Severe Symptomatic Aortic StenosisPortico TA EUNCT01742598
Assessment of St Jude Medical Portico Re-sheathable Transapical Aortic Valve System
A study testing Portico Transapical Aortic Valve System in people with Severe Symptomatic Aortic Stenosis, run by Abbott Medical Devices at 1 site in United Kingdom.
Trial summary
The purpose of this study is to assess the safety and performance of the 23mm Portico Transcatheter Heart Valve and the TAVI Transapical Delivery System in subjects with severe symptomatic aortic stenosis Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Severe Symptomatic Aortic Stenosis
- What is being tested?
- Portico Transapical Aortic Valve System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Dec 2015to Nov 2020
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Subject has signed the study Informed Consent Form and Data Protection Form prior to participating in the study.
- Subject is 65 years of age or older at the time of index procedure, and/or has comorbidities that, in the opinion of the Principal Investigator or the Subject Selection Committee, preclude surgical valve replacement.
- Subject's aortic annulus is 19-21mm diameter as measured by echocardiography (echo) or CT conducted within 90 days prior to the index procedure.
- Subject has senile degenerative aortic stenosis with echocardiography derived mean gradient greater than (>) 40mmHg or jet velocity greater than 4.0 m/s or an initial valve area of less than (<) 0.8 cm2 (or aortic valve area index less than or equal to (≤) 0.6 cm2/m2). (Baseline measurement taken by echo within 90 days of index procedure).
- Subject has symptomatic aortic stenosis as demonstrated by NYHA Functional Classification of II, III, or IV.
- Subject is deemed high operable risk and suitable for TAVI per the medical opinion of the Subject Selection Committee.
- Subject's predicted operative mortality or serious, irreversible morbidity risk is less than (<) 50% at 30 days post index procedure.
Who cannot join
- Subject is unwilling or unable to comply with all study-required follow-up evaluations.
- Subject has a documented history of a cerebral vascular accident (CVA) or transient ischemic attack (TIA) within 6 months (less than or equal to (≤) 180 days) prior to the index procedure.
- Subject has a chest condition than prevents transapical access.
- Subject has carotid artery disease requiring intervention.
- Subject has documented evidence of a myocardial infarction (MI) within 6 months (less than or equal to (≤) 180 days) prior to the index procedure.
- Subject has a native aortic valve that is congenitally unicuspid, bicuspid, quadricuspid or non-calcified as seen by echocardiography.
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- Subject has mitral valvular regurgitation greater than (>) grade III.
- Subject has moderate or severe mitral stenosis.
- Subject has aortic root angulation greater than (>) 70 degrees (horizontal aorta).
- The distance from the left ventricular apex to the aortic annulus is less than (<) 45mm (4.5cm).
- Subject has a pre-existing prosthetic cardiac device, valve, or prosthetic ring in any position.
- Subject refuses any blood product transfusion.
- Subject refuses surgical valve replacement.
- Subject has left ventricular ejection fraction (LVEF) less than (<) 20%.
- Subject has documented, untreated symptomatic coronary artery disease (CAD) requiring revascularization.
- Subject has had a percutaneous interventional or other invasive cardiovascular or peripheral vascular procedure less than or equal to (≤) 14 days of index procedure.
- Subject has severe basal septal hypertrophy that would interfere with transcatheter valve placement.
- Subject has a history of, or is currently diagnosed with endocarditis.
- Subject has imaging evidence of intracardiac mass, thrombus, or vegetation.
- Subject is considered hemodynamically unstable (requiring inotropic support or mechanical heart assistance).
- Subject is in acute pulmonary edema or requiring intravenous diuretic therapy to stabilize heart failure.
- Subject with significant pulmonary disease as determined and documented by the Investigator.
- Subject has significant chronic steroid use as determined and documented by the Investigator.
- Subject has a documented hypersensitivity or contraindication to anticoagulant or antiplatelet medication.
- Subject has renal insufficiency as evidenced by a serum creatinine greater than (>) 3.0 mg/dL (265.5µmol/L) or end-stage renal disease requiring chronic dialysis.
- Subject has morbid obesity defined as a BMI greater than or equal to (≥) 40.
- Subject has ongoing infection or sepsis.
- Subject has blood dyscrasias (e.g., leukopenia, acute anemia, thrombocytopenia, history of bleeding diathesis, or coagulopathy).
- Subject has a current autoimmune disease that, in the opinion of the Principal Investigator or the Subject Selection Committee, precludes the subject from study participation.
- Significant ascending aortic disease documented by diameter greater than 40mm.
- Subject has an active peptic ulcer or has had gastrointestinal (GI) bleeding within 90 days prior to the index procedure.
- Subject is currently participating in another investigational drug or device study.
- Subject requires emergency surgery for any reason.
- Subject has a life expectancy less than (<) 12 months.
- Subject has other medical, social or psychological conditions that, in the opinion of the Principal Investigator or the Subject Selection Committee, preclude the subject from study participation.
- Subject is diagnosed with dementia or admitted to a chronic care facility which would fundamentally complicate rehabilitation from the procedure or compliance with follow-up visits.
