Aortic StenosisNCT03325283
The PROTEMBO SF Trial
A study testing ProtEmbo Cerebral Protection System in people with Aortic Stenosis, run by Protembis GmbH at 2 sites in 2 countries.
Trial summary
The PROTEMBO SF Trial is a prospective, observational, multi-center, intention-to-treat study of the safety and feasibility of the ProtEmbo Cerebral Protection System in subjects with severe symptomatic native aortic valve stenosis indicated for TAVR. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Stenosis
- What is being tested?
- ProtEmbo Cerebral Protection System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 9 Aug 2017to 30 Oct 2018
- 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
- Approved indications for commercially available transcatheter aortic valves by transfemoral route. Refer to the selected valve IFU for additional details.
- Compatible left subclavian artery (≥ 4 mm diameter) without significant stenosis (> 70%) and distance between the origin of left subclavian artery and valve plain is ≥ 90mm as determined by Multi-Slice Computed Tomography (MSCT) scan or equivalent imaging modality.
- The subject and the treating physician agree that the subject will undergo the scheduled pre-procedural testing and return for all required post-procedure follow-up visits.
- The subject has been informed of the nature of the trial, agrees to its provisions and has provided written informed consent as approved by the national or local regulatory authorities of the respective clinical site.
- Subject is a minimum of 18 years of age.
Who cannot join
- Left upper limb vasculature precluding 6Fr sheath (radial or brachial access).
- Inadequate circulation to the left extremity as evidenced by signs of artery occlusion (modified Allen's test) or absence of radial/ brachial pulse.
- Hemodialysis shunt, graft, or arterio-venous fistula involving the upper extremity vasculature.
- TAVR conducted via other than transfemoral access (subclavian, axillar, transapical, transaortic, carotid or transcaval).
- Evidence of an acute myocardial infarction ≤ 1 month before the intended treatment.
- Aortic valve is a congenital unicuspid or bicuspid valve.
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- Mixed aortic valve disease (aortic stenosis and aortic regurgitation with predominant aortic regurgitation >3+).
- Any therapeutic invasive cardiac procedure resulting in a permanent implant that is performed within 30 days of the index procedure (unless part of planned strategy for treatment of concomitant coronary artery disease).
- Pre-existing prosthetic heart valve in any position, prosthetic ring, or severe (greater than 3+) mitral insufficiency.
- Blood dyscrasias as defined: Leukopenia, acute anemia, thrombocytopenia, history of bleeding diathesis or coagulopathy.
- Hemodynamic instability requiring inotropic support or mechanical heart assistance.
- Need for emergency surgery for any reason.
- Severe hypertrophic cardiomyopathy with or without obstruction.
- Severe ventricular dysfunction with LVEF ≤30%.
- Echocardiographic evidence of intracardiac or aortic mass, thrombus, or vegetation.
- Symptomatic or asymptomatic severe (≥ 70%) occlusive carotid disease requiring concomitant CEA/ stenting.
- Subject has undergone carotid stenting or carotid endarterectomy within the previous 6 weeks.
- Active peptic ulcer or upper GI bleeding within the prior 3 months.
- A known hypersensitivity or contraindication to aspirin, heparin, ticlopidine, or clopidogrel, device component material, or sensitivity to contrast media, which cannot be adequately pre-medicated.
- Recent (within 6 months) CVA or a TIA.
- Renal insufficiency (creatinine > 3.0 mg/ dL or GFR < 30) and/ or renal replacement therapy at the time of screening.
- Life expectancy < 12 months due to non-cardiac comorbid conditions.
- Subjects in whom anti-platelet and/ or anticoagulant therapy is contraindicated, or who will refuse transfusion.
- Subjects who have active bacterial endocarditis or other active infections.
- Currently participating in an investigational drug or another device study.
- Subjects who have a planned treatment with any other investigational device or procedure during the study follow-up period (30 days).
- Subjects with planned concomitant surgical or transcatheter ablation for Atrial fibrillation during the study follow-up period (30 days).
- Any subject with a balloon valvuloplasty (BAV) within 30 days of the procedure.
- Subject is a woman of child bearing age.
- Patient with Heparin-Induced Thrombocytopenia Syndrome.
- Inner diameter of aortic arch is less than 25mm.
- Type I Aortic Arch: Distance of the origin of the innominate artery from the top of aortic arch is less than one times the diameter of left common carotid artery.
- Brachiocephalic trunk originating from the aortic arch that splits into the bilateral subclavian arteries and a bicarotid trunk (Origin D).
- Neurological:
- Subject has active major psychiatric disease.
- Subject has severe visual, auditory, or learning impairment and is unable to comprehend English or local language and therefore unable to be consented for the study.
- Subjects with neurodegenerative or other progressive neurological disease or history of significant head trauma followed by persistent neurologic defaults or known structural brain abnormalities.
- Angiographic:
- Excessive tortuosity in the left radial/ brachial/subclavian artery preventing ProtEmbo System access and insertion.
- Subject whose left radial/ brachial/ subclavian artery reveals significant stenosis, calcification, ectasia, dissection, or aneurysm.
