Symptomatic Aortic StenosisNCT01493284
Portico TAVI Implant With Transfemoral Delivery System
A study testing Transcatheter Aortic Valve Implantation in people with Symptomatic Aortic Stenosis, run by Abbott Medical Devices at 14 sites in 5 countries.
Trial summary
The purpose of this study is to assess the safety and effectiveness of the SJM Portico Transcatheter Heart Valve and the SJM TAVI Transfemoral Transcatheter delivery system in subjects with severe symptomatic aortic stenosis (AS). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Symptomatic Aortic Stenosis
- What is being tested?
- Transcatheter Aortic Valve Implantation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 222 participants
- Where
- 14 sitesin 5 countries
- Study dates
- Dec 2011to Sep 2016
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject has given written study Informed Consent for participation prior to procedure.
- Subject is ≥ 18 years of age or legal age in host country.
- Subject's aortic annulus diameter meets the range indicated in the Instructions for use as measured by echocardiogram (echo) or CT conducted within the past 90 days.
- Subject has senile degenerative aortic stenosis with echocardiography (echo) derived mean gradient >40mmHg or jet velocity greater than 4.0 m/s or an initial valve area of <1.0 cm2 (or aortic valve area index ≤ 0.6 cm2/m2). (Baseline measurement taken by echo within 30 days of procedure).
- Subject has symptomatic aortic stenosis as demonstrated by NYHA Functional Classification of II or greater.
- Subject is deemed high operable risk and suitable for TAVI per the medical opinion of the Subject Selection Committee (See Section 3.1 for the definition of the Subject Selection Committee)
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- Subject's predicted operative mortality or serious, irreversible morbidity risk is <50% at 30 days.
- In the opinion of the Subject Selection Committee and based upon angiographic measurements, the subject has suitable peripheral vessels and aorta to allow for access of the 18 French delivery system.
- Subject has structurally normal cardiac anatomy.
- Subject is willing and able to comply with all required follow-up evaluations.
Who cannot join
- Subject has a history of a cerebral vascular accident (CVA) or transient ischemic attack (TIA) within the past 6 months (≤180 days) of the index procedure.
- Subject has carotid artery disease requiring intervention.
- Subject has evidence of a myocardial infarction (MI) within the past 6 months (≤180 days) of the index procedure.
- Subject has hypertrophic cardiomyopathy.
- Subject has a native aortic valve that is congenitally unicuspid, bicuspid, quadricuspid or non-calcified as seen by echocardiography.
- Subject has mitral or tricuspid valvular regurgitation (>grade III) or moderate to severe mitral stenosis.
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- Subject has aortic root angulation >70 degrees (horizontal aorta).
- Subject has a pre-existing prosthetic valve or prosthetic ring in any position.
- Subject refuses blood transfusion or surgical valve replacement.
- Subject has left ventricular ejection fraction (LVEF) < 20%.
- The subject has documented, untreated coronary artery disease (CAD) requiring revascularization.
- Subject has severe basal septal hypertrophy.
- Subject has had a percutaneous interventional or other invasive cardiac or peripheral procedure ≤ 14 days of the index procedure.
- Subject has a history of or has active endocarditis.
- Subject has echocardiographic evidence of intracardiac mass, thrombus, or vegetation.
- Subject has hemodynamic instability (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.
- Subject has significant chronic steroid use.
- Subject has a known hypersensitivity or contraindication to anticoagulant or antiplatelet medication.
- Subject has renal insufficiency as evidenced by a serum creatinine > 3.0 mg/dL (265µmol/L) or end-stage renal disease requiring chronic dialysis.
- Subject has morbid obesity defined as BMI ≥ 40.
- Subject's iliac arteries have severe calcification, tortuosity (>two 90 degree bends), diameter <6mm, or subject has had an aorto-femoral bypass.
- Subject has ongoing infection or sepsis.
- Subject has blood dyscrasias (leukopenia, acute anemia, thrombocytopenia, history of bleeding diathesis, or coagulopathy).
- Subject has a current autoimmune disease that, in the opinion of the Principal Investigator precludes the subject from study participation.
- Subject has significant aortic disease, including:
- aortic abdominal aneurysm (AAA) ≥ 4cm
- thoracic aneurysm (defined as a maximal luminal diameter of 5 cm or greater)
- marked tortuosity
- significant aortic arch atheroma or narrowing of the abdominal or thoracic aorta
- severe tortuosity of the thoracic aorta.
- Subject has a pre-existing endovascular stent graft in the supra- or infrarenal aorta or pre-existing stent grafts in the ileo-femoral arteries.
