Risk of Coronary Obstruction Following Transcatheter Aortic Valve Replacement (TAVR) ProcedureNCT04952909
The ShortCut™ Study Protocol
A study testing ShortCut™ in people with Risk of Coronary Obstruction Following Transcatheter Aortic Valve Replacement (TAVR) Procedure, run by Pi-cardia at 23 sites in 5 countries.
Trial 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 (ViV) transcatheter aortic valve replacement (TAVR) procedure for an… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Risk of Coronary Obstruction Following Transcatheter Aortic Valve Replacement (TAVR) Procedure
- What is being tested?
- ShortCut™
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 23 sitesin 5 countries
- Study dates
- 21 Jan 2022to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient is planned to undergo a percutaneous valve-in-valve procedure for an approved valve-in-valve indication due to a failed bioprosthetic valve.
- 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.
Who cannot join
- An excessive aortic valve leaflet Calcium morphology or anatomy not suitable for the use of the ShortCut™ device.
- Coronary, carotid or vertebral artery disease that, in the opinion of the local Heart Team, should be treated; or treatment of such disease ≤ 1 month prior to index procedure.
- Cerebrovascular Accident (CVA) or Transient Ischemic Attack (TIA) ≤ 6 months prior to index procedure, or severe neurological disability.
- Myocardial infarction (MI) ≤ 6 weeks prior to index procedure.
- Hemodynamic or respiratory instability.
- Left ventricle ejection fraction < 30%.
Show all 10Show fewer
- Ongoing severe infection, sepsis or endocarditis.
- Renal insufficiency
- Need for emergency surgery for any reason.
- Life expectancy is less than 1 year.
Trial locations and contacts
23 sites in 5 countries.
23 sites in 5 countries
United States13 sites
University of Michigan
Ann Arbor, Michigan, 48109
Carolinas Medical Center / Atrium Health
Charlotte, North Carolina, 28204
Smidt Heart Institute Cedars-Sinai Medical
Los Angeles, California, 90048
Morristown Medical Center
Morristown, New Jersey, 07960
Intermountain Medical Center
Murray, Utah, 84107
Columbia University Medical Center
New York, New York, 10032
Advocate Christ Medical Center
Oak Lawn, Illinois, 60453
Baylor Scott & White, The Heart Hospital Plano
Plano, Texas, 75093
Kaiser Permanente - San Francisco Medical Center
San Francisco, California, 94115
Los Robles Regional Medical Center
Thousand Oaks, California, 91360
Tucson Medical Center
Tucson, Arizona, 85712
Medstar Washington Hospital Center
Washington D.C., District of Columbia, 20010
UPMC Pinnacle
Wormleysburg, Pennsylvania, 17043
France3 sites
CHU de Bordeaux (Bordeaux University Hospital)
Bordeaux
Institute Mutualiste Montsouris
Paris
Clinique Pasteur
Toulouse
Germany3 sites
German Heart Institute Berlin
Berlin
University Hospital Hamburg
Hamburg
Leipzig Heart Institute
Leipzig
Israel2 sites
Sha'are Tzedek Medical Center
Jerusalem
Rabin Medical Center
Petah Tikva
United Kingdom2 sites
Royal Sussex County Hospital
Brighton
Leeds General Infirmary
Leeds
About this study
Official title: A Prospective, Multicenter, Non-Randomized, Single-Arm, Open-Label Clinical Study to Demonstrate the Safety and Effectiveness of the ShortCut™ Device (The ShortCut™ Study)
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 (ViV) transcatheter aortic valve replacement (TAVR) procedure for an approved ViV indication, and who are at risk for TAVR-induced coronary artery ostium obstruction.
- Conditions
- Risk of Coronary Obstruction Following Transcatheter Aortic Valve Replacement (TAVR) Procedure
- Being tested
- ShortCut™
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ShortCut™Device
Splitting bioprosthetic aortic valve leaflets
| Study group | Role | What they receive |
|---|---|---|
| ShortCut™ | Experimental | Not described Receives: Device: ShortCut™ |
What is being measured
The primary outcome is the main question the study is designed to answer.
(Number of Patients With) ShortCut™ Device- and/or ShortCut™ Procedure-related Mortality and All Cause Stroke
Measured: Discharge or at 7 days post-procedure, whichever occurs first
(Number of Patients With) Leaflet Splitting Success Using the ShortCut™ Device
Assessed by echo and/or angiography
Measured: Intra-procedure
Secondary outcomes (11)
(Number of Patients With) All-cause Mortality
(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.
Measured: 30 days post procedure
(Number of Patients With) All-cause Stroke
(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.
Measured: 30 days post procedure
(Number of Patients With) Coronary Obstruction
(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.
Measured: 30 days post procedure
(Number of Patients With) Myocardial Infarction With New Evidence of Coronary Artery Obstruction Requiring Intervention
(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.
