Trial Outcomes & Findings for COMMENCE Pulmonary: Clinical Evaluation of Edwards Pericardial Aortic Bioprosthesis (Model 11000A) for Pulmonary Valve Replacement (NCT NCT02656290)

NCT ID: NCT02656290

Last Updated: 2023-11-21

Results Overview

Subject's freedom from device or procedure related death and/or reoperation at 1-year post-implant. Time to events were estimated by Kaplan-Meier method. A higher number means a better outcome.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 26 participants
• Primary outcome timeframe: 1-year post-implant
• Results posted on: 2023-11-21

Participant Flow

Participant milestones

Measure	Edwards Pericardial Aortic Bioprosthesis Model 11000A Edwards Pericardial Aortic Bioprosthesis Model 11000A in the pulmonary position in subjects five years or older requiring replacement of their native or prosthetic pulmonary valve.
Overall Study STARTED	26
Overall Study Discharge	26
Overall Study 30 Days	26
Overall Study 3-6 Months	25
Overall Study 1 Year	25
Overall Study 2 Years	24
Overall Study 3 Years	24
Overall Study 4 Years	19
Overall Study 5 Years	22
Overall Study COMPLETED	22
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Measure	Edwards Pericardial Aortic Bioprosthesis Model 11000A Edwards Pericardial Aortic Bioprosthesis Model 11000A in the pulmonary position in subjects five years or older requiring replacement of their native or prosthetic pulmonary valve.
Overall Study Lost to Follow-up	1
Overall Study Reintervention	3

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Edwards Pericardial Aortic Bioprosthesis Model 11000A n=26 Participants Edwards Pericardial Aortic Bioprosthesis Model 11000A in the pulmonary position in subjects five years or older requiring replacement of their native or prosthetic pulmonary valve.
Age, Continuous	18.7 years STANDARD_DEVIATION 10.0 • n=26 Participants
Sex: Female, Male Female	11 Participants n=26 Participants
Sex: Female, Male Male	15 Participants n=26 Participants

PRIMARY outcome

Timeframe: 1-year post-implant

Population: The outcome is reported for subjects who received the Edwards Pericardial Aortic Bioprosthesis Model 11000A device in the pulmonary position where data is available.

Subject's freedom from device or procedure related death and/or reoperation at 1-year post-implant. Time to events were estimated by Kaplan-Meier method. A higher number means a better outcome.

Outcome measures

Measure	Edwards Pericardial Aortic Bioprosthesis Model 11000A n=26 Participants Edwards Pericardial Aortic Bioprosthesis Model 11000A in the pulmonary position in subjects five years or older requiring replacement of their native or prosthetic pulmonary valve.	Edwards Pericardial Aortic Bioprosthesis Model 11000A - 23 mm Edwards Pericardial Aortic Bioprosthesis Model 11000A in the pulmonary position in subjects five years or older requiring replacement of their native or prosthetic pulmonary valve.	Edwards Pericardial Aortic Bioprosthesis Model 11000A - 25 mm Edwards Pericardial Aortic Bioprosthesis Model 11000A in the pulmonary position in subjects five years or older requiring replacement of their native or prosthetic pulmonary valve.	Edwards Pericardial Aortic Bioprosthesis Model 11000A - 27 mm Edwards Pericardial Aortic Bioprosthesis Model 11000A in the pulmonary position in subjects five years or older requiring replacement of their native or prosthetic pulmonary valve.
Percentage of Subject's With Freedom From Device or Procedure Related Death and/or Reoperation at 1-year Post-implant.	100.0 percentage of subjects	—	—	—

SECONDARY outcome

Timeframe: Percentage of events occurring within 30 days of procedure

Population: The outcome is reported for subjects who received the Edwards Pericardial Aortic Bioprosthesis Model 11000A device in the pulmonary position where data is available.

Number of early adverse events occurring within 30 days of procedure divided by the total number of enrolled subjects times 100.

Outcome measures

Measure	Edwards Pericardial Aortic Bioprosthesis Model 11000A n=26 Participants Edwards Pericardial Aortic Bioprosthesis Model 11000A in the pulmonary position in subjects five years or older requiring replacement of their native or prosthetic pulmonary valve.	Edwards Pericardial Aortic Bioprosthesis Model 11000A - 23 mm Edwards Pericardial Aortic Bioprosthesis Model 11000A in the pulmonary position in subjects five years or older requiring replacement of their native or prosthetic pulmonary valve.	Edwards Pericardial Aortic Bioprosthesis Model 11000A - 25 mm Edwards Pericardial Aortic Bioprosthesis Model 11000A in the pulmonary position in subjects five years or older requiring replacement of their native or prosthetic pulmonary valve.	Edwards Pericardial Aortic Bioprosthesis Model 11000A - 27 mm Edwards Pericardial Aortic Bioprosthesis Model 11000A in the pulmonary position in subjects five years or older requiring replacement of their native or prosthetic pulmonary valve.
Percentage of Early Adverse Events All Cause Death	0.0 percentage of subjects	—	—	—
Percentage of Early Adverse Events Valve Related Death	0.0 percentage of subjects	—	—	—
Percentage of Early Adverse Events All Paravalvular Leak (PVL)	0.0 percentage of subjects	—	—	—
Percentage of Early Adverse Events All Transvalvular Leak (TVL)	0.0 percentage of subjects	—	—	—
Percentage of Early Adverse Events Major Transvalvular Leak	0.0 percentage of subjects	—	—	—
Percentage of Early Adverse Events Minor Transvalvular Leak	0.0 percentage of subjects	—	—	—
Percentage of Early Adverse Events Endocarditis	0.0 percentage of subjects	—	—	—
Percentage of Early Adverse Events Reintervention	0.0 percentage of subjects	—	—	—
Percentage of Early Adverse Events Explant	0.0 percentage of subjects	—	—	—
Percentage of Early Adverse Events Thromboembolism	0.0 percentage of subjects	—	—	—
Percentage of Early Adverse Events Structural Valve Deterioration	0.0 percentage of subjects	—	—	—
Percentage of Early Adverse Events Non-Structural Valve Deterioration Other than Paravalvular Leak	0.0 percentage of subjects	—	—	—
Percentage of Early Adverse Events Valve Thrombosis - Pulmonary	0.0 percentage of subjects	—	—	—
Percentage of Early Adverse Events Major Bleeding	3.8 percentage of subjects	—	—	—
Percentage of Early Adverse Events Minor Bleeding	0.0 percentage of subjects	—	—	—
Percentage of Early Adverse Events Hemolysis	0.0 percentage of subjects	—	—	—
Percentage of Early Adverse Events All Bleeding	3.8 percentage of subjects	—	—	—

SECONDARY outcome

Timeframe: Events occurring ≥ 31 days and up through 5 years post implant.

Population: The outcome is reported for subjects who received the Edwards Pericardial Aortic Bioprosthesis Model 11000A in the pulmonary position where data is available.

Late patient years are calculated from 31 days post-implant to the date of the last follow-up visit (or contact) or adverse event. Late patient year calculation: [(Number of late events/sum of late patient years) x 100]

Outcome measures

Measure	Edwards Pericardial Aortic Bioprosthesis Model 11000A n=26 Participants Edwards Pericardial Aortic Bioprosthesis Model 11000A in the pulmonary position in subjects five years or older requiring replacement of their native or prosthetic pulmonary valve.	Edwards Pericardial Aortic Bioprosthesis Model 11000A - 23 mm Edwards Pericardial Aortic Bioprosthesis Model 11000A in the pulmonary position in subjects five years or older requiring replacement of their native or prosthetic pulmonary valve.	Edwards Pericardial Aortic Bioprosthesis Model 11000A - 25 mm Edwards Pericardial Aortic Bioprosthesis Model 11000A in the pulmonary position in subjects five years or older requiring replacement of their native or prosthetic pulmonary valve.	Edwards Pericardial Aortic Bioprosthesis Model 11000A - 27 mm Edwards Pericardial Aortic Bioprosthesis Model 11000A in the pulmonary position in subjects five years or older requiring replacement of their native or prosthetic pulmonary valve.
Number of Late Adverse Events Divided by Late Patient Years (Expressed as a Percentage) for the Trial Valve Cohort. Explant	0.0 Percentage of events/late patient years	—	—	—
Number of Late Adverse Events Divided by Late Patient Years (Expressed as a Percentage) for the Trial Valve Cohort. Thromboembolism	0.0 Percentage of events/late patient years	—	—	—
Number of Late Adverse Events Divided by Late Patient Years (Expressed as a Percentage) for the Trial Valve Cohort. Structural Valve Deterioration	2.3 Percentage of events/late patient years	—	—	—
Number of Late Adverse Events Divided by Late Patient Years (Expressed as a Percentage) for the Trial Valve Cohort. Non-Structural Valve Deterioration other than PVL	0.0 Percentage of events/late patient years	—	—	—
Number of Late Adverse Events Divided by Late Patient Years (Expressed as a Percentage) for the Trial Valve Cohort. Valve Thrombosis - Pulmonary	0.0 Percentage of events/late patient years	—	—	—
Number of Late Adverse Events Divided by Late Patient Years (Expressed as a Percentage) for the Trial Valve Cohort. All Bleeding	0.8 Percentage of events/late patient years	—	—	—
Number of Late Adverse Events Divided by Late Patient Years (Expressed as a Percentage) for the Trial Valve Cohort. Major Bleeding	0.0 Percentage of events/late patient years	—	—	—
Number of Late Adverse Events Divided by Late Patient Years (Expressed as a Percentage) for the Trial Valve Cohort. Minor Bleeding	0.8 Percentage of events/late patient years	—	—	—
Number of Late Adverse Events Divided by Late Patient Years (Expressed as a Percentage) for the Trial Valve Cohort. Hemolysis	0.0 Percentage of events/late patient years	—	—	—
Number of Late Adverse Events Divided by Late Patient Years (Expressed as a Percentage) for the Trial Valve Cohort. All cause death	0.0 Percentage of events/late patient years	—	—	—
Number of Late Adverse Events Divided by Late Patient Years (Expressed as a Percentage) for the Trial Valve Cohort. Valve related death	0.0 Percentage of events/late patient years	—	—	—
Number of Late Adverse Events Divided by Late Patient Years (Expressed as a Percentage) for the Trial Valve Cohort. All Paravalvular leak (PVL)	0.0 Percentage of events/late patient years	—	—	—
Number of Late Adverse Events Divided by Late Patient Years (Expressed as a Percentage) for the Trial Valve Cohort. All Transvalvular Leak (TVL)	13.7 Percentage of events/late patient years	—	—	—
Number of Late Adverse Events Divided by Late Patient Years (Expressed as a Percentage) for the Trial Valve Cohort. Major Transvalvular Leak	2.3 Percentage of events/late patient years	—	—	—
Number of Late Adverse Events Divided by Late Patient Years (Expressed as a Percentage) for the Trial Valve Cohort. Minor Transvalvular	11.4 Percentage of events/late patient years	—	—	—
Number of Late Adverse Events Divided by Late Patient Years (Expressed as a Percentage) for the Trial Valve Cohort. Endocarditis	0.0 Percentage of events/late patient years	—	—	—
Number of Late Adverse Events Divided by Late Patient Years (Expressed as a Percentage) for the Trial Valve Cohort. Reintervention	2.3 Percentage of events/late patient years	—	—	—

SECONDARY outcome

Timeframe: Baseline, 30 days, 3 months, and annually thereafter for up to 5 years

Population: This outcome is reported for subjects who received the trial valve. Note that the number of participants analyzed is different from that in the participant flow as there was some missing data.