- Subject has an active peptic ulcer or has had gastrointestinal (GI) bleeding within the past 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 < 12 months.
- Subject has other medical, social or psychological conditions that, in the opinion of the Subject Selection Committee, preclude the subject from study participation.
- Subject is suffering from 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 known allergy to contrast media, nitinol alloys, porcine tissue, or bovine tissue.
Trial locations and contacts
14 sites in 5 countries.
14 sites in 5 countries
Germany6 sites
Kerckhoff Klinik
Bad Nauheim
Heart Center Bernau
Bernau
Asklepios Klinik-St. Georg
Hamburg
Klinikum der Universität Jena
Jena
Klinik fur Herzhirurgie Karlruhe GmbH
Karlsruhe
Herzzentrum Leipzig
Leipzig
United Kingdom5 sites
Royal Victoria Hospital
Belfast, Northern Ireland, BT12 6BA
Glenfield Hospital
Leicester
Kings College
London
St. Thomas' Hospital
London
Derriford Hospital, Plymouth
Plymouth
About this study
Official title: Assessment Of The St. Jude Medical Portico™ Transcatheter Aortic Valve Implant (TAVI) And The SJM TAVI Transfemoral Delivery System (Portico TF EU)
The purpose of this study is to assess the safety and effectiveness of the SJM Portico Transcatheter Heart Valve and the SJM TAVI Transfemoral Transcatheter delivery system in subjects with severe symptomatic aortic stenosis (AS).
Read the detailed description
Data will be collected at baseline, procedure, discharge, 30 days post implant, 3 months post implant, 6 months post implant, and 12 months post implant.
- Conditions
- Symptomatic Aortic Stenosis
- Being tested
- Transcatheter Aortic Valve Implantation
- Keywords
- aortic stenosis, aortic valve stenosis, valvular heart disease, aortic valve replacement, transcatheter aortic valve implantation, TAVI
- 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.
Transcatheter Aortic Valve ImplantationDevice
Placement of the SJM Portico aortic valve with a transfemoral delivery system
| Study group | Role | What they receive |
|---|---|---|
| Transfemoral Access | Experimental | Transfemoral Access for transcatheter aortic valve implant Receives: Device: Transcatheter Aortic Valve Implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
All Cause Mortality
Number of participants that reported all cause mortality
Measured: 30 days
Secondary outcomes (3)
Number of Select Cardiovascular Adverse Events
Number of participants with select cardiovascular adverse events
Measured: 30 days
Participant NYHA Classification at Day 30
The New York Heart Association (NYHA) functional classification system relates symptoms to everyday activities and the patient's quality of life.
Class I. Patients with cardiac disease but without resulting limitation of physical activity.
Class II. Patients with cardiac disease resulting in slight limitation of physical activity. They are comfortable at rest.
Class III. Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest.
Class IV. Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of heart failure or the anginal syndrome may be present even at rest.
The Criteria Committee of the New York Heart Association. Nomenclature and Criteria for Diagnosis of Diseases of the Heart and Great Vessels. 9th ed. Boston, Mass: Little, Brown \& Co; 1994:253-256.
Measured: day 30
Number of Participants With Acute Device Success
- Successful vascular 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 >1.2 cm2 and mean aortic valve gradient <20 mmHg or peak velocity <3 m/s, without moderate or severe prosthetic valve AR)
- Only one valve implanted in the proper anatomical location
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2011 (estimated)
- Study startDec 2011
- Primary completionOct 2015
- Study completionSep 2016
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.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 222 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ganesh Manoharan, MD, Principal investigator, Royal Victoria Hospital, Belfast
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01493284
- Sponsor's protocol ID
- 1105
- Status last verified
- Jan 2019
- First submitted
- 5 Dec 2011
- Last updated
- 4 Feb 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Walther T, Manoharan G, Linke A, Mollmann H, Holzhey D, Worthley SG, Kim WK, Schafer U. Incidence of new-onset left bundle branch block and predictors of new permanent pacemaker following transcatheter aortic valve replacement with the Portico valve. Eur J Cardiothorac Surg. 2018 Sep 1;54(3):467-474. doi: 10.1093/ejcts/ezy078.
PubMed 29534170Linke A, Holzhey D, Mollmann H, Manoharan G, Schafer U, Frerker C, Worthley SG, van Boven AJ, Redwood S, Kovac J, Butter C, Sondergaard L, Lauten A, Schymik G, Walther T. Treatment of Aortic Stenosis With a Self-Expanding, Resheathable Transcatheter Valve: One-Year Results of the International Multicenter Portico Transcatheter Aortic Valve Implantation System Study. Circ Cardiovasc Interv. 2018 Feb;11(2):e005206. doi: 10.1161/CIRCINTERVENTIONS.117.005206.
