Aortic Valve StenosisPORTICO-1NCT01802788
5 Year Observation of Patients With PORTICO Valves
An observational study of Aortic Valve Stenosis, run by Abbott Medical Devices at 60 sites in 13 countries.
Trial summary
The purpose of this clinical investigation is to further assess the performance and safety profile of the commercially-available Portico™ TAVI System in patients with severe symptomatic aortic stenosis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Valve Stenosis
- What is being tested?
- St Jude Medical Portico replacement aortic valve and Transcatheter Aortic Valve Implant
- Type of treatment
- Medical device, Surgery or procedure
- How many people
- 1,032 participants
- Where
- 60 sitesin 13 countries
- Study dates
- 16 Apr 2013to 19 Oct 2022
- Phase
- Observational
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
Study population: The study population comprises of Cohort A and Cohort B with severe symptomatic aortic stenosis (AS). Cohort A: Patients enrolled directly into the Portico I study. Cohort B: Patients implanted in previous SJM-sponsored regulatory (pre-market) investigations and first-in-human trials whom consent for ongoing follow-up in the Portico I study after the completion of their participation in the initial study.
Who may be able to join
- Patient has signed the Patient Informed Consent prior to participating in the clinical investigation.
- Patient has been referred for a Portico Valve implant as per Heart Team decision or patient has received a Portico Valve as per participation in an SJM sponsored regulatory or first-in-human trial.
- Patient has senile degenerative aortic valve stenosis confirmed by echocardiographically derived criteria*:
- An initial aortic valve area (AVA) of less than or equal to (≤) 1.0 cm2 (or indexed EOA less than or equal to (≤) 0.6 cm2/m2) AND
- A mean gradient greater than (>)40 mmHg or jet velocity greater than (>)4.0 m/s or Doppler Velocity Index less than (<)0.25. If the mean gradient is <40 mmHg and left ventricular ejection fraction (LVEF) <55%, then the site may as well perform a dobutamine stress echo to see if the mean gradient increases to >40 mmHg." (Baseline measurement taken by echo within 6 months of index procedure.)
- Patient has a life expectancy more than (>) 12 months.
Show all 9Show fewer
- For patients enrolled in a French site:
- Patient is at high risk for surgery as demonstrated by a Logistic EuroSCORE equal or more than (≥) 20 and/or a Society of Thoracic Surgeon (STS) mortality risk score of more than (>) 10% and/or by clinical judgment of the Heart Team based on the individual risk profile (comorbidities).
- Not applicable for a patient who has received a Portico Valve as per participation in an SJM sponsored Regulatory or First-In-Human trial.
Who cannot join
- Any case in which the Portico Valve would not be indicated for the patient as per current instructions for use (i.e any "off-label" use).
- Patient has any other aortic valve than tricuspid one.
- Patient has a prosthetic valve or ring in the aortic position.
- Patient needs a concomitant structural heart procedure..
- Patient needs the usage of an embolic protection device.
- Patient is unwilling or unable to comply with all clinical investigation-required follow-up evaluations.
- Patient is pregnant
Trial locations and contacts
60 sites in 13 countries.
