Transcatheter Aortic Valve ReplacementNCT04659538
The CAPTIS® Study - Embolic Protection in TAVR
A study testing CAPTIS Embolic Protection device in people with Transcatheter Aortic Valve Replacement, run by Filterlex Medical Ltd. at 3 sites in Israel.
Trial summary
This is a First in Human study with the Filerlex CAPTIS device designed to demonstrate the safety and feasibility of the device in subjects undergoing Transcatheter Aortic Valve Replacement (TAVR) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Transcatheter Aortic Valve Replacement
- What is being tested?
- CAPTIS Embolic Protection device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 3 sitesIsrael
- Study dates
- 24 Nov 2020to 3 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patient must be ≥18 years of age.
- Patient has clinical indications for TAVR procedure.
- TAVR procedure planned with femoral artery access site
- TAVR device approved for use in the US, Europe or Israel
- Femoral and iliac artery with a minimal luminal diameter of at least 6 mm
- Descending Aorta diameter of 20 to 27mm measured 10cm from the left subclavian, determined by CT scan analysis
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- The distance between the innominate and left-subclavian arteries (including their lumens) is less than 65mm
- Patient is willing to comply with protocol-specified preprocedure and follow-up evaluations.
- The patient has been informed of the nature of the trial, agrees to its provisions and has provided written informed consent as approved by the ethics committee of the clinical site.
Who cannot join
- General
- Pregnant or nursing female patients. Female patients of child-bearing potential must have a negative pregnancy test done within 7 days prior to surgical procedure per site standard test
- Hemodialysis shunt, graft, or arterio-venous fistula involving the lower extremity vasculature
- Blood dyscrasias: WBC <5000/microliter, Hb <10.0 mg/dL, PLT <100,000/microliter, history of bleeding diathesis, coagulopathy, or conditions associated with increased thrombogenicity
- Hemodynamic instability requiring pharmacological or mechanical circulatory support. Patient in whom hemodynamic instability is expected or at increased risk, will also be excluded.
- Any surgery or procedure (including endovascular) planned for the 30 days post TAVR
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- Severe left-ventricle dysfunction with LVEF ≤30%
- Echocardiographic evidence of intracardiac or aortic mass, thrombus, or vegetation
- Active or recent bacterial endocarditis
- Active peptic ulcer or upper GI bleeding within the prior 3 months
- A known hypersensitivity or contraindication to aspirin, heparin, bivalirudin, clopidogrel, ticagrelor, or contrast media, which cannot be adequately pre-medicated or replaced by an alternative agent
- Renal insufficiency (GFR < 30). Patients on renal replacement therapy (dialysis) can be enrolled into the study.
- Life expectancy < 12 months due to non-cardiac comorbid conditions
- Patients who refuse blood transfusion
- Chronic or persistent atrial fibrillation, frequent recurring atrial fibrillation, and patients with planned ablation for atrial fibrillation
- Currently participating in another investigational drug or device study
- Patient is otherwise not appropriate for the study as determined by the investigator or the Eligibility Committee
- Neurologic
- Prior CVA or a TIA
- Patient has undergone carotid stenting or carotid endarterectomy within the previous 6 months
- Patient has active major psychiatric disease that prevent a conscious consent
- Patient with neurodegenerative or other progressive neurological disease or history of significant head trauma followed by persistent neurologic deficit or known structural brain abnormalities
- Vascular
- Severe tortuosity or luminal diameter of less than 6 mm of the femoral or iliac arteries
- Excessive tortuosity or calcification or atherosclerosis of any segment of the aorta and iliac arteries
- Patient whose innominate, carotid, or subclavian arteries reveals significant stenosis, ostial calcification, ectasia, dissection, or aneurysm at the ostium
Trial locations and contacts
3 sites in 1 country.
