5 Year Observation of Patients With PORTICO Valves | NCT01802788

Status Module

Description Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Cohort A		Patients implanted with a Portico valve after CE mark	Device: St Jude Medical Portico replacement aortic valve Procedure: Transcatheter Aortic Valve Implant
Cohort B		Patients implanted in previous SJM-sponsored premarket studies	Device: St Jude Medical Portico replacement aortic valve Procedure: Transcatheter Aortic Valve Implant

Name	Type	Description	Arm Group Labels	Other Names
St Jude Medical Portico replacement aortic valve	Device		Cohort A Cohort B
Transcatheter Aortic Valve Implant

Outcomes Module

Measure	Description	Time Frame
Percentage of Participants With All-cause Mortality	Percentage of participants that died for any reason at 1 year post implantation	1 year post implant

Secondary Outcomes

Measure	Description	Time Frame
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	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

Eligibility Module

Eligibility Criteria

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.

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

Name	Affiliation	Role
Francesco Maisano, MD	San Raffaele Hospital	Principal Investigator
Stephen Worthley	St Andrews Hospital	Principal Investigator
Josep Rodes-Cabau	Institut de Cardiologie de Quebec (Hospital Laval)	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Royal Adelaide Hospital		Adelaide			Australia
St Andrews Hospital

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
41133305	Derived	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.
30261238

Results Section

Participant Flow Module

ID	Title	Description
FG000	Cohort A	Patients implanted with a Portico valve after CE mark
FG001	Cohort B	Patients implanted in previous SJM-sponsored premarket studies

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Jul 14, 2016

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	OG00012.1(10.1 to 14.4)

Secondary

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

Cohort B subjects in the Portico I study scheduled follow-up visit starting with the 2 year follow-up.

Posted

Number

percentage of participants

30 days through 5 years post implant

ID	Title	Description
OG000	Cohort A	Patients implanted with a Portico valve after CE mark

Units	Counts
Participants	OG000941

Secondary

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.

Cohort B subjects in the Portico I study scheduled follow-up visit starting with the 2 year follow-up.

Posted

Count of Participants

Participants

30 days through 5 years post implant

ID	Title	Description
OG000	Cohort B	Patients implanted in previous SJM-sponsored premarket studies

Units	Counts
Participants	OG000

Secondary

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

Cohort B subjects in the Portico I study scheduled follow-up visit starting with the 2 year follow-up.

Posted

Number

percentage of participants

30 days through 5 years post implant

ID	Title	Description
OG000	Cohort A	Patients implanted with a Portico valve after CE mark

Units	Counts
Participants	OG000

Secondary

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.

Cohort B subjects in the Portico I study scheduled follow-up visit starting with the 2 year follow-up.

Posted

Count of Participants

Participants

30 days through 5 years post implant

ID	Title	Description
OG000	Cohort B	Patients implanted in previous SJM-sponsored premarket studies

Units	Counts
Participants	OG000

Secondary

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

Posted

Number

percentage of participants

30 days through 5 years post implant

ID	Title	Description
OG000	Cohort A	Patients implanted with a Portico valve after CE mark

Units	Counts
Participants	OG000941

Secondary

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.

Cohort B subjects in the Portico I study scheduled follow-up visit starting with the 2 year follow-up.

Posted

Count of Participants

Participants

30 days through 5 years post implant

ID	Title	Description
OG000	Cohort B	Patients implanted in previous SJM-sponsored premarket studies

Units	Counts
Participants	OG000

Secondary

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

Cohort B subjects in the Portico I study scheduled follow-up visit starting with the 2 year follow-up.

Posted

Number

percentage of participants

30 days through 5 years post implant

ID	Title	Description
OG000	Cohort A	Patients implanted with a Portico valve after CE mark

Units	Counts
Participants	OG000

Secondary

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

Cohort B subjects in the Portico I study scheduled follow-up visit starting with the 2 year follow-up.

Posted

Count of Participants

Participants

30 days through 5 years post implant

ID	Title	Description
OG000	Cohort B	Patients implanted in previous SJM-sponsored premarket studies

Units	Counts
Participants	OG000

Secondary

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

Cohort B subjects in the Portico I study scheduled follow-up visit starting with the 2 year follow-up.