Mean gradient is the average flow of blood through the aortic valve measured in millimeters of mercury. Gradients are evaluated by echocardiography over time. In general, a higher value is considered worse, and a lower value is considered better but the value is dependent on the size and type of valve.

Outcome measures

Measure	Edwards Pericardial Aortic Bioprosthesis Model 11000A n=1 Participants Edwards Pericardial Aortic Bioprosthesis Model 11000A in the pulmonary position in subjects five years or older requiring replacement of their native or prosthetic pulmonary valve.	Edwards Pericardial Aortic Bioprosthesis Model 11000A - 23 mm n=3 Participants Edwards Pericardial Aortic Bioprosthesis Model 11000A in the pulmonary position in subjects five years or older requiring replacement of their native or prosthetic pulmonary valve.	Edwards Pericardial Aortic Bioprosthesis Model 11000A - 25 mm n=12 Participants Edwards Pericardial Aortic Bioprosthesis Model 11000A in the pulmonary position in subjects five years or older requiring replacement of their native or prosthetic pulmonary valve.	Edwards Pericardial Aortic Bioprosthesis Model 11000A - 27 mm n=10 Participants Edwards Pericardial Aortic Bioprosthesis Model 11000A in the pulmonary position in subjects five years or older requiring replacement of their native or prosthetic pulmonary valve.
Subject's Average Mean Gradient Measurements Over Time. Baseline	—	8.0 mmHg Standard Deviation 1.7	9.0 mmHg Standard Deviation 8.6	8.4 mmHg Standard Deviation 3.0
Subject's Average Mean Gradient Measurements Over Time. 30 days	—	—	7.7 mmHg Standard Deviation 2.5	7.8 mmHg Standard Deviation 2.8
Subject's Average Mean Gradient Measurements Over Time. 3 months	9.5 mmHg Standard Deviation NA The sample size is 1 and therefore no standard deviation is available.	12.9 mmHg Standard Deviation 3.5	9.5 mmHg Standard Deviation 3.3	8.8 mmHg Standard Deviation 2.1
Subject's Average Mean Gradient Measurements Over Time. 1 Year	15.0 mmHg Standard Deviation NA The sample size is 1 and therefore no standard deviation is available.	—	10.9 mmHg Standard Deviation 4.3	10.3 mmHg Standard Deviation 4.2
Subject's Average Mean Gradient Measurements Over Time. 2 Years	14.4 mmHg Standard Deviation NA The sample size is 1 and therefore no standard deviation is available.	14.3 mmHg Standard Deviation NA The sample size is 1 and therefore no standard deviation is available.	10.8 mmHg Standard Deviation 3.8	10.7 mmHg Standard Deviation 3.7
Subject's Average Mean Gradient Measurements Over Time. 3 Years	35.1 mmHg Standard Deviation NA The sample size is 1 and therefore no standard deviation is available.	24.9 mmHg Standard Deviation NA The sample size is 1 and therefore no standard deviation is available.	10.8 mmHg Standard Deviation 3.5	11.7 mmHg Standard Deviation 5.1
Subject's Average Mean Gradient Measurements Over Time. 4 Years	—	—	11.4 mmHg Standard Deviation 3.1	11.3 mmHg Standard Deviation 4.3
Subject's Average Mean Gradient Measurements Over Time. 5 Years	44.6 mmHg Standard Deviation NA The sample size is 1 and therefore no standard deviation is available.	—	11.8 mmHg Standard Deviation 2.6	10.9 mmHg Standard Deviation 4.4

SECONDARY outcome

Timeframe: Baseline, 30 days, 3 months, and annually thereafter for up to 5 years

Population: This outcome is reported for subjects who received the trial valve. Note that the number of participants analyzed is different from that in the participant flow as there was some missing data.

Peak gradient is the maximum value measured of flow of blood through the aortic valve as measured in millimeters of mercury. Gradients are evaluated by echocardiography over time. In general, a higher value is considered worse, and a lower value is considered better but the value is dependent on the size and type of valve.

Outcome measures

Measure	Edwards Pericardial Aortic Bioprosthesis Model 11000A n=1 Participants Edwards Pericardial Aortic Bioprosthesis Model 11000A in the pulmonary position in subjects five years or older requiring replacement of their native or prosthetic pulmonary valve.	Edwards Pericardial Aortic Bioprosthesis Model 11000A - 23 mm n=3 Participants Edwards Pericardial Aortic Bioprosthesis Model 11000A in the pulmonary position in subjects five years or older requiring replacement of their native or prosthetic pulmonary valve.	Edwards Pericardial Aortic Bioprosthesis Model 11000A - 25 mm n=12 Participants Edwards Pericardial Aortic Bioprosthesis Model 11000A in the pulmonary position in subjects five years or older requiring replacement of their native or prosthetic pulmonary valve.	Edwards Pericardial Aortic Bioprosthesis Model 11000A - 27 mm n=10 Participants Edwards Pericardial Aortic Bioprosthesis Model 11000A in the pulmonary position in subjects five years or older requiring replacement of their native or prosthetic pulmonary valve.
Subject's Average Peak Gradient Measurements Over Time. Baseline	—	15.6 mmHg Standard Deviation 2.9	16.1 mmHg Standard Deviation 14.4	16.4 mmHg Standard Deviation 5.5
Subject's Average Peak Gradient Measurements Over Time. 30 days	—	—	13.7 mmHg Standard Deviation 4.5	13.6 mmHg Standard Deviation 4.8
Subject's Average Peak Gradient Measurements Over Time. 3 months	17.0 mmHg Standard Deviation NA The sample size is 1 and therefore no standard deviation is available.	22.5 mmHg Standard Deviation 5.3	16.7 mmHg Standard Deviation 6.2	15.5 mmHg Standard Deviation 3.2
Subject's Average Peak Gradient Measurements Over Time. 1 Year	26.8 mmHg Standard Deviation NA The sample size is 1 and therefore no standard deviation is available.	—	19.1 mmHg Standard Deviation 7.4	18.3 mmHg Standard Deviation 7.5
Subject's Average Peak Gradient Measurements Over Time. 2 Years	23.4 mmHg Standard Deviation NA The sample size is 1 and therefore no standard deviation is available.	23.8 mmHg Standard Deviation NA The sample size is 1 and therefore no standard deviation is available.	19.4 mmHg Standard Deviation 6.7	19.1 mmHg Standard Deviation 6.4
Subject's Average Peak Gradient Measurements Over Time. 3 Years	62.4 mmHg Standard Deviation NA The sample size is 1 and therefore no standard deviation is available.	42.0 mmHg Standard Deviation NA The sample size is 1 and therefore no standard deviation is available.	19.2 mmHg Standard Deviation 6.5	20.6 mmHg Standard Deviation 8.9
Subject's Average Peak Gradient Measurements Over Time. 4 Years	—	—	19.9 mmHg Standard Deviation 5.0	19.7 mmHg Standard Deviation 7.3
Subject's Average Peak Gradient Measurements Over Time. 5 Years	77.8 mmHg Standard Deviation NA The sample size is 1 and therefore no standard deviation is available.	—	20.9 mmHg Standard Deviation 5.0	19.8 mmHg Standard Deviation 7.9

SECONDARY outcome

Timeframe: Discharge, 30 days, 3 months, and annually thereafter for up to 5 years

Population: This outcome is reported for subjects who received the trial valve. Note that the number of participants analyzed is different from that in the participant flow as there was some missing data.

Paravalvular leak refers to blood flowing through a channel between the implanted artificial valve and the cardiac tissue as a result of inappropriate sealing. Paravalvular leak is evaluated by echocardiography over time. It is assessed on a scale from 0 to 4, where 0 represents no regurgitation/leak (a better outcome) and 4 represents severe regurgitation/leak (a worse outcome).

