Trial Outcomes & Findings for Clinical Evaluation of MDT-2111 in Subjects With Small Aortic Annuli and Symptomatic Severe Aortic Stenosis (NCT NCT01634269)

NCT ID: NCT01634269

Last Updated: 2019-10-15

Results Overview

The primary endpoint is a composite of functional effectiveness as measured by improvement of at least 1 NYHA class from baseline to 6 months and anatomical effectiveness as measured by Effective Orifice Area (EOA) ≥1.0 cm² at 6 months.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 20 participants
• Primary outcome timeframe: baseline and 6 months
• Results posted on: 2019-10-15

Participant Flow

Participant milestones

Measure	MDT-2111 TAVI 23 mm Transcatheter Aortic Valve Implantation (TAVI) using the 23 mm MDT-2111 system.
Overall Study STARTED	20
Overall Study 30 Days	20
Overall Study 6 Month	20
Overall Study 12 Month	20
Overall Study 24 Month	18
Overall Study COMPLETED	18
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Clinical Evaluation of MDT-2111 in Subjects With Small Aortic Annuli and Symptomatic Severe Aortic Stenosis

Baseline characteristics by cohort

Measure	MDT-2111 TAVI 23 mm n=20 Participants Transcatheter Aortic Valve Implantation (TAVI) using the 23 mm MDT-2111 system.
Age, Continuous	81.0 years STANDARD_DEVIATION 6.6 • n=5 Participants
Sex: Female, Male Female	19 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants
Region of Enrollment Japan	20 participants n=5 Participants
NYHA Class NYHA Class II	0 participants n=5 Participants
NYHA Class NYHA Class III	19 participants n=5 Participants
NYHA Class NYHA IV	1 participants n=5 Participants
STS Score	7.0 percent STANDARD_DEVIATION 3.3 • n=5 Participants
Logistic EuroScore	22.3 percent STANDARD_DEVIATION 10.1 • n=5 Participants
Body Surface Area	1.4 m² STANDARD_DEVIATION 0.1 • n=5 Participants

PRIMARY outcome

Timeframe: baseline and 6 months

Population: Implanted subjects

The primary endpoint is a composite of functional effectiveness as measured by improvement of at least 1 NYHA class from baseline to 6 months and anatomical effectiveness as measured by Effective Orifice Area (EOA) ≥1.0 cm² at 6 months.

Outcome measures

Measure	All Implanted Subjects n=20 Participants The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 TAVI 23 mm device.	Iliofemoral Implanted Subjects n=16 Participants The IF Implanted population consisted of all IF As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.
Composite Score of Change in New York Heart Association (NYHA) Class and Effective Orifice Area (EOA).	75.0 percentage of participants analyzed	87.5 percentage of participants analyzed

SECONDARY outcome

Timeframe: 30 days

Population: All Implanted Subjects

NEW YORK HEART ASSOCIATION CLASSIFICATION (NYHA) Class I: Subject with cardiac disease but without resulting limitations of physical activity.

Class II: Subjects with cardiac disease resulting in slight limitation of physical activity.

Class III: Subjects with cardiac disease resulting in marked limitation of physical activity.

Class IV: Subjects with cardiac disease resulting in inability to carry on any physical activity without discomfort.

Outcome measures

Measure	All Implanted Subjects n=20 Participants The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 TAVI 23 mm device.	Iliofemoral Implanted Subjects The IF Implanted population consisted of all IF As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.
New York Heart Classification (NYHA) Over Time NYHA I	45.0 percentage of participants analyzed	—
New York Heart Classification (NYHA) Over Time NYHA II	50.0 percentage of participants analyzed	—
New York Heart Classification (NYHA) Over Time NYHA III	5.0 percentage of participants analyzed	—
New York Heart Classification (NYHA) Over Time NYHA IV	0.0 percentage of participants analyzed	—
New York Heart Classification (NYHA) Over Time Death	0.0 percentage of participants analyzed	—

SECONDARY outcome

Timeframe: 6 months

Population: All Implanted Subjects

NEW YORK HEART ASSOCIATION CLASSIFICATION (NYHA) Class I: Subject with cardiac disease but without resulting limitations of physical activity.

Class II: Subjects with cardiac disease resulting in slight limitation of physical activity.

Class III: Subjects with cardiac disease resulting in marked limitation of physical activity.

Class IV: Subjects with cardiac disease resulting in inability to carry on any physical activity without discomfort.

Outcome measures

Measure	All Implanted Subjects n=20 Participants The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 TAVI 23 mm device.	Iliofemoral Implanted Subjects The IF Implanted population consisted of all IF As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.
New York Heart Classification (NYHA) Over Time NYHA I	55.0 percentage of participants analyzed	—
New York Heart Classification (NYHA) Over Time NYHA II	45.0 percentage of participants analyzed	—
New York Heart Classification (NYHA) Over Time NYHA III	0.0 percentage of participants analyzed	—
New York Heart Classification (NYHA) Over Time NYHA IV	0.0 percentage of participants analyzed	—
New York Heart Classification (NYHA) Over Time Death	0.0 percentage of participants analyzed	—

SECONDARY outcome

Timeframe: 12 months

Population: All Implanted Subjects

NEW YORK HEART ASSOCIATION CLASSIFICATION (NYHA) Class I: Subject with cardiac disease but without resulting limitations of physical activity.

Class II: Subjects with cardiac disease resulting in slight limitation of physical activity.

Class III: Subjects with cardiac disease resulting in marked limitation of physical activity.

Class IV: Subjects with cardiac disease resulting in inability to carry on any physical activity without discomfort.

Outcome measures

Measure	All Implanted Subjects n=20 Participants The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 TAVI 23 mm device.	Iliofemoral Implanted Subjects The IF Implanted population consisted of all IF As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.
New York Heart Classification (NYHA) Over Time NYHA I	40.0 percentage of participants analyzed	—
New York Heart Classification (NYHA) Over Time NYHA II	60.0 percentage of participants analyzed	—
New York Heart Classification (NYHA) Over Time NYHA III	0.0 percentage of participants analyzed	—
New York Heart Classification (NYHA) Over Time NYHA IV	0.0 percentage of participants analyzed	—
New York Heart Classification (NYHA) Over Time Death	0.0 percentage of participants analyzed	—

SECONDARY outcome

Timeframe: 24 months

Population: All Implanted Subjects

NEW YORK HEART ASSOCIATION CLASSIFICATION (NYHA) Class I: Subject with cardiac disease but without resulting limitations of physical activity.

Class II: Subjects with cardiac disease resulting in slight limitation of physical activity.

Class III: Subjects with cardiac disease resulting in marked limitation of physical activity.

Class IV: Subjects with cardiac disease resulting in inability to carry on any physical activity without discomfort.

Outcome measures

Measure	All Implanted Subjects n=19 Participants The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 TAVI 23 mm device.	Iliofemoral Implanted Subjects The IF Implanted population consisted of all IF As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.
New York Heart Classification (NYHA) Over Time NYHA I	47.4 percentage of participants analyzed	—
New York Heart Classification (NYHA) Over Time NYHA II	47.4 percentage of participants analyzed	—
New York Heart Classification (NYHA) Over Time NYHA III	0.0 percentage of participants analyzed	—
New York Heart Classification (NYHA) Over Time NYHA IV	0.0 percentage of participants analyzed	—
New York Heart Classification (NYHA) Over Time Death	5.3 percentage of participants analyzed	—

SECONDARY outcome

Timeframe: 0 day to 30 days

Population: The Kaplan-Meier Method was used to calculate the number.

MACCE is defined as a composite of:

• all-cause death
• myocardial infarction (MI)
• all stroke, and
• reintervention (defined as any cardiac surgery or percutaneous reintervention catheter procedure that repairs, otherwise alters or adjusts, or replaces a previously implanted valve)

Outcome measures

Measure	All Implanted Subjects n=20 Participants The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 TAVI 23 mm device.	Iliofemoral Implanted Subjects The IF Implanted population consisted of all IF As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.
Major Adverse Cardiovascular and Cerebrovascular Event (MACCE)	100 prob of freedom from event @ 30 days	—

SECONDARY outcome

Timeframe: 0 day to 6 months

Population: The Kaplan-Meier Method was used to calculate the number.

MACCE is defined as a composite of:

• all-cause death
• myocardial infarction (MI)
• all stroke, and
• reintervention (defined as any cardiac surgery or percutaneous reintervention catheter procedure that repairs, otherwise alters or adjusts, or replaces a previously implanted valve)

Outcome measures

Measure	All Implanted Subjects n=20 Participants The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 TAVI 23 mm device.	Iliofemoral Implanted Subjects The IF Implanted population consisted of all IF As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.
Major Adverse Cardiovascular and Cerebrovascular Event (MACCE)	95.0 prob of freedom from event @ 183 days	—

SECONDARY outcome

Timeframe: 0 day to 12 months

Population: The Kaplan-Meier Method was used to calculate the number.

MACCE is defined as a composite of:

• all-cause death
• myocardial infarction (MI)
• all stroke, and
• reintervention (defined as any cardiac surgery or percutaneous reintervention catheter procedure that repairs, otherwise alters or adjusts, or replaces a previously implanted valve)

Outcome measures

Measure	All Implanted Subjects n=20 Participants The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 TAVI 23 mm device.	Iliofemoral Implanted Subjects The IF Implanted population consisted of all IF As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.
Major Adverse Cardiovascular and Cerebrovascular Event (MACCE)	95.0 prob of freedom from event @ 365 days	—

SECONDARY outcome

Timeframe: 0 day to 24 months

Population: The Kaplan-Meier Method was used to calculate the number.

MACCE is defined as a composite of:

• all-cause death
• myocardial infarction (MI)
• all stroke, and
• reintervention (defined as any cardiac surgery or percutaneous reintervention catheter procedure that repairs, otherwise alters or adjusts, or replaces a previously implanted valve)

Outcome measures

Measure	All Implanted Subjects n=20 Participants The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 TAVI 23 mm device.	Iliofemoral Implanted Subjects The IF Implanted population consisted of all IF As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.
Major Adverse Cardiovascular and Cerebrovascular Event (MACCE)	90.0 prob of freedom from event @ 730 days	—

SECONDARY outcome

Timeframe: after procedure or discharge

Population: This includes subjects with an index procedure. Index procedure is defined as the first procedure that Medtronic MDT-2111 TAV system delivery catheter is introduced.

The following components must be satisfied for device success:

1. successful vascular access, delivery and deployment of device and successful retrieval of delivery system

2. correct position of device in the proper anatomical location

3. EOA≥1.0 cm² AND mean gradient <20 mmHg or peak velocity <3 m/s, without moderate or severe AR

4. only one valve implanted.

Outcome measures

Measure	All Implanted Subjects n=20 Participants The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 TAVI 23 mm device.	Iliofemoral Implanted Subjects The IF Implanted population consisted of all IF As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.
Device Success as Defined in the Description.	65.0 percentage of participants analyzed	—

SECONDARY outcome

Timeframe: from admission for procedure to discharge

Population: This includes subjects with an index procedure. Index procedure is defined as the first procedure that Medtronic MDT-2111 TAV system delivery catheter is introduced.

Procedural success is defined as device success and absence of in-hospital MACCE.

Outcome measures

Measure	All Implanted Subjects n=20 Participants The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 TAVI 23 mm device.	Iliofemoral Implanted Subjects The IF Implanted population consisted of all IF As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.
Procedural Success, Defined as Device Success and Absence of In-hospital MACCE	65.0 percent	—

SECONDARY outcome

Timeframe: 30 days

Outcome measures

Measure	All Implanted Subjects n=20 Participants The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 TAVI 23 mm device.	Iliofemoral Implanted Subjects The IF Implanted population consisted of all IF As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.
Echocardiographic Assessment of Prosthetic Valve Performance - Mean Gradient	16.8 mmHg Standard Deviation 4.8	—

SECONDARY outcome

Timeframe: 6 months

Outcome measures

Measure	All Implanted Subjects n=20 Participants The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 TAVI 23 mm device.	Iliofemoral Implanted Subjects The IF Implanted population consisted of all IF As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.
Echocardiographic Assessment of Prosthetic Valve Performance - Mean Gradient	17.1 mmHg Standard Deviation 7.7	—

SECONDARY outcome

Timeframe: 12 months

Outcome measures

Measure	All Implanted Subjects n=20 Participants The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 TAVI 23 mm device.	Iliofemoral Implanted Subjects The IF Implanted population consisted of all IF As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.
Echocardiographic Assessment of Prosthetic Valve Performance - Mean Gradient	15.2 mmHg Standard Deviation 5.6	—

SECONDARY outcome

Timeframe: 24 months

Outcome measures

Measure	All Implanted Subjects n=18 Participants The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 TAVI 23 mm device.	Iliofemoral Implanted Subjects The IF Implanted population consisted of all IF As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.
Echocardiographic Assessment of Prosthetic Valve Performance - Mean Gradient	13.7 mmHg Standard Deviation 5.6	—

SECONDARY outcome

Timeframe: 30 days

Outcome measures

Measure	All Implanted Subjects n=20 Participants The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 TAVI 23 mm device.	Iliofemoral Implanted Subjects The IF Implanted population consisted of all IF As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.
Echocardiographic Assessment of Prosthetic Valve Performance - Effective Orifice Area (EOA)	1.2 cm² Standard Deviation 0.3	—

SECONDARY outcome

Timeframe: 6 months

Outcome measures

Measure	All Implanted Subjects n=20 Participants The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 TAVI 23 mm device.	Iliofemoral Implanted Subjects The IF Implanted population consisted of all IF As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.
Echocardiographic Assessment of Prosthetic Valve Performance - Effective Orifice Area (EOA)	1.2 cm² Standard Deviation 0.3	—

SECONDARY outcome

Timeframe: 12 months

Outcome measures

Measure	All Implanted Subjects n=19 Participants The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 TAVI 23 mm device.	Iliofemoral Implanted Subjects The IF Implanted population consisted of all IF As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.
Echocardiographic Assessment of Prosthetic Valve Performance - Effective Orifice Area (EOA)	1.2 cm² Standard Deviation 0.3	—

SECONDARY outcome

Timeframe: 24 months

Outcome measures

Measure	All Implanted Subjects n=16 Participants The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 TAVI 23 mm device.	Iliofemoral Implanted Subjects The IF Implanted population consisted of all IF As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.
Echocardiographic Assessment of Prosthetic Valve Performance - Effective Orifice Area (EOA)	1.3 cm² Standard Deviation 0.3	—

SECONDARY outcome

Timeframe: 30 days

Outcome measures

Measure	All Implanted Subjects n=20 Participants The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 TAVI 23 mm device.	Iliofemoral Implanted Subjects The IF Implanted population consisted of all IF As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.
Echocardiographic Assessment of Prosthetic Valve Performance - Left Ventricular Ejection Fraction (LVEF)	64.5 percent Standard Deviation 6.5	—

SECONDARY outcome

Timeframe: 6 months

Outcome measures

Measure	All Implanted Subjects n=20 Participants The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 TAVI 23 mm device.	Iliofemoral Implanted Subjects The IF Implanted population consisted of all IF As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.
Echocardiographic Assessment of Prosthetic Valve Performance - Left Ventricular Ejection Fraction (LVEF)	66.8 percent Standard Deviation 5.4	—

SECONDARY outcome

Timeframe: 12 months

Outcome measures

Measure	All Implanted Subjects n=20 Participants The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 TAVI 23 mm device.	Iliofemoral Implanted Subjects The IF Implanted population consisted of all IF As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.
Echocardiographic Assessment of Prosthetic Valve Performance - Left Ventricular Ejection Fraction (LVEF)	67.5 percent Standard Deviation 7.9	—

SECONDARY outcome

Timeframe: 24 months

Outcome measures

Measure	All Implanted Subjects n=18 Participants The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 TAVI 23 mm device.	Iliofemoral Implanted Subjects The IF Implanted population consisted of all IF As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.
Echocardiographic Assessment of Prosthetic Valve Performance - Left Ventricular Ejection Fraction (LVEF)	67.9 percent Standard Deviation 4.9	—

SECONDARY outcome

Timeframe: 30 days

Outcome measures

Measure	All Implanted Subjects n=20 Participants The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 TAVI 23 mm device.	Iliofemoral Implanted Subjects The IF Implanted population consisted of all IF As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.
Echocardiographic Assessment of Prosthetic Valve Performance - Total Aortic Regurgitation (Transvalvular & Paravalvular) (Total AR) None	10.0 percentage of participants analyzed	—
Echocardiographic Assessment of Prosthetic Valve Performance - Total Aortic Regurgitation (Transvalvular & Paravalvular) (Total AR) Trace	0.0 percentage of participants analyzed	—
Echocardiographic Assessment of Prosthetic Valve Performance - Total Aortic Regurgitation (Transvalvular & Paravalvular) (Total AR) Mild	75.0 percentage of participants analyzed	—
Echocardiographic Assessment of Prosthetic Valve Performance - Total Aortic Regurgitation (Transvalvular & Paravalvular) (Total AR) Moderate	15.0 percentage of participants analyzed	—
Echocardiographic Assessment of Prosthetic Valve Performance - Total Aortic Regurgitation (Transvalvular & Paravalvular) (Total AR) Severe	0.0 percentage of participants analyzed	—

SECONDARY outcome

Timeframe: 6 months

Outcome measures

Measure	All Implanted Subjects n=20 Participants The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 TAVI 23 mm device.	Iliofemoral Implanted Subjects The IF Implanted population consisted of all IF As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.
Echocardiographic Assessment of Prosthetic Valve Performance - Total Aortic Regurgitation (Transvalvular & Paravalvular) (Total AR) Trace	30.0 percentage of participants analyzed	—
Echocardiographic Assessment of Prosthetic Valve Performance - Total Aortic Regurgitation (Transvalvular & Paravalvular) (Total AR) None	0.0 percentage of participants analyzed	—
Echocardiographic Assessment of Prosthetic Valve Performance - Total Aortic Regurgitation (Transvalvular & Paravalvular) (Total AR) Mild	55.0 percentage of participants analyzed	—
Echocardiographic Assessment of Prosthetic Valve Performance - Total Aortic Regurgitation (Transvalvular & Paravalvular) (Total AR) Moderate	15.0 percentage of participants analyzed	—
Echocardiographic Assessment of Prosthetic Valve Performance - Total Aortic Regurgitation (Transvalvular & Paravalvular) (Total AR) Severe	0.0 percentage of participants analyzed	—

SECONDARY outcome

Timeframe: 12 months

Outcome measures

Measure	All Implanted Subjects n=20 Participants The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 TAVI 23 mm device.	Iliofemoral Implanted Subjects The IF Implanted population consisted of all IF As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.
Echocardiographic Assessment of Prosthetic Valve Performance - Total Aortic Regurgitation (Transvalvular & Paravalvular) (Total AR) None	5.0 percentage of participants analyzed	—
Echocardiographic Assessment of Prosthetic Valve Performance - Total Aortic Regurgitation (Transvalvular & Paravalvular) (Total AR) Trace	15.0 percentage of participants analyzed	—
Echocardiographic Assessment of Prosthetic Valve Performance - Total Aortic Regurgitation (Transvalvular & Paravalvular) (Total AR) Mild	70.0 percentage of participants analyzed	—
Echocardiographic Assessment of Prosthetic Valve Performance - Total Aortic Regurgitation (Transvalvular & Paravalvular) (Total AR) Moderate	10.0 percentage of participants analyzed	—
Echocardiographic Assessment of Prosthetic Valve Performance - Total Aortic Regurgitation (Transvalvular & Paravalvular) (Total AR) Severe	0.0 percentage of participants analyzed	—

SECONDARY outcome

Timeframe: 24 months

Outcome measures

Measure	All Implanted Subjects n=18 Participants The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 TAVI 23 mm device.	Iliofemoral Implanted Subjects The IF Implanted population consisted of all IF As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.
Echocardiographic Assessment of Prosthetic Valve Performance - Total Aortic Regurgitation (Transvalvular & Paravalvular) (Total AR) None	11.1 percentage of participants analyzed	—
Echocardiographic Assessment of Prosthetic Valve Performance - Total Aortic Regurgitation (Transvalvular & Paravalvular) (Total AR) Trace	38.9 percentage of participants analyzed	—
Echocardiographic Assessment of Prosthetic Valve Performance - Total Aortic Regurgitation (Transvalvular & Paravalvular) (Total AR) Mild	44.4 percentage of participants analyzed	—
Echocardiographic Assessment of Prosthetic Valve Performance - Total Aortic Regurgitation (Transvalvular & Paravalvular) (Total AR) Moderate	5.6 percentage of participants analyzed	—
Echocardiographic Assessment of Prosthetic Valve Performance - Total Aortic Regurgitation (Transvalvular & Paravalvular) (Total AR) Severe	0.0 percentage of participants analyzed	—

SECONDARY outcome

Timeframe: 0 day to 30 days

Outcome measures

Measure	All Implanted Subjects n=20 Participants The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 TAVI 23 mm device.	Iliofemoral Implanted Subjects The IF Implanted population consisted of all IF As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.
Repeat Hospitalization	80.0 prob of freedom from event @ 30 days	—

SECONDARY outcome

Timeframe: 0 day to 6 months

Outcome measures

Measure	All Implanted Subjects n=20 Participants The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 TAVI 23 mm device.	Iliofemoral Implanted Subjects The IF Implanted population consisted of all IF As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.
Repeat Hospitalization	55.0 prob of freedom from event @ 183 days	—

SECONDARY outcome

Timeframe: 0 day to 12 months

Outcome measures

Measure	All Implanted Subjects n=20 Participants The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 TAVI 23 mm device.	Iliofemoral Implanted Subjects The IF Implanted population consisted of all IF As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.
Repeat Hospitalization	35.0 prob of freedom from event @ 365 days	—

SECONDARY outcome

Timeframe: 0 day to 24 months

Outcome measures

Measure	All Implanted Subjects n=20 Participants The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 TAVI 23 mm device.	Iliofemoral Implanted Subjects The IF Implanted population consisted of all IF As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.
Repeat Hospitalization	30.0 prob of freedom from event @ 730 days	—

SECONDARY outcome

Timeframe: 0 day to 30 days

Outcome measures

Measure	All Implanted Subjects n=20 Participants The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 TAVI 23 mm device.	Iliofemoral Implanted Subjects The IF Implanted population consisted of all IF As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.
Valve-related Deaths	100.0 prob of freedom from event @ 30 days	—

SECONDARY outcome

Timeframe: 0 day to 6 months

Outcome measures

Measure	All Implanted Subjects n=20 Participants The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 TAVI 23 mm device.	Iliofemoral Implanted Subjects The IF Implanted population consisted of all IF As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.
Valve-related Deaths	100.0 prob of freedom from event @ 183 days	—

SECONDARY outcome

Timeframe: 0 day to 12 months

Outcome measures

Measure	All Implanted Subjects n=20 Participants The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 TAVI 23 mm device.	Iliofemoral Implanted Subjects The IF Implanted population consisted of all IF As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.
Valve-related Deaths	100.0 prob of freedom from event @ 365 days	—

SECONDARY outcome

Timeframe: 0 day to 24 months

Outcome measures

Measure	All Implanted Subjects n=20 Participants The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 TAVI 23 mm device.	Iliofemoral Implanted Subjects The IF Implanted population consisted of all IF As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.
Valve-related Deaths	100 prob of freedom from event @ 730 days	—

SECONDARY outcome

Timeframe: Baseline to 30 days

The SF-36 assessment was used to evaluate subject Quality of life (QoL) by assessing change in physical function and general health status. The SF-36 v2 ͭ ͫ Scoring Program was used to convert raw scores ranging from 0 to 100 into norm-based scores, allowing direct comparison to the reference values for the Japanese population. The Z-score of each subdomain is calculated as the numbers of standard deviation away from the Japanese population mean of the corresponding raw score. Norm-based score is then derived as fifty plus 10 times of the z-score. A norm-based score of less than 50 was interpreted as below average when compared to the Japanese population whereas norm-based scores greater than 50 were interpreted as above average.

Outcome measures

Measure	All Implanted Subjects n=20 Participants The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 TAVI 23 mm device.	Iliofemoral Implanted Subjects The IF Implanted population consisted of all IF As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.
Quality of Life Assessment Using SF-36 Questionnaire - Physical Component Summary (Paired Change From Baseline)	5.1 points Interval -12.2 to 18.0	—

SECONDARY outcome

Timeframe: Baseline to 6 months

The SF-36 assessment was used to evaluate subject Quality of life (QoL) by assessing change in physical function and general health status. The SF-36 v2 ͭ ͫ Scoring Program was used to convert raw scores ranging from 0 to 100 into norm-based scores, allowing direct comparison to the reference values for the Japanese population. The Z-score of each subdomain is calculated as the numbers of standard deviation away from the Japanese population mean of the corresponding raw score. Norm-based score is then derived as fifty plus 10 times of the z-score. A norm-based score of less than 50 was interpreted as below average when compared to the Japanese population whereas norm-based scores greater than 50 were interpreted as above average.

Outcome measures

Measure	All Implanted Subjects n=20 Participants The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 TAVI 23 mm device.	Iliofemoral Implanted Subjects The IF Implanted population consisted of all IF As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.
Quality of Life Assessment Using SF-36 Questionnaire - Physical Component Summary (Paired Change From Baseline)	1.7 points Interval -12.6 to 16.3	—

SECONDARY outcome

Timeframe: Baseline to 12 months

The SF-36 assessment was used to evaluate subject Quality of life (QoL) by assessing change in physical function and general health status. The SF-36 v2 ͭ ͫ Scoring Program was used to convert raw scores ranging from 0 to 100 into norm-based scores, allowing direct comparison to the reference values for the Japanese population. The Z-score of each subdomain is calculated as the numbers of standard deviation away from the Japanese population mean of the corresponding raw score. Norm-based score is then derived as fifty plus 10 times of the z-score. A norm-based score of less than 50 was interpreted as below average when compared to the Japanese population whereas norm-based scores greater than 50 were interpreted as above average.

Outcome measures

Measure	All Implanted Subjects n=20 Participants The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 TAVI 23 mm device.	Iliofemoral Implanted Subjects The IF Implanted population consisted of all IF As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.
Quality of Life Assessment Using SF-36 Questionnaire - Physical Component Summary (Paired Change From Baseline)	4.6 points Interval -9.5 to 15.7	—

SECONDARY outcome

Timeframe: Baseline to 24 months

The SF-36 assessment was used to evaluate subject Quality of life (QoL) by assessing change in physical function and general health status. The SF-36 v2 ͭ ͫ Scoring Program was used to convert raw scores ranging from 0 to 100 into norm-based scores, allowing direct comparison to the reference values for the Japanese population. The Z-score of each subdomain is calculated as the numbers of standard deviation away from the Japanese population mean of the corresponding raw score. Norm-based score is then derived as fifty plus 10 times of the z-score. A norm-based score of less than 50 was interpreted as below average when compared to the Japanese population whereas norm-based scores greater than 50 were interpreted as above average.

Outcome measures

Measure	All Implanted Subjects n=18 Participants The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 TAVI 23 mm device.	Iliofemoral Implanted Subjects The IF Implanted population consisted of all IF As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.
Quality of Life Assessment Using SF-36 Questionnaire - Physical Component Summary (Paired Change From Baseline)	5.3 points Interval -8.0 to 19.8	—

Adverse Events

Iliofemoral (As Treated Subjects)

Serious events: 13 serious events

Other events: 16 other events

Deaths: 0 deaths

Direct Aortic (As Treated Subjects)

Serious events: 3 serious events

Other events: 4 other events

Deaths: 0 deaths

All Subjects (As Treated Subjects)

Serious events: 16 serious events

Other events: 20 other events

Deaths: 0 deaths

Serious adverse events

Measure	Iliofemoral (As Treated Subjects) n=16 participants at risk The iliofemoral approach is used as the primary access site because there is a large body of clinical data in the past using this approach in patients implanted with Transcatheter Aortic Valve Implantation (TAVI) using the 23 mm MDT-2111 system.	Direct Aortic (As Treated Subjects) n=4 participants at risk For patients who would benefit from the therapy but have unfavorable non-aortic vasculature of the transfemoral and subclavian/axillary access sites (i.e. excessive atherosclerosis, calcifications, or tortuosity of arteries), the direct aortic approach is currently being used in overseas (EU and US) in clinical practice with similar outcomes to transfemoral and subclavian/ axillary artery approaches with the Transcatheter Aortic Valve Implantation (TAVI) using the 23 mm MDT-2111 system.	All Subjects (As Treated Subjects) n=20 participants at risk This includes subjects from all access approaches, iliofemoral and direct aortic who were implanted with the Transcatheter Aortic Valve Implantation (TAVI) using the 23 mm MDT-2111 system.
Cardiac disorders Aortic Valvular Disorders	6.2% 1/16 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/4 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	5.0% 1/20 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Cardiac disorders Cardiac Conduction Disorders	25.0% 4/16 • Number of events 4 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/4 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	20.0% 4/20 • Number of events 4 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Cardiac disorders Cardiac Disorders Nec	6.2% 1/16 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/4 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	5.0% 1/20 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Cardiac disorders Heart Failures Nec	6.2% 1/16 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/4 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	5.0% 1/20 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Cardiac disorders Pericardial Disorders Nec	6.2% 1/16 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	25.0% 1/4 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	10.0% 2/20 • Number of events 2 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Cardiac disorders Supraventricular Arrhythmias	12.5% 2/16 • Number of events 3 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/4 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	10.0% 2/20 • Number of events 3 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Eye disorders Blindness (Excl Colour Blindness)	6.2% 1/16 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/4 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	5.0% 1/20 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Eye disorders Cataract Conditions	0.00% 0/16 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	25.0% 1/4 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	5.0% 1/20 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Gastrointestinal disorders Non-Site Specific Gastrointestinal Haemorrhages	6.2% 1/16 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/4 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	5.0% 1/20 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Gastrointestinal disorders Oesophageal Stenosis And Obstruction	6.2% 1/16 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/4 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	5.0% 1/20 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
General disorders Device Issues Nec	6.2% 1/16 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	25.0% 1/4 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	10.0% 2/20 • Number of events 2 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Hepatobiliary disorders Hepatic Fibrosis And Cirrhosis	6.2% 1/16 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/4 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	5.0% 1/20 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Hepatobiliary disorders Hepatocellular Damage And Hepatitis Nec	6.2% 1/16 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/4 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	5.0% 1/20 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Infections and infestations Cardiac Infections	0.00% 0/16 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	25.0% 1/4 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	5.0% 1/20 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Infections and infestations Influenza Viral Infections	6.2% 1/16 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/4 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	5.0% 1/20 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Infections and infestations Lower Respiratory Tract And Lung Infections	25.0% 4/16 • Number of events 4 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/4 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	20.0% 4/20 • Number of events 4 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Infections and infestations Sepsis, Bacteraemia, Viraemia And Fungaemia Nec	6.2% 1/16 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/4 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	5.0% 1/20 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Infections and infestations Staphylococcal Infections	0.00% 0/16 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	25.0% 1/4 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	5.0% 1/20 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Injury, poisoning and procedural complications Lower Limb Fractures And Dislocations	6.2% 1/16 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	25.0% 1/4 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	10.0% 2/20 • Number of events 2 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Injury, poisoning and procedural complications Skull Fractures, Facial Bone Fractures And Dislocations	6.2% 1/16 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/4 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	5.0% 1/20 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Injury, poisoning and procedural complications Spinal Fractures And Dislocations	0.00% 0/16 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	25.0% 1/4 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	5.0% 1/20 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Metabolism and nutrition disorders Total Fluid Volume Decreased	0.00% 0/16 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	25.0% 1/4 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	5.0% 1/20 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Musculoskeletal and connective tissue disorders Arthropathies Nec	6.2% 1/16 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/4 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	5.0% 1/20 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast And Nipple Neoplasms Malignant	6.2% 1/16 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/4 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	5.0% 1/20 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Nervous system disorders Central Nervous System Haemorrhages And Cerebrovascular Accidents	0.00% 0/16 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	25.0% 1/4 • Number of events 2 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	5.0% 1/20 • Number of events 2 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Respiratory, thoracic and mediastinal disorders Breathing Abnormalities	6.2% 1/16 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/4 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	5.0% 1/20 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Respiratory, thoracic and mediastinal disorders Pneumothorax And Pleural Effusions Nec	0.00% 0/16 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	25.0% 1/4 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	5.0% 1/20 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Vascular disorders Aortic Necrosis And Vascular Insufficiency	6.2% 1/16 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/4 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	5.0% 1/20 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Vascular disorders Lymphangiopathies	6.2% 1/16 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/4 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	5.0% 1/20 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Vascular disorders Non-Site Specific Necrosis And Vascular Insufficiency Nec	0.00% 0/16 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	25.0% 1/4 • Number of events 4 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	5.0% 1/20 • Number of events 4 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Vascular disorders Peripheral Embolism And Thrombosis	6.2% 1/16 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/4 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	5.0% 1/20 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.

Other adverse events

Measure	Iliofemoral (As Treated Subjects) n=16 participants at risk The iliofemoral approach is used as the primary access site because there is a large body of clinical data in the past using this approach in patients implanted with Transcatheter Aortic Valve Implantation (TAVI) using the 23 mm MDT-2111 system.	Direct Aortic (As Treated Subjects) n=4 participants at risk For patients who would benefit from the therapy but have unfavorable non-aortic vasculature of the transfemoral and subclavian/axillary access sites (i.e. excessive atherosclerosis, calcifications, or tortuosity of arteries), the direct aortic approach is currently being used in overseas (EU and US) in clinical practice with similar outcomes to transfemoral and subclavian/ axillary artery approaches with the Transcatheter Aortic Valve Implantation (TAVI) using the 23 mm MDT-2111 system.	All Subjects (As Treated Subjects) n=20 participants at risk This includes subjects from all access approaches, iliofemoral and direct aortic who were implanted with the Transcatheter Aortic Valve Implantation (TAVI) using the 23 mm MDT-2111 system.
Blood and lymphatic system disorders Anaemia Deficiencies	0.00% 0/16 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	25.0% 1/4 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	5.0% 1/20 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Blood and lymphatic system disorders Anaemias Nec	37.5% 6/16 • Number of events 7 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	50.0% 2/4 • Number of events 2 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	40.0% 8/20 • Number of events 9 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Blood and lymphatic system disorders Lymphatic System Disorders Nec	0.00% 0/16 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	25.0% 1/4 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	5.0% 1/20 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Cardiac disorders Cardiac Conduction Disorders	56.2% 9/16 • Number of events 10 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	75.0% 3/4 • Number of events 4 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	60.0% 12/20 • Number of events 14 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Cardiac disorders Heart Failures Nec	6.2% 1/16 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	25.0% 1/4 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	10.0% 2/20 • Number of events 2 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Cardiac disorders Rate And Rhythm Disorders Nec	0.00% 0/16 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	25.0% 1/4 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	5.0% 1/20 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Cardiac disorders Supraventricular Arrhythmias	25.0% 4/16 • Number of events 5 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/4 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	20.0% 4/20 • Number of events 5 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Cardiac disorders Ventricular Arrhythmias And Cardiac Arrest	18.8% 3/16 • Number of events 3 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/4 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	15.0% 3/20 • Number of events 3 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Gastrointestinal disorders Diarrhoea (Excl Infective)	18.8% 3/16 • Number of events 3 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/4 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	15.0% 3/20 • Number of events 3 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Gastrointestinal disorders Gastrointestinal And Abdominal Pains (Excl Oral And Throat)	12.5% 2/16 • Number of events 2 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/4 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	10.0% 2/20 • Number of events 2 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Gastrointestinal disorders Gastrointestinal Atonic And Hypomotility Disorders Nec	12.5% 2/16 • Number of events 2 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	50.0% 2/4 • Number of events 2 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	20.0% 4/20 • Number of events 4 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Gastrointestinal disorders Nausea And Vomiting Symptoms	18.8% 3/16 • Number of events 3 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	50.0% 2/4 • Number of events 2 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	25.0% 5/20 • Number of events 5 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
General disorders Administration Site Reactions Nec	6.2% 1/16 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	25.0% 1/4 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	10.0% 2/20 • Number of events 2 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
General disorders Complications Associated With Device Nec	6.2% 1/16 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/4 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	5.0% 1/20 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
General disorders Device Physical Property And Chemical Issues	6.2% 1/16 • Number of events 2 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/4 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	5.0% 1/20 • Number of events 2 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
General disorders Febrile Disorders	6.2% 1/16 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/4 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	5.0% 1/20 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
General disorders Implant And Catheter Site Reactions	18.8% 3/16 • Number of events 3 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/4 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	15.0% 3/20 • Number of events 3 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
General disorders Inflammations	12.5% 2/16 • Number of events 2 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/4 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	10.0% 2/20 • Number of events 2 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
General disorders Infusion Site Reactions	6.2% 1/16 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/4 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	5.0% 1/20 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
General disorders Oedema Nec	6.2% 1/16 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	50.0% 2/4 • Number of events 2 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	15.0% 3/20 • Number of events 3 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
General disorders Pain And Discomfort Nec	6.2% 1/16 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	25.0% 1/4 • Number of events 2 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	10.0% 2/20 • Number of events 3 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Hepatobiliary disorders Hepatic And Hepatobiliary Disorders Nec	0.00% 0/16 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	25.0% 1/4 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	5.0% 1/20 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Hepatobiliary disorders Hepatic Enzymes And Function Abnormalities	6.2% 1/16 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/4 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	5.0% 1/20 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Infections and infestations Herpes Viral Infections	6.2% 1/16 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/4 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	5.0% 1/20 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Infections and infestations Infections Nec	0.00% 0/16 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	25.0% 1/4 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	5.0% 1/20 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Infections and infestations Influenza Viral Infections	6.2% 1/16 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/4 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	5.0% 1/20 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Infections and infestations Upper Respiratory Tract Infections	6.2% 1/16 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/4 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	5.0% 1/20 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Infections and infestations Urinary Tract Infections	0.00% 0/16 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	25.0% 1/4 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	5.0% 1/20 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Injury, poisoning and procedural complications Fractures And Dislocations Nec	0.00% 0/16 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	25.0% 1/4 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	5.0% 1/20 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Injury, poisoning and procedural complications Non-Site Specific Injuries Nec	25.0% 4/16 • Number of events 6 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	25.0% 1/4 • Number of events 2 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	25.0% 5/20 • Number of events 8 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Injury, poisoning and procedural complications Non-Site Specific Procedural Complications	6.2% 1/16 • Number of events 2 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	50.0% 2/4 • Number of events 3 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	15.0% 3/20 • Number of events 5 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Injury, poisoning and procedural complications Skin Injuries Nec	6.2% 1/16 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	25.0% 1/4 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	10.0% 2/20 • Number of events 2 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Injury, poisoning and procedural complications Spinal Fractures And Dislocations	6.2% 1/16 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/4 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	5.0% 1/20 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Investigations Carbohydrate Tolerance Analyses (Incl Diabetes)	6.2% 1/16 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/4 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	5.0% 1/20 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Investigations Liver Function Analyses	37.5% 6/16 • Number of events 6 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	50.0% 2/4 • Number of events 2 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	40.0% 8/20 • Number of events 8 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Investigations Metabolism Tests Nec	37.5% 6/16 • Number of events 6 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	50.0% 2/4 • Number of events 2 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	40.0% 8/20 • Number of events 8 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Investigations Mineral And Electrolyte Analyses	6.2% 1/16 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	25.0% 1/4 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	10.0% 2/20 • Number of events 2 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Investigations Platelet Analyses	43.8% 7/16 • Number of events 7 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	75.0% 3/4 • Number of events 4 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	50.0% 10/20 • Number of events 11 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Investigations Protein Analyses Nec	56.2% 9/16 • Number of events 11 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	75.0% 3/4 • Number of events 4 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	60.0% 12/20 • Number of events 15 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Investigations Renal Function Analyses	6.2% 1/16 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	25.0% 1/4 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	10.0% 2/20 • Number of events 2 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Investigations Skeletal And Cardiac Muscle Analyses	25.0% 4/16 • Number of events 4 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	50.0% 2/4 • Number of events 3 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	30.0% 6/20 • Number of events 7 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Investigations Tissue Enzyme Analyses Nec	18.8% 3/16 • Number of events 3 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	25.0% 1/4 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	20.0% 4/20 • Number of events 4 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Investigations Vascular Tests Nec (Incl Blood Pressure)	25.0% 4/16 • Number of events 5 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	25.0% 1/4 • Number of events 2 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	25.0% 5/20 • Number of events 7 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Investigations White Blood Cell Analyses	6.2% 1/16 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	25.0% 1/4 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	10.0% 2/20 • Number of events 2 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Metabolism and nutrition disorders Hyperlipidaemias Nec	0.00% 0/16 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	25.0% 1/4 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	5.0% 1/20 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Metabolism and nutrition disorders Lipid Metabolism And Deposit Disorders Nec	6.2% 1/16 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/4 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	5.0% 1/20 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Metabolism and nutrition disorders Potassium Imbalance	12.5% 2/16 • Number of events 2 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	50.0% 2/4 • Number of events 2 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	20.0% 4/20 • Number of events 4 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Metabolism and nutrition disorders Protein Metabolism Disorders Nec	18.8% 3/16 • Number of events 3 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	25.0% 1/4 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	20.0% 4/20 • Number of events 4 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Musculoskeletal and connective tissue disorders Joint Related Signs And Symptoms	0.00% 0/16 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	50.0% 2/4 • Number of events 2 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	10.0% 2/20 • Number of events 2 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Musculoskeletal and connective tissue disorders Muscle Related Signs And Symptoms Nec	6.2% 1/16 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/4 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	5.0% 1/20 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Musculoskeletal and connective tissue disorders Musculoskeletal And Connective Tissue Pain And Discomfort	18.8% 3/16 • Number of events 4 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	50.0% 2/4 • Number of events 2 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	25.0% 5/20 • Number of events 6 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Musculoskeletal and connective tissue disorders Musculoskeletal And Connective Tissue Signs And Symptoms Nec	6.2% 1/16 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	25.0% 1/4 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	10.0% 2/20 • Number of events 2 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Musculoskeletal and connective tissue disorders Rheumatoid Arthropathies	6.2% 1/16 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/4 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	5.0% 1/20 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Musculoskeletal and connective tissue disorders Soft Tissue Disorders Nec	12.5% 2/16 • Number of events 2 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/4 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	10.0% 2/20 • Number of events 2 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Nervous system disorders Central Nervous System Haemorrhages And Cerebrovascular Accidents	0.00% 0/16 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	25.0% 1/4 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	5.0% 1/20 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Nervous system disorders Headaches Nec	6.2% 1/16 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/4 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	5.0% 1/20 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Nervous system disorders Memory Loss (Excl Dementia)	0.00% 0/16 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	25.0% 1/4 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	5.0% 1/20 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Nervous system disorders Neurological Signs And Symptoms Nec	6.2% 1/16 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	25.0% 1/4 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	10.0% 2/20 • Number of events 2 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Nervous system disorders Structural Brain Disorders Nec	0.00% 0/16 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	25.0% 1/4 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	5.0% 1/20 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Psychiatric disorders Confusion And Disorientation	0.00% 0/16 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	25.0% 1/4 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	5.0% 1/20 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Psychiatric disorders Disturbances In Initiating And Maintaining Sleep	0.00% 0/16 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	25.0% 1/4 • Number of events 2 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	5.0% 1/20 • Number of events 2 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Renal and urinary disorders Urinary Abnormalities	6.2% 1/16 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/4 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	5.0% 1/20 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Respiratory, thoracic and mediastinal disorders Breathing Abnormalities	6.2% 1/16 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	25.0% 1/4 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	10.0% 2/20 • Number of events 2 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Respiratory, thoracic and mediastinal disorders Coughing And Associated Symptoms	0.00% 0/16 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	25.0% 1/4 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	5.0% 1/20 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Respiratory, thoracic and mediastinal disorders Lower Respiratory Tract Inflammatory And Immunologic Conditions	6.2% 1/16 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/4 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	5.0% 1/20 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Respiratory, thoracic and mediastinal disorders Nasal Disorders Nec	12.5% 2/16 • Number of events 2 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	25.0% 1/4 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	15.0% 3/20 • Number of events 3 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Respiratory, thoracic and mediastinal disorders Pneumothorax And Pleural Effusions Nec	6.2% 1/16 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/4 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	5.0% 1/20 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Skin and subcutaneous tissue disorders Dermatitis Ascribed To Specific Agent	6.2% 1/16 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/4 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	5.0% 1/20 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Skin and subcutaneous tissue disorders Rashes, Eruptions And Exanthems Nec	0.00% 0/16 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	25.0% 1/4 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	5.0% 1/20 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Skin and subcutaneous tissue disorders Skin Haemorrhages	25.0% 4/16 • Number of events 4 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/4 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	20.0% 4/20 • Number of events 4 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Vascular disorders Blood Pressure Disorders Nec	0.00% 0/16 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	50.0% 2/4 • Number of events 2 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	10.0% 2/20 • Number of events 2 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Vascular disorders Haemorrhages Nec	12.5% 2/16 • Number of events 2 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/4 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	10.0% 2/20 • Number of events 2 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Vascular disorders Lymphangiopathies	6.2% 1/16 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/4 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	5.0% 1/20 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Vascular disorders Lymphoedemas	6.2% 1/16 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/4 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	5.0% 1/20 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Vascular disorders Peripheral Aneurysms And Dissections	18.8% 3/16 • Number of events 3 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	0.00% 0/4 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	15.0% 3/20 • Number of events 3 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Vascular disorders Vascular Hypotensive Disorders	6.2% 1/16 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	25.0% 1/4 • Number of events 1 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.	10.0% 2/20 • Number of events 2 • Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.

Additional Information

Hiroko Ookubo

Medttronic

Phone: 81367760811

Email: hiroko.ookubo@medtronic.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place