 Participants
STS score	10.3 units on a scale STANDARD_DEVIATION 12.3

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	0 / 8
other Total, other adverse events	0 / 8
serious Total, serious adverse events	2 / 8

Outcome results

Primary

Number of Participants With Leaflet Splitting Success Using the Shortcut Device, Assessed by Echo and/or Angiography

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

Time frame: Intra-procedure

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Shortcut	Number of Participants With Leaflet Splitting Success Using the Shortcut Device, Assessed by Echo and/or Angiography	8 Participants

Primary

ShortCut™ Device- and/or ShortCut™ Procedure-related: Mortality, Stroke

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

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

Arm	Measure	Value (NUMBER)
Shortcut	ShortCut™ Device- and/or ShortCut™ Procedure-related: Mortality, Stroke	0 Participants

Secondary