Posted

Number

percentage of participants

30 days post implant

ID	Title	Description
OG000	Cohort A	Patients implanted with a Portico valve after CE mark

Units	Counts
Participants	OG000

Secondary

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

Cohort B subjects in the Portico I study scheduled follow-up visit starting with the 2 year follow-up.

Posted

Number

percentage of participants

30 days post implant

ID	Title	Description
OG000	Cohort A	Patients implanted with a Portico valve after CE mark

Units	Counts
Participants	OG000941

Secondary

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

Cohort B subjects in the Portico I study scheduled follow-up visit starting with the 2 year follow-up.

Posted

Number

percentage of participants

30 days post implant

ID	Title	Description
OG000	Cohort A	Patients implanted with a Portico valve after CE mark

Units	Counts
Participants	OG000

Secondary

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

The data for the number of participants available at the time has been provided. For Cohort A, a total of 941 subjects participated in the study; however, only 574 were available for AVA analysis.

Posted

Mean

Standard Deviation

cm^2

30 days through 5 years post implant

ID	Title	Description
OG000	Cohort A	Patients implanted with a Portico valve after CE mark
OG001	Cohort B	Patients implanted in previous SJM-sponsored premarket studies

Units	Counts
Participants	OG000

Secondary

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

The data for the number of participants available at the time has been provided. For Cohort A, a total of 941 subjects participated in the study; however, only 684 were available for mean aortic gradient analysis.

Posted

Mean

Standard Deviation

mmHg

30 days through 5 years post implant

ID	Title	Description
OG000	Cohort A	Patients implanted with a Portico valve after CE mark
OG001	Cohort B	Patients implanted in previous SJM-sponsored premarket studies

Units	Counts
Participants	OG000

Secondary

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.

The data for the number of participants available at the time has been provided

Posted

Count of Participants

Participants

30 days post implant

ID	Title	Description
OG000	Cohort A	Patients implanted with a Portico valve after CE mark
OG001	Cohort B	Patients implanted in previous SJM-sponsored premarket studies

Units	Counts
Participants

Secondary

Number of Participants With New York Heart Association (NYHA) Functional Classification of Heart Failure

The data for the number of participants available at the time has been provided

Posted

Count of Participants

Participants

1 year post implant

ID	Title	Description
OG000	Cohort A	Patients implanted with a Portico valve after CE mark
OG001	Cohort B	Patients implanted in previous SJM-sponsored premarket studies

Units	Counts
Participants

Secondary

Number of Participants With New York Heart Association (NYHA) Functional Classification of Heart Failure

The data for the number of participants available at the time has been provided

Posted

Count of Participants

Participants

2 years post implant

ID	Title	Description
OG000	Cohort A	Patients implanted with a Portico valve after CE mark
OG001	Cohort B	Patients implanted in previous SJM-sponsored premarket studies

Units	Counts
Participants

Secondary

Number of Participants With New York Heart Association (NYHA) Functional Classification of Heart Failure

The data for the number of participants available at the time has been provided

Posted

Count of Participants

Participants

3 years post implant

ID	Title	Description
OG000	Cohort A	Patients implanted with a Portico valve after CE mark
OG001	Cohort B	Patients implanted in previous SJM-sponsored premarket studies

Units	Counts
Participants

Secondary

Number of Participants With New York Heart Association (NYHA) Functional Classification of Heart Failure

The data for the number of participants available at the time has been provided

Posted

Count of Participants

Participants

4 years post implant

ID	Title	Description
OG000	Cohort A	Patients implanted with a Portico valve after CE mark
OG001	Cohort B	Patients implanted in previous SJM-sponsored premarket studies

Units	Counts
Participants

Secondary

Number of Participants With New York Heart Association (NYHA) Functional Classification of Heart Failure

The data for the number of participants available at the time has been provided

Posted

Count of Participants

Participants

5 years post implant

ID	Title	Description
OG000	Cohort A	Patients implanted with a Portico valve after CE mark
OG001	Cohort B	Patients implanted in previous SJM-sponsored premarket studies

Units	Counts
Participants

Secondary

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.

The data for the number of participants available at the time has been provided. For Cohort A, a total of 941 subjects participated in the study; however, only 569 were available for 6 minute walk test.

Posted

Mean

Standard Deviation

meter

30 days through 5 years post implant

ID	Title	Description
OG000	Cohort A	Patients implanted with a Portico valve after CE mark
OG001	Cohort B	Patients implanted in previous SJM-sponsored premarket studies

Units	Counts
Participants	OG000

Secondary

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'.