Israel3 sites
Wolfson Medical Center
Holon, 5822012
Rabin Medical Center
Petah Tikva
Sheba Medical Center
Ramat Gan
About this study
Official title: A Prospective, Single Arm, FIH Study to Evaluate the Safety and Feasibility of the CAPTIS Device in Patients Undergoing Transcatheter Aortic Valve Replacement (TAVR)
This is a First in Human study with the Filerlex CAPTIS device designed to demonstrate the safety and feasibility of the device in subjects undergoing Transcatheter Aortic Valve Replacement (TAVR)
Read the detailed description
This is a prospective, multi center, single arm, FIH safety and feasibility study enrolling up to 20 patients. Patients undergoing clinically indicated TAVR who comply with the study inclusion/exclusion criteria will be enrolled to have embolic protection with the CAPTIS® Device during the TAVR procedure.
Screening activities will include initial screening by the site, analysis of patient CT scan by the sponsor and core-lab, and review of the clinical and imaging data by an eligibility committee to confirm that all inclusion/exclusion criteria are met. Final eligibility for study enrollment is then determined by the investigator in the cardiac catheterization laboratory.
Enrolled patients will undergo safety assessment during the procedure, post-procedure, and at 30 days post-procedure; Feasibility evaluation will be assessed during procedure.
- Conditions
- Transcatheter Aortic Valve Replacement
- Being tested
- CAPTIS Embolic Protection device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CAPTIS Embolic Protection deviceDevice
The CAPTIS Embolic Protection device will be deployed during standard of care TAVR procedure. The device's safety will be assessed up to one month post procedure. The device's technical performance and feasibility to capture and remove debris during the procedure will be evaluated.
| Study group | Role | What they receive |
|---|---|---|
| CAPTIS Embolic Protection | Experimental | TAVR will be performed according to standard institutional practice under local or general anesthesia by the transfemoral approach. The investigational device will be advanced and deployed across the aortic arch covering the ostia of the 3 great vessels (innominate, left carotid, and left-subclavian arteries) at the initiation of the procedure and withdrawn at the completion of the TAVR procedure. Receives: Device: CAPTIS Embolic Protection device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety - Occurrence of MACCE
Occurrence of all MACCE at 72 hours post procedure, with MACCE defined as all death and all cerebrovascular events (all TIA and stroke).
Measured: 72 hours
Safety - Device related complications
Number of device related complications [at 72 hours]
Measured: 72 hours
Secondary outcomes (4)
Secondary Safety - Occurrence of MACCE
All MACCE, number of stroke events, number of TIA events [at 30 days]
Measured: 30 days
Secondary Safety - Acute Kidney Injury
Number of subjects with acute kidney injury (defined as increase in creatinine level of 25% or 0.5mg/dL at 72 hours (or discharge) as compared to pre-procedure baseline)
Measured: 72 hours
Device feasibility - Histopathologic examination of debris captured and removed by the device
All devices will be sent for histopathologic examination to determine the device's feasibility to catch and remove debris during the TAVR procedure
Measured: Day 0
Technical Device Performance - the ability to deploy and retrieve the device without device malfunction
Number of procedures performed without device malfunction
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2020
- Study start24 Nov 2020
- Primary completion3 May 2022
- Study completion3 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transcatheter Aortic Valve ReplacementStudies 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
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Filterlex Medical Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04659538
- Sponsor's protocol ID
- CLD-FLX-001
- Status last verified
- May 2022
- First submitted
- 17 Nov 2020
- Last updated
- 25 May 2022
- Results posted
- No
- Data monitoring committee
- No
- 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 25 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single Arm, FIH Study to Evaluate the Safety and Feasibility of the CAPTIS Device in Patients Undergoing Transcatheter Aortic Valve Replacement (TAVR)
- ClinicalTrials.gov ID
- NCT04659538
- Acronym / sponsor ID
- CLD-FLX-001
- Conditions
- Transcatheter Aortic Valve Replacement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Filterlex Medical Ltd.Industry (pharma, biotech, devices)
- Study start
- 24 Nov 2020 (actual)
- Primary completion
- 3 May 2022 (actual)
- Study completion
- 3 May 2022 (actual)
- First posted
- 9 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a First in Human study with the Filerlex CAPTIS device designed to demonstrate the safety and feasibility of the device in subjects undergoing Transcatheter Aortic Valve Replacement (TAVR)
Detailed description
This is a prospective, multi center, single arm, FIH safety and feasibility study enrolling up to 20 patients. Patients undergoing clinically indicated TAVR who comply with the study inclusion/exclusion criteria will be enrolled to have embolic protection with the CAPTIS® Device during the TAVR procedure.
