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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT01802788




Registration number
NCT01802788
Ethics application status
Date submitted
21/02/2013
Date registered
1/03/2013
Date last updated
18/02/2020

Titles & IDs
Public title
5 Year Observation of Patients With PORTICO Valves
Scientific title
International Long-term Follow-up Study of Patients Implanted With a Porticoâ„¢ Valve
Secondary ID [1] 0 0
CV-12-054-EU-PV
Universal Trial Number (UTN)
Trial acronym
PORTICO-1
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Aortic Valve Stenosis 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Treatment: Devices - St Jude Medical Portico replacement aortic valve
Treatment: Surgery - Transcatheter Aortic Valve Implant

Cohort A - Patients implanted with a Portico valve bearing the CE mark (implanted after St Jude Medical declared the device "compliant" with all applicable essential requirements within the European union and marketed the device bearing the CE mark.)

Cohort B - Patients implanted with a Portico valve as part of an Investigational Device study.


Treatment: Devices: St Jude Medical Portico replacement aortic valve


Treatment: Surgery: Transcatheter Aortic Valve Implant


Intervention code [1] 0 0
Treatment: Devices
Intervention code [2] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
All-cause Mortality - Death rate for any reason at 1 year
Timepoint [1] 0 0
1 year
Secondary outcome [1] 0 0
All Cause Mortality - Death rate for any reason at specified times
Timepoint [1] 0 0
30 days, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years post device implant.
Secondary outcome [2] 0 0
Frequency of Cardiovascular Mortality as defined by the Valve Academic Research Consortium (VARC) - Any one of the following criteria:
Death due to proximate cardiac cause (e.g., myocardial infarction, cardiac tamponade, worsening heart failure).
Death caused by non-coronary vascular conditions such as neurological events, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular disease.
All procedure-related deaths, including those related to a complication of the procedure or treatment for a complication of the procedure.
All valve-related deaths including structural or non-structural valve dysfunction or other valve-related adverse event.
Sudden or witnessed death.
Death of unknown cause.
Timepoint [2] 0 0
30 days, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years post device implant.
Secondary outcome [3] 0 0
Frequency of Myocardial Infarction as defined by VARC - Please refer to the following publication for a detailed description of this and all further VARC defined endpoints:
Kappetein AP, Head SJ, Généreux P, et al. Updated standardized endpoint definitions for transcatheter aortic valve implantation: The Valve Academic Research Consortium-2 consensus document. The Journal of Thoracic and Cardiovascular Surgery 2013;145(1):6-23.
Timepoint [3] 0 0
30 days, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years post device implant.
Secondary outcome [4] 0 0
Frequency of Stroke as defined by VARC. - Rate of stroke at each time point according to the Valve Academic Research Consortium definitions.
Timepoint [4] 0 0
30 days, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years post device implant.
Secondary outcome [5] 0 0
Frequency of Bleeding events as defined by VARC. - Rate of minor, major and life threatening bleeding events at each time point according to the Valve Academic Research Consortium definitions.
Timepoint [5] 0 0
30 days, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years post device implant.
Secondary outcome [6] 0 0
Frequency of Acute Kidney injury as defined by VARC - Rate of AKI at each time point according to the Valve Academic Research Consortium definitions.
Timepoint [6] 0 0
30 days, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years post device implant.
Secondary outcome [7] 0 0