Outcome measures

Measure	Edwards Pericardial Aortic Bioprosthesis Model 11000A n=1 Participants Edwards Pericardial Aortic Bioprosthesis Model 11000A in the pulmonary position in subjects five years or older requiring replacement of their native or prosthetic pulmonary valve.	Edwards Pericardial Aortic Bioprosthesis Model 11000A - 23 mm n=3 Participants Edwards Pericardial Aortic Bioprosthesis Model 11000A in the pulmonary position in subjects five years or older requiring replacement of their native or prosthetic pulmonary valve.	Edwards Pericardial Aortic Bioprosthesis Model 11000A - 25 mm n=12 Participants Edwards Pericardial Aortic Bioprosthesis Model 11000A in the pulmonary position in subjects five years or older requiring replacement of their native or prosthetic pulmonary valve.	Edwards Pericardial Aortic Bioprosthesis Model 11000A - 27 mm n=10 Participants Edwards Pericardial Aortic Bioprosthesis Model 11000A in the pulmonary position in subjects five years or older requiring replacement of their native or prosthetic pulmonary valve.
Amount of Paravalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size Discharge · None (0)	1 Participants	3 Participants	8 Participants	10 Participants
Amount of Paravalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size Discharge · Trival/Trace (+1)	0 Participants	0 Participants	3 Participants	0 Participants
Amount of Paravalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size Discharge · Mild (+2)	0 Participants	0 Participants	0 Participants	0 Participants
Amount of Paravalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size Discharge · Moderate (+3)	0 Participants	0 Participants	0 Participants	0 Participants
Amount of Paravalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size Discharge · Severe (+4)	0 Participants	0 Participants	0 Participants	0 Participants
Amount of Paravalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size 30 days · None (0)	—	1 Participants	9 Participants	8 Participants
Amount of Paravalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size 30 days · Trival/Trace (+1)	—	0 Participants	1 Participants	0 Participants
Amount of Paravalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size 30 days · Mild (+2)	—	0 Participants	0 Participants	0 Participants
Amount of Paravalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size 30 days · Moderate (+3)	—	0 Participants	0 Participants	0 Participants
Amount of Paravalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size 30 days · Severe (+4)	—	0 Participants	0 Participants	0 Participants
Amount of Paravalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size 3 months · None (0)	1 Participants	3 Participants	11 Participants	7 Participants
Amount of Paravalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size 3 months · Trival/Trace (+1)	0 Participants	0 Participants	0 Participants	0 Participants
Amount of Paravalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size 3 months · Mild (+2)	0 Participants	0 Participants	0 Participants	0 Participants
Amount of Paravalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size 3 months · Moderate (+3)	0 Participants	0 Participants	0 Participants	0 Participants
Amount of Paravalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size 3 months · Severe (+4)	0 Participants	0 Participants	0 Participants	0 Participants
Amount of Paravalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size 1 year · None (0)	1 Participants	2 Participants	10 Participants	9 Participants
Amount of Paravalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size 1 year · Trival/Trace (+1)	0 Participants	0 Participants	1 Participants	0 Participants
Amount of Paravalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size 1 year · Mild (+2)	0 Participants	0 Participants	0 Participants	0 Participants
Amount of Paravalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size 1 year · Moderate (+3)	0 Participants	0 Participants	0 Participants	0 Participants
Amount of Paravalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size 1 year · Severe (+4)	0 Participants	0 Participants	0 Participants	0 Participants
Amount of Paravalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size 2 years · None (0)	1 Participants	2 Participants	11 Participants	7 Participants
Amount of Paravalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size 2 years · Trival/Trace (+1)	0 Participants	0 Participants	0 Participants	1 Participants
Amount of Paravalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size 2 years · Mild (+2)	0 Participants	0 Participants	0 Participants	0 Participants
Amount of Paravalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size 2 years · Moderate (+3)	0 Participants	0 Participants	0 Participants	0 Participants
Amount of Paravalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size 2 years · Severe (+4)	0 Participants	0 Participants	0 Participants	0 Participants
Amount of Paravalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size 3 years · None (0)	1 Participants	2 Participants	10 Participants	9 Participants
Amount of Paravalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size 3 years · Trival/Trace (+1)	0 Participants	0 Participants	0 Participants	0 Participants
Amount of Paravalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size 3 years · Mild (+2)	0 Participants	0 Participants	0 Participants	0 Participants
Amount of Paravalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size 3 years · Moderate (+3)	0 Participants	0 Participants	0 Participants	0 Participants
Amount of Paravalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size 3 years · Severe (+4)	0 Participants	0 Participants	0 Participants	0 Participants
Amount of Paravalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size 4 years · None (0)	—	1 Participants	10 Participants	5 Participants
Amount of Paravalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size 4 years · Trival/Trace (+1)	—	0 Participants	0 Participants	0 Participants
Amount of Paravalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size 4 years · Mild (+2)	—	0 Participants	0 Participants	0 Participants
Amount of Paravalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size 4 years · Moderate (+3)	—	0 Participants	0 Participants	0 Participants
Amount of Paravalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size 4 years · Severe (+4)	—	0 Participants	0 Participants	0 Participants
Amount of Paravalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size 5 years · None (0)	1 Participants	1 Participants	8 Participants	8 Participants
Amount of Paravalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size 5 years · Trival/Trace (+1)	0 Participants	0 Participants	0 Participants	0 Participants
Amount of Paravalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size 5 years · Mild (+2)	0 Participants	0 Participants	0 Participants	0 Participants
Amount of Paravalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size 5 years · Moderate (+3)	0 Participants	0 Participants	0 Participants	0 Participants
Amount of Paravalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size 5 years · Severe (+4)	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Discharge, 30 days, 3 months, and annually thereafter for up to 5 years

Population: This outcome is reported for subjects who received the trial valve. Note that the number of participants analyzed is different from that in the participant flow as there was some missing data.

Valvular regurgitation occurs when the valve in the heart does not close tightly allowing some of the blood that was pumped out of the heart to leak back into it. Valvular regurgitation is evaluated by echocardiography over time. It is assessed on a scale from 0 to 4, where 0 represents no regurgitation (a better outcome) and 4 represents severe regurgitation (a worse outcome).

Outcome measures

Measure	Edwards Pericardial Aortic Bioprosthesis Model 11000A n=1 Participants Edwards Pericardial Aortic Bioprosthesis Model 11000A in the pulmonary position in subjects five years or older requiring replacement of their native or prosthetic pulmonary valve.	Edwards Pericardial Aortic Bioprosthesis Model 11000A - 23 mm n=3 Participants Edwards Pericardial Aortic Bioprosthesis Model 11000A in the pulmonary position in subjects five years or older requiring replacement of their native or prosthetic pulmonary valve.	Edwards Pericardial Aortic Bioprosthesis Model 11000A - 25 mm n=12 Participants Edwards Pericardial Aortic Bioprosthesis Model 11000A in the pulmonary position in subjects five years or older requiring replacement of their native or prosthetic pulmonary valve.	Edwards Pericardial Aortic Bioprosthesis Model 11000A - 27 mm n=10 Participants Edwards Pericardial Aortic Bioprosthesis Model 11000A in the pulmonary position in subjects five years or older requiring replacement of their native or prosthetic pulmonary valve.
Amount of Transvalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size 3 months · Moderate (+3)	0 Participants	0 Participants	0 Participants	0 Participants
Amount of Transvalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size 3 months · Severe (+4)	0 Participants	0 Participants	0 Participants	0 Participants
Amount of Transvalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size 1 year · None (0)	0 Participants	0 Participants	1 Participants	0 Participants
Amount of Transvalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size 1 year · Trival/Trace (+1)	0 Participants	0 Participants	7 Participants	5 Participants
Amount of Transvalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size 1 year · Mild (+2)	1 Participants	2 Participants	2 Participants	3 Participants
Amount of Transvalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size 1 year · Moderate (+3)	0 Participants	0 Participants	1 Participants	0 Participants
Amount of Transvalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size Discharge · None (0)	0 Participants	0 Participants	0 Participants	0 Participants
Amount of Transvalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size Discharge · Trival/Trace (+1)	1 Participants	3 Participants	11 Participants	9 Participants
Amount of Transvalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size Discharge · Mild (+2)	0 Participants	0 Participants	0 Participants	1 Participants
Amount of Transvalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size Discharge · Moderate (+3)	0 Participants	0 Participants	0 Participants	0 Participants
Amount of Transvalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size 1 year · Severe (+4)	0 Participants	0 Participants	0 Participants	2 Participants
Amount of Transvalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size Discharge · Severe (+4)	0 Participants	0 Participants	0 Participants	0 Participants
Amount of Transvalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size 30 days · None (0)	—	0 Participants	0 Participants	0 Participants
Amount of Transvalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size 30 days · Trival/Trace (+1)	—	1 Participants	10 Participants	6 Participants
Amount of Transvalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size 30 days · Mild (+2)	—	0 Participants	0 Participants	2 Participants
Amount of Transvalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size 30 days · Moderate (+3)	—	0 Participants	0 Participants	0 Participants
Amount of Transvalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size 30 days · Severe (+4)	—	0 Participants	0 Participants	0 Participants
Amount of Transvalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size 3 months · None (0)	0 Participants	0 Participants	3 Participants	0 Participants
Amount of Transvalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size 3 months · Trival/Trace (+1)	0 Participants	1 Participants	7 Participants	6 Participants
Amount of Transvalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size 3 months · Mild (+2)	1 Participants	2 Participants	1 Participants	1 Participants
Amount of Transvalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size 2 years · None (0)	0 Participants	0 Participants	0 Participants	0 Participants
Amount of Transvalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size 2 years · Trival/Trace (+1)	0 Participants	0 Participants	6 Participants	2 Participants
Amount of Transvalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size 2 years · Mild (+2)	1 Participants	1 Participants	2 Participants	5 Participants
Amount of Transvalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size 2 years · Moderate (+3)	0 Participants	1 Participants	3 Participants	0 Participants
Amount of Transvalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size 2 years · Severe (+4)	0 Participants	0 Participants	0 Participants	1 Participants
Amount of Transvalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size 3 years · None (0)	0 Participants	0 Participants	0 Participants	0 Participants
Amount of Transvalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size 3 years · Trival/Trace (+1)	0 Participants	0 Participants	4 Participants	3 Participants
Amount of Transvalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size 3 years · Mild (+2)	0 Participants	1 Participants	2 Participants	3 Participants
Amount of Transvalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size 3 years · Moderate (+3)	1 Participants	0 Participants	3 Participants	2 Participants
Amount of Transvalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size 3 years · Severe (+4)	0 Participants	1 Participants	1 Participants	1 Participants
Amount of Transvalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size 4 years · None (0)	—	0 Participants	0 Participants	0 Participants
Amount of Transvalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size 4 years · Trival/Trace (+1)	—	0 Participants	2 Participants	1 Participants
Amount of Transvalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size 4 years · Mild (+2)	—	0 Participants	3 Participants	1 Participants
Amount of Transvalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size 4 years · Moderate (+3)	—	0 Participants	3 Participants	2 Participants
Amount of Transvalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size 4 years · Severe (+4)	—	1 Participants	2 Participants	1 Participants
Amount of Transvalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size 5 years · None (0)	0 Participants	0 Participants	0 Participants	0 Participants
Amount of Transvalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size 5 years · Trival/Trace (+1)	0 Participants	0 Participants	1 Participants	2 Participants
Amount of Transvalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size 5 years · Mild (+2)	0 Participants	0 Participants	2 Participants	0 Participants
Amount of Transvalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size 5 years · Moderate (+3)	0 Participants	0 Participants	4 Participants	3 Participants
Amount of Transvalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size 5 years · Severe (+4)	1 Participants	1 Participants	1 Participants	3 Participants

SECONDARY outcome

Timeframe: Baseline, 30 days, 3 months, and annually thereafter for up to 5 years

Population: This outcome is reported for subjects who received the trial valve. Note that the number of participants analyzed is different from that in the participant flow as there was some missing data.