- Subject has a documented allergy to contrast media, nitinol alloys, porcine tissue, or bovine tissue.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to assess the safety and performance of the 23mm Portico Transcatheter Heart Valve and the TAVI Transapical Delivery System in subjects with severe symptomatic aortic stenosis
- Conditions
- Severe Symptomatic Aortic Stenosis
- Being tested
- Portico Transapical Aortic Valve System
- Keywords
- TAVI, TAVR, aortic stenosis, Transcatheter, valvular heart disease, aortic valve stenosis, aortic valve replacement, transcatheter aortic valve implantation
- 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 Transapical Aortic Valve SystemDevice
| Study group | Role | What they receive |
|---|---|---|
| Portico Implant | Experimental | Not described Receives: Device: Portico Transapical Aortic Valve System |
What is being measured
The primary outcome is the main question the study is designed to answer.
All cause mortality
Measured: 30 days
Secondary outcomes (3)
Event rates
- Cardiovascular mortality
- Myocardial Infarction (MI)
- Major Stroke
- Minor Stroke
- Acute Kidney Injury (AKI)
- Vascular access site and Access-related complications
- Bleeding
- Composite of periprocedural encephalopathy, all stroke, and all TIA
Measured: 30 days
Functional improvements from baseline
- NYHA Functional Classification
- Six Minute Walk Test
- Effective Orifice Area (EOA)
Measured: 30 days
Acute device success
- Successful apical access, delivery and deployment of the device and successful retrieval of the delivery system,
- Correct position of the device in the proper anatomical location,
- Intended performance of the prosthetic heart valve (Aortic Valve Area greater than (>)1.0 cm2 and mean aortic valve gradient less than (<) 20 mmHg or peak velocity less than (<) 3 m/s, without moderate or severe prosthetic valve AR), and
- Only one valve implanted in the proper anatomical location
Measured: At time of procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2012 (estimated)
- Study startDec 2015
- Primary completionJul 2016 (estimated)
- Study completionNov 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe Symptomatic 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Thomas Walther, MD, PhD, Principal investigator, Kerckhoff Klinik
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01742598
- Sponsor's protocol ID
- 1106
- Acronym
- Portico TA EU
- Status last verified
- Feb 2019
- First submitted
- 3 Dec 2012
- Last updated
- 4 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of St Jude Medical Portico Re-sheathable Transapical Aortic Valve System
- ClinicalTrials.gov ID
- NCT01742598
- Acronym / sponsor ID
- Portico TA EU / 1106
- Conditions
- Severe Symptomatic Aortic Stenosis
- Keywords
- TAVI, TAVR, aortic stenosis, Transcatheter, valvular heart disease, aortic valve stenosis, aortic valve replacement, transcatheter aortic valve implantation
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- Dec 2015
- Primary completion
- Jul 2016 (estimated)
- Study completion
- Nov 2020 (estimated)
- First posted
- 5 Dec 2012 (estimated)
- 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 purpose of this study is to assess the safety and performance of the 23mm Portico Transcatheter Heart Valve and the TAVI Transapical Delivery System in subjects with severe symptomatic aortic stenosis
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Portico Implant | Experimental | Device: Portico Transapical Aortic Valve System |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (7 listed)
- Subject has signed the study Informed Consent Form and Data Protection Form prior to participating in the study.
- Subject is 65 years of age or older at the time of index procedure, and/or has comorbidities that, in the opinion of the Principal Investigator or the Subject Selection Committee, preclude surgical valve replacement.
- Subject's aortic annulus is 19-21mm diameter as measured by echocardiography (echo) or CT conducted within 90 days prior to the index procedure.
- Subject has senile degenerative aortic stenosis with echocardiography derived mean gradient greater than (>) 40mmHg or jet velocity greater than 4.0 m/s or an initial valve area of less than (<) 0.8 cm2 (or aortic valve area index less than or equal to (≤) 0.6 cm2/m2). (Baseline measurement taken by echo within 90 days of index procedure).
- Subject has symptomatic aortic stenosis as demonstrated by NYHA Functional Classification of II, III, or IV.
Key exclusion criteria (37 listed)
- Subject is unwilling or unable to comply with all study-required follow-up evaluations.
- Subject has a documented history of a cerebral vascular accident (CVA) or transient ischemic attack (TIA) within 6 months (less than or equal to (≤) 180 days) prior to the index procedure.
- Subject has a chest condition than prevents transapical access.
- Subject has carotid artery disease requiring intervention.
- Subject has documented evidence of a myocardial infarction (MI) within 6 months (less than or equal to (≤) 180 days) prior to the index procedure.
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 Transapical Aortic Valve System | Device | Portico Implant |
Primary outcome
All cause mortality
Time frame: 30 days
3 secondary outcomes
Event rates
Time frame: 30 days
Functional improvements from baseline
Time frame: 30 days
Acute device success
Time frame: At time of procedure
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2019.
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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.
Thomas Walther, MD, PhD principal investigator
Kerckhoff Klinik
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Portico Transapical Aortic Valve System in people with Severe Symptomatic Aortic Stenosis, run by Abbott Medical Devices at 1 site in United Kingdom.
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 7 inclusion and 37 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: withdrawn, as of the sponsor's last update on 4 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
All cause mortality (time frame: 30 days). 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 4 Feb 2019.