Measured: 30 days post procedure
(Number of Patients With) Major Vascular Complications
(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.
Measured: 30 days post procedure
(Number of Patients With) Cardiac Tamponade
(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.
Measured: 30 days post procedure
(Number of Patients With) Acute Kidney Injury
(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.
Measured: 30 days post procedure
(Number of Patients With) Access-related Type 3-4 Bleeding
(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
Measured: 30 days post procedure
(Number of Patients With) Freedom From Coronary Artery Ostia Obstruction Related to the Intervened Leaflet
Measured: 30 days post index procedure
(Number of Patients With) Freedom From Coronary Artery Intervention Related to the Intervened Leaflet
Measured: 30 days post index procedure
(Number of Patients With) ShortCut™ Technical Success
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.
Measured: At exit from procedure room
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2021
- Study start21 Jan 2022
- Primary completion30 Sep 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Risk of Coronary Obstruction Following Transcatheter Aortic Valve Replacement (TAVR) ProcedureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pi-cardia
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04952909
- Sponsor's protocol ID
- S01-CLN-002
- Status last verified
- Aug 2023
- First submitted
- 28 Jun 2021
- Last updated
- 3 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Non-Randomized, Single-Arm, Open-Label Clinical Study to Demonstrate the Safety and Effectiveness of the ShortCut™ Device (The ShortCut™ Study)
- ClinicalTrials.gov ID
- NCT04952909
- Acronym / sponsor ID
- S01-CLN-002
- Conditions
- Risk of Coronary Obstruction Following Transcatheter Aortic Valve Replacement (TAVR) Procedure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Pi-cardiaIndustry (pharma, biotech, devices)
- Study start
- 21 Jan 2022 (actual)
- Primary completion
- 30 Sep 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 7 Jul 2021 (actual)
- Results
- Posted 3 Feb 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 (ViV) transcatheter aortic valve replacement (TAVR) procedure for an approved ViV indication, and who are at risk for TAVR-induced coronary artery ostium obstruction.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ShortCut™ | Experimental | Device: ShortCut™ |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patient is planned to undergo a percutaneous valve-in-valve procedure for an approved valve-in-valve indication due to a failed bioprosthetic valve.
- 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.
Key exclusion criteria (10 listed)
- An excessive aortic valve leaflet Calcium morphology or anatomy not suitable for the use of the ShortCut™ device.
- Coronary, carotid or vertebral artery disease that, in the opinion of the local Heart Team, should be treated; or treatment of such disease ≤ 1 month prior to index procedure.
- Cerebrovascular Accident (CVA) or Transient Ischemic Attack (TIA) ≤ 6 months prior to index procedure, or severe neurological disability.
- Myocardial infarction (MI) ≤ 6 weeks prior to index procedure.
- Hemodynamic or respiratory instability.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ShortCut™Splitting bioprosthetic aortic valve leaflets | Device | ShortCut™ |
Primary outcome
(Number of Patients With) ShortCut™ Device- and/or ShortCut™ Procedure-related Mortality and All Cause Stroke
Time frame: Discharge or at 7 days post-procedure, whichever occurs first
(Number of Patients With) Leaflet Splitting Success Using the ShortCut™ Device
Time frame: Intra-procedure
Assessed by echo and/or angiography
11 secondary outcomes
(Number of Patients With) All-cause Mortality
Time frame: 30 days post procedure
(Number of Patients With) All-cause Stroke
Time frame: 30 days post procedure
(Number of Patients With) Coronary Obstruction
Time frame: 30 days post procedure
(Number of Patients With) Myocardial Infarction With New Evidence of Coronary Artery Obstruction Requiring Intervention
Time frame: 30 days post procedure
(Number of Patients With) Major Vascular Complications
Time frame: 30 days post procedure
(Number of Patients With) Cardiac Tamponade
Time frame: 30 days post procedure
(Number of Patients With) Acute Kidney Injury
Time frame: 30 days post procedure
(Number of Patients With) Access-related Type 3-4 Bleeding
Time frame: 30 days post procedure
(Number of Patients With) Freedom From Coronary Artery Ostia Obstruction Related to the Intervened Leaflet
Time frame: 30 days post index procedure
(Number of Patients With) Freedom From Coronary Artery Intervention Related to the Intervened Leaflet
Time frame: 30 days post index procedure
(Number of Patients With) ShortCut™ Technical Success
Time frame: At exit from procedure room
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
23 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ShortCut™ in people with Risk of Coronary Obstruction Following Transcatheter Aortic Valve Replacement (TAVR) Procedure, run by Pi-cardia at 23 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in United States, France, Germany, Israel, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
(Number of Patients With) ShortCut™ Device- and/or ShortCut™ Procedure-related Mortality and All Cause Stroke (time frame: Discharge or at 7 days post-procedure, whichever occurs first). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2025.