60 sites in 13 countries
Germany14 sites
Kerckhoff-Klinik gGmbH
Bad Nauheim
Deutsches Herzzentrum Berlin
Berlin
Universitatsmedizin Berlin - Campus Benjamin Franklin (CBF)
Berlin
Immanuelklinikum Bernau und Herzzentrum Brandenburg
Bernau
St Johannes Hospital
Dortmund
Herzzentrum Dresden GmbH Universitatsklinik
Dresden
Klinikum der Johann Wolfgang Goethe-Universitat Frankfurt
Frankfurt
Universitatsmedizin Gottingen Georg-August-Universitat
Göttingen
Asklepios Klinikum St Georg
Hamburg
UKE Hamburg (Universitatsklinik Eppendorf)
Hamburg
Universitatsklinikum Jena
Jena
Stadtisches Klinikum Karlsruhe gGmbH Medizinischen Klinik I
Karlsruhe
Herzzentrum Leipzig GmbH
Leipzig
Deutsches Herzzentrum Munchen des Freistaates Bayern
München
Australia10 sites
Royal Adelaide Hospital
Adelaide
St Andrews Hospital
Adelaide
Heart Care Partners-Wesley Hospital
Auchenflower
The Prince Charles Hospital
Chermside
Royal North Shore hospital
Leonards Hill
The Alfred Hospital
Melbourne
Royal Melbourne Hospital - City Campus
Parkville
Fiona Stanley Hospital
Perth
North Shore Private Hospital
St Leonards
Princess Alexandra Hospital
Woolloongabba
Italy9 sites
Clinica Citta di Alessandria
Alessandria
Azienda Ospedali V. Emanuele Ferrarotto E S. Bambino
Catania
Fondazione Toscana Gabriele Monasterio - Ospedale del Cuore
Massa
Istituto Sant'Ambrogio
Milan
Ospedale Niguarda Ca'Granda
Milan
Ospedale San Raffaele
Milan
PoliclinicoSan Donato
Milan
Centro Cardiologico Monzino
Milan
Policlinico di Monza
Monza
Canada8 sites
Foothills Medical Centre
Calgary
Queen Elizabeth II Heath Sciences
Halifax
Institut de Cardiologie de Montreal (Montreal Heart Inst.)
Montreal
Ottawa Heart Institute
Ottawa
Institut de Cardiologie de Quebec (Hospital Laval)
Québec
Saint John Regional Hospital - New Brunswick Heart Centre
Saint John
Toronto General Hospital
Toronto
St. Paul's Hospital
Vancouver
United Kingdom4 sites
Royal Victoria Hospital
Belfast
The Royal Sussex Country Hospital
Brighton
Kings College Hospital
London
Morriston hospital-ABM University Health Board
Morriston
Belgium3 sites
AZ Middelheim
Antwerp
Cliniques Universitaires Saint-Luc
Brussels
CHR Citadelle
Liège
France3 sites
CHRU Hopital de Pontchaillou
Rennes
CHU Rangueil Toulouse
Toulouse
Clinique Pasteur Toulouse
Toulouse
Spain3 sites
Hospital de la Santa Creu I Sant Pau
Barcelona
Hospital Clinico Universitario Virgen de Arrixaca
El Palmar
Hospital Universitario Virgen Macarena
Seville
About this study
Official title: International Long-term Follow-up Study of Patients Implanted With a Portico™ Valve
The purpose of this clinical investigation is to further assess the performance and safety profile of the commercially-available Portico™ TAVI System in patients with severe symptomatic aortic stenosis.
Read the detailed description
This is an international multicenter, prospective, non-randomized clinical investigation without concurrent or matched control, designed to assess the mid-term safety and performance of the Portico valve in patients with severe symptomatic aortic stenosis whom are high risk for surgical valve replacement. The primary endpoint is 1 year all-cause mortality. In addition, the performance and safety profile of the Portico valve will be further evaluated at 30 days, 1 year, and annually through 5 years post-implant.
The investigation will be conducted at approximately 65 centers in approximately 15 countries in Europe, Middle-East, Africa, Canada, Australia and New Zealand.
- Conditions
- Aortic Valve Stenosis
- Being tested
- St Jude Medical Portico replacement aortic valve, Transcatheter Aortic Valve Implant
- Keywords
- Aortic Stenosis, CV-12-054-EU-PV, Heart Valve Prosthesis, Trans Catheter Aortic Valve Replacement, TAVR, Trans Catheter Aortic Valve Implant, TAVI
- 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.