Tricuspid regurgitation (TR) gradient (peak systolic) is defined as the maximum value measured of blood flowing back through the tricuspid valve during systole as measured in millimeters of mercury. In general, a higher value is considered worse, and a lower value is considered better but the value is dependent on the size and type of valve.

Outcome measures

Measure	Edwards Pericardial Aortic Bioprosthesis Model 11000A n=1 Participants Edwards Pericardial Aortic Bioprosthesis Model 11000A in the pulmonary position in subjects five years or older requiring replacement of their native or prosthetic pulmonary valve.	Edwards Pericardial Aortic Bioprosthesis Model 11000A - 23 mm n=3 Participants Edwards Pericardial Aortic Bioprosthesis Model 11000A in the pulmonary position in subjects five years or older requiring replacement of their native or prosthetic pulmonary valve.	Edwards Pericardial Aortic Bioprosthesis Model 11000A - 25 mm n=12 Participants Edwards Pericardial Aortic Bioprosthesis Model 11000A in the pulmonary position in subjects five years or older requiring replacement of their native or prosthetic pulmonary valve.	Edwards Pericardial Aortic Bioprosthesis Model 11000A - 27 mm n=10 Participants Edwards Pericardial Aortic Bioprosthesis Model 11000A in the pulmonary position in subjects five years or older requiring replacement of their native or prosthetic pulmonary valve.
Subject's Average Tricuspid Regurgitation (TR) Gradient Measurement Over Time. Baseline	—	21.5 mmHg Standard Deviation 0.6	36.2 mmHg Standard Deviation 30.6	28.8 mmHg Standard Deviation 6.1
Subject's Average Tricuspid Regurgitation (TR) Gradient Measurement Over Time. 30 days	—	—	30.8 mmHg Standard Deviation 9.3	25.2 mmHg Standard Deviation 7.2
Subject's Average Tricuspid Regurgitation (TR) Gradient Measurement Over Time. 3 months	—	31.6 mmHg Standard Deviation 7.3	32.9 mmHg Standard Deviation 9.4	28.8 mmHg Standard Deviation 6.9
Subject's Average Tricuspid Regurgitation (TR) Gradient Measurement Over Time. 1 Year	23.6 mmHg Standard Deviation NA The sample size is 1 and therefore no standard deviation is available.	30.2 mmHg Standard Deviation NA The sample size is 1 and therefore no standard deviation is available.	27.7 mmHg Standard Deviation 7.4	27.7 mmHg Standard Deviation 3.8
Subject's Average Tricuspid Regurgitation (TR) Gradient Measurement Over Time. 2 Years	—	27.7 mmHg Standard Deviation NA The sample size is 1 and therefore no standard deviation is available.	30.9 mmHg Standard Deviation 9.7	24.0 mmHg Standard Deviation 8.0
Subject's Average Tricuspid Regurgitation (TR) Gradient Measurement Over Time. 3 Years	—	37.2 mmHg Standard Deviation NA The sample size is 1 and therefore no standard deviation is available.	29.2 mmHg Standard Deviation 12.0	29.2 mmHg Standard Deviation 7.7
Subject's Average Tricuspid Regurgitation (TR) Gradient Measurement Over Time. 4 Years	—	28.0 mmHg Standard Deviation NA The sample size is 1 and therefore no standard deviation is available.	35.5 mmHg Standard Deviation 8.9	29.9 mmHg Standard Deviation 10.1
Subject's Average Tricuspid Regurgitation (TR) Gradient Measurement Over Time. 5 Years	—	42.8 mmHg Standard Deviation NA The sample size is 1 and therefore no standard deviation is available.	30.3 mmHg Standard Deviation 8.5	29.4 mmHg Standard Deviation 8.3

SECONDARY outcome

Timeframe: Baseline, 30 days, 3 months, and annually thereafter for up to 5 years

Population: This outcome is reported for subjects who received the trial valve. Note that the number of participants analyzed is different from that in the participant flow as there was some missing data.

Peak velocity is defined as the maximum speed in meters per second that the blood is flowing through the pulmonic heart valve in a given direction. In general, a higher value is considered worse, and a lower value is considered better but the value is dependent on the size and type of valve.

Outcome measures

Measure	Edwards Pericardial Aortic Bioprosthesis Model 11000A n=1 Participants Edwards Pericardial Aortic Bioprosthesis Model 11000A in the pulmonary position in subjects five years or older requiring replacement of their native or prosthetic pulmonary valve.	Edwards Pericardial Aortic Bioprosthesis Model 11000A - 23 mm n=3 Participants Edwards Pericardial Aortic Bioprosthesis Model 11000A in the pulmonary position in subjects five years or older requiring replacement of their native or prosthetic pulmonary valve.	Edwards Pericardial Aortic Bioprosthesis Model 11000A - 25 mm n=12 Participants Edwards Pericardial Aortic Bioprosthesis Model 11000A in the pulmonary position in subjects five years or older requiring replacement of their native or prosthetic pulmonary valve.	Edwards Pericardial Aortic Bioprosthesis Model 11000A - 27 mm n=10 Participants Edwards Pericardial Aortic Bioprosthesis Model 11000A in the pulmonary position in subjects five years or older requiring replacement of their native or prosthetic pulmonary valve.
Subject's Average Peak Velocity Measurement Over Time Baseline	—	2.0 m/s Standard Deviation 0.2	1.8 m/s Standard Deviation 0.8	2.0 m/s Standard Deviation 0.4
Subject's Average Peak Velocity Measurement Over Time 30 days	—	—	1.8 m/s Standard Deviation 0.3	1.8 m/s Standard Deviation 0.3
Subject's Average Peak Velocity Measurement Over Time 3 Months	2.1 m/s Standard Deviation NA The sample size is 1 and therefore no standard deviation is available.	2.4 m/s Standard Deviation 0.3	2.0 m/s Standard Deviation 0.4	2.0 m/s Standard Deviation 0.2
Subject's Average Peak Velocity Measurement Over Time 1 Year	2.6 m/s Standard Deviation NA The sample size is 1 and therefore no standard deviation is available.	—	2.2 m/s Standard Deviation 0.4	2.1 m/s Standard Deviation 0.4
Subject's Average Peak Velocity Measurement Over Time 2 Years	2.4 m/s Standard Deviation NA The sample size is 1 and therefore no standard deviation is available.	2.4 m/s Standard Deviation NA The sample size is 1 and therefore no standard deviation is available.	2.2 m/s Standard Deviation 0.4	2.2 m/s Standard Deviation 0.4
Subject's Average Peak Velocity Measurement Over Time 3 Years	4.0 m/s Standard Deviation NA The sample size is 1 and therefore no standard deviation is available.	3.2 m/s Standard Deviation NA The sample size is 1 and therefore no standard deviation is available.	2.1 m/s Standard Deviation 0.4	2.2 m/s Standard Deviation 0.5
Subject's Average Peak Velocity Measurement Over Time 4 Years	—	—	2.1 m/s Standard Deviation 0.4	2.2 m/s Standard Deviation 0.4
Subject's Average Peak Velocity Measurement Over Time 5 Years	4.4 m/s Standard Deviation NA The sample size is 1 and therefore no standard deviation is available.	—	2.3 m/s Standard Deviation 0.3	2.1 m/s Standard Deviation 0.5

SECONDARY outcome

Timeframe: Baseline, 30 days, 3 months, and annually thereafter for up to 5 years

Population: This outcome is reported for subjects who received the trial valve. Note that the number of participants analyzed is different from that in the participant flow as there was some missing data.

The Doppler Velocity Index (DVI) is a calculation of the ratio of the sub valvular velocity obtained by pulse wave Doppler and the maximum velocity obtained by continuous wave Doppler across the prosthetic valve, i.e. Time velocity interval (TVI) of the pulmonic valve / TVI of the RVOT. There are no normal ranges issued by the American Society of Echocardiography's Guidelines and Standards Committee for the pulmonary valve, however the expectation is that DVI should remain relatively steady over time but will generally decrease as the degree of stenosis (narrowing or constriction of the valve opening) worsens.

Outcome measures

Measure	Edwards Pericardial Aortic Bioprosthesis Model 11000A n=1 Participants Edwards Pericardial Aortic Bioprosthesis Model 11000A in the pulmonary position in subjects five years or older requiring replacement of their native or prosthetic pulmonary valve.	Edwards Pericardial Aortic Bioprosthesis Model 11000A - 23 mm n=3 Participants Edwards Pericardial Aortic Bioprosthesis Model 11000A in the pulmonary position in subjects five years or older requiring replacement of their native or prosthetic pulmonary valve.	Edwards Pericardial Aortic Bioprosthesis Model 11000A - 25 mm n=12 Participants Edwards Pericardial Aortic Bioprosthesis Model 11000A in the pulmonary position in subjects five years or older requiring replacement of their native or prosthetic pulmonary valve.	Edwards Pericardial Aortic Bioprosthesis Model 11000A - 27 mm n=10 Participants Edwards Pericardial Aortic Bioprosthesis Model 11000A in the pulmonary position in subjects five years or older requiring replacement of their native or prosthetic pulmonary valve.
Subject's Average Doppler Velocity Index (DVI) Baseline	—	0.7 Ratio Standard Deviation 0.1	0.6 Ratio Standard Deviation 0.1	0.6 Ratio Standard Deviation 0.2
Subject's Average Doppler Velocity Index (DVI) 30 days	—	—	0.5 Ratio Standard Deviation 0.0	0.5 Ratio Standard Deviation 0.1
Subject's Average Doppler Velocity Index (DVI) 3 months	0.7 Ratio Standard Deviation NA The sample size is 1 and therefore no standard deviation is available.	0.5 Ratio Standard Deviation NA The sample size is 1 and therefore no standard deviation is available.	0.5 Ratio Standard Deviation 0.1	0.4 Ratio Standard Deviation 0.1
Subject's Average Doppler Velocity Index (DVI) 1 Year	0.5 Ratio Standard Deviation NA The sample size is 1 and therefore no standard deviation is available.	—	0.4 Ratio Standard Deviation 0.1	0.5 Ratio Standard Deviation 0.1
Subject's Average Doppler Velocity Index (DVI) 2 Years	0.5 Ratio Standard Deviation NA The sample size is 1 and therefore no standard deviation is available.	0.4 Ratio Standard Deviation NA The sample size is 1 and therefore no standard deviation is available.	0.5 Ratio Standard Deviation 0.1	0.5 Ratio Standard Deviation 0.1
Subject's Average Doppler Velocity Index (DVI) 3 Years	0.3 Ratio Standard Deviation NA The sample size is 1 and therefore no standard deviation is available.	0.4 Ratio Standard Deviation NA The sample size is 1 and therefore no standard deviation is available.	0.5 Ratio Standard Deviation 0.2	0.4 Ratio Standard Deviation 0.1
Subject's Average Doppler Velocity Index (DVI) 4 Years	—	—	0.4 Ratio Standard Deviation 0.1	0.5 Ratio Standard Deviation 0.2
Subject's Average Doppler Velocity Index (DVI) 5 Years	0.2 Ratio Standard Deviation NA The sample size is 1 and therefore no standard deviation is available.	—	0.4 Ratio Standard Deviation 0.1	0.6 Ratio Standard Deviation 0.1

SECONDARY outcome

Timeframe: Baseline, 30 days, 3 months, and annually thereafter for up to 5 years

Population: This outcome is reported for subjects who received the trial valve. Note that the number of participants analyzed is different from that in the participant flow as there was some missing data.

