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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT01802788
Ethics application status
Date submitted
21/02/2013
Date registered
1/03/2013

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 Portico™ 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
Cohort A - Patients implanted with a Portico valve after CE mark

Cohort B - Patients implanted in previous SJM-sponsored premarket studies
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants With All-cause Mortality
Timepoint [1] 0 0
1 year post implant
Secondary outcome [1] 0 0
Percentage of Participants With All Cause Mortality in Cohort A
Timepoint [1] 0 0
30 days through 5 years post implant
Secondary outcome [2] 0 0
Number of Participants With All-cause Mortality (30 Days, Annually From 1 Year Through 5 Years) in Cohort B
Timepoint [2] 0 0
30 days through 5 years post implant
Secondary outcome [3] 0 0
Percentage of Participants With Cardiovascular Mortality as Defined by the Valve Academic Research Consortium-2 (VARC-2) in Cohort A
Timepoint [3] 0 0
30 days through 5 years post implant
Secondary outcome [4] 0 0
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
Timepoint [4] 0 0
30 days through 5 years post implant
Secondary outcome [5] 0 0
Percentage of Participants With Non-Cardiovascular Mortality as Defined by the Valve Academic Research Consortium-2 (VARC-2) in Cohort A
Timepoint [5] 0 0
30 days through 5 years post implant
Secondary outcome [6] 0 0
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
Timepoint [6] 0 0
30 days through 5 years post implant
Secondary outcome [7] 0 0
Percentage of Participants With Myocardial Infarction as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort A
Timepoint [7] 0 0
30 days through 5 years post implant
Secondary outcome [8] 0 0
Number of Participants With Myocardial Infarction as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort B
Timepoint [8] 0 0
30 days through 5 years post implant
Secondary outcome [9] 0 0
Percentage of Participants With Vascular Access Site Complication as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort A
Timepoint [9] 0 0
30 days post implant
Secondary outcome [10] 0 0
Percentage of Participants With Bleeding Events as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort A
Timepoint [10] 0 0
30 days post implant
Secondary outcome [11] 0 0
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
Timepoint [11] 0 0
30 days post implant
Secondary outcome [12] 0 0
Mean Prosthetic Valve Function as Defined by Valve Academic Research Consortium-2 (VARC-2) (Aortic Valve Area)
Timepoint [12] 0 0
30 days through 5 years post implant
Secondary outcome [13] 0 0
Mean Prosthetic Valve Function as Defined by Valve Academic Research Consortium-2 (VARC-2) (Mean Transvalvular Gradient)
Timepoint [13] 0 0
30 days through 5 years post implant
Secondary outcome [14] 0 0
Number of Participants With New York Heart Association (NYHA) Functional Classification of Heart Failure
Timepoint [14] 0 0
30 days post implant
Secondary outcome [15] 0 0
Number of Participants With New York Heart Association (NYHA) Functional Classification of Heart Failure
Timepoint [15] 0 0
1 year post implant
Secondary outcome [16] 0 0
Number of Participants With New York Heart Association (NYHA) Functional Classification of Heart Failure
Timepoint [16] 0 0
2 years post implant
Secondary outcome [17] 0 0
Number of Participants With New York Heart Association (NYHA) Functional Classification of Heart Failure
Timepoint [17] 0 0
3 years post implant
Secondary outcome [18] 0 0
Number of Participants With New York Heart Association (NYHA) Functional Classification of Heart Failure
Timepoint [18] 0 0
4 years post implant
Secondary outcome [19] 0 0
Number of Participants With New York Heart Association (NYHA) Functional Classification of Heart Failure
Timepoint [19] 0 0
5 years post implant
Secondary outcome [20] 0 0
Mean Six Minute Walk Test (6MWT)
Timepoint [20] 0 0
30 days through 5 years post implant
Secondary outcome [21] 0 0
Mean Quality of Life Assessment in Cohort A
Timepoint [21] 0 0
30 days and 1 year post implant
Secondary outcome [22] 0 0
Percentage of Participants With Transient Ischemic Attack in Cohort A
Timepoint [22] 0 0
30 days through 5 years post implantation
Secondary outcome [23] 0 0
Number of Participants With Transient Ischemic Attack in Cohort B
Timepoint [23] 0 0
30 days through 5 years post implantation
Secondary outcome [24] 0 0
Percentage of Participants With Stroke as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort A
Timepoint [24] 0 0
30 days post implant
Secondary outcome [25] 0 0
Percentage of Participants With Stroke as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort A