Frequency of Vascular and access related complications as defined by VARC - Rate of major and minor VASC events at each time point according to the Valve Academic Research Consortium definitions.
Timepoint [7] 0 0
30 days, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years post device implant.
Secondary outcome [8] 0 0
Frequency of Conduction disturbances and cardiac arrythmias as defined by VARC. - In particular this includes the rate of pacemaker implantation at 30 days post procedure
Timepoint [8] 0 0
30 days, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years post device implant.
Secondary outcome [9] 0 0
Frequency of other TAVI related complications as defined by VARC. - Conversion to open surgery
Unplanned use of cardiopulmonary bypass (CPB)
Coronary obstruction
Ventricular septal perforation
Mitral valve apparatus damage or dysfunction
Cardiac tamponade
Endocarditis
Valve thrombosis
Valve malpositioning
Transcatheter valve in Transcatheter valve deployment
Timepoint [9] 0 0
30 days, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years post device implant.
Secondary outcome [10] 0 0
Prosthetic valve function as defined by VARC - Prosthetic valve stenosis
Prosthetic valve regurgitation
Timepoint [10] 0 0
30 days, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years post device implant.
Secondary outcome [11] 0 0
VARC defined "device success" composite endpoint - Absence of procedural mortality AND
Correct positioning of a single prosthetic heart valve into the proper anatomical location AND
Intended performance of the prosthetic heart valve (no prosthesis-patient mismatch and mean aortic valve gradient <20 mmHg or peak velocity <3 m/s, AND no moderate or severe prosthetic valve regurgitation)
Timepoint [11] 0 0
30 days
Secondary outcome [12] 0 0
VARC defined "Early Safety" composite endpoint - All-cause mortality
All stroke (disabling and non-disabling)
Life-threatening bleeding
Acute kidney injury-Stage 2 or 3 (including renal replacement therapy)
Coronary artery obstruction requiring intervention
Major vascular complication
Valve-related dysfunction requiring repeat procedure (Balloon Aortic Valvuloplasty (BAV), Trans Catheter Aortic Valve Implant (TAVI), or Surgical Aortic Valve Replacement (SAVR))
Timepoint [12] 0 0
30 days
Secondary outcome [13] 0 0
VARC defined "Clinical Efficacy" composite endpoint - All-cause mortality
All stroke (disabling and non-disabling)
Requiring hospitalizations for valve-related symptoms or worsening congestive heart failure
NYHA (New york Heart Association) class III or IV functional classification of heart failure.
Valve-related dysfunction (mean aortic valve gradient =20 mmHg, Effective Orifice Area (EOA) =0.9-1.1 cm2(c) and/or Doppler Velocity Integral (DVI) <0. 35 m/s, AND/OR moderate or severe prosthetic valve regurgitation.
Timepoint [13] 0 0
From 30 days post procedure to completion of follow up at 5 years.
Secondary outcome [14] 0 0
VARC defined "Time-related valve safety" composite endpoint - Structural valve deterioration
Valve-related dysfunction (mean aortic valve gradient
=20 mmHg, EOA =0.9-1.1 cm2cand/or DVI <0.35 m/s, AND/OR moderate or severe prosthetic valve regurgitation)
Requiring repeat procedure (TAVI or SAVR)
Prosthetic valve endocarditis
Prosthetic valve thrombosis
Thrombo-embolic events (e.g. stroke)
VARC bleeding, unless clearly unrelated to valve therapy (e.g. trauma)
Timepoint [14] 0 0
From device implant to completion of follow up at 5 years.
Secondary outcome [15] 0 0
New York Heart Association (NYHA) Functional classification of heart failure. - Change in NYHA class between baseline and each follow-up
Timepoint [15] 0 0
30 days, 6 months, 1, 2, 3, 4 and 5 years
Secondary outcome [16] 0 0
Six minute walk test (6MWT) - Distance in metres that the participant can walk in 6 minutes.
Timepoint [16] 0 0
Change between baseline and 30 days, 6 months, 1, 2, 3, 4 and 5 years
Secondary outcome [17] 0 0
Quality of Life Assessment. - Quality of life is quantified using the EQ-5D-5L questionnaire.
Timepoint [17] 0 0
Change in Quality of Life from Baseline to 30 days, 6 months, 1, 2, 3, 4 and 5 years

