Symptomatic Severe Aortic StenosisNCT03724812
FlexNav EU CE Mark Study
A study testing Portico Valve and FlexNav™ Delivery System in people with Symptomatic Severe Aortic Stenosis, run by Abbott Medical Devices at 6 sites in 4 countries.
Trial summary
The purpose of this clinical investigation is to characterize the safety of the next-generation FlexNav™ Delivery System for transfemoral implantation of the Portico™ Transcatheter Aortic Heart Valve in symptomatic severe aortic stenosis patients who are considered of high or extreme risk for surgical aortic valve… Read more about this study
- Who is it for?
- Ages 21 to 100 years
- Conditions the study is for
- Symptomatic Severe Aortic Stenosis
- What is being tested?
- Portico Valve and FlexNav™ Delivery System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 6 sitesin 4 countries
- Study dates
- 26 Feb 2019to 10 Feb 2021
- 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 21 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Candidates for High Risk classification must meet all the following inclusion criteria:
- Subjects must have co-morbidities such that the local heart team concur the predicted risk of operative mortality is ≥15% or a minimum Society of Thoracic Surgeons (STS) score of 8%.
- A candidate who does not meet the STS score criteria of ≥ 8% may be included in the study if at least one surgeon in the local heart team concludes and documents the patient's predicted risk of operative mortality is ≥15%. The surgeon's assessment of operative comorbidities (including frailty indices) not captured by the STS score must be documented in the study case report form as well as in the patient medical record.
- Subject is of legal age or older for consent in the host country.
- Subject has senile degenerative aortic valve stenosis with echo-derived criteria: mean gradient >40 mmHg or jet velocity greater than 4.0 m/s or doppler velocity index (DVI) <0.25 and an initial aortic valve area (AVA) of ≤1.0 cm2 (indexed Effective Orifice Area (EOA) ≤ 0.6 cm2/m2). (Qualifying AVA baseline measurement must be within 60 days prior to informed consent).
- Subject has symptomatic aortic stenosis as demonstrated by NYHA Functional Classification of II, III, or IV.
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- The subject has been informed of the nature of the study, agrees to its provisions and has provided written informed consent as approved by the Institutional Review Board (IRB) of the respective clinical site.
- The subject and the treating physician agree that the subject will return for all required post-procedure follow-up visits.
- Subject's aortic annulus is 19-27mm diameter as measured by computed tomography (CT) conducted within 12 months prior to informed consent. If a CT i contraindicated and/or not possible to be obtained for certain subjects, a 3D echo and non-contrast CT of chest and abdomen/pelvis may be accepted.
- All candidates for Extreme Risk classification must meet # 2, 3, 4, 5, 6, 7 of the above criteria, and
- After formal consultation with the local heart team (including at least one surgeon) it is agreed that medical factors preclude the subject from undergoing operation, based on a conclusion that the probability of death or serious, irreversible morbidity exceeds the probability of meaningful improvement. Specifically, the probability of death or serious, irreversible morbidity should exceed 50%. The local heart teams' consult notes shall specify the medical or anatomic factors leading to that conclusion and include a printout of the calculation of the STS score to additionally identify the risks in these patients.
Who cannot join
- Candidates will be excluded if any of the following conditions are present:
- Evidence of an acute myocardial infarction (defined as: ST Segment Elevation as evidenced on 12 Lead ECG) within 30 days prior to index procedure.
- Aortic valve is a congenital unicuspid or congenital bicuspid valve, or is noncalcified as verified by echocardiography.
- Mixed aortic valve disease (aortic stenosis and aortic regurgitation with predominant aortic regurgitation 3-4+).
- Any percutaneous coronary or peripheral interventional procedure performed within 30 days prior to index procedure.
- Pre-existing prosthetic heart valve or other implant in any valve position, prosthetic ring, severe circumferential mitral annular calcification (MAC) which is continuous with calcium in the LVOT, severe (greater than 3+) mitral insufficiency, or severe mitral stenosis with pulmonary compromise.
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- Blood dyscrasias as defined: leukopenia (WBC<3000 mm3), acute anemia (Hb < 9 g/dL), thrombocytopenia (platelet count <50,000 cells/mm³).
- History of bleeding diathesis or coagulopathy.
- Cardiogenic shock manifested by low cardiac output, vasopressor dependence, or mechanical hemodynamic support.
- Untreated clinically significant coronary artery disease requiring revascularization.
- Hemodynamic instability requiring inotropic support or mechanical heart assistance.
- Need for emergency surgery for any reason.
- Hypertrophic cardiomyopathy with or without obstruction (HOCM).
- Severe ventricular dysfunction with left ventricular ejection fraction (LVEF) <20% as measured by resting echocardiogram.
- Echocardiographic evidence of intracardiac mass, thrombus or vegetation.
- Active peptic ulcer or upper GI bleeding within 3 months prior to index procedure.
- A known hypersensitivity or contraindication to aspirin, heparin, ticlopidine (Ticlid), or clopidogrel (Plavix), or sensitivity to contrast media which cannot be adequately premedicated.