St Jude Medical Portico replacement aortic valveDevice
Transcatheter Aortic Valve ImplantProcedure or surgery
Also called TAVI, Transcatheter Aortic Valve Replacement, TAVR
| Study group | Role | What they receive |
|---|---|---|
| Cohort A | Patients implanted with a Portico valve after CE mark Receives: Device: St Jude Medical Portico replacement aortic valve; Procedure: Transcatheter Aortic Valve Implant | |
| Cohort B | Patients implanted in previous SJM-sponsored premarket studies Receives: Device: St Jude Medical Portico replacement aortic valve; Procedure: Transcatheter Aortic Valve Implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With All-cause Mortality
Percentage of participants that died for any reason at 1 year post implantation
Measured: 1 year post implant
Secondary outcomes (49)
Percentage of Participants With All Cause Mortality in Cohort A
Percentage of participants that died for any reason at 30 days through 5 years post implantation
Measured: 30 days through 5 years post implant
Number of Participants With All-cause Mortality (30 Days, Annually From 1 Year Through 5 Years) in Cohort B
Number of participants who died for any reason at different time points such as 30 days, 1 year, 2 years, 3 years, 4 years and 5 years.
Measured: 30 days through 5 years post implant
Percentage of Participants With Cardiovascular Mortality as Defined by the Valve Academic Research Consortium-2 (VARC-2) in Cohort A
Percentage of participants that died for cardiovascular or unknown reasons as defined by VARC-2 at 30 days through 5 years post implantation
Measured: 30 days through 5 years post implant
Number of Participants With Cardiovascular Mortality Occurring at Each Time Window (30 Days, 1 Year, 2 Years, 3 Years, 4 Years and 5 Years) in Cohort B
Number of participants who died for any reason at different time points such as 30 days, 1 year, 2 years, 3 years, 4 years and 5 years.
Measured: 30 days through 5 years post implant
Percentage of Participants With Non-Cardiovascular Mortality as Defined by the Valve Academic Research Consortium-2 (VARC-2) in Cohort A
Percentage of participants that died for any reason at 30 days through 5 years post implantation
Measured: 30 days through 5 years post implant
Number of Participants With Non-Cardiovascular Mortality Occurring at Each Time Window (30 Days, 1 Year, 2 Years, 3 Years, 4 Years and 5 Years) in Cohort B
Number of participants who died for any reason at different time points such as 30 days, 1 year, 2 years, 3 years, 4 years and 5 years.
Measured: 30 days through 5 years post implant
Percentage of Participants With Myocardial Infarction as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort A
Percentage of participants with a myocardial infarction as defined by VARC-2 at 30 days through 5 years post implantation post implantation
Measured: 30 days through 5 years post implant
Number of Participants With Myocardial Infarction as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort B
Number of participants with a myocardial infarction as defined by VARC-2 at 30 days through 5 years post implantation post implantation
Measured: 30 days through 5 years post implant
Percentage of Participants With Vascular Access Site Complication as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort A
Percentage of participants with vascular access site complication (major or minor) as defined by VARC-2 at 30 days post implantation
Measured: 30 days post implant
Percentage of Participants With Bleeding Events as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort A
Percentage of participants with a bleeding events (life threatening, major or minor) as defined by VARC-2 at 30 days post implantation
Measured: 30 days post implant
Percentage of Participants With Stage 1, 2 and 3 Acute Kidney Injury as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort A
Percentage of participants with a Stage 1, 2 or Stage 3 acute kidney injury as defined by VARC-2 at 30 days post implantation
Measured: 30 days post implant
Mean Prosthetic Valve Function as Defined by Valve Academic Research Consortium-2 (VARC-2) (Aortic Valve Area)
The aortic valve area as interpreted by an independent echocardiographic core laboratory at 30 days through 5 years post implantation
Measured: 30 days through 5 years post implant
Mean Prosthetic Valve Function as Defined by Valve Academic Research Consortium-2 (VARC-2) (Mean Transvalvular Gradient)
The mean transvalvular gradient as interpreted by an independent echocardiographic core laboratory at 30 days through 5 years post implantation
Measured: 30 days through 5 years post implant
Number of Participants With New York Heart Association (NYHA) Functional Classification of Heart Failure
The New York Heart Association (NYHA) Functional Classification provides a simple way of classifying the extent of heart failure. It classifies patients in one of four categories based on their limitations during physical activity:
Class I - No symptoms and no limitation in ordinary physical activity; Class II - Mild symptoms (mild shortness of breath and/or angina) and slight limitation during ordinary activity; Class III - Marked limitation in activity due to symptoms; Class IV - Severe limitations.