Cohort B subjects in the Portico I study scheduled follow-up visit starting with the 2 year follow-up. For Cohort A, a total of 941 subjects participated in the study; however, only 774 were available for EQ5D analysis.

Posted

Mean

Standard Deviation

score on a scale

30 days and 1 year post implant

ID	Title	Description
OG000	Cohort A	Patients implanted with a Portico valve after CE mark

Units	Counts
Participants	OG000

Secondary

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

Posted

Number

percentage of participants

30 days through 5 years post implantation

ID	Title	Description
OG000	Cohort A	Patients implanted with a Portico valve after CE mark

Units	Counts
Participants	OG000941

Secondary

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

Cohort B subjects in the Portico I study scheduled follow-up visit starting with the 2 year follow-up.

Posted

Count of Participants

Participants

30 days through 5 years post implantation

ID	Title	Description
OG000	Cohort B	Patients implanted in previous SJM-sponsored premarket studies

Units	Counts
Participants	OG00059

Secondary

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

Cohort B subjects in the Portico I study scheduled follow-up visit starting with the 2 year follow-up.

Posted

Number

percentage of participants

30 days post implant

ID	Title	Description
OG000	Cohort A	Patients implanted with a Portico valve after CE mark

Units	Counts
Participants	OG000941

Secondary

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

Cohort B subjects in the Portico I study scheduled follow-up visit starting with the 2 year follow-up.

Posted

Number

percentage of participants

1 year post implant

ID	Title	Description
OG000	Cohort A	Patients implanted with a Portico valve after CE mark

Units	Counts
Participants	OG000941

Secondary

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

Cohort B subjects in the Portico I study scheduled follow-up visit starting with the 2 year follow-up.

Posted

Number

percentage of participants

2 years post implant

ID	Title	Description
OG000	Cohort A	Patients implanted with a Portico valve after CE mark

Units	Counts
Participants	OG000941

Secondary

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

Cohort B subjects in the Portico I study scheduled follow-up visit starting with the 2 year follow-up.

Posted

Number

percentage of participants

3 years post implant

ID	Title	Description
OG000	Cohort A	Patients implanted with a Portico valve after CE mark

Units	Counts
Participants	OG000941

Secondary

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

Cohort B subjects in the Portico I study scheduled follow-up visit starting with the 2 year follow-up.

Posted

Number

percentage of participants

4 years post implant

ID	Title	Description
OG000	Cohort A	Patients implanted with a Portico valve after CE mark

Units	Counts
Participants	OG000941

Secondary

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

Cohort B subjects in the Portico I study scheduled follow-up visit starting with the 2 year follow-up.

Posted

Number

percentage of participants

5 years post implant

ID	Title	Description
OG000	Cohort A	Patients implanted with a Portico valve after CE mark

Units	Counts
Participants	OG000941

Secondary

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

Cohort B subjects in the Portico I study scheduled follow-up visit starting with the 2year follow-up.

Posted

Count of Participants

Participants

2 years post implant

ID	Title	Description
OG000	Cohort B	Patients implanted in previous SJM-sponsored premarket studies

Units	Counts
Participants	OG00059

Secondary

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

Cohort B subjects in the Portico I study scheduled follow-up visit starting with the 2year follow-up.

Posted

Count of Participants

Participants

3 years post implant

ID	Title	Description
OG000	Cohort B	Patients implanted in previous SJM-sponsored premarket studies

Units	Counts
Participants	OG00059

Secondary

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

Cohort B subjects in the Portico I study scheduled follow-up visit starting with the 2year follow-up.

Posted

Count of Participants

Participants

4 years post implant

ID	Title	Description
OG000	Cohort B	Patients implanted in previous SJM-sponsored premarket studies

Units	Counts
Participants	OG00059

Secondary

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

Cohort B subjects in the Portico I study scheduled follow-up visit starting with the 2year follow-up.

Posted

Count of Participants

Participants

5 years post implant

ID	Title	Description
OG000	Cohort B	Patients implanted in previous SJM-sponsored premarket studies

Units	Counts
Participants	OG00059

Secondary

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

Cohort B subjects in the Portico I study scheduled follow-up visit starting with the 2 year follow-up.

