Aortic Valve DiseaseNCT03130491
European Study Evaluating the EMBLOK Embolic Protection System During TAVR
A study testing Transcatheter Aortic Valve Replacement (TAVR) and EMBLOK filter in people with Aortic Valve Disease, run by Emblok, Inc. at 2 sites in Italy.
Trial summary
The primary objective is to evaluate the performance and the treatment effect of the use of the Emblok embolic protection system use during transcatheter aortic valve replacement with respect to procedure-related cerebral embolic burden as determined by DW-MRI. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Aortic Valve Disease
- What is being tested?
- Transcatheter Aortic Valve Replacement (TAVR) and EMBLOK filter
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 2 sitesItaly
- Study dates
- 8 Mar 2017to 28 Jan 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Inclusion Criteria: Subject is between 18 and 90 years of age.Subject is scheduled to undergo transcatheter aortic valve replacement (TAVR) procedure on a native aortic valve and is qualified based on pre-operative trans-thoracic echocardiogram (TTE). Subject anatomy is compatible with correct device positioning with: Iliofemoral access compatible with a 12 French arterial access system for the EMBLOK catheter (> 4 mm vessel diameter). Ascending aorta length greater than or equal to 9 cm. Ascending aorta/aortic arch diameter less than or equal to 35mm.
Female subjects of child bearing potential must have a negative pregnancy test within 48 hours prior to the index study procedure.Subject agrees to comply with all study required visits. Subject or subject's legal representative completes written Informed Consent.
Exclusion Criteria: Subject requires an emergent procedure. Contraindications to MRI including: Subjects with any non-MRI compatible implantable temporary or permanent pacemaker or defibrillator, metal implants in field of view, metallic fragments, clips, or devices in the brain or eye before TAVI procedure, claustrophobia, planned implantation of non-MRI compatible pacemaker or implantable cardioverter defibrillator within 30 days after TAVR.
Subject has experienced a myocardial infarction within 30 days of the planned index procedure.
Subject has renal insufficiency, defined as a creatinine level > 2.5 mg/dl at the time of treatment.
Subject has documented history of stroke or TIA within prior 3 months. Subject has an ejection fraction of 30% or less. Subject has a history of intolerance, allergic reaction or contraindication to any of the study medications, including heparin, aspirin, clopidogrel or a sensitivity to contrast media or anesthesia which cannot be adequately pre-treated.
Subject has known allergy to any materials used in the EMBLOK device or allergy to intravascular contrast agents that cannot be pre-medicated.
Subject has active endocarditis or an ongoing systemic infection defined as fever within temperature > 38° C and/ or WBC > 15,000 IU.
Subjects undergoing therapeutic thrombolysis. Subject has history of bleeding diathesis or a major coagulopathy. Subject is known or suspected to be pregnant, or is lactating. Subject is currently participating in another drug or device clinical study, or has other medical illnesses that may cause the subject to be non-compliant with the protocol or confound the data interpretation.
Trial locations and contacts
2 sites in 1 country.
Italy2 sites
Hospital San Donato
Milan, Milano, 20097
Hospital San Raffaele
Milan, 20132
About this study
Official title: European Study Evaluating the EMBLOK Cerebral Embolic Protection System During Transcatheter Aortic Valve Replacement (TAVR)
The primary objective is to evaluate the performance and the treatment effect of the use of the Emblok embolic protection system use during transcatheter aortic valve replacement with respect to procedure-related cerebral embolic burden as determined by DW-MRI.
Read the detailed description
The enrollment of up to thirty subjects with severe native aortic valve stenosis who meet clinically approved indications for transcatheter aortic valve replacement. The primary objective evaluates performance and treatment effect of the use of the EMBLOK. A secondary objective of this study is to analyze the safety profile and the type of captured debris from the Emblok filter after TAVR. Due to the small sample size, the study is not powered to detect a reduction in actual stroke rates. However, the potential risk of stroke will be assessed based on neurological evaluations pre and post procedure. In addition, silent ischemic damage and cerebral embolic burden will be assessed using DW MRI studies.