Measured: 30 days post implant
Number of Participants With New York Heart Association (NYHA) Functional Classification of Heart Failure
The New York Heart Association (NYHA) Functional Classification provides a simple way of classifying the extent of heart failure. It classifies patients in one of four categories based on their limitations during physical activity:
Class I - No symptoms and no limitation in ordinary physical activity; Class II - Mild symptoms (mild shortness of breath and/or angina) and slight limitation during ordinary activity; Class III - Marked limitation in activity due to symptoms; Class IV - Severe limitations.
Measured: 1 year post implant
Number of Participants With New York Heart Association (NYHA) Functional Classification of Heart Failure
The New York Heart Association (NYHA) Functional Classification provides a simple way of classifying the extent of heart failure. It classifies patients in one of four categories based on their limitations during physical activity:
Class I - No symptoms and no limitation in ordinary physical activity; Class II - Mild symptoms (mild shortness of breath and/or angina) and slight limitation during ordinary activity; Class III - Marked limitation in activity due to symptoms; Class IV - Severe limitations.
Measured: 2 years post implant
Number of Participants With New York Heart Association (NYHA) Functional Classification of Heart Failure
The New York Heart Association (NYHA) Functional Classification provides a simple way of classifying the extent of heart failure. It classifies patients in one of four categories based on their limitations during physical activity:
Class I - No symptoms and no limitation in ordinary physical activity; Class II - Mild symptoms (mild shortness of breath and/or angina) and slight limitation during ordinary activity; Class III - Marked limitation in activity due to symptoms; Class IV - Severe limitations.
Measured: 3 years post implant
Number of Participants With New York Heart Association (NYHA) Functional Classification of Heart Failure
The New York Heart Association (NYHA) Functional Classification provides a simple way of classifying the extent of heart failure. It classifies patients in one of four categories based on their limitations during physical activity:
Class I - No symptoms and no limitation in ordinary physical activity; Class II - Mild symptoms (mild shortness of breath and/or angina) and slight limitation during ordinary activity; Class III - Marked limitation in activity due to symptoms; Class IV - Severe limitations.
Measured: 4 years post implant
Number of Participants With New York Heart Association (NYHA) Functional Classification of Heart Failure
The New York Heart Association (NYHA) Functional Classification provides a simple way of classifying the extent of heart failure. It classifies patients in one of four categories based on their limitations during physical activity:
Class I - No symptoms and no limitation in ordinary physical activity; Class II - Mild symptoms (mild shortness of breath and/or angina) and slight limitation during ordinary activity; Class III - Marked limitation in activity due to symptoms; Class IV - Severe limitations.
Measured: 5 years post implant
Mean Six Minute Walk Test (6MWT)
Distance in metres that the participant can walk in 6 minutes. The six-minute walking test (6MWT) is a commonly used objective measure of functional exercise capacity in individuals with moderately severe impairment.
Measured: 30 days through 5 years post implant
Mean Quality of Life Assessment in Cohort A
EuroQuol-5 Dimensions (EQ5D) is a standardized instrument for use as a measure of health outcome applicable to a wide range of health conditions and treatments. A visual analog scale (VAS) for health is also included in the measure as a patient-reported estimate of overall health status. This scale ranges between 0-100, where 0 is 'the worst health you can imagine' and 100 is 'the best health you can imagine'.