Timepoint [25] 0 0
1 year post implant
Secondary outcome [26] 0 0
Percentage of Participants With Stroke as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort A
Timepoint [26] 0 0
2 years post implant
Secondary outcome [27] 0 0
Percentage of Participants With Stroke as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort A
Timepoint [27] 0 0
3 years post implant
Secondary outcome [28] 0 0
Percentage of Participants With Stroke as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort A
Timepoint [28] 0 0
4 years post implant
Secondary outcome [29] 0 0
Percentage of Participants With Stroke as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort A
Timepoint [29] 0 0
5 years post implant
Secondary outcome [30] 0 0
Number of Participants With Stroke as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort B
Timepoint [30] 0 0
2 years post implant
Secondary outcome [31] 0 0
Number of Participants With Stroke as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort B
Timepoint [31] 0 0
3 years post implant
Secondary outcome [32] 0 0
Number of Participants With Stroke as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort B
Timepoint [32] 0 0
4 years post implant
Secondary outcome [33] 0 0
Number of Participants With Stroke as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort B
Timepoint [33] 0 0
5 years post implant
Secondary outcome [34] 0 0
Percentage of Participants With Conduction Disturbances and Cardiac Arrythmias as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort A
Timepoint [34] 0 0
30 days post implant
Secondary outcome [35] 0 0
Percentage of Participants With Conduction Disturbances and Cardiac Arrythmias as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort A
Timepoint [35] 0 0
1 year post implant
Secondary outcome [36] 0 0
Percentage of Participants With Conduction Disturbances and Cardiac Arrythmias as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort A
Timepoint [36] 0 0
2 years post implant
Secondary outcome [37] 0 0
Percentage of Participants With Conduction Disturbances and Cardiac Arrythmias as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort A
Timepoint [37] 0 0
3 years post implant
Secondary outcome [38] 0 0
Percentage of Participants With Conduction Disturbances and Cardiac Arrythmias as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort A
Timepoint [38] 0 0
4 years post implant
Secondary outcome [39] 0 0
Percentage of Participants With Conduction Disturbances and Cardiac Arrythmias as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort A
Timepoint [39] 0 0
5 years post implant
Secondary outcome [40] 0 0
Number of Participants With Conduction Disturbances and Cardiac Arrythmias as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort B
Timepoint [40] 0 0
2 years post implant
Secondary outcome [41] 0 0
Number of Participants With Conduction Disturbances and Cardiac Arrythmias as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort B
Timepoint [41] 0 0
3 years post implant
Secondary outcome [42] 0 0
Number of Participants With Conduction Disturbances and Cardiac Arrythmias as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort B
Timepoint [42] 0 0
4 years post implant
Secondary outcome [43] 0 0
Number of Participants With Conduction Disturbances and Cardiac Arrythmias as Defined by Valve Academic Research Consortium-2 (VARC-2) in Cohort B
Timepoint [43] 0 0
5 years post implant
Secondary outcome [44] 0 0
Percentage of Participants With Prosthetic Valve Function as Defined by Valve Academic Research Consortium-2 (VARC-2) (Paravalvular Aortic Regurgitation) in Cohort A
Timepoint [44] 0 0
30 days post implant
Secondary outcome [45] 0 0
Percentage of Participants With Prosthetic Valve Function as Defined by Valve Academic Research Consortium-2 (VARC-2) (Paravalvular Aortic Regurgitation) in Cohort A
Timepoint [45] 0 0
1 year post implant
Secondary outcome [46] 0 0
Percentage of Participants With Prosthetic Valve Function as Defined by Valve Academic Research Consortium-2 (VARC-2) (Paravalvular Aortic Regurgitation)
Timepoint [46] 0 0
2 years post implant
Secondary outcome [47] 0 0
Percentage of Participants With Prosthetic Valve Function as Defined by Valve Academic Research Consortium-2 (VARC-2) (Paravalvular Aortic Regurgitation)
Timepoint [47] 0 0
3 years post implant
Secondary outcome [48] 0 0
Percentage of Participants With Prosthetic Valve Function as Defined by Valve Academic Research Consortium-2 (VARC-2) (Paravalvular Aortic Regurgitation)
Timepoint [48] 0 0
4 years post implant
Secondary outcome [49] 0 0
Percentage of Participants With Prosthetic Valve Function as Defined by Valve Academic Research Consortium-2 (VARC-2) (Paravalvular Aortic Regurgitation)
Timepoint [49] 0 0
5 years post implant