- Recent (within 6 months prior to index procedure date) cerebrovascular accident (CVA) or a transient ischemic attack (TIA).
- Renal insufficiency (creatinine > 3.0 mg/dL) and/or end stage renal disease requiring chronic dialysis.
- Life expectancy < 12 months from the time of informed consent due to noncardiac co-morbid conditions.
- Significant aortic disease, including abdominal aortic or thoracic aneurysm defined as maximal luminal diameter 5cm or greater; marked tortuosity (hyperacute bend), aortic arch atheroma (especially if thick [> 5 mm], protruding or ulcerated) or narrowing (especially with calcification and surface irregularities) of the abdominal or thoracic aorta, severe "unfolding" and tortuosity of the thoracic aorta.
- Native aortic annulus size < 19 mm or > 27 mm per the baseline diagnostic imaging.
- Aortic root angulation > 70°.
- Currently participating in an investigational drug or device study.
- Active bacterial endocarditis within 6 months prior to the index procedure.
- Bulky calcified aortic valve leaflets in close proximity to coronary ostia.
- Non-calcified aortic annulus.
- Iliofemoral vessel characteristics that would preclude safe insertion of the FlexNav™ delivery system with or without an arterial introducer sheath such as severe obstructive calcification, or severe tortuosity.
- In the judgment of the investigator, a condition that could limit a patient's ability or willingness to participate in the study, comply with study required testing and/or follow- up visits or that could impact scientific integrity of the study.
Trial locations and contacts
6 sites in 4 countries.
6 sites in 4 countries
Switzerland2 sites
Kantonsspital St. Gallen
Sankt Gallen, 9007
Universitaets Spital Zuerich
Zurich, 8091
United Kingdom2 sites
Royal Victoria Hospital
Belfast, BT12 6BA
Morriston Hospital - ABM University Health Board
Morriston, Swansea, SA6 6NL
About this study
Official title: Assessment of the Abbott FlexNav™ Delivery System for Portico Transcatheter Aortic Valve Implantation in High and Extreme Risk Patients With Symptomatic Severe Aortic Stenosis
The purpose of this clinical investigation is to characterize the safety of the next-generation FlexNav™ Delivery System for transfemoral implantation of the Portico™ Transcatheter Aortic Heart Valve in symptomatic severe aortic stenosis patients who are considered of high or extreme risk for surgical aortic valve replacement. Data from the study will be used to support CE Mark of the FlexNav™ Delivery System and Loading System in Europe.
Read the detailed description
The FlexNav European Union (EU) study will be conducted as a prospective, multi-center, single-arm investigational study.
High or extreme risk patients with symptomatic, severe native aortic stenosis who are determined by an independent subject selection committee to meet eligibility criteria for Portico™ Transcatheter Aortic Heart Valve implantation via a transfemoral access approach will undergo a Portico valve implant using the next-generation FlexNav Delivery System.
Subject data will be collected at screening, baseline, pre-procedure, peri-procedure, post-procedure, discharge, 30 days, 6 months and 1-year from the index procedure.
- Conditions
- Symptomatic Severe Aortic Stenosis
- Being tested
- Portico Valve and FlexNav™ Delivery System
- Keywords
- Aortic Stenosis, FlexNav™ Delivery System, Portico Delivery System, Transcatheter Aortic Valve Replacement, Heart Valve Disease, High surgical risk
- Medical subject headings
- Aortic Valve Stenosis, Heart Valve Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Portico Valve and FlexNav™ Delivery SystemDevice
Subjects will undergo transcatheter aortic valve replacement (TAVR) with the Portico valve and second-generation FlexNav Delivery system via a transfemoral access approach
| Study group | Role | What they receive |
|---|---|---|
| Portico valve and FlexNav™ Delivery System | Experimental | Portico valve implantation with the second-generation FlexNav Delivery system Receives: Device: Portico Valve and FlexNav™ Delivery System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major Vascular Complications
Percentage of patients with a VARC-2 defined major vascular complication event
Measured: At 30 days post index procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2018
- Study start26 Feb 2019
- Primary completion14 Jan 2020
- Study completion10 Feb 2021
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 Symptomatic Severe Aortic StenosisStudies of the same condition, open and under way.
- More trials run by Abbott Medical DevicesThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Devices under investigation in this clinical investigation include the FlexNav™ Delivery System(s) (18 F and 19 F) and FlexNav™ Loading System(s) (Small and Large), which are both approved for investigational use only. Other devices to be used in the clinical investigation include all four (4) market released Abbott Portico™ valve sizes (23mm, 25mm, 27mm and 29mm).