Measured: 30 days and 1 year post implant
Percentage of Participants With Transient Ischemic Attack in Cohort A
Percentage of participants with transient ischemic attack as defined by VARC-2 at 30 days through 5 years post implantation
Measured: 30 days through 5 years post implantation
Number of Participants With Transient Ischemic Attack in Cohort B
Number of participants with transient ischemic attack as defined by VARC-2 at 30 days through 5 years post implantation
Measured: 30 days through 5 years post implantation
Percentage of Participants With Stroke as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort A
Percentage of participants with a stroke (disabling and non-disabling) as defined by VARC-2 at 30 days post implantation
Measured: 30 days post implant
Percentage of Participants With Stroke as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort A
Percentage of participants with a stroke (disabling and non-disabling) as defined by VARC-2 at 1 year post implantation
Measured: 1 year post implant
Percentage of Participants With Stroke as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort A
Percentage of participants with a stroke (disabling and non-disabling) as defined by VARC-2 at 2 years post implantation
Measured: 2 years post implant
Percentage of Participants With Stroke as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort A
Percentage of participants with a stroke (disabling and non-disabling) as defined by VARC-2 at 3 years post implantation
Measured: 3 years post implant
Percentage of Participants With Stroke as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort A
Percentage of participants with a stroke (disabling and non-disabling) as defined by VARC-2 at 4 years post implantation
Measured: 4 years post implant
Percentage of Participants With Stroke as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort A
Percentage of participants with a stroke (disabling and non-disabling) as defined by VARC-2 at 5 years post implantation
Measured: 5 years post implant
Number of Participants With Stroke as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort B
Number of participants with a stroke (disabling and non-disabling) as defined by VARC-2 at 2 years post implantation
Measured: 2 years post implant
Number of Participants With Stroke as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort B
Number of participants with a stroke (disabling and non-disabling) as defined by VARC-2 at 3 years post implantation
Measured: 3 years post implant
Number of Participants With Stroke as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort B
Number of participants with a stroke (disabling and non-disabling) as defined by VARC-2 at 4 years post implantation
Measured: 4 years post implant
Number of Participants With Stroke as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort B
Number of participants with a stroke (disabling and non-disabling) as defined by VARC-2 at 5 years post implantation
Measured: 5 years post implant
Percentage of Participants With Conduction Disturbances and Cardiac Arrythmias as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort A
Percentage of participants with a conduction disturbances and cardiac arrhythmias as defined by VARC-2 at 30 days post implantation
Measured: 30 days post implant
Percentage of Participants With Conduction Disturbances and Cardiac Arrythmias as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort A
Percentage of participants with a conduction disturbances and cardiac arrhythmias as defined by VARC-2 at 1 year post implantation
Measured: 1 year post implant
Percentage of Participants With Conduction Disturbances and Cardiac Arrythmias as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort A
Percentage of participants with a conduction disturbances and cardiac arrhythmias as defined by VARC-2 at 2 years post implantation
Measured: 2 years post implant
Percentage of Participants With Conduction Disturbances and Cardiac Arrythmias as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort A
Percentage of participants with a conduction disturbances and cardiac arrhythmias as defined by VARC-2 at 3 years post implantation
Measured: 3 years post implant
Percentage of Participants With Conduction Disturbances and Cardiac Arrythmias as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort A
Percentage of participants with a conduction disturbances and cardiac arrhythmias as defined by VARC-2 at 4 years post implantation
Measured: 4 years post implant
Percentage of Participants With Conduction Disturbances and Cardiac Arrythmias as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort A
Percentage of participants with a conduction disturbances and cardiac arrhythmias as defined by VARC-2 at 5 years post implantation