Transvalvular regurgitation velocity time interval (VTI) is defined as the measurement in centimeters of the blood flowing backwards through the tricuspid valve, averaged over time. There are no defined normal ranges for VTI. The VTI value is dependent on the function of the right ventricle of the heart (chamber within the heart that is responsible for pumping oxygen-depleted blood to the lungs) and the expectation is the value should be relatively steady over time.

Outcome measures

Measure	Edwards Pericardial Aortic Bioprosthesis Model 11000A n=1 Participants Edwards Pericardial Aortic Bioprosthesis Model 11000A in the pulmonary position in subjects five years or older requiring replacement of their native or prosthetic pulmonary valve.	Edwards Pericardial Aortic Bioprosthesis Model 11000A - 23 mm n=3 Participants Edwards Pericardial Aortic Bioprosthesis Model 11000A in the pulmonary position in subjects five years or older requiring replacement of their native or prosthetic pulmonary valve.	Edwards Pericardial Aortic Bioprosthesis Model 11000A - 25 mm n=12 Participants Edwards Pericardial Aortic Bioprosthesis Model 11000A in the pulmonary position in subjects five years or older requiring replacement of their native or prosthetic pulmonary valve.	Edwards Pericardial Aortic Bioprosthesis Model 11000A - 27 mm n=10 Participants Edwards Pericardial Aortic Bioprosthesis Model 11000A in the pulmonary position in subjects five years or older requiring replacement of their native or prosthetic pulmonary valve.
Subject's Average Transvalvular Velocity Time Interval (VTI) Baseline	—	70.2 cm Standard Deviation 7.3	82.9 cm Standard Deviation 35.4	76.5 cm Standard Deviation 12.0
Subject's Average Transvalvular Velocity Time Interval (VTI) 30 days	—	—	77.8 cm Standard Deviation 19.7	69.0 cm Standard Deviation 17.2
Subject's Average Transvalvular Velocity Time Interval (VTI) 3 Months	—	73.9 cm Standard Deviation 11.9	86.9 cm Standard Deviation 16.8	75.9 cm Standard Deviation 15.5
Subject's Average Transvalvular Velocity Time Interval (VTI) 1 Year	61.1 cm Standard Deviation NA The sample size is 1 and therefore no standard deviation is available.	76.9 cm Standard Deviation NA The sample size is 1 and therefore no standard deviation is available.	82.4 cm Standard Deviation 18.8	73.9 cm Standard Deviation 13.8
Subject's Average Transvalvular Velocity Time Interval (VTI) 2 Years	—	77.3 cm Standard Deviation NA The sample size is 1 and therefore no standard deviation is available.	81.3 cm Standard Deviation 17.2	64.1 cm Standard Deviation 15.4
Subject's Average Transvalvular Velocity Time Interval (VTI) 3 Years	—	87.9 cm Standard Deviation NA The sample size is 1 and therefore no standard deviation is available.	73.1 cm Standard Deviation 18.5	70.3 cm Standard Deviation 16.8
Subject's Average Transvalvular Velocity Time Interval (VTI) 4 Years	—	—	96.0 cm Standard Deviation 16.9	79.1 cm Standard Deviation 16.9
Subject's Average Transvalvular Velocity Time Interval (VTI) 5 Years	—	98.7 cm Standard Deviation NA The sample size is 1 and therefore no standard deviation is available.	79.3 cm Standard Deviation 20.3	74.1 cm Standard Deviation 18.1

SECONDARY outcome

Timeframe: Baseline, 30 days, 3 months, and annually thereafter for up to 5 years

Population: This outcome is reported for subjects who received the trial valve. Note that the number of participants analyzed is different from that in the participant flow as there was some missing data. NYHA was performed for subjects ≥13 years and the Modified Ross was performed for subjects ≤12 years. The following subjects converted to NYHA from Ross at the follow-up visit(s) due to meeting the age criteria: #6 at 5 Year, #7 at 5 Year, #13 at 4 Year and 5 Year, #22 at 3 Year, 4 Year and 5 Year.

The New York Heart Association (NYHA)/Modified Ross functional classification system relates symptoms to everyday activities and the patient's quality of life.

Class I. No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, shortness of breath.

Class II. Slight limitation of physical activity. Comfortable at rest. Ordinary physical activity results in fatigue, palpitation, shortness of breath.

Class III. Marked limitation of physical activity. Comfortable at rest. Less than ordinary activity causes fatigue, palpitation, or shortness of breath.

Class IV. Unable to carry on any physical activity without discomfort. Symptoms of heart failure at rest. If any physical activity is undertaken, discomfort increases.

Changes in NYHA/Modified Ross HF classification from the preoperative baseline to the respective completed follow-up visits are shown as the number of subjects in each class who improved, worsened, or stayed the same.

Outcome measures

Measure	Edwards Pericardial Aortic Bioprosthesis Model 11000A n=26 Participants Edwards Pericardial Aortic Bioprosthesis Model 11000A in the pulmonary position in subjects five years or older requiring replacement of their native or prosthetic pulmonary valve.	Edwards Pericardial Aortic Bioprosthesis Model 11000A - 23 mm n=26 Participants Edwards Pericardial Aortic Bioprosthesis Model 11000A in the pulmonary position in subjects five years or older requiring replacement of their native or prosthetic pulmonary valve.	Edwards Pericardial Aortic Bioprosthesis Model 11000A - 25 mm Edwards Pericardial Aortic Bioprosthesis Model 11000A in the pulmonary position in subjects five years or older requiring replacement of their native or prosthetic pulmonary valve.	Edwards Pericardial Aortic Bioprosthesis Model 11000A - 27 mm Edwards Pericardial Aortic Bioprosthesis Model 11000A in the pulmonary position in subjects five years or older requiring replacement of their native or prosthetic pulmonary valve.
Change in Subject's New York Heart Association (NYHA)/Modified Ross Heart Failure Functional Class 30 days · Improved	0 Participants	10 Participants	0 Participants	0 Participants
Change in Subject's New York Heart Association (NYHA)/Modified Ross Heart Failure Functional Class 30 days · Same	16 Participants	0 Participants	0 Participants	0 Participants
Change in Subject's New York Heart Association (NYHA)/Modified Ross Heart Failure Functional Class 30 days · Worsened	0 Participants	0 Participants	0 Participants	0 Participants
Change in Subject's New York Heart Association (NYHA)/Modified Ross Heart Failure Functional Class 1 year · Improved	0 Participants	10 Participants	0 Participants	0 Participants
Change in Subject's New York Heart Association (NYHA)/Modified Ross Heart Failure Functional Class 3 months · Improved	0 Participants	10 Participants	0 Participants	0 Participants
Change in Subject's New York Heart Association (NYHA)/Modified Ross Heart Failure Functional Class 3 months · Same	14 Participants	0 Participants	0 Participants	0 Participants
Change in Subject's New York Heart Association (NYHA)/Modified Ross Heart Failure Functional Class 3 months · Worsened	0 Participants	0 Participants	0 Participants	0 Participants
Change in Subject's New York Heart Association (NYHA)/Modified Ross Heart Failure Functional Class 1 year · Same	15 Participants	0 Participants	0 Participants	0 Participants
Change in Subject's New York Heart Association (NYHA)/Modified Ross Heart Failure Functional Class 1 year · Worsened	0 Participants	0 Participants	0 Participants	0 Participants
Change in Subject's New York Heart Association (NYHA)/Modified Ross Heart Failure Functional Class 2 years · Improved	0 Participants	9 Participants	0 Participants	0 Participants
Change in Subject's New York Heart Association (NYHA)/Modified Ross Heart Failure Functional Class 2 years · Same	14 Participants	0 Participants	0 Participants	0 Participants
Change in Subject's New York Heart Association (NYHA)/Modified Ross Heart Failure Functional Class 2 years · Worsened	0 Participants	0 Participants	0 Participants	0 Participants
Change in Subject's New York Heart Association (NYHA)/Modified Ross Heart Failure Functional Class 3 years · Improved	0 Participants	9 Participants	0 Participants	0 Participants
Change in Subject's New York Heart Association (NYHA)/Modified Ross Heart Failure Functional Class 3 years · Same	14 Participants	0 Participants	0 Participants	0 Participants
Change in Subject's New York Heart Association (NYHA)/Modified Ross Heart Failure Functional Class 3 years · Worsened	1 Participants	0 Participants	0 Participants	0 Participants
Change in Subject's New York Heart Association (NYHA)/Modified Ross Heart Failure Functional Class 4 years · Improved	0 Participants	5 Participants	0 Participants	0 Participants
Change in Subject's New York Heart Association (NYHA)/Modified Ross Heart Failure Functional Class 4 years · Same	9 Participants	2 Participants	0 Participants	0 Participants
Change in Subject's New York Heart Association (NYHA)/Modified Ross Heart Failure Functional Class 4 years · Worsened	2 Participants	0 Participants	0 Participants	0 Participants
Change in Subject's New York Heart Association (NYHA)/Modified Ross Heart Failure Functional Class 5 years · Improved	0 Participants	8 Participants	0 Participants	0 Participants
Change in Subject's New York Heart Association (NYHA)/Modified Ross Heart Failure Functional Class 5 years · Same	13 Participants	0 Participants	0 Participants	0 Participants
Change in Subject's New York Heart Association (NYHA)/Modified Ross Heart Failure Functional Class 5 years · Worsened	1 Participants	0 Participants	0 Participants	0 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, Discharge, 30 days, 3 months, and annually for up to 5 years

Population: This outcome is reported for subjects who received the trial valve. Note that the number of participants analyzed is different from that in the participant flow as there was some missing data.