Posted

Number

percentage of participants

30 days post implant

ID	Title	Description
OG000	Cohort A	Patients implanted with a Portico valve after CE mark

Units	Counts
Participants	OG000

Secondary

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

Cohort B subjects in the Portico I study scheduled follow-up visit starting with the 2 year follow-up.

Posted

Number

percentage of participants

1 year post implant

ID	Title	Description
OG000	Cohort A	Patients implanted with a Portico valve after CE mark

Units	Counts
Participants	OG000

Secondary

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

Cohort B subjects in the Portico I study scheduled follow-up visit starting with the 2 year follow-up.

Posted

Number

percentage of participants

2 years post implant

ID	Title	Description
OG000	Cohort A	Patients implanted with a Portico valve after CE mark

Units	Counts
Participants	OG000

Secondary

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

Cohort B subjects in the Portico I study scheduled follow-up visit starting with the 2 year follow-up.

Posted

Number

percentage of participants

3 years post implant

ID	Title	Description
OG000	Cohort A	Patients implanted with a Portico valve after CE mark

Units	Counts
Participants	OG000

Secondary

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

Cohort B subjects in the Portico I study scheduled follow-up visit starting with the 2 year follow-up.

Posted

Number

percentage of participants

4 years post implant

ID	Title	Description
OG000	Cohort A	Patients implanted with a Portico valve after CE mark

Units	Counts
Participants	OG000

Secondary

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

Cohort B subjects in the Portico I study scheduled follow-up visit starting with the 2 year follow-up.

Posted

Number

percentage of participants

5 years post implant

ID	Title	Description
OG000	Cohort A	Patients implanted with a Portico valve after CE mark

Units	Counts
Participants	OG000

Secondary

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

Cohort B subjects in the Portico I study scheduled follow-up visit starting with the 2 year follow-up.

Posted

Count of Participants

Participants

2 years post implant

ID	Title	Description
OG000	Cohort B	Patients implanted in previous SJM-sponsored premarket studies

Units	Counts
Participants	OG000

Secondary

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

Cohort B subjects in the Portico I study scheduled follow-up visit starting with the 2 year follow-up.

Posted

Count of Participants

Participants

3 years post implant

ID	Title	Description
OG000	Cohort B	Patients implanted in previous SJM-sponsored premarket studies

Units	Counts
Participants	OG000

Secondary

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

Cohort B subjects in the Portico I study scheduled follow-up visit starting with the 2 year follow-up.

Posted

Count of Participants

Participants

4 years post implant

ID	Title	Description
OG000	Cohort B	Patients implanted in previous SJM-sponsored premarket studies

Units	Counts
Participants	OG000

Secondary

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

Cohort B subjects in the Portico I study scheduled follow-up visit starting with the 2 year follow-up.

Posted

Count of Participants

Participants

5 years post implant

ID	Title	Description
OG000	Cohort B	Patients implanted in previous SJM-sponsored premarket studies

Units	Counts
Participants	OG000

Secondary

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

Cohort B subjects in the Portico I study scheduled follow-up visit starting with the 2 year follow-up.

Posted

Number

percentage of participants

30 days post implant

ID	Title	Description
OG000	Cohort A	Patients implanted with a Portico valve after CE mark

Units	Counts
Participants	OG000

Secondary

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

Cohort B subjects in the Portico I study scheduled follow-up visit starting with the 2 year follow-up.

Posted

Number

percentage of participants

1 year post implant

ID	Title	Description
OG000	Cohort A	Patients implanted with a Portico valve after CE mark

Units	Counts
Participants	OG000

Secondary

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

Posted

Number

percentage of participants

2 years post implant

ID	Title	Description
OG000	Cohort A	Patients implanted with a Portico valve after CE mark
OG001	Cohort B	Patients implanted in previous SJM-sponsored premarket studies

Units	Counts
Participants	OG000

Secondary

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

Posted

Number

percentage of participants

3 years post implant

ID	Title	Description
OG000	Cohort A	Patients implanted with a Portico valve after CE mark
OG001	Cohort B	Patients implanted in previous SJM-sponsored premarket studies

Units	Counts
Participants	OG000

Secondary

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

Posted

Number

percentage of participants

4 years post implant

ID	Title	Description
OG000	Cohort A	Patients implanted with a Portico valve after CE mark
OG001	Cohort B	Patients implanted in previous SJM-sponsored premarket studies