Measured: 5 years post implant
Number of Participants With Conduction Disturbances and Cardiac Arrythmias as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort B
Number of participants with a conduction disturbances and cardiac arrhythmias as defined by VARC-2 at 2 years post implantation
Measured: 2 years post implant
Number of Participants With Conduction Disturbances and Cardiac Arrythmias as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort B
Number of participants with a conduction disturbances and cardiac arrhythmias as defined by VARC-2 at 3 years post implantation
Measured: 3 years post implant
Number of Participants With Conduction Disturbances and Cardiac Arrythmias as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort B
Number of participants with a conduction disturbances and cardiac arrhythmias as defined by VARC-2 at 4 years post implantation
Measured: 4 years post implant
Number of Participants With Conduction Disturbances and Cardiac Arrythmias as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort B
Number of participants with a conduction disturbances and cardiac arrhythmias as defined by VARC-2 at 5 years post implantation
Measured: 5 years post implant
Percentage of Participants With Prosthetic Valve Function as Defined by Valve Academic Research Consortium-2 (VARC-2) (Paravalvular Aortic Regurgitation) in Cohort A
Percentage of participants with a paravalvular aortic regurgitation as defined by VARC-2 at 30 days post implantation
Measured: 30 days post implant
Percentage of Participants With Prosthetic Valve Function as Defined by Valve Academic Research Consortium-2 (VARC-2) (Paravalvular Aortic Regurgitation) in Cohort A
Percentage of participants with a paravalvular aortic regurgitation as defined by VARC-2 at 1 year post implantation
Measured: 1 year post implant
Percentage of Participants With Prosthetic Valve Function as Defined by Valve Academic Research Consortium-2 (VARC-2) (Paravalvular Aortic Regurgitation)
Percentage of participants with a paravalvular aortic regurgitation as defined by VARC-2 at 2 years post implantation
Measured: 2 years post implant
Percentage of Participants With Prosthetic Valve Function as Defined by Valve Academic Research Consortium-2 (VARC-2) (Paravalvular Aortic Regurgitation)
Percentage of participants with a paravalvular aortic regurgitation as defined by VARC-2 at 3 years post implantation
Measured: 3 years post implant
Percentage of Participants With Prosthetic Valve Function as Defined by Valve Academic Research Consortium-2 (VARC-2) (Paravalvular Aortic Regurgitation)
Percentage of participants with a paravalvular aortic regurgitation as defined by VARC-2 at 4 years post implantation
Measured: 4 years post implant
Percentage of Participants With Prosthetic Valve Function as Defined by Valve Academic Research Consortium-2 (VARC-2) (Paravalvular Aortic Regurgitation)
Percentage of participants with a paravalvular aortic regurgitation as defined by VARC-2 at 5 years post implantation
Measured: 5 years post implant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2013 (estimated)
- Study start16 Apr 2013
- Primary completion25 Sep 2018
- Study completion19 Oct 2022
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 Aortic Valve 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,032 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Francesco Maisano, MD, Principal investigator, San Raffaele HospitalStephen Worthley, Principal investigator, St Andrews HospitalJosep Rodes-Cabau, Principal investigator, Institut de Cardiologie de Quebec (Hospital Laval)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01802788
- Sponsor's protocol ID
- CV-12-054-EU-PV
- Acronym
- PORTICO-1
- Status last verified
- Feb 2025
- First submitted
- 21 Feb 2013
- Last updated
- 11 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Puri R, Thiele H, Fichtlscherer S, Westermann D, Makkar R, Waksman R, Hakmi S, Sondergaard L, Groh M, Montarello JK, Kempfert J, Yong G, Bedogni F, Maisano F, Worthley SG, Rodes-Cabau J, Fontana GP, Mollmann H. Five-Year Clinical Outcomes and Durability of a Self-Expanding Transcatheter Heart Valve With Intra-Annular Leaflets. Circ Cardiovasc Interv. 2025 Dec;18(12):e015430. doi: 10.1161/CIRCINTERVENTIONS.125.015430. Epub 2025 Oct 24.
PubMed 41133305Sondergaard L, Rodes-Cabau J, Hans-Peter Linke A, Fichtlscherer S, Schafer U, Kuck KH, Kempfert J, Arzamendi D, Bedogni F, Asch FM, Worthley S, Maisano F. Transcatheter Aortic Valve Replacement With a Repositionable Self-Expanding Prosthesis: The PORTICO-I Trial 1-Year Outcomes. J Am Coll Cardiol. 2018 Dec 11;72(23 Pt A):2859-2867. doi: 10.1016/j.jacc.2018.09.014. Epub 2018 Sep 24.
PubMed 30261238