Laboratory analysis of White Blood Cell (WBC) count on blood drawn from subject; WBC fight infection. The normal reference range for WBC count is 4.5 to 10.0 10^3 cells/microliters. In general, results either lower or higher than the normal range can indicate something is wrong.

Outcome measures

Measure	Edwards Pericardial Aortic Bioprosthesis Model 11000A n=26 Participants Edwards Pericardial Aortic Bioprosthesis Model 11000A in the pulmonary position in subjects five years or older requiring replacement of their native or prosthetic pulmonary valve.	Edwards Pericardial Aortic Bioprosthesis Model 11000A - 23 mm Edwards Pericardial Aortic Bioprosthesis Model 11000A in the pulmonary position in subjects five years or older requiring replacement of their native or prosthetic pulmonary valve.	Edwards Pericardial Aortic Bioprosthesis Model 11000A - 25 mm Edwards Pericardial Aortic Bioprosthesis Model 11000A in the pulmonary position in subjects five years or older requiring replacement of their native or prosthetic pulmonary valve.	Edwards Pericardial Aortic Bioprosthesis Model 11000A - 27 mm Edwards Pericardial Aortic Bioprosthesis Model 11000A in the pulmonary position in subjects five years or older requiring replacement of their native or prosthetic pulmonary valve.
Subject's Average White Blood Cell Count Baseline	5.94 10^3 cells/microliters Standard Deviation 1.41	—	—	—
Subject's Average White Blood Cell Count Discharge	7.40 10^3 cells/microliters Standard Deviation 2.12	—	—	—
Subject's Average White Blood Cell Count 30 days	7.60 10^3 cells/microliters Standard Deviation 2.47	—	—	—
Subject's Average White Blood Cell Count 3 months	6.15 10^3 cells/microliters Standard Deviation 1.38	—	—	—
Subject's Average White Blood Cell Count 1 year	5.57 10^3 cells/microliters Standard Deviation 1.24	—	—	—
Subject's Average White Blood Cell Count 2 years	6.13 10^3 cells/microliters Standard Deviation 1.35	—	—	—
Subject's Average White Blood Cell Count 3 years	5.70 10^3 cells/microliters Standard Deviation 1.74	—	—	—
Subject's Average White Blood Cell Count 4 years	6.02 10^3 cells/microliters Standard Deviation 1.43	—	—	—
Subject's Average White Blood Cell Count 5 years	6.55 10^3 cells/microliters Standard Deviation 1.02	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, Discharge, 30 days, 3 months, and annually for up to 5 years

Population: This outcome is reported for subjects who received the trial valve. Note that the number of participants analyzed is different from that in the participant flow as there was some missing data.

The red blood cell (RBC) count is a test that measures the number of oxygen-carrying blood cells in your blood. The red blood cell count normal range for women is 4.2 to 5.4 10^6 cells/microliters and for men is 4.7 to 6.1 10^6 cells/microliters. A high red blood cell count may indicate that you have a condition that's preventing you from getting enough oxygen. A low RBC may be caused by an infection, or a medical condition related to anemia. In general, results either lower or higher than the normal range can indicate something is wrong.

Outcome measures

Measure	Edwards Pericardial Aortic Bioprosthesis Model 11000A n=26 Participants Edwards Pericardial Aortic Bioprosthesis Model 11000A in the pulmonary position in subjects five years or older requiring replacement of their native or prosthetic pulmonary valve.	Edwards Pericardial Aortic Bioprosthesis Model 11000A - 23 mm Edwards Pericardial Aortic Bioprosthesis Model 11000A in the pulmonary position in subjects five years or older requiring replacement of their native or prosthetic pulmonary valve.	Edwards Pericardial Aortic Bioprosthesis Model 11000A - 25 mm Edwards Pericardial Aortic Bioprosthesis Model 11000A in the pulmonary position in subjects five years or older requiring replacement of their native or prosthetic pulmonary valve.	Edwards Pericardial Aortic Bioprosthesis Model 11000A - 27 mm Edwards Pericardial Aortic Bioprosthesis Model 11000A in the pulmonary position in subjects five years or older requiring replacement of their native or prosthetic pulmonary valve.
Subject's Average Red Blood Cell Count Baseline	4.70 10^6 cells/microliter Standard Deviation 0.33	—	—	—
Subject's Average Red Blood Cell Count Discharge	3.69 10^6 cells/microliter Standard Deviation 0.37	—	—	—
Subject's Average Red Blood Cell Count 30 days	4.25 10^6 cells/microliter Standard Deviation 0.31	—	—	—
Subject's Average Red Blood Cell Count 3 months	4.69 10^6 cells/microliter Standard Deviation 0.26	—	—	—
Subject's Average Red Blood Cell Count 1 year	4.62 10^6 cells/microliter Standard Deviation 0.38	—	—	—
Subject's Average Red Blood Cell Count 2 years	4.75 10^6 cells/microliter Standard Deviation 0.41	—	—	—
Subject's Average Red Blood Cell Count 3 years	4.47 10^6 cells/microliter Standard Deviation 0.26	—	—	—
Subject's Average Red Blood Cell Count 4 years	4.49 10^6 cells/microliter Standard Deviation 0.31	—	—	—
Subject's Average Red Blood Cell Count 5 years	4.46 10^6 cells/microliter Standard Deviation 0.43	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, Discharge, 30 days, 3 months, and annually for up to 5 years

Population: This outcome is reported for subjects who received the trial valve. Note that the number of participants analyzed is different from that in the participant flow as there was some missing data.

This is the laboratory analysis of Hemoglobin count on blood drawn from subjects. Hemoglobin is an oxygen-carrying protein in red blood cells. In males, a healthy hemoglobin level is between 13.2 and 16.6 g/dL. In females, a hemoglobin count of between 11.6 and 15 g/dL is considered normal and healthy. In general, results either lower or higher than the normal range can indicate something is wrong.

Outcome measures

Measure	Edwards Pericardial Aortic Bioprosthesis Model 11000A n=26 Participants Edwards Pericardial Aortic Bioprosthesis Model 11000A in the pulmonary position in subjects five years or older requiring replacement of their native or prosthetic pulmonary valve.	Edwards Pericardial Aortic Bioprosthesis Model 11000A - 23 mm Edwards Pericardial Aortic Bioprosthesis Model 11000A in the pulmonary position in subjects five years or older requiring replacement of their native or prosthetic pulmonary valve.	Edwards Pericardial Aortic Bioprosthesis Model 11000A - 25 mm Edwards Pericardial Aortic Bioprosthesis Model 11000A in the pulmonary position in subjects five years or older requiring replacement of their native or prosthetic pulmonary valve.	Edwards Pericardial Aortic Bioprosthesis Model 11000A - 27 mm Edwards Pericardial Aortic Bioprosthesis Model 11000A in the pulmonary position in subjects five years or older requiring replacement of their native or prosthetic pulmonary valve.
Subject's Average Hemoglobin Count Baseline	13.61 g/dL Standard Deviation 1.47	—	—	—
Subject's Average Hemoglobin Count Discharge	10.80 g/dL Standard Deviation 1.07	—	—	—
Subject's Average Hemoglobin Count 30 days	12.18 g/dL Standard Deviation 1.17	—	—	—
Subject's Average Hemoglobin Count 3 months	13.34 g/dL Standard Deviation 1.04	—	—	—
Subject's Average Hemoglobin Count 1 year	13.62 g/dL Standard Deviation 1.33	—	—	—
Subject's Average Hemoglobin Count 2 years	14.13 g/dL Standard Deviation 1.41	—	—	—
Subject's Average Hemoglobin Count 3 years	13.06 g/dL Standard Deviation 1.59	—	—	—
Subject's Average Hemoglobin Count 4 years	13.84 g/dL Standard Deviation 0.89	—	—	—
Subject's Average Hemoglobin Count 5 years	13.11 g/dL Standard Deviation 1.16	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, Discharge, 30 days, 3 months, and annually for up to 5 years

Population: This outcome is reported for subjects who received the trial valve. Note that the number of participants analyzed is different from that in the participant flow as there was some missing data.

This is laboratory analysis of Hematocrit percentage on blood drawn from subjects. A hematocrit test measures the proportion of red blood cells in your blood. Red blood cells carry oxygen throughout your body. Having too few or too many red blood cells can be a sign of certain diseases. Normal hematocrit ranges for adult females are 36% to 44% and for adult males are 41% to 50%. In general, results either lower or higher than the normal range can indicate something is wrong.

Outcome measures

Measure	Edwards Pericardial Aortic Bioprosthesis Model 11000A n=26 Participants Edwards Pericardial Aortic Bioprosthesis Model 11000A in the pulmonary position in subjects five years or older requiring replacement of their native or prosthetic pulmonary valve.	Edwards Pericardial Aortic Bioprosthesis Model 11000A - 23 mm Edwards Pericardial Aortic Bioprosthesis Model 11000A in the pulmonary position in subjects five years or older requiring replacement of their native or prosthetic pulmonary valve.	Edwards Pericardial Aortic Bioprosthesis Model 11000A - 25 mm Edwards Pericardial Aortic Bioprosthesis Model 11000A in the pulmonary position in subjects five years or older requiring replacement of their native or prosthetic pulmonary valve.	Edwards Pericardial Aortic Bioprosthesis Model 11000A - 27 mm Edwards Pericardial Aortic Bioprosthesis Model 11000A in the pulmonary position in subjects five years or older requiring replacement of their native or prosthetic pulmonary valve.
Subject's Average Hematocrit Percentage Baseline	41.17 Percentage of red blood cells Standard Deviation 3.51	—	—	—
Subject's Average Hematocrit Percentage Discharge	32.35 Percentage of red blood cells Standard Deviation 2.97	—	—	—
Subject's Average Hematocrit Percentage 30 days	37.22 Percentage of red blood cells Standard Deviation 3.30	—	—	—
Subject's Average Hematocrit Percentage 3 months	40.47 Percentage of red blood cells Standard Deviation 2.99	—	—	—
Subject's Average Hematocrit Percentage 1 year	40.86 Percentage of red blood cells Standard Deviation 3.53	—	—	—
Subject's Average Hematocrit Percentage 2 years	41.88 Percentage of red blood cells Standard Deviation 3.61	—	—	—
Subject's Average Hematocrit Percentage 3 years	39.81 Percentage of red blood cells Standard Deviation 4.05	—	—	—
Subject's Average Hematocrit Percentage 4 years	41.61 Percentage of red blood cells Standard Deviation 2.92	—	—	—
Subject's Average Hematocrit Percentage 5 years	40.30 Percentage of red blood cells Standard Deviation 3.90	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, Discharge, 30 days, 3 months, and annually for up to 5 years

Population: This outcome is reported for subjects who received the trial valve. Note that the number of participants analyzed is different from that in the participant flow as there was some missing data.