Units	Counts
Participants	OG000

Secondary

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

Posted

Number

percentage of participants

5 years post implant

ID	Title	Description
OG000	Cohort A	Patients implanted with a Portico valve after CE mark
OG001	Cohort B	Patients implanted in previous SJM-sponsored premarket studies

Units	Counts
Participants	OG000

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Clinical significant bleeding	Blood and lymphatic system disorders	MedDRA (11.0)	Systematic Assessment	EG00067 affected941 at risk EG0013 affected59 at risk
Life threatening bleeding	Blood and lymphatic system disorders	MedDRA (11.0)	Systematic Assessment	EG00031 affected941 at risk EG0010 affected59 at risk
Major bleeding	Blood and lymphatic system disorders	MedDRA (11.0)	Systematic Assessment	EG00074 affected941 at risk EG0010 affected59 at risk
Minor bleeding	Blood and lymphatic system disorders	MedDRA (11.0)	Systematic Assessment	EG00015 affected941 at risk EG0010 affected59 at risk
Not clinical significant bleeding	Blood and lymphatic system disorders	MedDRA (11.0)	Systematic Assessment	EG00017 affected941 at risk EG0011 affected59 at risk
Arrhythmia / Conduction abnormality	Cardiac disorders	MedDRA (11.0)	Systematic Assessment	EG000256 affected941 at risk EG0013 affected59 at risk
Coronary obstruction	Cardiac disorders	MedDRA (11.0)	Systematic Assessment	EG0001 affected941 at risk EG0010 affected59 at risk
Endocarditis	Cardiac disorders	MedDRA (11.0)	Systematic Assessment	EG0007 affected941 at risk EG0010 affected59 at risk
New Onset of Atrial Fibrillation	Cardiac disorders	MedDRA (11.0)	Systematic Assessment	EG00025 affected941 at risk EG0011 affected59 at risk
Peri-Procedural MI	Cardiac disorders	MedDRA (11.0)	Systematic Assessment	EG00011 affected941 at risk EG0010 affected59 at risk
Prosthetic aortic valve regurgitation	Cardiac disorders	MedDRA (11.0)	Systematic Assessment	EG0007 affected941 at risk EG0010 affected59 at risk
Prosthetic aortic valve stenosis	Cardiac disorders	MedDRA (11.0)	Systematic Assessment	EG0002 affected941 at risk EG0010 affected59 at risk
Spontaneous MI	Cardiac disorders	MedDRA (11.0)	Systematic Assessment	EG00034 affected941 at risk EG0012 affected59 at risk
Disabling stroke	General disorders	MedDRA (11.0)	Systematic Assessment	EG00053 affected941 at risk EG0010 affected59 at risk
Non-Disabling stroke	General disorders	MedDRA (11.0)	Systematic Assessment	EG00035 affected941 at risk EG0010 affected59 at risk
Other	General disorders	MedDRA (11.0)	Systematic Assessment	EG000597 affected941 at risk EG00133 affected59 at risk
TIA	General disorders	MedDRA (11.0)	Systematic Assessment	EG00017 affected941 at risk EG0011 affected59 at risk
Stage 1 AKI	Renal and urinary disorders	MedDRA (11.0)	Systematic Assessment	EG0006 affected941 at risk EG0010 affected59 at risk
Stage 2 AKI	Renal and urinary disorders	MedDRA (11.0)	Systematic Assessment	EG0008 affected941 at risk EG0010 affected59 at risk
Stage 3 AKI	Renal and urinary disorders	MedDRA (11.0)	Systematic Assessment	EG00039 affected941 at risk EG0010 affected59 at risk
Undetermined AKI	Renal and urinary disorders	MedDRA (11.0)	Systematic Assessment	EG00013 affected941 at risk EG0012 affected59 at risk
Need for second TAVI	Surgical and medical procedures	MedDRA (11.0)	Systematic Assessment	EG0008 affected941 at risk EG0010 affected59 at risk
Pacemaker implantation	Surgical and medical procedures	MedDRA (11.0)	Systematic Assessment	EG000204 affected941 at risk EG0011 affected59 at risk
Major vascular complications	Vascular disorders	MedDRA (11.0)	Systematic Assessment	EG00065 affected941 at risk EG0010 affected59 at risk
Minor vascular complications	Vascular disorders	MedDRA (11.0)	Systematic Assessment	EG00014 affected941 at risk EG0010 affected59 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Clinical significant bleeding	Blood and lymphatic system disorders	MedDRA (11.0)	Systematic Assessment	EG0003 affected941 at risk EG0010 affected59 at risk