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Francesco Bedogni, MD, Principal investigator, Policlinico San Donato
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03724812
- Sponsor's protocol ID
- ABT-CIP-10260
- Status last verified
- Oct 2021
- First submitted
- 29 Oct 2018
- Last updated
- 24 Nov 2021
- Results posted
- Yes, on ClinicalTrials.gov
- 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 24 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Abbott FlexNav™ Delivery System for Portico Transcatheter Aortic Valve Implantation in High and Extreme Risk Patients With Symptomatic Severe Aortic Stenosis
- ClinicalTrials.gov ID
- NCT03724812
- Acronym / sponsor ID
- ABT-CIP-10260
- Conditions
- Symptomatic Severe Aortic Stenosis
- Keywords
- Aortic Stenosis, FlexNav™ Delivery System, Portico Delivery System, Transcatheter Aortic Valve Replacement, Heart Valve Disease, High surgical risk
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- 26 Feb 2019 (actual)
- Primary completion
- 14 Jan 2020 (actual)
- Study completion
- 10 Feb 2021 (actual)
- First posted
- 30 Oct 2018 (actual)
- Results
- Posted 16 Mar 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this clinical investigation is to characterize the safety of the next-generation FlexNav™ Delivery System for transfemoral implantation of the Portico™ Transcatheter Aortic Heart Valve in symptomatic severe aortic stenosis patients who are considered of high or extreme risk for surgical aortic valve replacement. Data from the study will be used to support CE Mark of the FlexNav™ Delivery System and Loading System in Europe.
Detailed description
The FlexNav European Union (EU) study will be conducted as a prospective, multi-center, single-arm investigational study.
High or extreme risk patients with symptomatic, severe native aortic stenosis who are determined by an independent subject selection committee to meet eligibility criteria for Portico™ Transcatheter Aortic Heart Valve implantation via a transfemoral access approach will undergo a Portico valve implant using the next-generation FlexNav Delivery System.
Subject data will be collected at screening, baseline, pre-procedure, peri-procedure, post-procedure, discharge, 30 days, 6 months and 1-year from the index procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Devices under investigation in this clinical investigation include the FlexNav™ Delivery System(s) (18 F and 19 F) and FlexNav™ Loading System(s) (Small and Large), which are both approved for investigational use only. Other devices to be used in the clinical investigation include all four (4) market released Abbott Portico™ valve sizes (23mm, 25mm, 27mm and 29mm).
| Arm | Type | Receives |
|---|---|---|
| Portico valve and FlexNav™ Delivery System | Experimental | Device: Portico Valve and FlexNav™ Delivery SystemPortico valve implantation with the second-generation FlexNav Delivery system |
Who may qualify
- Ages
- 21 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Candidates for High Risk classification must meet all the following inclusion criteria:
- Subjects must have co-morbidities such that the local heart team concur the predicted risk of operative mortality is ≥15% or a minimum Society of Thoracic Surgeons (STS) score of 8%.
- Subject is of legal age or older for consent in the host country.
- Subject has senile degenerative aortic valve stenosis with echo-derived criteria: mean gradient >40 mmHg or jet velocity greater than 4.0 m/s or doppler velocity index (DVI) <0.25 and an initial aortic valve area (AVA) of ≤1.0 cm2 (indexed Effective Orifice Area (EOA) ≤ 0.6 cm2/m2). (Qualifying AVA baseline measurement must be within 60 days prior to informed consent).
- Subject has symptomatic aortic stenosis as demonstrated by NYHA Functional Classification of II, III, or IV.
Key exclusion criteria (29 listed)
- Evidence of an acute myocardial infarction (defined as: ST Segment Elevation as evidenced on 12 Lead ECG) within 30 days prior to index procedure.
- Aortic valve is a congenital unicuspid or congenital bicuspid valve, or is noncalcified as verified by echocardiography.
- Mixed aortic valve disease (aortic stenosis and aortic regurgitation with predominant aortic regurgitation 3-4+).
- Any percutaneous coronary or peripheral interventional procedure performed within 30 days prior to index procedure.
- Pre-existing prosthetic heart valve or other implant in any valve position, prosthetic ring, severe circumferential mitral annular calcification (MAC) which is continuous with calcium in the LVOT, severe (greater than 3+) mitral insufficiency, or severe mitral stenosis with pulmonary compromise.
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 |
|---|---|---|
| Portico Valve and FlexNav™ Delivery SystemSubjects will undergo transcatheter aortic valve replacement (TAVR) with the Portico valve and second-generation FlexNav Delivery system via a transfemoral access approach | Device | Portico valve and FlexNav™ Delivery System |
Primary outcome
Major Vascular Complications
Time frame: At 30 days post index procedure
Percentage of patients with a VARC-2 defined major vascular complication event
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Francesco Bedogni, MD principal investigator
Policlinico San Donato
6 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Portico Valve and FlexNav™ Delivery System in people with Symptomatic Severe Aortic Stenosis, run by Abbott Medical Devices at 6 sites in 4 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 11 inclusion and 29 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 24 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Switzerland, United Kingdom, Denmark, 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?
Yes. Results are posted in the registry (first posted 16 Mar 2021). 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?
Major Vascular Complications (time frame: At 30 days post index procedure). 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 24 Nov 2021; AzTrials last refreshed its copy on 28 Oct 2026.