- Conditions
- Aortic Valve Disease
- Being tested
- Transcatheter Aortic Valve Replacement (TAVR), EMBLOK filter
- Medical subject headings
- Aortic Valve Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcatheter Aortic Valve Replacement (TAVR)Procedure or surgery
placement of a filter to capture and remove embolic material from entering the cerebral vascular circulation during aortic valve replacement
EMBLOK filterDevice
Embolic Filter Protection System During TAVR
| Study group | Role | What they receive |
|---|---|---|
| TAVR + Embolic protection | Other | subjects with severe native aortic valve stenosis who meet the commercially approved indications for transcatheter aortic valve replacement Receives: Procedure: Transcatheter Aortic Valve Replacement (TAVR); Device: EMBLOK filter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance Endpoint
successful insertion, placement and removal of the EMBLOK system
Measured: Day 1 to post procedure
Secondary outcomes (1)
Safety Endpoint (Rate of MACCE)
Rate of MACCE
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2017
- Study start8 Mar 2017
- Primary completion1 Nov 2021
- Study completion28 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Aortic Valve DiseaseStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emblok, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Meditrial Europe Ltd.
- Responsible party
- Sponsor
- Investigators
- Azeem Latib, MD, Principal investigator, Hospital San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03130491
- Sponsor's protocol ID
- CLP002-2016
- Status last verified
- Sep 2023
- First submitted
- 11 Apr 2017
- Last updated
- 5 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Latib A, Mangieri A, Vezzulli P, Spagnolo P, Sardanelli F, Fellegara G, Pagnesi M, Giannini F, Falini A, Gorla R, Montorfano M, Bedogni F, Colombo A, Popma J, Merhi WM, De Marco F. First-in-Man Study Evaluating the Emblok Embolic Protection System During Transcatheter Aortic Valve Replacement. JACC Cardiovasc Interv. 2020 Apr 13;13(7):860-868. doi: 10.1016/j.jcin.2019.11.017.
PubMed 32273098
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- European Study Evaluating the EMBLOK Cerebral Embolic Protection System During Transcatheter Aortic Valve Replacement (TAVR)
- ClinicalTrials.gov ID
- NCT03130491
- Acronym / sponsor ID
- CLP002-2016
- Conditions
- Aortic Valve Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Emblok, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Meditrial Europe Ltd.
- Study start
- 8 Mar 2017 (actual)
- Primary completion
- 1 Nov 2021 (actual)
- Study completion
- 28 Jan 2022 (actual)
- First posted
- 26 Apr 2017 (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.
The primary objective is to evaluate the performance and the treatment effect of the use of the Emblok embolic protection system use during transcatheter aortic valve replacement with respect to procedure-related cerebral embolic burden as determined by DW-MRI.
Detailed description
The enrollment of up to thirty subjects with severe native aortic valve stenosis who meet clinically approved indications for transcatheter aortic valve replacement. The primary objective evaluates performance and treatment effect of the use of the EMBLOK. A secondary objective of this study is to analyze the safety profile and the type of captured debris from the Emblok filter after TAVR. Due to the small sample size, the study is not powered to detect a reduction in actual stroke rates. However, the potential risk of stroke will be assessed based on neurological evaluations pre and post procedure. In addition, silent ischemic damage and cerebral embolic burden will be assessed using DW MRI studies.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TAVR + Embolic protection | Other | Procedure: Transcatheter Aortic Valve Replacement (TAVR), Device: EMBLOK filtersubjects with severe native aortic valve stenosis who meet the commercially approved indications for transcatheter aortic valve replacement |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Transcatheter Aortic Valve Replacement (TAVR)placement of a filter to capture and remove embolic material from entering the cerebral vascular circulation during aortic valve replacement | Procedure or surgery | TAVR + Embolic protection |
| EMBLOK filterEmbolic Filter Protection System During TAVR | Device | TAVR + Embolic protection |
Primary outcome
Performance Endpoint
Time frame: Day 1 to post procedure
successful insertion, placement and removal of the EMBLOK system
1 secondary outcome
Safety Endpoint (Rate of MACCE)
Time frame: 30 days
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 5 Mar 2024.
- Derived from this study: PubMed 32273098Latib A, Mangieri A, Vezzulli P, Spagnolo P, Sardanelli F, Fellegara G, Pagnesi M, Giannini F, Falini A, Gorla R, Montorfano M, Bedogni F, Colombo A, Popma J, Merhi WM, De Marco F. First-in-Man Study Evaluating the Emblok Embolic Protection System During Transcatheter Aortic Valve Replacement. JACC Cardiovasc Interv. 2020 Apr 13;13(7):860-868. doi: 10.1016/j.jcin.2019.11.017.
- Individual participant dataSharing planned: No
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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.
Azeem Latib, MD principal investigator
Hospital San Raffaele
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcatheter Aortic Valve Replacement (TAVR) and EMBLOK filter in people with Aortic Valve Disease, run by Emblok, Inc. at 2 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 5 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. 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?
Performance Endpoint (time frame: Day 1 to post procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03130491, which also lists 1 linked publication.
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 5 Mar 2024.