Life threatening bleeding	Blood and lymphatic system disorders	MedDRA (11.0)	Systematic Assessment	EG0001 affected941 at risk EG0010 affected59 at risk
Major bleeding	Blood and lymphatic system disorders	MedDRA (11.0)	Systematic Assessment	EG0005 affected941 at risk EG0010 affected59 at risk
Minor bleeding	Blood and lymphatic system disorders	MedDRA (11.0)	Systematic Assessment	EG00069 affected941 at risk EG0010 affected59 at risk
Not clinical significant bleeding	Blood and lymphatic system disorders	MedDRA (11.0)	Systematic Assessment	EG0007 affected941 at risk EG0010 affected59 at risk
Endocarditis	Cardiac disorders	MedDRA (11.0)	Systematic Assessment	EG0003 affected941 at risk EG0010 affected59 at risk
New Onset of Atrial Fibrillation	Cardiac disorders	MedDRA (11.0)	Systematic Assessment	EG00050 affected941 at risk EG0013 affected59 at risk
Peri-Procedural MI	Cardiac disorders	MedDRA (11.0)	Systematic Assessment	EG0002 affected941 at risk EG0010 affected59 at risk
Prosthetic aortic valve regurgitation	Cardiac disorders	MedDRA (11.0)	Systematic Assessment	EG00027 affected941 at risk EG0010 affected59 at risk
Prosthetic aortic valve stenosis	Cardiac disorders	MedDRA (11.0)	Systematic Assessment	EG0006 affected941 at risk EG0010 affected59 at risk
Arrhythmia / Conduction abnormality	Cardiac disorders	MedDRA (11.0)	Systematic Assessment	EG000284 affected941 at risk EG0015 affected59 at risk
Other	General disorders	MedDRA (11.0)	Systematic Assessment	EG000312 affected941 at risk EG00117 affected59 at risk
TIA	General disorders	MedDRA (11.0)	Systematic Assessment	EG0005 affected941 at risk EG0010 affected59 at risk
Stage 1 AKI	Renal and urinary disorders	MedDRA (11.0)	Systematic Assessment	EG0003 affected941 at risk EG0010 affected59 at risk
Stage 2 AKI	Renal and urinary disorders	MedDRA (11.0)	Systematic Assessment	EG0002 affected941 at risk EG0011 affected59 at risk
Stage 3 AKI	Renal and urinary disorders	MedDRA (11.0)	Systematic Assessment	EG0002 affected941 at risk EG0010 affected59 at risk
Undetermined AKI	Renal and urinary disorders	MedDRA (11.0)	Systematic Assessment	EG0005 affected941 at risk EG0010 affected59 at risk
Need for second TAVI	Surgical and medical procedures	MedDRA (11.0)	Systematic Assessment	EG0005 affected941 at risk EG0010 affected59 at risk
Pacemaker implantation	Surgical and medical procedures	MedDRA (11.0)	Systematic Assessment	EG0008 affected941 at risk EG0010 affected59 at risk
Major vascular complications	Vascular disorders	MedDRA (11.0)	Systematic Assessment	EG0002 affected941 at risk EG0010 affected59 at risk
Minor vascular complications	Vascular disorders	MedDRA (11.0)	Systematic Assessment	EG00045 affected941 at risk EG0010 affected59 at risk
Undetermined vascular complications	Vascular disorders	MedDRA (11.0)	Systematic Assessment	EG0002 affected941 at risk EG0010 affected59 at risk

ID	Term
D000082862	Aortic Valve Disease
D006349	Heart Valve Diseases
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D014694	Ventricular Outflow Obstruction

ID	Term
D019918	Heart Valve Prosthesis Implantation
D006348	Cardiac Surgical Procedures
D013504	Cardiovascular Surgical Procedures
D013514	Surgical Procedures, Operative
D019919	Prosthesis Implantation
D019616	Thoracic Surgical Procedures

ID	Title	Description
BG000	Cohort A	Patients implanted with a Portico valve after CE mark
BG001	Cohort B	Patients implanted in previous SJM-sponsored premarket studies
BG002	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Cohort A	Patients implanted with a Portico valve after CE mark	382	941	754	941	526	941
EG001	Cohort B	Patients implanted in previous SJM-sponsored premarket studies	18	59	40	59	22	59