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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
Date last updated
10/06/2024

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
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.
Trial website
https://clinicaltrials.gov/study/NCT01802788
Trial related presentations / publications
Sondergaard 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.
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

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01802788