This is laboratory analysis of Platelet count on blood drawn from subjects. The purpose of platelets is to create hemostasis, which is the prevention of hemorrhaging (bleeding) and the process of keeping blood inside the vessel walls. A normal platelet range is 150 to 450 10^3 cells/microliter. In general, results either lower or higher than the normal range can indicate something is wrong.

Outcome measures

Measure	Edwards Pericardial Aortic Bioprosthesis Model 11000A n=26 Participants Edwards Pericardial Aortic Bioprosthesis Model 11000A in the pulmonary position in subjects five years or older requiring replacement of their native or prosthetic pulmonary valve.	Edwards Pericardial Aortic Bioprosthesis Model 11000A - 23 mm Edwards Pericardial Aortic Bioprosthesis Model 11000A in the pulmonary position in subjects five years or older requiring replacement of their native or prosthetic pulmonary valve.	Edwards Pericardial Aortic Bioprosthesis Model 11000A - 25 mm Edwards Pericardial Aortic Bioprosthesis Model 11000A in the pulmonary position in subjects five years or older requiring replacement of their native or prosthetic pulmonary valve.	Edwards Pericardial Aortic Bioprosthesis Model 11000A - 27 mm Edwards Pericardial Aortic Bioprosthesis Model 11000A in the pulmonary position in subjects five years or older requiring replacement of their native or prosthetic pulmonary valve.
Subject's Average Platelet Count Baseline	223.04 10^3 cells/microliter Standard Deviation 55.45	—	—	—
Subject's Average Platelet Count Discharge	183.42 10^3 cells/microliter Standard Deviation 54.00	—	—	—
Subject's Average Platelet Count 30 days	304.84 10^3 cells/microliter Standard Deviation 108.21	—	—	—
Subject's Average Platelet Count 3 months	249.06 10^3 cells/microliter Standard Deviation 70.77	—	—	—
Subject's Average Platelet Count 1 year	240.17 10^3 cells/microliter Standard Deviation 67.06	—	—	—
Subject's Average Platelet Count 2 years	242.77 10^3 cells/microliter Standard Deviation 64.46	—	—	—
Subject's Average Platelet Count 3 years	252.17 10^3 cells/microliter Standard Deviation 69.17	—	—	—
Subject's Average Platelet Count 4 years	229.75 10^3 cells/microliter Standard Deviation 89.74	—	—	—
Subject's Average Platelet Count 5 years	232.25 10^3 cells/microliter Standard Deviation 48.12	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, Discharge, 30 days, 3 months, and annually for up to 5 years

Population: This outcome is reported for subjects who received the trial valve. Note that the number of participants analyzed is different from that in the participant flow as there was some missing data. The protocol allowed subjects to have the option of having a serum LDH test or plasma free hemoglobin test or a haptoglobin test at each timeframe. Not all three tests were required for the subject.

The lactate dehydrogenase (LDH) test looks for signs of damage to the body's tissues. Normal levels of LDH in the blood can vary depending on the lab, but usually range between 140 units per liter (U/L) to 280 U/L for adults and tend to be higher for children and teens.

Outcome measures

Measure	Edwards Pericardial Aortic Bioprosthesis Model 11000A n=21 Participants Edwards Pericardial Aortic Bioprosthesis Model 11000A in the pulmonary position in subjects five years or older requiring replacement of their native or prosthetic pulmonary valve.	Edwards Pericardial Aortic Bioprosthesis Model 11000A - 23 mm Edwards Pericardial Aortic Bioprosthesis Model 11000A in the pulmonary position in subjects five years or older requiring replacement of their native or prosthetic pulmonary valve.	Edwards Pericardial Aortic Bioprosthesis Model 11000A - 25 mm Edwards Pericardial Aortic Bioprosthesis Model 11000A in the pulmonary position in subjects five years or older requiring replacement of their native or prosthetic pulmonary valve.	Edwards Pericardial Aortic Bioprosthesis Model 11000A - 27 mm Edwards Pericardial Aortic Bioprosthesis Model 11000A in the pulmonary position in subjects five years or older requiring replacement of their native or prosthetic pulmonary valve.
Subject's Average Serum LDH Baseline	153.69 U/L Standard Deviation 32.84	—	—	—
Subject's Average Serum LDH Discharge	282.82 U/L Standard Deviation 61.92	—	—	—
Subject's Average Serum LDH 30 days	207.77 U/L Standard Deviation 34.15	—	—	—
Subject's Average Serum LDH 3 months	224.59 U/L Standard Deviation 49.81	—	—	—
Subject's Average Serum LDH 1 year	201.00 U/L Standard Deviation 45.37	—	—	—
Subject's Average Serum LDH 2 years	199.15 U/L Standard Deviation 40.50	—	—	—
Subject's Average Serum LDH 3 years	209.50 U/L Standard Deviation 44.07	—	—	—
Subject's Average Serum LDH 4 years	203.75 U/L Standard Deviation 37.16	—	—	—
Subject's Average Serum LDH 5 years	192.60 U/L Standard Deviation 22.81	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, Discharge, 30 days, 3 months, and annually for up to 5 years

Population: This outcome is reported for subjects who received the trial valve. Note that the number of participants analyzed is different from that in the participant flow as there was some missing data. The protocol allowed subjects to have the option of having a serum LDH test or plasma free hemoglobin test or a haptoglobin test at each timeframe. Not all three tests were required for the subject.

Laboratory Analysis of Plasma Free Hemoglobin (Hgb) of blood drawn from subject. This blood test measures the level of free hemoglobin in the plasma (liquid portion of the blood). The reference range for plasma free hemoglobin is 0.0 to 15.2 mg/dL. In general, values higher than this can indicate something is wrong.

Outcome measures

Measure	Edwards Pericardial Aortic Bioprosthesis Model 11000A n=5 Participants Edwards Pericardial Aortic Bioprosthesis Model 11000A in the pulmonary position in subjects five years or older requiring replacement of their native or prosthetic pulmonary valve.	Edwards Pericardial Aortic Bioprosthesis Model 11000A - 23 mm Edwards Pericardial Aortic Bioprosthesis Model 11000A in the pulmonary position in subjects five years or older requiring replacement of their native or prosthetic pulmonary valve.	Edwards Pericardial Aortic Bioprosthesis Model 11000A - 25 mm Edwards Pericardial Aortic Bioprosthesis Model 11000A in the pulmonary position in subjects five years or older requiring replacement of their native or prosthetic pulmonary valve.	Edwards Pericardial Aortic Bioprosthesis Model 11000A - 27 mm Edwards Pericardial Aortic Bioprosthesis Model 11000A in the pulmonary position in subjects five years or older requiring replacement of their native or prosthetic pulmonary valve.
Subject's Average Plasma Free Hemoglobin Baseline	45.00 mg/dl Standard Deviation 33.54	—	—	—
Subject's Average Plasma Free Hemoglobin Discharge	30.00 mg/dl Standard Deviation NA The sample is 1 and therefore no standard deviation is available.	—	—	—
Subject's Average Plasma Free Hemoglobin 1 year	5.80 mg/dl Standard Deviation NA The sample is 1 and therefore no standard deviation is available.	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, Discharge, 30 days, 3 months, and annually for up to 5 years

Population: This outcome is reported for subjects who received the trial valve who were on anticoagulant therapy during the trial. Note that only three of the 26 total participants were on anticoagulant therapy and that the number of participants analyzed is different from that in the participant flow as there was also some missing data.

The INR is a calculation based on results of a prothrombin time (PT). The PT is a blood test that measures the time it takes for the liquid portion (plasma) of the blood to clot. The normal range of INR depends on the patient. If they are not on an anticoagulant therapy, then the normal range is 0.9 - 1.1 and if they are on anticoagulant therapy then the normal range is 2 - 3.

Outcome measures

Measure	Edwards Pericardial Aortic Bioprosthesis Model 11000A n=3 Participants Edwards Pericardial Aortic Bioprosthesis Model 11000A in the pulmonary position in subjects five years or older requiring replacement of their native or prosthetic pulmonary valve.	Edwards Pericardial Aortic Bioprosthesis Model 11000A - 23 mm Edwards Pericardial Aortic Bioprosthesis Model 11000A in the pulmonary position in subjects five years or older requiring replacement of their native or prosthetic pulmonary valve.	Edwards Pericardial Aortic Bioprosthesis Model 11000A - 25 mm Edwards Pericardial Aortic Bioprosthesis Model 11000A in the pulmonary position in subjects five years or older requiring replacement of their native or prosthetic pulmonary valve.	Edwards Pericardial Aortic Bioprosthesis Model 11000A - 27 mm Edwards Pericardial Aortic Bioprosthesis Model 11000A in the pulmonary position in subjects five years or older requiring replacement of their native or prosthetic pulmonary valve.
Subject's Average International Normalized Ratio (INR) Baseline	1.05 Ratio of blood clotting Standard Deviation 0.02	—	—	—
Subject's Average International Normalized Ratio (INR) Discharge	1.23 Ratio of blood clotting Standard Deviation 0.27	—	—	—
Subject's Average International Normalized Ratio (INR) 30 days	1.99 Ratio of blood clotting Standard Deviation NA The sample size is 1 and therefore no standard deviation is available.	—	—	—
Subject's Average International Normalized Ratio (INR) 1 year	2.45 Ratio of blood clotting Standard Deviation NA The sample size is 1 and therefore no standard deviation is available.	—	—	—
Subject's Average International Normalized Ratio (INR) 3 years	1.02 Ratio of blood clotting Standard Deviation NA The sample size is 1 and therefore no standard deviation is available.	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, Discharge, 30 days, 3 months, and annually for up to 5 years

Population: This outcome is reported for subjects who received the trial valve and required the urine urobilinogen clinical test. There were no subjects in the trial who required this clinical test.