- Magnetic Resonance Imaging:
- Subject Body Mass Index (BMI) precluding imaging in scanner.
- Contraindications to MRI (subjects with any implantable temporary or permanent pacemaker or defibrillator, metal implants in field of view, metallic fragments, clips, or devices in the brain or eye before TAVR procedure).
- Patients who have a high risk of complete AV block after TAVR, with the need of permanent pacemaker (e.g. patients with pre-existing bifascicular block or complete right bundle branch block plus any degree of AV block).
- Planned implantation of a pacemaker or defibrillator implantation within the first 7 days after TAVR.
- Claustrophobia precluding MRI scanning.
- No scanner hardware, software, coil or protocol changes should occur during the course of the study.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Ireland1 site
Department of Cardiology Galway University Hospital and SAOLTA Healthcare Group
Galway, County Galway, H91HHTO
About this study
Official title: Cerebral Protection in Transcatheter Aortic Valve Replacement
The PROTEMBO SF Trial is a prospective, observational, multi-center, intention-to-treat study of the safety and feasibility of the ProtEmbo Cerebral Protection System in subjects with severe symptomatic native aortic valve stenosis indicated for TAVR.
Read the detailed description
The PROTEMBO SF Trial is a prospective, single arm, observational, multi-center, intention-to-treat study of the safety and feasibility of the ProtEmbo Cerebral Protection System in subjects with severe symptomatic native aortic valve stenosis indicated for TAVR.
- Conditions
- Aortic Stenosis
- Being tested
- ProtEmbo Cerebral Protection System
- Keywords
- stroke prevention, embolic protection, cognition
- Medical subject headings
- Aortic Valve Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProtEmbo Cerebral Protection SystemDevice
A catheter-based embolic deflection device will be positioned in the arch of the aorta to prevent debris liberated during the TAVR procedure from entering the three major vessels of the aortic arch.
| Study group | Role | What they receive |
|---|---|---|
| Protembo device treatment | Experimental | Patients who consent to participate in the PROTEMBO SF Trial and in whom the ProtEmbo Cerebral Protection System is used or is attempted to be used. Receives: Device: ProtEmbo Cerebral Protection System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Procedural success
defined as successful access, delivery to, deployment within, and retrieval of the ProtEmbo System from the aortic arch as well as adequate coverage of side branch vessels and maintenance of position for duration of the TAVR procedure.
Measured: 1 day
In-hospital procedural safety up to 7 days
defined as occurrence of all Major Adverse Cardiac and Cerebrovascular Events (MACCEs) defined by the Valve Academic Research Consortium (VARC-2) criteria, including device-related safety outcomes (peri-procedural rates of TIA, all-cause mortality, all stroke (disabling and non-disabling), life-threatening (or disabling) bleeding, acute kidney injury (stage 2 or 3), major vascular complications and other device related complications).
Measured: 7 days
Stroke severity
quantified according to the National Institutes of Health Stroke Scale (NIHSS) score at day 3 (±2).
Measured: 3 days
Stroke severity
quantified according to the National Institutes of Health Stroke Scale (NIHSS) score at 30 days (±7).
Measured: 30 days
Occurrence of Serious Adverse Events
as defined by ISO 14155 up to 3 (±2) days or discharge (whichever is later) and 30 days (±7).
Measured: 3 days
Occurrence of Serious Adverse Events
as defined by ISO 14155 at 30 days (±7).
Measured: 30 days
Secondary outcomes (7)
Frequency of new cerebral lesions
defined by diffusion weighted magnetic resonance imaging (DW-MRI) prior to discharge at day 3 (±2) compared to baseline and/ or historical control group;
Measured: 3 days
Number of new cerebral lesions
defined by diffusion weighted magnetic resonance imaging (DW-MRI) prior to discharge at day 3 (±2) compared to baseline and/ or historical control group;
Measured: 3 days
Volume of new cerebral lesions
defined by diffusion weighted magnetic resonance imaging (DW-MRI) prior to discharge at day 3 (±2) compared to baseline and/ or historical control group;
Measured: 3 days
Frequency of new cerebral lesions
defined by Diffusion weighted- and FLAIR-MRI sequence at 30 days (±7 days).
Measured: 30 days
Number of new cerebral lesions
defined by Diffusion weighted- and FLAIR-MRI sequence at 30 days (±7 days).
Measured: 30 days
Volume of new cerebral lesions
defined by Diffusion weighted- and FLAIR-MRI sequence at 30 days (±7 days).
Measured: 30 days
Cognitive function
defined as change in neurocognitive testing at 30 (+/- 7) days post-procedure using MoCA post-procedure compared to baseline.