Eligibility
Key inclusion criteria
- 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.

- Patient has senile degenerative aortic stenosis with an initial valve area of less
than (<) 1.0 cm2 (or aortic valve area index less than or equal to (=) 0.6 cm2/m2) AND
a mean transvalvular gradient greater than (>) 40mmHg or jet velocity greater than (>)
4.0 m/s derived by resting echocardiogram [or dobutamine stress echocardiogram if
subject has a left ventricular ejection fraction (LVEF) < 50%]. (Baseline measurement
taken by echo within 45 days of index procedure).

- Patient has a life expectancy more than (>) 12 months.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- 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 than tricuspid valve.

- 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

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [2] 0 0
St Andrews Hospital - Adelaide
Recruitment hospital [3] 0 0
Heart Care Partners-Wesley Hospital - Auchenflower
Recruitment hospital [4] 0 0
The Prince Charles Hospital - Chermside
Recruitment hospital [5] 0 0
Royal North Shore hospital - Leonards Hill
Recruitment hospital [6] 0 0
The Alfred Hospital - Melbourne
Recruitment hospital [7] 0 0
Royal Melbourne Hospital - City Campus - Parkville
Recruitment hospital [8] 0 0
Fiona Stanley Hospital - Perth
Recruitment hospital [9] 0 0
Royal North Shore Hospital - St Leonards
Recruitment hospital [10] 0 0
Princess Alexandra Hospital - Woolloongabba
Recruitment postcode(s) [1] 0 0
- Adelaide
Recruitment postcode(s) [2] 0 0
- Auchenflower
Recruitment postcode(s) [3] 0 0
- Chermside
Recruitment postcode(s) [4] 0 0
- Leonards Hill
Recruitment postcode(s) [5] 0 0
- Melbourne
Recruitment postcode(s) [6] 0 0
- Parkville
Recruitment postcode(s) [7] 0 0
- Perth
Recruitment postcode(s) [8] 0 0
- St Leonards
Recruitment postcode(s) [9] 0 0
- Woolloongabba
Recruitment outside Australia
Country [1] 0 0
Belgium
State/province [1] 0 0
Antwerp
Country [2] 0 0
Belgium
State/province [2] 0 0
Bruxelles
Country [3] 0 0
Belgium
State/province [3] 0 0
Liege
Country [4] 0 0
Canada
State/province [4] 0 0
Calgary
Country [5] 0 0
Canada
State/province [5] 0 0
Halifax
Country [6] 0 0
Canada
State/province [6] 0 0
Montreal
Country [7] 0 0
Canada
State/province [7] 0 0
Ottawa
Country [8] 0 0
Canada
State/province [8] 0 0
Quebec
Country [9] 0 0
Canada
State/province [9] 0 0
Saint John
Country [10] 0 0
Canada
State/province [10] 0 0
Toronto
Country [11] 0 0
Canada
State/province [11] 0 0
Vancouver
Country [12] 0 0
Denmark
State/province [12] 0 0
Copenhagen
Country [13] 0 0
France
State/province [13] 0 0
Paris
Country [14] 0 0
France
State/province [14] 0 0
Rennes
Country [15] 0 0
France
State/province [15] 0 0
Toulouse
Country [16] 0 0
Germany
State/province [16] 0 0
Bad Nauheim
Country [17] 0 0
Germany
State/province [17] 0 0
Berlin
Country [18] 0 0
Germany
State/province [18] 0 0
Bernau
Country [19] 0 0
Germany
State/province [19] 0 0
Dortmund
Country [20] 0 0
Germany
State/province [20] 0 0
Dresden
Country [21] 0 0
Germany
State/province [21] 0 0
Frankfurt
Country [22] 0 0
Germany
State/province [22] 0 0
Göttingen
Country [23] 0 0
Germany
State/province [23] 0 0
Hamburg
Country [24] 0 0
Germany
State/province [24] 0 0
Jena
Country [25] 0 0
Germany
State/province [25] 0 0
Karlsruhe
Country [26] 0 0
Germany
State/province [26] 0 0
Leipzig
Country [27] 0 0
Germany
State/province [27] 0 0
Munchen
Country [28] 0 0
Israel
State/province [28] 0 0
Re?ovot
Country [29] 0 0
Italy
State/province [29] 0 0
Alessandria
Country [30] 0 0
Italy
State/province [30] 0 0
Catania
Country [31] 0 0
Italy
State/province [31] 0 0
Massa
Country [32] 0 0
Italy
State/province [32] 0 0
Milano
Country [33] 0 0
Italy
State/province [33] 0 0
Milan
Country [34] 0 0
Italy
State/province [34] 0 0
Monza
Country [35] 0 0
Lithuania
State/province [35] 0 0
Vilnius
Country [36] 0 0
Netherlands
State/province [36] 0 0
Amsterdam
Country [37] 0 0
Netherlands
State/province [37] 0 0
Leeuwarden
Country [38] 0 0
Spain
State/province [38] 0 0
Barcelona
Country [39] 0 0
Spain
State/province [39] 0 0
El Palmar
Country [40] 0 0
Spain
State/province [40] 0 0
Sevilla
Country [41] 0 0
Switzerland
State/province [41] 0 0
Zurich
Country [42] 0 0
United Kingdom
State/province [42] 0 0
Belfast
Country [43] 0 0
United Kingdom
State/province [43] 0 0
Brighton
Country [44] 0 0
United Kingdom
State/province [44] 0 0
London
Country [45] 0 0
United Kingdom
State/province [45] 0 0
Morriston

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Abbott Medical Devices
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This study will further assess the performance and safety profile of the commercially
available Portico Valve implanted, using the Delivery System and the Loading System, in
patients with severe symptomatic aortic stenosis through 5 years of follow-up.
Trial website
https://clinicaltrials.gov/show/NCT01802788
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Lars Søndergaard, DMSc
Address 0 0
Rigshopitalet University Hospital, Copenhagen
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications