Trial Outcomes & Findings for Magna Mitral - 23mm (NCT NCT01312779)

NCT ID: NCT01312779

Last Updated: 2020-03-18

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 39 participants
• Primary outcome timeframe: Events occuring within 30 days of procedure
• Results posted on: 2020-03-18

Participant Flow

Participant milestones

Measure	Magna Mitral 23 Clinical Evaluation of the size 23 mm Carpentier-Edwards PERIMOUNT Magna Mitral Bioprosthesis, Model 7000TFX
Overall Study STARTED	39
Overall Study Implanted With Device	12
Overall Study COMPLETED	7
Overall Study NOT COMPLETED	32

Reasons for withdrawal

Measure	Magna Mitral 23 Clinical Evaluation of the size 23 mm Carpentier-Edwards PERIMOUNT Magna Mitral Bioprosthesis, Model 7000TFX
Overall Study Withdrawal by Subject	2
Overall Study Death	3
Overall Study Not Implanted with Device	27

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Magna Mitral 23 n=12 Participants Clinical Evaluation of the size 23 mm Carpentier-Edwards PERIMOUNT Magna Mitral Bioprosthesis, Model 7000TFX
Age, Continuous	67.5 years STANDARD_DEVIATION 14.0 • n=12 Participants
Sex: Female, Male Female	12 Participants n=12 Participants
Sex: Female, Male Male	0 Participants n=12 Participants

PRIMARY outcome

Timeframe: Events occuring within 30 days of procedure

Population: The outcome is reported for subjects who received the Magna Mitral, Model 7000TFX device where data is available.

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

Outcome measures

Measure	Magna Mitral 23 n=12 Participants Clinical Evaluation of the size 23 mm Carpentier-Edwards PERIMOUNT Magna Mitral Bioprosthesis, Model 7000TFX	Magna Mitral 23 - 1 Year Post-implant Clinical Evaluation of the size 23 mm Carpentier-Edwards PERIMOUNT Magna Mitral Bioprosthesis, Model 7000TFX	Magna Mitral 23 - 2 Years Post-implant Clinical Evaluation of the size 23 mm Carpentier-Edwards PERIMOUNT Magna Mitral Bioprosthesis, Model 7000TFX	Magna Mitral 23 - 3 Years Post-implant Clinical Evaluation of the size 23 mm Carpentier-Edwards PERIMOUNT Magna Mitral Bioprosthesis, Model 7000TFX	Magna Mitral 23 - 4 Years Post-implant Clinical Evaluation of the size 23 mm Carpentier-Edwards PERIMOUNT Magna Mitral Bioprosthesis, Model 7000TFX	Magna Mitral 23 - 5 Years Post-implant Clinical Evaluation of the size 23 mm Carpentier-Edwards PERIMOUNT Magna Mitral Bioprosthesis, Model 7000TFX
Percent of Early Adverse Events Divided Death	8.3 percentage of subjects	—	—	—	—	—
Percent of Early Adverse Events Divided Valve-Related Death	0.0 percentage of subjects	—	—	—	—	—
Percent of Early Adverse Events Divided Thromboembolism	0.0 percentage of subjects	—	—	—	—	—
Percent of Early Adverse Events Divided Valve Thrombosis	0.0 percentage of subjects	—	—	—	—	—
Percent of Early Adverse Events Divided Hemorrhage	0.0 percentage of subjects	—	—	—	—	—
Percent of Early Adverse Events Divided Major Hemorrhage	0.0 percentage of subjects	—	—	—	—	—
Percent of Early Adverse Events Divided Non-Structural Valve Dysfunction (study valve)	8.3 percentage of subjects	—	—	—	—	—
Percent of Early Adverse Events Divided All Clinically Significant PVL	8.3 percentage of subjects	—	—	—	—	—
Percent of Early Adverse Events Divided Major Clinically Significant PVL	0.0 percentage of subjects	—	—	—	—	—
Percent of Early Adverse Events Divided Hemolysis	0.0 percentage of subjects	—	—	—	—	—
Percent of Early Adverse Events Divided Endocarditis	0.0 percentage of subjects	—	—	—	—	—
Percent of Early Adverse Events Divided Structural Valve Deterioration	0.0 percentage of subjects	—	—	—	—	—
Percent of Early Adverse Events Divided Reoperation	0.0 percentage of subjects	—	—	—	—	—
Percent of Early Adverse Events Divided Explant	0.0 percentage of subjects	—	—	—	—	—

PRIMARY outcome

Timeframe: Events occurring >= 31 days and up through 5 years post-implant

Population: The outcome is reported for subjects who received the Magna Mitral, Model 7000TFX device where data is available.

Number of late events divided by the total number of late patient years times 100. Late patient years are calculated from 31 days post-implant to the date of the last contact (follow up or adverse event).

Outcome measures

Measure	Magna Mitral 23 n=11 Participants Clinical Evaluation of the size 23 mm Carpentier-Edwards PERIMOUNT Magna Mitral Bioprosthesis, Model 7000TFX	Magna Mitral 23 - 1 Year Post-implant Clinical Evaluation of the size 23 mm Carpentier-Edwards PERIMOUNT Magna Mitral Bioprosthesis, Model 7000TFX	Magna Mitral 23 - 2 Years Post-implant Clinical Evaluation of the size 23 mm Carpentier-Edwards PERIMOUNT Magna Mitral Bioprosthesis, Model 7000TFX	Magna Mitral 23 - 3 Years Post-implant Clinical Evaluation of the size 23 mm Carpentier-Edwards PERIMOUNT Magna Mitral Bioprosthesis, Model 7000TFX	Magna Mitral 23 - 4 Years Post-implant Clinical Evaluation of the size 23 mm Carpentier-Edwards PERIMOUNT Magna Mitral Bioprosthesis, Model 7000TFX	Magna Mitral 23 - 5 Years Post-implant Clinical Evaluation of the size 23 mm Carpentier-Edwards PERIMOUNT Magna Mitral Bioprosthesis, Model 7000TFX
Percent of Late Adverse Events Death	4.5 percentage of events/late patient years	—	—	—	—	—
Percent of Late Adverse Events Valve-Related Death	2.2 percentage of events/late patient years	—	—	—	—	—
Percent of Late Adverse Events Thromboembolism	2.2 percentage of events/late patient years	—	—	—	—	—
Percent of Late Adverse Events Valve Thrombosis	0.0 percentage of events/late patient years	—	—	—	—	—
Percent of Late Adverse Events Hemorrhage	2.2 percentage of events/late patient years	—	—	—	—	—
Percent of Late Adverse Events Major Hemorrhage	2.2 percentage of events/late patient years	—	—	—	—	—
Percent of Late Adverse Events Non-Structural Valve Dysfunction (study valve)	0.0 percentage of events/late patient years	—	—	—	—	—
Percent of Late Adverse Events All Clinically Significant PVL	0.0 percentage of events/late patient years	—	—	—	—	—
Percent of Late Adverse Events Major Clinically Significant PVL	0.0 percentage of events/late patient years	—	—	—	—	—
Percent of Late Adverse Events Hemolysis	0.0 percentage of events/late patient years	—	—	—	—	—
Percent of Late Adverse Events Endocarditis	2.2 percentage of events/late patient years	—	—	—	—	—
Percent of Late Adverse Events Structural Valve Deterioration	6.7 percentage of events/late patient years	—	—	—	—	—
Percent of Late Adverse Events Reoperation	6.7 percentage of events/late patient years	—	—	—	—	—
Percent of Late Adverse Events Explant	6.7 percentage of events/late patient years	—	—	—	—	—

PRIMARY outcome

Timeframe: >30 Days, 1 Year, 2 Years, 3 Years, 4 Years, and 5 Years post-implant

Population: The outcome is reported for subjects who received the Magna Mitral, Model 7000TFX device where data is available.

Subject's freedom from Serious Adverse Events at > 30 days post-implant. Time to events were estimated by Kaplan-Meier method.

Outcome measures

Measure	Magna Mitral 23 n=11 Participants Clinical Evaluation of the size 23 mm Carpentier-Edwards PERIMOUNT Magna Mitral Bioprosthesis, Model 7000TFX	Magna Mitral 23 - 1 Year Post-implant n=11 Participants Clinical Evaluation of the size 23 mm Carpentier-Edwards PERIMOUNT Magna Mitral Bioprosthesis, Model 7000TFX	Magna Mitral 23 - 2 Years Post-implant n=11 Participants Clinical Evaluation of the size 23 mm Carpentier-Edwards PERIMOUNT Magna Mitral Bioprosthesis, Model 7000TFX	Magna Mitral 23 - 3 Years Post-implant n=11 Participants Clinical Evaluation of the size 23 mm Carpentier-Edwards PERIMOUNT Magna Mitral Bioprosthesis, Model 7000TFX	Magna Mitral 23 - 4 Years Post-implant n=11 Participants Clinical Evaluation of the size 23 mm Carpentier-Edwards PERIMOUNT Magna Mitral Bioprosthesis, Model 7000TFX	Magna Mitral 23 - 5 Years Post-implant n=11 Participants Clinical Evaluation of the size 23 mm Carpentier-Edwards PERIMOUNT Magna Mitral Bioprosthesis, Model 7000TFX
Percentage of Subjects With Freedom From Serious Adverse Events (SAE) Post-implant > 30 Days Death	100.00 percentage of subjects	90.91 percentage of subjects	90.91 percentage of subjects	90.91 percentage of subjects	80.81 percentage of subjects	80.81 percentage of subjects
Percentage of Subjects With Freedom From Serious Adverse Events (SAE) Post-implant > 30 Days Valve-related Death	100.00 percentage of subjects	100.0 percentage of subjects	100.0 percentage of subjects	100.0 percentage of subjects	88.89 percentage of subjects	88.89 percentage of subjects
Percentage of Subjects With Freedom From Serious Adverse Events (SAE) Post-implant > 30 Days Reoperation	100.00 percentage of subjects	100.00 percentage of subjects	100.00 percentage of subjects	100.00 percentage of subjects	100.00 percentage of subjects	87.50 percentage of subjects
Percentage of Subjects With Freedom From Serious Adverse Events (SAE) Post-implant > 30 Days Explant	100.00 percentage of subjects	100.00 percentage of subjects	100.00 percentage of subjects	100.00 percentage of subjects	100.00 percentage of subjects	87.50 percentage of subjects
Percentage of Subjects With Freedom From Serious Adverse Events (SAE) Post-implant > 30 Days Bleeding Event	100.00 percentage of subjects	90.00 percentage of subjects	90.00 percentage of subjects	90.00 percentage of subjects	90.00 percentage of subjects	90.00 percentage of subjects
Percentage of Subjects With Freedom From Serious Adverse Events (SAE) Post-implant > 30 Days Major Bleeding Event	100.00 percentage of subjects	90.00 percentage of subjects	90.00 percentage of subjects	90.00 percentage of subjects	90.00 percentage of subjects	90.00 percentage of subjects
Percentage of Subjects With Freedom From Serious Adverse Events (SAE) Post-implant > 30 Days Thromboembolism	100.00 percentage of subjects	100.00 percentage of subjects	88.89 percentage of subjects	88.89 percentage of subjects	88.89 percentage of subjects	88.89 percentage of subjects
Percentage of Subjects With Freedom From Serious Adverse Events (SAE) Post-implant > 30 Days Endocarditis	100.00 percentage of subjects	100.00 percentage of subjects	100.00 percentage of subjects	100.00 percentage of subjects	88.89 percentage of subjects	88.89 percentage of subjects
Percentage of Subjects With Freedom From Serious Adverse Events (SAE) Post-implant > 30 Days Perivalvular Leak	100.00 percentage of subjects	100.00 percentage of subjects	100.00 percentage of subjects	100.00 percentage of subjects	100.00 percentage of subjects	100.00 percentage of subjects
Percentage of Subjects With Freedom From Serious Adverse Events (SAE) Post-implant > 30 Days Major Perivalvular Leak	100.00 percentage of subjects	100.00 percentage of subjects	100.00 percentage of subjects	100.00 percentage of subjects	100.00 percentage of subjects	100.00 percentage of subjects
Percentage of Subjects With Freedom From Serious Adverse Events (SAE) Post-implant > 30 Days Hemolysis	100.00 percentage of subjects	100.00 percentage of subjects	100.00 percentage of subjects	100.00 percentage of subjects	100.00 percentage of subjects	100.00 percentage of subjects
Percentage of Subjects With Freedom From Serious Adverse Events (SAE) Post-implant > 30 Days Non-structural Valve Dysfunction	100.00 percentage of subjects	100.00 percentage of subjects	100.00 percentage of subjects	100.00 percentage of subjects	100.00 percentage of subjects	100.00 percentage of subjects
Percentage of Subjects With Freedom From Serious Adverse Events (SAE) Post-implant > 30 Days Structural Valve Deterioration	100.00 percentage of subjects	100.00 percentage of subjects	100.00 percentage of subjects	100.00 percentage of subjects	100.00 percentage of subjects	87.50 percentage of subjects
Percentage of Subjects With Freedom From Serious Adverse Events (SAE) Post-implant > 30 Days Valve Thrombosis	100.00 percentage of subjects	100.00 percentage of subjects	100.00 percentage of subjects	100.00 percentage of subjects	100.00 percentage of subjects	100.00 percentage of subjects

PRIMARY outcome

Timeframe: Pre-procedure and 1 Year post-Implant

Population: The outcome is reported for subjects who received the Magna Mitral, Model 7000TFX device where data is available.

Effective orifice area represents the cross-sectional area of the blood flow downstream of the mitral valve. Effective orifice area is evaluated by echocardiography over time.

Outcome measures

Measure	Magna Mitral 23 n=12 Participants Clinical Evaluation of the size 23 mm Carpentier-Edwards PERIMOUNT Magna Mitral Bioprosthesis, Model 7000TFX	Magna Mitral 23 - 1 Year Post-implant Clinical Evaluation of the size 23 mm Carpentier-Edwards PERIMOUNT Magna Mitral Bioprosthesis, Model 7000TFX	Magna Mitral 23 - 2 Years Post-implant Clinical Evaluation of the size 23 mm Carpentier-Edwards PERIMOUNT Magna Mitral Bioprosthesis, Model 7000TFX	Magna Mitral 23 - 3 Years Post-implant Clinical Evaluation of the size 23 mm Carpentier-Edwards PERIMOUNT Magna Mitral Bioprosthesis, Model 7000TFX	Magna Mitral 23 - 4 Years Post-implant Clinical Evaluation of the size 23 mm Carpentier-Edwards PERIMOUNT Magna Mitral Bioprosthesis, Model 7000TFX	Magna Mitral 23 - 5 Years Post-implant Clinical Evaluation of the size 23 mm Carpentier-Edwards PERIMOUNT Magna Mitral Bioprosthesis, Model 7000TFX
Subject's Average Effective Orifice Area (EOA) Measurement Pre-Procedure	0.8 Centimeters Squared Standard Deviation 0.2	—	—	—	—	—
Subject's Average Effective Orifice Area (EOA) Measurement 1 Year	1.2 Centimeters Squared Standard Deviation 0.2	—	—	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Pre-procedure and 1 Year post-implant

Population: The outcome is reported for subjects who received the Magna Mitral, Model 7000TFX device where data is available.

Mean gradient is the average flow of blood through the mitral valve measured in millimeters of mercury. Gradients are evaluated by echocardiography over time. Mean gradient values depend on the size and type of valve.

Outcome measures

Measure	Magna Mitral 23 n=12 Participants Clinical Evaluation of the size 23 mm Carpentier-Edwards PERIMOUNT Magna Mitral Bioprosthesis, Model 7000TFX	Magna Mitral 23 - 1 Year Post-implant Clinical Evaluation of the size 23 mm Carpentier-Edwards PERIMOUNT Magna Mitral Bioprosthesis, Model 7000TFX	Magna Mitral 23 - 2 Years Post-implant Clinical Evaluation of the size 23 mm Carpentier-Edwards PERIMOUNT Magna Mitral Bioprosthesis, Model 7000TFX	Magna Mitral 23 - 3 Years Post-implant Clinical Evaluation of the size 23 mm Carpentier-Edwards PERIMOUNT Magna Mitral Bioprosthesis, Model 7000TFX	Magna Mitral 23 - 4 Years Post-implant Clinical Evaluation of the size 23 mm Carpentier-Edwards PERIMOUNT Magna Mitral Bioprosthesis, Model 7000TFX	Magna Mitral 23 - 5 Years Post-implant Clinical Evaluation of the size 23 mm Carpentier-Edwards PERIMOUNT Magna Mitral Bioprosthesis, Model 7000TFX
Subject's Average Mean Gradient Measurement Pre-Procedure	9.8 mmHg Standard Deviation 5.3	—	—	—	—	—
Subject's Average Mean Gradient Measurement 1 Year	7.5 mmHg Standard Deviation 1.7	—	—	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Pre-procedure and 1 Year post-implant

Population: The outcome is reported for subjects who received the Magna Mitral, Model 7000TFX device where data is available.

Peak gradient is the maximum value measured of flow of blood through the mitral valve as measured in millimeters of mercury. Gradients are evaluated by echocardiography over time.

Outcome measures

Measure	Magna Mitral 23 n=12 Participants Clinical Evaluation of the size 23 mm Carpentier-Edwards PERIMOUNT Magna Mitral Bioprosthesis, Model 7000TFX	Magna Mitral 23 - 1 Year Post-implant Clinical Evaluation of the size 23 mm Carpentier-Edwards PERIMOUNT Magna Mitral Bioprosthesis, Model 7000TFX	Magna Mitral 23 - 2 Years Post-implant Clinical Evaluation of the size 23 mm Carpentier-Edwards PERIMOUNT Magna Mitral Bioprosthesis, Model 7000TFX	Magna Mitral 23 - 3 Years Post-implant Clinical Evaluation of the size 23 mm Carpentier-Edwards PERIMOUNT Magna Mitral Bioprosthesis, Model 7000TFX	Magna Mitral 23 - 4 Years Post-implant Clinical Evaluation of the size 23 mm Carpentier-Edwards PERIMOUNT Magna Mitral Bioprosthesis, Model 7000TFX	Magna Mitral 23 - 5 Years Post-implant Clinical Evaluation of the size 23 mm Carpentier-Edwards PERIMOUNT Magna Mitral Bioprosthesis, Model 7000TFX
Subject's Average Peak Gradient Measurement Pre-Procedure	19.1 mmHg Standard Deviation 7.5	—	—	—	—	—
Subject's Average Peak Gradient Measurement 1 Year	16.8 mmHg Standard Deviation 5.1	—	—	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Pre-procedure and 1 Year post-implant

Population: The outcome is reported for subjects who received the Magna Mitral, Model 7000TFX device where data is available.

Effective orifice area index represents the minimal cross-sectional area of the blood flow downstream of the mitral valve divided by the person's body surface area. Effective orifice area index is evaluated by echocardiography over time.

Outcome measures

Measure	Magna Mitral 23 n=12 Participants Clinical Evaluation of the size 23 mm Carpentier-Edwards PERIMOUNT Magna Mitral Bioprosthesis, Model 7000TFX	Magna Mitral 23 - 1 Year Post-implant Clinical Evaluation of the size 23 mm Carpentier-Edwards PERIMOUNT Magna Mitral Bioprosthesis, Model 7000TFX	Magna Mitral 23 - 2 Years Post-implant Clinical Evaluation of the size 23 mm Carpentier-Edwards PERIMOUNT Magna Mitral Bioprosthesis, Model 7000TFX	Magna Mitral 23 - 3 Years Post-implant Clinical Evaluation of the size 23 mm Carpentier-Edwards PERIMOUNT Magna Mitral Bioprosthesis, Model 7000TFX	Magna Mitral 23 - 4 Years Post-implant Clinical Evaluation of the size 23 mm Carpentier-Edwards PERIMOUNT Magna Mitral Bioprosthesis, Model 7000TFX	Magna Mitral 23 - 5 Years Post-implant Clinical Evaluation of the size 23 mm Carpentier-Edwards PERIMOUNT Magna Mitral Bioprosthesis, Model 7000TFX
Subject's Average Effective Orifice Area Index (EOAI) Measurement Pre-Procedure	0.5 cm^2/m^2 Standard Deviation 0.1	—	—	—	—	—
Subject's Average Effective Orifice Area Index (EOAI) Measurement 1 Year	0.7 cm^2/m^2 Standard Deviation 0.1	—	—	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Pre-procedure and 1 Year post-Implant

Population: The outcome is reported for subjects who received the Magna Mitral, Model 7000TFX device where data is available.

Performance index is defined as the subject's effective orifice area (the cross sectional area of the blood flow downstream of the mitral valve) divided by the subject's native orifice area. Effective orifice area is evaluated by echocardiography over time.

Outcome measures

Measure	Magna Mitral 23 n=12 Participants Clinical Evaluation of the size 23 mm Carpentier-Edwards PERIMOUNT Magna Mitral Bioprosthesis, Model 7000TFX	Magna Mitral 23 - 1 Year Post-implant Clinical Evaluation of the size 23 mm Carpentier-Edwards PERIMOUNT Magna Mitral Bioprosthesis, Model 7000TFX	Magna Mitral 23 - 2 Years Post-implant Clinical Evaluation of the size 23 mm Carpentier-Edwards PERIMOUNT Magna Mitral Bioprosthesis, Model 7000TFX	Magna Mitral 23 - 3 Years Post-implant Clinical Evaluation of the size 23 mm Carpentier-Edwards PERIMOUNT Magna Mitral Bioprosthesis, Model 7000TFX	Magna Mitral 23 - 4 Years Post-implant Clinical Evaluation of the size 23 mm Carpentier-Edwards PERIMOUNT Magna Mitral Bioprosthesis, Model 7000TFX	Magna Mitral 23 - 5 Years Post-implant Clinical Evaluation of the size 23 mm Carpentier-Edwards PERIMOUNT Magna Mitral Bioprosthesis, Model 7000TFX
Subject's Average Performance Index Measurement Pre-Procedure	0.7 cm^2/cm^2 Standard Deviation 0.2	—	—	—	—	—
Subject's Average Performance Index Measurement 1 Year	1.0 cm^2/cm^2 Standard Deviation 0.1	—	—	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Pre-procedure and 1 Year post-implant

Population: The outcome is reported for subjects who received the Magna Mitral, Model 7000TFX device where data is available.

The amount of blood the heart pumps through the circulatory system in a minute.

Outcome measures

Measure	Magna Mitral 23 n=12 Participants Clinical Evaluation of the size 23 mm Carpentier-Edwards PERIMOUNT Magna Mitral Bioprosthesis, Model 7000TFX	Magna Mitral 23 - 1 Year Post-implant Clinical Evaluation of the size 23 mm Carpentier-Edwards PERIMOUNT Magna Mitral Bioprosthesis, Model 7000TFX	Magna Mitral 23 - 2 Years Post-implant Clinical Evaluation of the size 23 mm Carpentier-Edwards PERIMOUNT Magna Mitral Bioprosthesis, Model 7000TFX	Magna Mitral 23 - 3 Years Post-implant Clinical Evaluation of the size 23 mm Carpentier-Edwards PERIMOUNT Magna Mitral Bioprosthesis, Model 7000TFX	Magna Mitral 23 - 4 Years Post-implant Clinical Evaluation of the size 23 mm Carpentier-Edwards PERIMOUNT Magna Mitral Bioprosthesis, Model 7000TFX	Magna Mitral 23 - 5 Years Post-implant Clinical Evaluation of the size 23 mm Carpentier-Edwards PERIMOUNT Magna Mitral Bioprosthesis, Model 7000TFX
Subject's Average Cardiac Output Pre-Procedure	4.0 Liters/minute Standard Deviation 0.8	—	—	—	—	—
Subject's Average Cardiac Output 1 Year	4.8 Liters/minute Standard Deviation 0.7	—	—	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Pre-procedure and 1 Year post-implant

Population: The outcome is reported for subjects who received the Magna Mitral, Model 7000TFX device where data is available.

Cardiac index is an assessment that divides the cardiac output from the left ventricle in one minute by the person's body surface area (BSA), thus relating heart performance to the size of the individual.

Outcome measures

Measure	Magna Mitral 23 n=12 Participants Clinical Evaluation of the size 23 mm Carpentier-Edwards PERIMOUNT Magna Mitral Bioprosthesis, Model 7000TFX	Magna Mitral 23 - 1 Year Post-implant Clinical Evaluation of the size 23 mm Carpentier-Edwards PERIMOUNT Magna Mitral Bioprosthesis, Model 7000TFX	Magna Mitral 23 - 2 Years Post-implant Clinical Evaluation of the size 23 mm Carpentier-Edwards PERIMOUNT Magna Mitral Bioprosthesis, Model 7000TFX	Magna Mitral 23 - 3 Years Post-implant Clinical Evaluation of the size 23 mm Carpentier-Edwards PERIMOUNT Magna Mitral Bioprosthesis, Model 7000TFX	Magna Mitral 23 - 4 Years Post-implant Clinical Evaluation of the size 23 mm Carpentier-Edwards PERIMOUNT Magna Mitral Bioprosthesis, Model 7000TFX	Magna Mitral 23 - 5 Years Post-implant Clinical Evaluation of the size 23 mm Carpentier-Edwards PERIMOUNT Magna Mitral Bioprosthesis, Model 7000TFX
Subject's Average Cardiac Index Pre-Procedure	2.4 L/min/m2 Standard Deviation 0.4	—	—	—	—	—
Subject's Average Cardiac Index 1 Year	2.9 L/min/m2 Standard Deviation 0.5	—	—	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Pre-procedure and 1 Year post-implant

Population: The outcome is reported for subjects who received the Magna Mitral, Model 7000TFX device where data is available.

Patients can experience an enlargement of the left ventricle (chamber) of their heart because it works harder with a defective heart valve. Left ventricular mass regression evaluates if the patient experiences a decrease in the size of the left ventricle (chamber) after the repair or replacement of their heart valve.

Outcome measures

Measure	Magna Mitral 23 n=12 Participants Clinical Evaluation of the size 23 mm Carpentier-Edwards PERIMOUNT Magna Mitral Bioprosthesis, Model 7000TFX	Magna Mitral 23 - 1 Year Post-implant Clinical Evaluation of the size 23 mm Carpentier-Edwards PERIMOUNT Magna Mitral Bioprosthesis, Model 7000TFX	Magna Mitral 23 - 2 Years Post-implant Clinical Evaluation of the size 23 mm Carpentier-Edwards PERIMOUNT Magna Mitral Bioprosthesis, Model 7000TFX	Magna Mitral 23 - 3 Years Post-implant Clinical Evaluation of the size 23 mm Carpentier-Edwards PERIMOUNT Magna Mitral Bioprosthesis, Model 7000TFX	Magna Mitral 23 - 4 Years Post-implant Clinical Evaluation of the size 23 mm Carpentier-Edwards PERIMOUNT Magna Mitral Bioprosthesis, Model 7000TFX	Magna Mitral 23 - 5 Years Post-implant Clinical Evaluation of the size 23 mm Carpentier-Edwards PERIMOUNT Magna Mitral Bioprosthesis, Model 7000TFX
Subject's Average Left Ventricular Mass Regression Pre-Procedure	161.0 grams Standard Deviation 42.4	—	—	—	—	—
Subject's Average Left Ventricular Mass Regression 1 Year	130.7 grams Standard Deviation 35.1	—	—	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 1 Year post-implant

Population: The outcome is reported for subjects who received the Magna Mitral, Model 7000TFX device where data is available.

Mitral valvular regurgitation occurs when the mitral 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. Mitral valvular regurgitation is evaluated by echocardiography over time. It is assessed on a scale from 0 to 4, where 0 represents no regurgitation and 4 represents severe regurgitation.

Outcome measures

Measure	Magna Mitral 23 n=9 Participants Clinical Evaluation of the size 23 mm Carpentier-Edwards PERIMOUNT Magna Mitral Bioprosthesis, Model 7000TFX	Magna Mitral 23 - 1 Year Post-implant Clinical Evaluation of the size 23 mm Carpentier-Edwards PERIMOUNT Magna Mitral Bioprosthesis, Model 7000TFX	Magna Mitral 23 - 2 Years Post-implant Clinical Evaluation of the size 23 mm Carpentier-Edwards PERIMOUNT Magna Mitral Bioprosthesis, Model 7000TFX	Magna Mitral 23 - 3 Years Post-implant Clinical Evaluation of the size 23 mm Carpentier-Edwards PERIMOUNT Magna Mitral Bioprosthesis, Model 7000TFX	Magna Mitral 23 - 4 Years Post-implant Clinical Evaluation of the size 23 mm Carpentier-Edwards PERIMOUNT Magna Mitral Bioprosthesis, Model 7000TFX	Magna Mitral 23 - 5 Years Post-implant Clinical Evaluation of the size 23 mm Carpentier-Edwards PERIMOUNT Magna Mitral Bioprosthesis, Model 7000TFX
Subject's Severity of Central Mitral Regurgitation at 1 Year Post-implant. None	3 Participants	—	—	—	—	—
Subject's Severity of Central Mitral Regurgitation at 1 Year Post-implant. +1 Trivial/Trace	5 Participants	—	—	—	—	—
Subject's Severity of Central Mitral Regurgitation at 1 Year Post-implant. +2 Mild	1 Participants	—	—	—	—	—
Subject's Severity of Central Mitral Regurgitation at 1 Year Post-implant. +3 Modearte	0 Participants	—	—	—	—	—
Subject's Severity of Central Mitral Regurgitation at 1 Year Post-implant. +4 Severe	0 Participants	—	—	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, 6 Month, 1 Year, 2 Years, 3 Years, 4 Years, and 5 Years post-implant

Population: The outcome is reported for subjects who received the Magna Mitral, Model 7000TFX device where data is available.

Laboratory Analysis of Red Blood Cell (RBC) Count on blood drawn from subjects; RBC carry oxygen.

Outcome measures

Measure	Magna Mitral 23 n=12 Participants Clinical Evaluation of the size 23 mm Carpentier-Edwards PERIMOUNT Magna Mitral Bioprosthesis, Model 7000TFX	Magna Mitral 23 - 1 Year Post-implant Clinical Evaluation of the size 23 mm Carpentier-Edwards PERIMOUNT Magna Mitral Bioprosthesis, Model 7000TFX	Magna Mitral 23 - 2 Years Post-implant Clinical Evaluation of the size 23 mm Carpentier-Edwards PERIMOUNT Magna Mitral Bioprosthesis, Model 7000TFX	Magna Mitral 23 - 3 Years Post-implant Clinical Evaluation of the size 23 mm Carpentier-Edwards PERIMOUNT Magna Mitral Bioprosthesis, Model 7000TFX	Magna Mitral 23 - 4 Years Post-implant Clinical Evaluation of the size 23 mm Carpentier-Edwards PERIMOUNT Magna Mitral Bioprosthesis, Model 7000TFX	Magna Mitral 23 - 5 Years Post-implant Clinical Evaluation of the size 23 mm Carpentier-Edwards PERIMOUNT Magna Mitral Bioprosthesis, Model 7000TFX
Subject's Average Red Blood Cells Count Baseline	4.1 10^6 cells/microliters Standard Deviation 0.7	—	—	—	—	—
Subject's Average Red Blood Cells Count 6 Month	4.4 10^6 cells/microliters Standard Deviation 0.9	—	—	—	—	—
Subject's Average Red Blood Cells Count 1 Year	4.4 10^6 cells/microliters Standard Deviation 0.3	—	—	—	—	—
Subject's Average Red Blood Cells Count 2 Year	4.1 10^6 cells/microliters Standard Deviation 0.6	—	—	—	—	—
Subject's Average Red Blood Cells Count 3 Year	3.9 10^6 cells/microliters Standard Deviation 1.0	—	—	—	—	—
Subject's Average Red Blood Cells Count 4 Year	4.1 10^6 cells/microliters Standard Deviation 0.6	—	—	—	—	—
Subject's Average Red Blood Cells Count 5 Year	4.0 10^6 cells/microliters Standard Deviation 0.6	—	—	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, 6 Month, 1 Year, 2 Years, 3 Years, 4 Years, and 5 Years post-implant

Population: The outcome is reported for subjects who received the Magna Mitral, Model 7000TFX device where data is available.

Laboratory analysis of White Blood Cell (WBC) Count on blood drawn from subject; WBC fight infection.

Outcome measures

Measure	Magna Mitral 23 n=12 Participants Clinical Evaluation of the size 23 mm Carpentier-Edwards PERIMOUNT Magna Mitral Bioprosthesis, Model 7000TFX	Magna Mitral 23 - 1 Year Post-implant Clinical Evaluation of the size 23 mm Carpentier-Edwards PERIMOUNT Magna Mitral Bioprosthesis, Model 7000TFX	Magna Mitral 23 - 2 Years Post-implant Clinical Evaluation of the size 23 mm Carpentier-Edwards PERIMOUNT Magna Mitral Bioprosthesis, Model 7000TFX	Magna Mitral 23 - 3 Years Post-implant Clinical Evaluation of the size 23 mm Carpentier-Edwards PERIMOUNT Magna Mitral Bioprosthesis, Model 7000TFX	Magna Mitral 23 - 4 Years Post-implant Clinical Evaluation of the size 23 mm Carpentier-Edwards PERIMOUNT Magna Mitral Bioprosthesis, Model 7000TFX	Magna Mitral 23 - 5 Years Post-implant Clinical Evaluation of the size 23 mm Carpentier-Edwards PERIMOUNT Magna Mitral Bioprosthesis, Model 7000TFX
Subject's Average White Blood Cell Count Baseline	7.1 10^3 cells /microliter Standard Deviation 1.7	—	—	—	—	—
Subject's Average White Blood Cell Count 6 Month	7.5 10^3 cells /microliter Standard Deviation 2.4	—	—	—	—	—
Subject's Average White Blood Cell Count 1 Year	7.4 10^3 cells /microliter Standard Deviation 2.3	—	—	—	—	—
Subject's Average White Blood Cell Count 2 Year	7.4 10^3 cells /microliter Standard Deviation 1.8	—	—	—	—	—
Subject's Average White Blood Cell Count 3 Year	7.1 10^3 cells /microliter Standard Deviation 1.8	—	—	—	—	—
Subject's Average White Blood Cell Count 4 Year	8.9 10^3 cells /microliter Standard Deviation 3.0	—	—	—	—	—
Subject's Average White Blood Cell Count 5 Year	7.1 10^3 cells /microliter Standard Deviation 1.4	—	—	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, 6 Month, 1 Year, 2 Years, 3 Years, 4 Years, and 5 Years post-implant

Population: The outcome is reported for subjects who received the Magna Mitral, Model 7000TFX device where data is available.

Laboratory Analysis of Hematocrit Percentage on blood drawn from subjects. Hematocrit is the proportion of red blood cells to the plasma (liquid portion of the blood).

Outcome measures

Measure	Magna Mitral 23 n=12 Participants Clinical Evaluation of the size 23 mm Carpentier-Edwards PERIMOUNT Magna Mitral Bioprosthesis, Model 7000TFX	Magna Mitral 23 - 1 Year Post-implant Clinical Evaluation of the size 23 mm Carpentier-Edwards PERIMOUNT Magna Mitral Bioprosthesis, Model 7000TFX	Magna Mitral 23 - 2 Years Post-implant Clinical Evaluation of the size 23 mm Carpentier-Edwards PERIMOUNT Magna Mitral Bioprosthesis, Model 7000TFX	Magna Mitral 23 - 3 Years Post-implant Clinical Evaluation of the size 23 mm Carpentier-Edwards PERIMOUNT Magna Mitral Bioprosthesis, Model 7000TFX	Magna Mitral 23 - 4 Years Post-implant Clinical Evaluation of the size 23 mm Carpentier-Edwards PERIMOUNT Magna Mitral Bioprosthesis, Model 7000TFX	Magna Mitral 23 - 5 Years Post-implant Clinical Evaluation of the size 23 mm Carpentier-Edwards PERIMOUNT Magna Mitral Bioprosthesis, Model 7000TFX
Subject's Average Hematocrit Percentage Baseline	38.3 percentage of red blood cells Standard Deviation 6.0	—	—	—	—	—
Subject's Average Hematocrit Percentage 6 Month	40.6 percentage of red blood cells Standard Deviation 6.6	—	—	—	—	—
Subject's Average Hematocrit Percentage 1 Year	41.2 percentage of red blood cells Standard Deviation 3.4	—	—	—	—	—
Subject's Average Hematocrit Percentage 2 Year	39.7 percentage of red blood cells Standard Deviation 4.3	—	—	—	—	—
Subject's Average Hematocrit Percentage 3 Year	36.3 percentage of red blood cells Standard Deviation 7.0	—	—	—	—	—
Subject's Average Hematocrit Percentage 4 Year	40.1 percentage of red blood cells Standard Deviation 4.0	—	—	—	—	—
Subject's Average Hematocrit Percentage 5 Year	37.4 percentage of red blood cells Standard Deviation 3.7	—	—	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, 6 Month, 1 Year, 2 Years, 3 Years, 4 Years, and 5 Years post-implant

Population: The outcome is reported for subjects who received the Magna Mitral, Model 7000TFX device where data is available.

Laboratory Analysis of Plasma Free Hemoglobin on blood drawn from subjects. This blood test measures the level of free hemoglobin in the plasma (liquid portion of the blood).

Outcome measures

Measure	Magna Mitral 23 n=12 Participants Clinical Evaluation of the size 23 mm Carpentier-Edwards PERIMOUNT Magna Mitral Bioprosthesis, Model 7000TFX	Magna Mitral 23 - 1 Year Post-implant Clinical Evaluation of the size 23 mm Carpentier-Edwards PERIMOUNT Magna Mitral Bioprosthesis, Model 7000TFX	Magna Mitral 23 - 2 Years Post-implant Clinical Evaluation of the size 23 mm Carpentier-Edwards PERIMOUNT Magna Mitral Bioprosthesis, Model 7000TFX	Magna Mitral 23 - 3 Years Post-implant Clinical Evaluation of the size 23 mm Carpentier-Edwards PERIMOUNT Magna Mitral Bioprosthesis, Model 7000TFX	Magna Mitral 23 - 4 Years Post-implant Clinical Evaluation of the size 23 mm Carpentier-Edwards PERIMOUNT Magna Mitral Bioprosthesis, Model 7000TFX	Magna Mitral 23 - 5 Years Post-implant Clinical Evaluation of the size 23 mm Carpentier-Edwards PERIMOUNT Magna Mitral Bioprosthesis, Model 7000TFX
Subject's Average Plasma Free Hemoglobin Baseline	12.9 mg/dl Standard Deviation 13.9	—	—	—	—	—
Subject's Average Plasma Free Hemoglobin 6 Month	23.1 mg/dl Standard Deviation 19.5	—	—	—	—	—
Subject's Average Plasma Free Hemoglobin 1 Year	11.2 mg/dl Standard Deviation 11.8	—	—	—	—	—
Subject's Average Plasma Free Hemoglobin 2 Year	14.8 mg/dl Standard Deviation 9.2	—	—	—	—	—
Subject's Average Plasma Free Hemoglobin 3 Year	5.1 mg/dl Standard Deviation 3.4	—	—	—	—	—
Subject's Average Plasma Free Hemoglobin 4 Year	22.3 mg/dl Standard Deviation 15.6	—	—	—	—	—
Subject's Average Plasma Free Hemoglobin 5 Year	9.9 mg/dl Standard Deviation 9.4	—	—	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, 6 Month, 1 Year, 2 Years, 3 Years, 4 Years, and 5 Years post-implant

Population: The outcome is reported for subjects who received the Magna Mitral, Model 7000TFX device where data is available.

Laboratory Analysis of Hemoglobin Count on blood drawn from subjects. Hemoglobin is an oxygen-carrying protein in red blood cells.

Outcome measures

Measure	Magna Mitral 23 n=12 Participants Clinical Evaluation of the size 23 mm Carpentier-Edwards PERIMOUNT Magna Mitral Bioprosthesis, Model 7000TFX	Magna Mitral 23 - 1 Year Post-implant Clinical Evaluation of the size 23 mm Carpentier-Edwards PERIMOUNT Magna Mitral Bioprosthesis, Model 7000TFX	Magna Mitral 23 - 2 Years Post-implant Clinical Evaluation of the size 23 mm Carpentier-Edwards PERIMOUNT Magna Mitral Bioprosthesis, Model 7000TFX	Magna Mitral 23 - 3 Years Post-implant Clinical Evaluation of the size 23 mm Carpentier-Edwards PERIMOUNT Magna Mitral Bioprosthesis, Model 7000TFX	Magna Mitral 23 - 4 Years Post-implant Clinical Evaluation of the size 23 mm Carpentier-Edwards PERIMOUNT Magna Mitral Bioprosthesis, Model 7000TFX	Magna Mitral 23 - 5 Years Post-implant Clinical Evaluation of the size 23 mm Carpentier-Edwards PERIMOUNT Magna Mitral Bioprosthesis, Model 7000TFX
Subject's Average Hemoglobin Count Baseline	12.5 g/dl Standard Deviation 2.1	—	—	—	—	—
Subject's Average Hemoglobin Count 6 Month	13.3 g/dl Standard Deviation 2.3	—	—	—	—	—
Subject's Average Hemoglobin Count 1 Year	13.5 g/dl Standard Deviation 1.5	—	—	—	—	—
Subject's Average Hemoglobin Count 2 Year	13.0 g/dl Standard Deviation 1.7	—	—	—	—	—
Subject's Average Hemoglobin Count 3 Year	12.1 g/dl Standard Deviation 2.6	—	—	—	—	—
Subject's Average Hemoglobin Count 4 Year	13.4 g/dl Standard Deviation 1.7	—	—	—	—	—
Subject's Average Hemoglobin Count 5 Year	12.1 g/dl Standard Deviation 1.5	—	—	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, 6 Month, 1 Year, 2 Years, 3 Years, 4 Years, and 5 Years post-implant

Population: The outcome is reported for subjects who received the Magna Mitral, Model 7000TFX device where data is available.

Laboratory Analysis of Platelet Count on blood drawn from subjects; platelets help with blood clotting.

Outcome measures

Measure	Magna Mitral 23 n=12 Participants Clinical Evaluation of the size 23 mm Carpentier-Edwards PERIMOUNT Magna Mitral Bioprosthesis, Model 7000TFX	Magna Mitral 23 - 1 Year Post-implant Clinical Evaluation of the size 23 mm Carpentier-Edwards PERIMOUNT Magna Mitral Bioprosthesis, Model 7000TFX	Magna Mitral 23 - 2 Years Post-implant Clinical Evaluation of the size 23 mm Carpentier-Edwards PERIMOUNT Magna Mitral Bioprosthesis, Model 7000TFX	Magna Mitral 23 - 3 Years Post-implant Clinical Evaluation of the size 23 mm Carpentier-Edwards PERIMOUNT Magna Mitral Bioprosthesis, Model 7000TFX	Magna Mitral 23 - 4 Years Post-implant Clinical Evaluation of the size 23 mm Carpentier-Edwards PERIMOUNT Magna Mitral Bioprosthesis, Model 7000TFX	Magna Mitral 23 - 5 Years Post-implant Clinical Evaluation of the size 23 mm Carpentier-Edwards PERIMOUNT Magna Mitral Bioprosthesis, Model 7000TFX
Subject's Average Platelet Count Baseline	244.8 10^3 platelets per microliter Standard Deviation 95.6	—	—	—	—	—
Subject's Average Platelet Count 6 Months	231.1 10^3 platelets per microliter Standard Deviation 77.7	—	—	—	—	—
Subject's Average Platelet Count 1 Year	199.7 10^3 platelets per microliter Standard Deviation 39.5	—	—	—	—	—
Subject's Average Platelet Count 2 Year	201.8 10^3 platelets per microliter Standard Deviation 63.8	—	—	—	—	—
Subject's Average Platelet Count 3 Year	217.9 10^3 platelets per microliter Standard Deviation 78.0	—	—	—	—	—
Subject's Average Platelet Count 4 Year	236.3 10^3 platelets per microliter Standard Deviation 98.8	—	—	—	—	—
Subject's Average Platelet Count 5 Year	208.6 10^3 platelets per microliter Standard Deviation 71.8	—	—	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline and 1 Year post-implant

Population: The outcome is reported for subjects who received the Magna Mitral, Model 7000TFX device where data is available.

The New York Heart Association (NYHA) 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, dyspnea (shortness of breath).

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

Outcome measures

Measure	Magna Mitral 23 n=12 Participants Clinical Evaluation of the size 23 mm Carpentier-Edwards PERIMOUNT Magna Mitral Bioprosthesis, Model 7000TFX	Magna Mitral 23 - 1 Year Post-implant n=9 Participants Clinical Evaluation of the size 23 mm Carpentier-Edwards PERIMOUNT Magna Mitral Bioprosthesis, Model 7000TFX	Magna Mitral 23 - 2 Years Post-implant Clinical Evaluation of the size 23 mm Carpentier-Edwards PERIMOUNT Magna Mitral Bioprosthesis, Model 7000TFX	Magna Mitral 23 - 3 Years Post-implant Clinical Evaluation of the size 23 mm Carpentier-Edwards PERIMOUNT Magna Mitral Bioprosthesis, Model 7000TFX	Magna Mitral 23 - 4 Years Post-implant Clinical Evaluation of the size 23 mm Carpentier-Edwards PERIMOUNT Magna Mitral Bioprosthesis, Model 7000TFX	Magna Mitral 23 - 5 Years Post-implant Clinical Evaluation of the size 23 mm Carpentier-Edwards PERIMOUNT Magna Mitral Bioprosthesis, Model 7000TFX
Number and Percentage of Subjects in NYHA Functional Class I or II at 1 Year Post-Implant. Class I	1 Participants	7 Participants	—	—	—	—
Number and Percentage of Subjects in NYHA Functional Class I or II at 1 Year Post-Implant. Class II	5 Participants	1 Participants	—	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 Months, 1 Year, 2 Years, 3 Years, 4 Years, and 5 Years post-implant

Population: The outcome is reported for subjects who received the Magna Mitral, Model 7000TFX device where data is available.

The New York Heart Association (NYHA) 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, dyspnea (shortness of breath).

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

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

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.

Outcome measures

Measure	Magna Mitral 23 n=12 Participants Clinical Evaluation of the size 23 mm Carpentier-Edwards PERIMOUNT Magna Mitral Bioprosthesis, Model 7000TFX	Magna Mitral 23 - 1 Year Post-implant Clinical Evaluation of the size 23 mm Carpentier-Edwards PERIMOUNT Magna Mitral Bioprosthesis, Model 7000TFX	Magna Mitral 23 - 2 Years Post-implant Clinical Evaluation of the size 23 mm Carpentier-Edwards PERIMOUNT Magna Mitral Bioprosthesis, Model 7000TFX	Magna Mitral 23 - 3 Years Post-implant Clinical Evaluation of the size 23 mm Carpentier-Edwards PERIMOUNT Magna Mitral Bioprosthesis, Model 7000TFX	Magna Mitral 23 - 4 Years Post-implant Clinical Evaluation of the size 23 mm Carpentier-Edwards PERIMOUNT Magna Mitral Bioprosthesis, Model 7000TFX	Magna Mitral 23 - 5 Years Post-implant Clinical Evaluation of the size 23 mm Carpentier-Edwards PERIMOUNT Magna Mitral Bioprosthesis, Model 7000TFX
Subject's New York Heart Association (NYHA) Functional Class Compared to Baseline 6 Months · Improved	7 Participants	—	—	—	—	—
Subject's New York Heart Association (NYHA) Functional Class Compared to Baseline 6 Months · Same	2 Participants	—	—	—	—	—
Subject's New York Heart Association (NYHA) Functional Class Compared to Baseline 6 Months · Worsened	0 Participants	—	—	—	—	—
Subject's New York Heart Association (NYHA) Functional Class Compared to Baseline 1 Year · Improved	8 Participants	—	—	—	—	—
Subject's New York Heart Association (NYHA) Functional Class Compared to Baseline 1 Year · Same	1 Participants	—	—	—	—	—
Subject's New York Heart Association (NYHA) Functional Class Compared to Baseline 1 Year · Worsened	0 Participants	—	—	—	—	—
Subject's New York Heart Association (NYHA) Functional Class Compared to Baseline 2 Year · Improved	7 Participants	—	—	—	—	—
Subject's New York Heart Association (NYHA) Functional Class Compared to Baseline 2 Year · Same	2 Participants	—	—	—	—	—
Subject's New York Heart Association (NYHA) Functional Class Compared to Baseline 2 Year · Worsened	0 Participants	—	—	—	—	—
Subject's New York Heart Association (NYHA) Functional Class Compared to Baseline 3 Year · Improved	7 Participants	—	—	—	—	—
Subject's New York Heart Association (NYHA) Functional Class Compared to Baseline 3 Year · Same	1 Participants	—	—	—	—	—
Subject's New York Heart Association (NYHA) Functional Class Compared to Baseline 3 Year · Worsened	1 Participants	—	—	—	—	—
Subject's New York Heart Association (NYHA) Functional Class Compared to Baseline 4 Year · Improved	5 Participants	—	—	—	—	—
Subject's New York Heart Association (NYHA) Functional Class Compared to Baseline 4 Year · Same	2 Participants	—	—	—	—	—
Subject's New York Heart Association (NYHA) Functional Class Compared to Baseline 4 Year · Worsened	1 Participants	—	—	—	—	—
Subject's New York Heart Association (NYHA) Functional Class Compared to Baseline 5 Year · Improved	3 Participants	—	—	—	—	—
Subject's New York Heart Association (NYHA) Functional Class Compared to Baseline 5 Year · Same	2 Participants	—	—	—	—	—
Subject's New York Heart Association (NYHA) Functional Class Compared to Baseline 5 Year · Worsened	2 Participants	—	—	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 Months and 1 Year post-implant

Population: The outcome is reported for subjects who received the Magna Mitral, Model 7000TFX device where data is available.

The EQ-5D is a standardized questionnaire that asks subjects to rate themselves (no problems, some problems, extreme problems) on mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The scale is indexed and ranges from a minimum of 0.275 and a maximum of 1.000. A lower number indicates the participants experiences more problems and a higher number indicates the participants experiences fewer problems.

Outcome measures

Measure	Magna Mitral 23 n=12 Participants Clinical Evaluation of the size 23 mm Carpentier-Edwards PERIMOUNT Magna Mitral Bioprosthesis, Model 7000TFX	Magna Mitral 23 - 1 Year Post-implant Clinical Evaluation of the size 23 mm Carpentier-Edwards PERIMOUNT Magna Mitral Bioprosthesis, Model 7000TFX	Magna Mitral 23 - 2 Years Post-implant Clinical Evaluation of the size 23 mm Carpentier-Edwards PERIMOUNT Magna Mitral Bioprosthesis, Model 7000TFX	Magna Mitral 23 - 3 Years Post-implant Clinical Evaluation of the size 23 mm Carpentier-Edwards PERIMOUNT Magna Mitral Bioprosthesis, Model 7000TFX	Magna Mitral 23 - 4 Years Post-implant Clinical Evaluation of the size 23 mm Carpentier-Edwards PERIMOUNT Magna Mitral Bioprosthesis, Model 7000TFX	Magna Mitral 23 - 5 Years Post-implant Clinical Evaluation of the size 23 mm Carpentier-Edwards PERIMOUNT Magna Mitral Bioprosthesis, Model 7000TFX
Subject's Average Score on the EQ-5D- Quality of Life Questionnaire Over Time Baseline	0.86 units on a scale Standard Deviation 0.07	—	—	—	—	—
Subject's Average Score on the EQ-5D- Quality of Life Questionnaire Over Time 6 Month	0.94 units on a scale Standard Deviation 0.07	—	—	—	—	—
Subject's Average Score on the EQ-5D- Quality of Life Questionnaire Over Time 1 Year	0.89 units on a scale Standard Deviation 0.11	—	—	—	—	—

Adverse Events

Magna Mitral 23

Serious events: 12 serious events

Other events: 11 other events

Deaths: 3 deaths

Serious adverse events

Measure	Magna Mitral 23 n=12 participants at risk Clinical Evaluation of the size 23 mm Carpentier-Edwards PERIMOUNT Magna Mitral Bioprosthesis, Model 7000TFX
Cardiac disorders Heart Failure - Acute	41.7% 5/12 • Number of events 6 • Events occurring from baseline through five years post implant The outcome is reported for subjects who received the Magna Mitral, Model 7000TFX device where data is available.
Gastrointestinal disorders Gastrointestinal - Other	25.0% 3/12 • Number of events 5 • Events occurring from baseline through five years post implant The outcome is reported for subjects who received the Magna Mitral, Model 7000TFX device where data is available.
Cardiac disorders Heart Failure - Chronic (CHF)	33.3% 4/12 • Number of events 4 • Events occurring from baseline through five years post implant The outcome is reported for subjects who received the Magna Mitral, Model 7000TFX device where data is available.
General disorders Cancer - Newly Diagnosed	25.0% 3/12 • Number of events 4 • Events occurring from baseline through five years post implant The outcome is reported for subjects who received the Magna Mitral, Model 7000TFX device where data is available.
General disorders Miscellaneous Complication	25.0% 3/12 • Number of events 4 • Events occurring from baseline through five years post implant The outcome is reported for subjects who received the Magna Mitral, Model 7000TFX device where data is available.
Psychiatric disorders Neurologic - Other	25.0% 3/12 • Number of events 4 • Events occurring from baseline through five years post implant The outcome is reported for subjects who received the Magna Mitral, Model 7000TFX device where data is available.
Respiratory, thoracic and mediastinal disorders Respiratory Infection - Pneumonia	25.0% 3/12 • Number of events 3 • Events occurring from baseline through five years post implant The outcome is reported for subjects who received the Magna Mitral, Model 7000TFX device where data is available.
Respiratory, thoracic and mediastinal disorders Other Infection/Inflammation	8.3% 1/12 • Number of events 3 • Events occurring from baseline through five years post implant The outcome is reported for subjects who received the Magna Mitral, Model 7000TFX device where data is available.
Cardiac disorders Arrhythmia - AV Block	16.7% 2/12 • Number of events 2 • Events occurring from baseline through five years post implant The outcome is reported for subjects who received the Magna Mitral, Model 7000TFX device where data is available.
Respiratory, thoracic and mediastinal disorders Respiratory Dysfunction/Insufficiency	16.7% 2/12 • Number of events 2 • Events occurring from baseline through five years post implant The outcome is reported for subjects who received the Magna Mitral, Model 7000TFX device where data is available.
Blood and lymphatic system disorders Anemia - Non-Bleeding Related	8.3% 1/12 • Number of events 1 • Events occurring from baseline through five years post implant The outcome is reported for subjects who received the Magna Mitral, Model 7000TFX device where data is available.
Cardiac disorders Angina, Unstable	8.3% 1/12 • Number of events 1 • Events occurring from baseline through five years post implant The outcome is reported for subjects who received the Magna Mitral, Model 7000TFX device where data is available.
Cardiac disorders Arrhythmia - Atrial Flutter	8.3% 1/12 • Number of events 1 • Events occurring from baseline through five years post implant The outcome is reported for subjects who received the Magna Mitral, Model 7000TFX device where data is available.
Cardiac disorders Arrhythmia - Paroxysmal Atrial Fibrillation (PAF)	8.3% 1/12 • Number of events 1 • Events occurring from baseline through five years post implant The outcome is reported for subjects who received the Magna Mitral, Model 7000TFX device where data is available.
Gastrointestinal disorders Biliary (Gallbladder)	8.3% 1/12 • Number of events 1 • Events occurring from baseline through five years post implant The outcome is reported for subjects who received the Magna Mitral, Model 7000TFX device where data is available.
Blood and lymphatic system disorders Bleeding - Cardiovascular	8.3% 1/12 • Number of events 1 • Events occurring from baseline through five years post implant The outcome is reported for subjects who received the Magna Mitral, Model 7000TFX device where data is available.
Cardiac disorders Cardiogenic Shock	8.3% 1/12 • Number of events 1 • Events occurring from baseline through five years post implant The outcome is reported for subjects who received the Magna Mitral, Model 7000TFX device where data is available.
Cardiac disorders Cardiovascular Other	8.3% 1/12 • Number of events 1 • Events occurring from baseline through five years post implant The outcome is reported for subjects who received the Magna Mitral, Model 7000TFX device where data is available.
Cardiac disorders Endocarditis	8.3% 1/12 • Number of events 1 • Events occurring from baseline through five years post implant The outcome is reported for subjects who received the Magna Mitral, Model 7000TFX device where data is available.
Gastrointestinal disorders Endocrine Complications	8.3% 1/12 • Number of events 1 • Events occurring from baseline through five years post implant The outcome is reported for subjects who received the Magna Mitral, Model 7000TFX device where data is available.
Gastrointestinal disorders Gastrointestinal - Infection (Diarrhea)	8.3% 1/12 • Number of events 1 • Events occurring from baseline through five years post implant The outcome is reported for subjects who received the Magna Mitral, Model 7000TFX device where data is available.
Psychiatric disorders Neurologic - Dizziness	8.3% 1/12 • Number of events 1 • Events occurring from baseline through five years post implant The outcome is reported for subjects who received the Magna Mitral, Model 7000TFX device where data is available.
Cardiac disorders Non Structural Valve Dysfunction (NSVD) - Non-Perivalvular Leak	8.3% 1/12 • Number of events 1 • Events occurring from baseline through five years post implant The outcome is reported for subjects who received the Magna Mitral, Model 7000TFX device where data is available.
Psychiatric disorders Psychiatric Disorder	8.3% 1/12 • Number of events 1 • Events occurring from baseline through five years post implant The outcome is reported for subjects who received the Magna Mitral, Model 7000TFX device where data is available.
Respiratory, thoracic and mediastinal disorders Pulmonary Edema	8.3% 1/12 • Number of events 1 • Events occurring from baseline through five years post implant The outcome is reported for subjects who received the Magna Mitral, Model 7000TFX device where data is available.
Respiratory, thoracic and mediastinal disorders Pulmonary Hypertension	8.3% 1/12 • Number of events 1 • Events occurring from baseline through five years post implant The outcome is reported for subjects who received the Magna Mitral, Model 7000TFX device where data is available.
Respiratory, thoracic and mediastinal disorders Respiratory Failure	8.3% 1/12 • Number of events 1 • Events occurring from baseline through five years post implant The outcome is reported for subjects who received the Magna Mitral, Model 7000TFX device where data is available.
Cardiac disorders Structural Valve Deterioration (SVD)	8.3% 1/12 • Number of events 1 • Events occurring from baseline through five years post implant The outcome is reported for subjects who received the Magna Mitral, Model 7000TFX device where data is available.
Cardiac disorders Thromboembolic Event - Transient Ischemic Attack (TIA)	8.3% 1/12 • Number of events 1 • Events occurring from baseline through five years post implant The outcome is reported for subjects who received the Magna Mitral, Model 7000TFX device where data is available.
Vascular disorders Vascular - Other	8.3% 1/12 • Number of events 1 • Events occurring from baseline through five years post implant The outcome is reported for subjects who received the Magna Mitral, Model 7000TFX device where data is available.

Other adverse events

Measure	Magna Mitral 23 n=12 participants at risk Clinical Evaluation of the size 23 mm Carpentier-Edwards PERIMOUNT Magna Mitral Bioprosthesis, Model 7000TFX
General disorders Miscellaneous Complication	50.0% 6/12 • Number of events 12 • Events occurring from baseline through five years post implant The outcome is reported for subjects who received the Magna Mitral, Model 7000TFX device where data is available.
Blood and lymphatic system disorders Thrombocytopenia - Non-Heparin Induced	41.7% 5/12 • Number of events 7 • Events occurring from baseline through five years post implant The outcome is reported for subjects who received the Magna Mitral, Model 7000TFX device where data is available.
Gastrointestinal disorders Gastrointestinal - Other	41.7% 5/12 • Number of events 6 • Events occurring from baseline through five years post implant The outcome is reported for subjects who received the Magna Mitral, Model 7000TFX device where data is available.
Respiratory, thoracic and mediastinal disorders Pleural Effusion	41.7% 5/12 • Number of events 6 • Events occurring from baseline through five years post implant The outcome is reported for subjects who received the Magna Mitral, Model 7000TFX device where data is available.
Respiratory, thoracic and mediastinal disorders Respiratory Infection - Upper (URI)	41.7% 5/12 • Number of events 6 • Events occurring from baseline through five years post implant The outcome is reported for subjects who received the Magna Mitral, Model 7000TFX device where data is available.
Blood and lymphatic system disorders Anemia - Bleeding Related	33.3% 4/12 • Number of events 6 • Events occurring from baseline through five years post implant The outcome is reported for subjects who received the Magna Mitral, Model 7000TFX device where data is available.
Respiratory, thoracic and mediastinal disorders Skin/Skeletal/Other	33.3% 4/12 • Number of events 6 • Events occurring from baseline through five years post implant The outcome is reported for subjects who received the Magna Mitral, Model 7000TFX device where data is available.
Respiratory, thoracic and mediastinal disorders Atelectasis	33.3% 4/12 • Number of events 5 • Events occurring from baseline through five years post implant The outcome is reported for subjects who received the Magna Mitral, Model 7000TFX device where data is available.
Blood and lymphatic system disorders Anemia - Non-Bleeding Related	33.3% 4/12 • Number of events 4 • Events occurring from baseline through five years post implant The outcome is reported for subjects who received the Magna Mitral, Model 7000TFX device where data is available.
Cardiac disorders Arrhythmia - Atrial Fibrillation	33.3% 4/12 • Number of events 4 • Events occurring from baseline through five years post implant The outcome is reported for subjects who received the Magna Mitral, Model 7000TFX device where data is available.
Cardiac disorders Arrhythmia - Bradycardia	33.3% 4/12 • Number of events 4 • Events occurring from baseline through five years post implant The outcome is reported for subjects who received the Magna Mitral, Model 7000TFX device where data is available.
Renal and urinary disorders Urinary Tract Infection (UTI)	33.3% 4/12 • Number of events 4 • Events occurring from baseline through five years post implant The outcome is reported for subjects who received the Magna Mitral, Model 7000TFX device where data is available.
Blood and lymphatic system disorders Blood/Lymphatic/Other	25.0% 3/12 • Number of events 3 • Events occurring from baseline through five years post implant The outcome is reported for subjects who received the Magna Mitral, Model 7000TFX device where data is available.
Respiratory, thoracic and mediastinal disorders Respiratory Dysfunction/Insufficiency	25.0% 3/12 • Number of events 3 • Events occurring from baseline through five years post implant The outcome is reported for subjects who received the Magna Mitral, Model 7000TFX device where data is available.
Cardiac disorders Arrhythmia - Bundle Branch Block	16.7% 2/12 • Number of events 3 • Events occurring from baseline through five years post implant The outcome is reported for subjects who received the Magna Mitral, Model 7000TFX device where data is available.
Respiratory, thoracic and mediastinal disorders Pneumothorax	16.7% 2/12 • Number of events 3 • Events occurring from baseline through five years post implant The outcome is reported for subjects who received the Magna Mitral, Model 7000TFX device where data is available.
Respiratory, thoracic and mediastinal disorders Other Infection/Inflammation	8.3% 1/12 • Number of events 3 • Events occurring from baseline through five years post implant The outcome is reported for subjects who received the Magna Mitral, Model 7000TFX device where data is available.
Cardiac disorders Arrhythmia - Atrial Flutter	16.7% 2/12 • Number of events 2 • Events occurring from baseline through five years post implant The outcome is reported for subjects who received the Magna Mitral, Model 7000TFX device where data is available.
Cardiac disorders Cardiovascular Other	16.7% 2/12 • Number of events 2 • Events occurring from baseline through five years post implant The outcome is reported for subjects who received the Magna Mitral, Model 7000TFX device where data is available.
Gastrointestinal disorders Gastrointestinal - Infection (Diarrhea)	16.7% 2/12 • Number of events 2 • Events occurring from baseline through five years post implant The outcome is reported for subjects who received the Magna Mitral, Model 7000TFX device where data is available.
Cardiac disorders Heart Failure - Acute	16.7% 2/12 • Number of events 2 • Events occurring from baseline through five years post implant The outcome is reported for subjects who received the Magna Mitral, Model 7000TFX device where data is available.
Cardiac disorders Hypotension	16.7% 2/12 • Number of events 2 • Events occurring from baseline through five years post implant The outcome is reported for subjects who received the Magna Mitral, Model 7000TFX device where data is available.
Psychiatric disorders Neurologic - Dizziness	16.7% 2/12 • Number of events 2 • Events occurring from baseline through five years post implant The outcome is reported for subjects who received the Magna Mitral, Model 7000TFX device where data is available.
Psychiatric disorders Neurologic - Other	16.7% 2/12 • Number of events 2 • Events occurring from baseline through five years post implant The outcome is reported for subjects who received the Magna Mitral, Model 7000TFX device where data is available.
Renal and urinary disorders Renal - Other	16.7% 2/12 • Number of events 2 • Events occurring from baseline through five years post implant The outcome is reported for subjects who received the Magna Mitral, Model 7000TFX device where data is available.
Cardiac disorders Arrhythmia - AV Block	8.3% 1/12 • Number of events 1 • Events occurring from baseline through five years post implant The outcome is reported for subjects who received the Magna Mitral, Model 7000TFX device where data is available.
Cardiac disorders Arrhythmia - Tachy-Bradycardia	8.3% 1/12 • Number of events 1 • Events occurring from baseline through five years post implant The outcome is reported for subjects who received the Magna Mitral, Model 7000TFX device where data is available.
Cardiac disorders Arrhythmia - Tachycardia	8.3% 1/12 • Number of events 1 • Events occurring from baseline through five years post implant The outcome is reported for subjects who received the Magna Mitral, Model 7000TFX device where data is available.
Blood and lymphatic system disorders Bleeding - Cardiovascular	8.3% 1/12 • Number of events 1 • Events occurring from baseline through five years post implant The outcome is reported for subjects who received the Magna Mitral, Model 7000TFX device where data is available.
Blood and lymphatic system disorders Bleeding - Peripheral Vascular (E.G. Nosebleeds; Hematomas)	8.3% 1/12 • Number of events 1 • Events occurring from baseline through five years post implant The outcome is reported for subjects who received the Magna Mitral, Model 7000TFX device where data is available.
General disorders Cancer - Newly Diagnosed	8.3% 1/12 • Number of events 1 • Events occurring from baseline through five years post implant The outcome is reported for subjects who received the Magna Mitral, Model 7000TFX device where data is available.
General disorders Cancer - Progression Of Underlying Disease	8.3% 1/12 • Number of events 1 • Events occurring from baseline through five years post implant The outcome is reported for subjects who received the Magna Mitral, Model 7000TFX device where data is available.
Gastrointestinal disorders Endocrine Complications	8.3% 1/12 • Number of events 1 • Events occurring from baseline through five years post implant The outcome is reported for subjects who received the Magna Mitral, Model 7000TFX device where data is available.
Gastrointestinal disorders Hepatic - Complication	8.3% 1/12 • Number of events 1 • Events occurring from baseline through five years post implant The outcome is reported for subjects who received the Magna Mitral, Model 7000TFX device where data is available.
Cardiac disorders Minor (<=+2) Paravalvular Leak	8.3% 1/12 • Number of events 1 • Events occurring from baseline through five years post implant The outcome is reported for subjects who received the Magna Mitral, Model 7000TFX device where data is available.
Psychiatric disorders Neurologic - Syncope	8.3% 1/12 • Number of events 1 • Events occurring from baseline through five years post implant The outcome is reported for subjects who received the Magna Mitral, Model 7000TFX device where data is available.
Respiratory, thoracic and mediastinal disorders Pulmonary/Respiratory Other	8.3% 1/12 • Number of events 1 • Events occurring from baseline through five years post implant The outcome is reported for subjects who received the Magna Mitral, Model 7000TFX device where data is available.
Respiratory, thoracic and mediastinal disorders Respiratory Failure	8.3% 1/12 • Number of events 1 • Events occurring from baseline through five years post implant The outcome is reported for subjects who received the Magna Mitral, Model 7000TFX device where data is available.
Respiratory, thoracic and mediastinal disorders Respiratory Infection - Pneumonia	8.3% 1/12 • Number of events 1 • Events occurring from baseline through five years post implant The outcome is reported for subjects who received the Magna Mitral, Model 7000TFX device where data is available.
Blood and lymphatic system disorders Thrombocytopenia - Heparin Induced (HIT)	8.3% 1/12 • Number of events 1 • Events occurring from baseline through five years post implant The outcome is reported for subjects who received the Magna Mitral, Model 7000TFX device where data is available.
Psychiatric disorders Transient Psychotic Syndrome	8.3% 1/12 • Number of events 1 • Events occurring from baseline through five years post implant The outcome is reported for subjects who received the Magna Mitral, Model 7000TFX device where data is available.
Renal and urinary disorders Vaginal Infection	8.3% 1/12 • Number of events 1 • Events occurring from baseline through five years post implant The outcome is reported for subjects who received the Magna Mitral, Model 7000TFX device where data is available.
Cardiac disorders Valve - Other	8.3% 1/12 • Number of events 1 • Events occurring from baseline through five years post implant The outcome is reported for subjects who received the Magna Mitral, Model 7000TFX device where data is available.
Vascular disorders Vascular - Other	8.3% 1/12 • Number of events 1 • Events occurring from baseline through five years post implant The outcome is reported for subjects who received the Magna Mitral, Model 7000TFX device where data is available.
General disorders Vision Disorder	8.3% 1/12 • Number of events 1 • Events occurring from baseline through five years post implant The outcome is reported for subjects who received the Magna Mitral, Model 7000TFX device where data is available.

Additional Information

Andrey Nersesov, Sr. Director of Clinical Affairs, Surgical Structural Heart

Edwards Lifesciences, LLC

Phone: 949-250-2500

Email: Andrey_Nersesov@edwards.com

Results disclosure agreements

• Principal investigator is a sponsor employee Publication of overall study results which have not been released requires written approval of Sponsor, but presentation of site-specific results can occur subject to review by Sponsor. Manuscripts will be submitted to Sponsor for review 30 days prior to submission of manuscript for publication/presentation. Sponsor may ask for a 60 day delay of submission of manuscripts for publication to protect proprietary information and filing of related patent applications.
• Publication restrictions are in place

Restriction type: OTHER