Screening activities will include initial screening by the site, analysis of patient CT scan by the sponsor and core-lab, and review of the clinical and imaging data by an eligibility committee to confirm that all inclusion/exclusion criteria are met. Final eligibility for study enrollment is then determined by the investigator in the cardiac catheterization laboratory.
Enrolled patients will undergo safety assessment during the procedure, post-procedure, and at 30 days post-procedure; Feasibility evaluation will be assessed during procedure.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CAPTIS Embolic Protection | Experimental | Device: CAPTIS Embolic Protection deviceTAVR will be performed according to standard institutional practice under local or general anesthesia by the transfemoral approach. The investigational device will be advanced and deployed across the aortic arch covering the ostia of the 3 great vessels (innominate, left carotid, and left-subclavian arteries) at the initiation of the procedure and withdrawn at the completion of the TAVR procedure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- The patient must be ≥18 years of age.
- Patient has clinical indications for TAVR procedure.
- TAVR procedure planned with femoral artery access site
- TAVR device approved for use in the US, Europe or Israel
- Femoral and iliac artery with a minimal luminal diameter of at least 6 mm
Key exclusion criteria (26 listed)
- General
- Pregnant or nursing female patients. Female patients of child-bearing potential must have a negative pregnancy test done within 7 days prior to surgical procedure per site standard test
- Hemodialysis shunt, graft, or arterio-venous fistula involving the lower extremity vasculature
- Blood dyscrasias: WBC <5000/microliter, Hb <10.0 mg/dL, PLT <100,000/microliter, history of bleeding diathesis, coagulopathy, or conditions associated with increased thrombogenicity
- Hemodynamic instability requiring pharmacological or mechanical circulatory support. Patient in whom hemodynamic instability is expected or at increased risk, will also be excluded.
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 |
|---|---|---|
| CAPTIS Embolic Protection deviceThe CAPTIS Embolic Protection device will be deployed during standard of care TAVR procedure. The device's safety will be assessed up to one month post procedure. The device's technical performance and feasibility to capture and remove debris during the procedure will be evaluated. | Device | CAPTIS Embolic Protection |
Primary outcome
Safety - Occurrence of MACCE
Time frame: 72 hours
Occurrence of all MACCE at 72 hours post procedure, with MACCE defined as all death and all cerebrovascular events (all TIA and stroke).
Safety - Device related complications
Time frame: 72 hours
Number of device related complications [at 72 hours]
4 secondary outcomes
Secondary Safety - Occurrence of MACCE
Time frame: 30 days
Secondary Safety - Acute Kidney Injury
Time frame: 72 hours
Device feasibility - Histopathologic examination of debris captured and removed by the device
Time frame: Day 0
Technical Device Performance - the ability to deploy and retrieve the device without device malfunction
Time frame: Day 0
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2022.
- Sponsor websiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Transcatheter Aortic Valve Replacement
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Not yet recruiting
Exercise and Diet Supplements for Older Patients Undergoing TAVI: the IRON-TAVI Trial
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Active, not recruiting
The JenaValve ALIGN-AR LVAD Registry
Aortic Regurgitation, Aortic Valve Insufficiency
Recruiting
Trial of the F2 Filter and Delivery System for Embolic Protection During TAVR
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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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CAPTIS Embolic Protection device in people with Transcatheter Aortic Valve Replacement, run by Filterlex Medical Ltd. at 3 sites in Israel.
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 9 inclusion and 26 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 25 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Israel. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Safety - Occurrence of MACCE (time frame: 72 hours). 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 25 May 2022.