PubMed 29444998
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 The St. Jude Medical Portico™ Transcatheter Aortic Valve Implant (TAVI) And The SJM TAVI Transfemoral Delivery System (Portico TF EU)
- ClinicalTrials.gov ID
- NCT01493284
- Acronym / sponsor ID
- 1105
- Conditions
- Symptomatic Aortic Stenosis
- Keywords
- aortic stenosis, aortic valve stenosis, valvular heart disease, aortic valve replacement, transcatheter aortic valve implantation, TAVI
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 222 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- Dec 2011
- Primary completion
- Oct 2015 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 15 Dec 2011 (estimated)
- Results
- Posted 23 Apr 2018
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 effectiveness of the SJM Portico Transcatheter Heart Valve and the SJM TAVI Transfemoral Transcatheter delivery system in subjects with severe symptomatic aortic stenosis (AS).
Detailed description
Data will be collected at baseline, procedure, discharge, 30 days post implant, 3 months post implant, 6 months post implant, and 12 months post implant.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Transfemoral Access | Experimental | Device: Transcatheter Aortic Valve ImplantationTransfemoral Access for transcatheter aortic valve implant |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Subject has given written study Informed Consent for participation prior to procedure.
- Subject is ≥ 18 years of age or legal age in host country.
- Subject's aortic annulus diameter meets the range indicated in the Instructions for use as measured by echocardiogram (echo) or CT conducted within the past 90 days.
- Subject has senile degenerative aortic stenosis with echocardiography (echo) derived mean gradient >40mmHg or jet velocity greater than 4.0 m/s or an initial valve area of <1.0 cm2 (or aortic valve area index ≤ 0.6 cm2/m2). (Baseline measurement taken by echo within 30 days of procedure).
- Subject has symptomatic aortic stenosis as demonstrated by NYHA Functional Classification of II or greater.
Key exclusion criteria (40 listed)
- Subject has a history of a cerebral vascular accident (CVA) or transient ischemic attack (TIA) within the past 6 months (≤180 days) of the index procedure.
- Subject has carotid artery disease requiring intervention.
- Subject has evidence of a myocardial infarction (MI) within the past 6 months (≤180 days) of the index procedure.
- Subject has hypertrophic cardiomyopathy.
- Subject has a native aortic valve that is congenitally unicuspid, bicuspid, quadricuspid or non-calcified as seen by echocardiography.
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 ImplantationPlacement of the SJM Portico aortic valve with a transfemoral delivery system | Device | Transfemoral Access |
Primary outcome
All Cause Mortality
Time frame: 30 days
Number of participants that reported all cause mortality
3 secondary outcomes
Number of Select Cardiovascular Adverse Events
Time frame: 30 days
Participant NYHA Classification at Day 30
Time frame: day 30
Number of Participants With Acute Device Success
Time frame: 7 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 29534170Walther T, Manoharan G, Linke A, Mollmann H, Holzhey D, Worthley SG, Kim WK, Schafer U. Incidence of new-onset left bundle branch block and predictors of new permanent pacemaker following transcatheter aortic valve replacement with the Portico valve. Eur J Cardiothorac Surg. 2018 Sep 1;54(3):467-474. doi: 10.1093/ejcts/ezy078.
- Derived from this study: PubMed 29444998Linke A, Holzhey D, Mollmann H, Manoharan G, Schafer U, Frerker C, Worthley SG, van Boven AJ, Redwood S, Kovac J, Butter C, Sondergaard L, Lauten A, Schymik G, Walther T. Treatment of Aortic Stenosis With a Self-Expanding, Resheathable Transcatheter Valve: One-Year Results of the International Multicenter Portico Transcatheter Aortic Valve Implantation System Study. Circ Cardiovasc Interv. 2018 Feb;11(2):e005206. doi: 10.1161/CIRCINTERVENTIONS.117.005206.
- 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.
Ganesh Manoharan, MD principal investigator
Royal Victoria Hospital, Belfast
14 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcatheter Aortic Valve Implantation in people with Symptomatic Aortic Stenosis, run by Abbott Medical Devices at 14 sites in 5 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 10 inclusion and 40 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 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 14 sites in Germany, United Kingdom, Australia, Denmark, Netherlands. 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 23 Apr 2018). 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?
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?
On the ClinicalTrials.gov record for NCT01493284, which also lists 2 linked publications.
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.