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 posted30 Oct 2017
- Study start9 Aug 2017
- Primary completion31 Aug 2018
- Study completion30 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic StenosisStudies 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
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Human patients indicated for transcatheter aortic valve replacement
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Protembis GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Avania
- Responsible party
- Sponsor
- Investigators
- James C. Leiter, M.D., Study director, Avania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03325283
- Sponsor's protocol ID
- CIP_00104, Rev 02, 23 May 2017
- Status last verified
- Oct 2018
- First submitted
- 13 Oct 2017
- Last updated
- 31 Oct 2018
- Results posted
- 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 31 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cerebral Protection in Transcatheter Aortic Valve Replacement
- ClinicalTrials.gov ID
- NCT03325283
- Acronym / sponsor ID
- CIP_00104, Rev 02, 23 May 2017
- Conditions
- Aortic Stenosis
- Keywords
- stroke prevention, embolic protection, cognition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Protembis GmbHIndustry (pharma, biotech, devices)
- Collaborators
- Avania
- Study start
- 9 Aug 2017 (actual)
- Primary completion
- 31 Aug 2018 (actual)
- Study completion
- 30 Oct 2018 (actual)
- First posted
- 30 Oct 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 PROTEMBO SF Trial is a prospective, observational, multi-center, intention-to-treat study of the safety and feasibility of the ProtEmbo Cerebral Protection System in subjects with severe symptomatic native aortic valve stenosis indicated for TAVR.
Detailed description
The PROTEMBO SF Trial is a prospective, single arm, observational, multi-center, intention-to-treat study of the safety and feasibility of the ProtEmbo Cerebral Protection System in subjects with severe symptomatic native aortic valve stenosis indicated for TAVR.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Human patients indicated for transcatheter aortic valve replacement
| Arm | Type | Receives |
|---|---|---|
| Protembo device treatment | Experimental | Device: ProtEmbo Cerebral Protection SystemPatients who consent to participate in the PROTEMBO SF Trial and in whom the ProtEmbo Cerebral Protection System is used or is attempted to be used. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Approved indications for commercially available transcatheter aortic valves by transfemoral route. Refer to the selected valve IFU for additional details.
- Compatible left subclavian artery (≥ 4 mm diameter) without significant stenosis (> 70%) and distance between the origin of left subclavian artery and valve plain is ≥ 90mm as determined by Multi-Slice Computed Tomography (MSCT) scan or equivalent imaging modality.
- The subject and the treating physician agree that the subject will undergo the scheduled pre-procedural testing and return for all required post-procedure follow-up visits.
- The subject has been informed of the nature of the trial, agrees to its provisions and has provided written informed consent as approved by the national or local regulatory authorities of the respective clinical site.
- Subject is a minimum of 18 years of age.
Key exclusion criteria (47 listed)
- Left upper limb vasculature precluding 6Fr sheath (radial or brachial access).
- Inadequate circulation to the left extremity as evidenced by signs of artery occlusion (modified Allen's test) or absence of radial/ brachial pulse.
- Hemodialysis shunt, graft, or arterio-venous fistula involving the upper extremity vasculature.
- TAVR conducted via other than transfemoral access (subclavian, axillar, transapical, transaortic, carotid or transcaval).
- Evidence of an acute myocardial infarction ≤ 1 month before the intended treatment.
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 |
|---|---|---|
| ProtEmbo Cerebral Protection SystemA catheter-based embolic deflection device will be positioned in the arch of the aorta to prevent debris liberated during the TAVR procedure from entering the three major vessels of the aortic arch. | Device | Protembo device treatment |
Primary outcome
Procedural success
Time frame: 1 day
defined as successful access, delivery to, deployment within, and retrieval of the ProtEmbo System from the aortic arch as well as adequate coverage of side branch vessels and maintenance of position for duration of the TAVR procedure.
In-hospital procedural safety up to 7 days
Time frame: 7 days
defined as occurrence of all Major Adverse Cardiac and Cerebrovascular Events (MACCEs) defined by the Valve Academic Research Consortium (VARC-2) criteria, including device-related safety outcomes (peri-procedural rates of TIA, all-cause mortality, all stroke (disabling and non-disabling), life-threatening (or disabling) bleeding, acute kidney injury (stage 2 or 3), major vascular complications and other device related complications).
Stroke severity
Time frame: 3 days
quantified according to the National Institutes of Health Stroke Scale (NIHSS) score at day 3 (±2).
Stroke severity
Time frame: 30 days
quantified according to the National Institutes of Health Stroke Scale (NIHSS) score at 30 days (±7).
Occurrence of Serious Adverse Events
Time frame: 3 days
as defined by ISO 14155 up to 3 (±2) days or discharge (whichever is later) and 30 days (±7).
Occurrence of Serious Adverse Events
Time frame: 30 days
as defined by ISO 14155 at 30 days (±7).
7 secondary outcomes
Frequency of new cerebral lesions
Time frame: 3 days
Number of new cerebral lesions
Time frame: 3 days
Volume of new cerebral lesions
Time frame: 3 days
Frequency of new cerebral lesions
Time frame: 30 days
Number of new cerebral lesions
Time frame: 30 days
Volume of new cerebral lesions
Time frame: 30 days
Cognitive function
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 31 Oct 2018.
- 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.
James C. Leiter, M.D. study director
Avania
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ProtEmbo Cerebral Protection System in people with Aortic Stenosis, run by Protembis GmbH at 2 sites in 2 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 5 inclusion and 47 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 31 Oct 2018. 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 Ireland, Latvia. 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?
Procedural success (time frame: 1 day). The study lists 6 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 31 Oct 2018.