Urobilinogen is a substance that is produced when bilirubin, a waste product produced by the breakdown of red blood cells, is processed in the liver and released into the intestine. The normal range of urobilinogen is less than 1 mg/dL. It is common to have values within the 0 to 8 mg/dL range. In general, results either lower or higher than the normal range can indicate something is wrong.

Outcome measures

Outcome data not reported

Adverse Events

Edwards Pericardial Aortic Bioprosthesis Model 11000A

Serious events: 10 serious events

Other events: 22 other events

Deaths: 0 deaths

Serious adverse events

Measure	Edwards Pericardial Aortic Bioprosthesis Model 11000A n=26 participants at risk Edwards Pericardial Aortic Bioprosthesis Model 11000A in the pulmonary position in subjects five years or older requiring replacement of their native or prosthetic pulmonary valve.
Cardiac disorders CARDIOVASCULAR - REGURGITATION | REGURGITATION - PULMONARY-CENTRAL/TRANSVALVULAR-+4	3.8% 1/26 • Number of events 1 • Events occurring from baseline through five years post-implant. The outcome is site reported for subjects who received the Edwards Pericardial Aortic Bioprosthesis Model 11000A device in the pulmonary position where data is available.
Cardiac disorders CARDIOVASCULAR - STENOSIS | STENOSIS - PULMONARY - MODERATE	7.7% 2/26 • Number of events 2 • Events occurring from baseline through five years post-implant. The outcome is site reported for subjects who received the Edwards Pericardial Aortic Bioprosthesis Model 11000A device in the pulmonary position where data is available.
Cardiac disorders CARDIOVASCULAR - ARRHYTHMIA | ARRHYTHMIA - SUPRAVENTRICULAR TACHYCARDIA (SVT)	3.8% 1/26 • Number of events 1 • Events occurring from baseline through five years post-implant. The outcome is site reported for subjects who received the Edwards Pericardial Aortic Bioprosthesis Model 11000A device in the pulmonary position where data is available.
Cardiac disorders CARDIOVASCULAR - REGURGITATION | REGURGITATION - PULMONARY-CENTRAL/TRANSVALVULAR-+3	7.7% 2/26 • Number of events 2 • Events occurring from baseline through five years post-implant. The outcome is site reported for subjects who received the Edwards Pericardial Aortic Bioprosthesis Model 11000A device in the pulmonary position where data is available.
General disorders NONSPECIFIC, UNKNOWN, OR OTHER BODY SYSTEM | ALLERGIC REACTION - MEDICATION RELATED	3.8% 1/26 • Number of events 1 • Events occurring from baseline through five years post-implant. The outcome is site reported for subjects who received the Edwards Pericardial Aortic Bioprosthesis Model 11000A device in the pulmonary position where data is available.
General disorders NONSPECIFIC, UNKNOWN, OR OTHER BODY SYSTEM | ANAPHYLACTIC REACTION	3.8% 1/26 • Number of events 1 • Events occurring from baseline through five years post-implant. The outcome is site reported for subjects who received the Edwards Pericardial Aortic Bioprosthesis Model 11000A device in the pulmonary position where data is available.
Cardiac disorders CARDIOVASCULAR - ARRHYTHMIA | ARRHYTHMIA - ATRIAL FLUTTER	3.8% 1/26 • Number of events 1 • Events occurring from baseline through five years post-implant. The outcome is site reported for subjects who received the Edwards Pericardial Aortic Bioprosthesis Model 11000A device in the pulmonary position where data is available.
Cardiac disorders CARDIOVASCULAR - ARRHYTHMIA | ARRHYTHMIA - TACHYCARDIA -VENTRICULAR	3.8% 1/26 • Number of events 1 • Events occurring from baseline through five years post-implant. The outcome is site reported for subjects who received the Edwards Pericardial Aortic Bioprosthesis Model 11000A device in the pulmonary position where data is available.
Blood and lymphatic system disorders BLOOD AND LYMPHATIC (INCLUDING ALL BLEEDING COMPLICATIONS) | BLEEDING - CARDIOVASCULAR - MAJOR	3.8% 1/26 • Number of events 1 • Events occurring from baseline through five years post-implant. The outcome is site reported for subjects who received the Edwards Pericardial Aortic Bioprosthesis Model 11000A device in the pulmonary position where data is available.
Blood and lymphatic system disorders BLOOD AND LYMPHATIC (INCLUDING ALL BLEEDING COMPLICATIONS) | BLEEDING - GASTROINTESTINAL UPPER - MAJ	3.8% 1/26 • Number of events 1 • Events occurring from baseline through five years post-implant. The outcome is site reported for subjects who received the Edwards Pericardial Aortic Bioprosthesis Model 11000A device in the pulmonary position where data is available.
Cardiac disorders CARDIOVASCULAR - MISC | PERICARDIAL EFFUSION - MINOR	3.8% 1/26 • Number of events 1 • Events occurring from baseline through five years post-implant. The outcome is site reported for subjects who received the Edwards Pericardial Aortic Bioprosthesis Model 11000A device in the pulmonary position where data is available.
Musculoskeletal and connective tissue disorders MUSCULAR SKELETAL/DERMATOLOGIC | STERNAL WOUND/THORACIC INFECTION	3.8% 1/26 • Number of events 1 • Events occurring from baseline through five years post-implant. The outcome is site reported for subjects who received the Edwards Pericardial Aortic Bioprosthesis Model 11000A device in the pulmonary position where data is available.

Other adverse events

Measure	Edwards Pericardial Aortic Bioprosthesis Model 11000A n=26 participants at risk Edwards Pericardial Aortic Bioprosthesis Model 11000A in the pulmonary position in subjects five years or older requiring replacement of their native or prosthetic pulmonary valve.
Cardiac disorders CARDIOVASCULAR - ARRHYTHMIA | ARRHYTHMIA - AV BLOCK - 1ST DEGREE	7.7% 2/26 • Number of events 2 • Events occurring from baseline through five years post-implant. The outcome is site reported for subjects who received the Edwards Pericardial Aortic Bioprosthesis Model 11000A device in the pulmonary position where data is available.
Cardiac disorders CARDIOVASCULAR - ARRHYTHMIA | ARRHYTHMIA - OTHER	7.7% 2/26 • Number of events 2 • Events occurring from baseline through five years post-implant. The outcome is site reported for subjects who received the Edwards Pericardial Aortic Bioprosthesis Model 11000A device in the pulmonary position where data is available.
Cardiac disorders CARDIOVASCULAR - MISC | CARDIOVASCULAR - OTHER	7.7% 2/26 • Number of events 2 • Events occurring from baseline through five years post-implant. The outcome is site reported for subjects who received the Edwards Pericardial Aortic Bioprosthesis Model 11000A device in the pulmonary position where data is available.
Cardiac disorders CARDIOVASCULAR - REGURGITATION | REGURGITATION - PULMONARY-CENTRAL/TRANSVALVULAR-+3	38.5% 10/26 • Number of events 10 • Events occurring from baseline through five years post-implant. The outcome is site reported for subjects who received the Edwards Pericardial Aortic Bioprosthesis Model 11000A device in the pulmonary position where data is available.
Cardiac disorders CARDIOVASCULAR - REGURGITATION | REGURGITATION - PULMONARY-CENTRAL/TRANSVALVULAR-+4	15.4% 4/26 • Number of events 4 • Events occurring from baseline through five years post-implant. The outcome is site reported for subjects who received the Edwards Pericardial Aortic Bioprosthesis Model 11000A device in the pulmonary position where data is available.
Cardiac disorders CARDIOVASCULAR - STENOSIS | STENOSIS - PULMONARY - MODERATE	7.7% 2/26 • Number of events 2 • Events occurring from baseline through five years post-implant. The outcome is site reported for subjects who received the Edwards Pericardial Aortic Bioprosthesis Model 11000A device in the pulmonary position where data is available.
Musculoskeletal and connective tissue disorders MUSCULAR SKELETAL/DERMATOLOGIC | MUSCULAR SKELETAL / DERMATOLOGIC - OTHER	7.7% 2/26 • Number of events 3 • Events occurring from baseline through five years post-implant. The outcome is site reported for subjects who received the Edwards Pericardial Aortic Bioprosthesis Model 11000A device in the pulmonary position where data is available.
General disorders NONSPECIFIC, UNKNOWN, OR OTHER BODY SYSTEM | NONSPECIFIC, UNKNOWN OR OTHER BODY SYSTEM - OTHER COMPL	15.4% 4/26 • Number of events 5 • Events occurring from baseline through five years post-implant. The outcome is site reported for subjects who received the Edwards Pericardial Aortic Bioprosthesis Model 11000A device in the pulmonary position where data is available.
Respiratory, thoracic and mediastinal disorders PULMONARY/RESPIRATORY | ATELECTASIS	30.8% 8/26 • Number of events 8 • Events occurring from baseline through five years post-implant. The outcome is site reported for subjects who received the Edwards Pericardial Aortic Bioprosthesis Model 11000A device in the pulmonary position where data is available.
Respiratory, thoracic and mediastinal disorders PULMONARY/RESPIRATORY | PLEURAL EFFUSION - BILATERAL	7.7% 2/26 • Number of events 2 • Events occurring from baseline through five years post-implant. The outcome is site reported for subjects who received the Edwards Pericardial Aortic Bioprosthesis Model 11000A device in the pulmonary position where data is available.

Additional Information

Aya Westbrook, PhD, Director of Clinical Affairs, Surgical Structural Heart

Edwards Lifesciences, LLC

Phone: 949-250-2500

Email: Aya_Westbrook@edwards.com

Results disclosure agreements

• Principal investigator is a sponsor employee PI can't publish/present on overall study results not yet published but may publish his own data subject to EW review. Manuscripts will be submitted to EW for review 30 days prior to submission of manuscript for publication/presentation. EW may ask for a 60 day delay to protect proprietary information/filing of related patent applications. Site-specific results of devices which haven't been market released shall not include claims of device safety/effectiveness and require EW review/approval.
• Publication restrictions are in place

Restriction type: OTHER