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 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.

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.
Minimum age
18 Years
Maximum age
No limit
Sex
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 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

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
16/04/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
19/10/2022
Sample size
Target
Accrual to date
Final
1032
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
North Shore Private 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
Rennes
Country [14] 0 0
France
State/province [14] 0 0
Toulouse
Country [15] 0 0
Germany
State/province [15] 0 0
Bad Nauheim
Country [16] 0 0
Germany
State/province [16] 0 0
Berlin
Country [17] 0 0
Germany
State/province [17] 0 0
Bernau
Country [18] 0 0
Germany
State/province [18] 0 0
Dortmund
Country [19] 0 0
Germany
State/province [19] 0 0
Dresden
Country [20] 0 0
Germany
State/province [20] 0 0
Frankfurt
Country [21] 0 0
Germany
State/province [21] 0 0
Göttingen
Country [22] 0 0
Germany
State/province [22] 0 0
Hamburg
Country [23] 0 0
Germany
State/province [23] 0 0
Jena
Country [24] 0 0
Germany
State/province [24] 0 0
Karlsruhe
Country [25] 0 0
Germany
State/province [25] 0 0
Leipzig
Country [26] 0 0
Germany
State/province [26] 0 0
Munchen
Country [27] 0 0
Israel
State/province [27] 0 0
Re?ovot
Country [28] 0 0
Italy
State/province [28] 0 0
Alessandria
Country [29] 0 0
Italy
State/province [29] 0 0
Catania
Country [30] 0 0
Italy
State/province [30] 0 0
Massa
Country [31] 0 0
Italy
State/province [31] 0 0
Milano
Country [32] 0 0
Italy
State/province [32] 0 0
Milan
Country [33] 0 0
Italy
State/province [33] 0 0
Monza
Country [34] 0 0
Lithuania
State/province [34] 0 0
Vilnius
Country [35] 0 0
Netherlands
State/province [35] 0 0
Amsterdam
Country [36] 0 0
Netherlands
State/province [36] 0 0
Leeuwarden
Country [37] 0 0
Spain
State/province [37] 0 0
Barcelona
Country [38] 0 0
Spain
State/province [38] 0 0
El Palmar
Country [39] 0 0
Spain
State/province [39] 0 0
Sevilla
Country [40] 0 0
Switzerland
State/province [40] 0 0
Zurich
Country [41] 0 0
United Kingdom
State/province [41] 0 0
Belfast
Country [42] 0 0
United Kingdom
State/province [42] 0 0
Brighton
Country [43] 0 0
United Kingdom
State/province [43] 0 0
London
Country [44] 0 0
United Kingdom
State/province [44] 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
Trial website
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT01802788