Trial Outcomes & Findings for Medtronic Evolut Transcatheter Aortic Valve Replacement in Low Risk Patients (NCT NCT02701283)

Last Updated: 2025-10-21

Results Overview

Assessment of procedural safety by: All-cause mortality: all deaths from any cause after valve intervention. This includes all cardiovascular and non-cardiovascular deaths. Disabling stroke: a modified rankin score (mRS) of 2 or more at 90 days post-stroke and an increase of at least one mRS category from an individual's pre-stroke baseline. All stroke: any stroke after valve intervention (ischemic, hemorrhagic, or undetermined stroke).

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

Target enrollment

2223 participants

Primary outcome timeframe

Randomized Controlled Trial - 24 months Continued Access Study - 12 months

Results posted on

2025-10-21

Participant Flow

Randomized Controlled Trial - As Treated Continued Access Study - Attempted Implant

Participant milestones

Participant milestones
Measure	Randomized Controlled Trial - Medtronic TAVR Systems Treatment with Medtronic CoreValve, Evolut R, and Evolut PRO systems in the Randomized Controlled Trial	Randomized Controlled Trial - SAVR Surgical Aortic Valve Replacement (SAVR) in the Randomized Controlled Trial	Continued Access Study - Medtronic TAVR Systems Treatment with Medtronic Evolut R and Evolut PRO systems in the Continued Access Study
Overall Study STARTED	737	741	745
Overall Study As Treated (Attempted Implant)	730	684	745
Overall Study Implanted	727	686	745
Overall Study COMPLETED	668	579	724
Overall Study NOT COMPLETED	69	162	21

Reasons for withdrawal

Reasons for withdrawal
Measure	Randomized Controlled Trial - Medtronic TAVR Systems Treatment with Medtronic CoreValve, Evolut R, and Evolut PRO systems in the Randomized Controlled Trial	Randomized Controlled Trial - SAVR Surgical Aortic Valve Replacement (SAVR) in the Randomized Controlled Trial	Continued Access Study - Medtronic TAVR Systems Treatment with Medtronic Evolut R and Evolut PRO systems in the Continued Access Study
Overall Study Death	25	29	19
Overall Study Lost to Follow-up	3	8	1
Overall Study Withdrawal by Subject	12	41	1
Overall Study Missed 2-year visit	22	27	0
Overall Study Exited prior to procedure (3 subjects crossed over from SAVR to TAVR)	7	57	0

Baseline Characteristics

Medtronic Evolut Transcatheter Aortic Valve Replacement in Low Risk Patients

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: Randomized Controlled Trial - 24 months Continued Access Study - 12 months

Population: Randomized Controlled Trial - As treated set Continued Access Study - Attempted implant set

Outcome measures

Outcome measures
Measure	Randomized Controlled Trial - Medtronic TAVR Systems n=730 Participants Treatment with Medtronic CoreValve, Evolut R, and Evolut PRO systems in the Randomized Controlled Trial	Randomized Controlled Trial - SAVR n=684 Participants Surgical Aortic Valve Replacement (SAVR) in the Randomized Controlled Trial	Continued Access Study - Medtronic TAVR Systems n=745 Participants Treatment with Medtronic Evolut R and Evolut PRO systems in the Continued Access Study
Safety: All Cause Mortality or Disabling Stroke Rate at 24 Months, Randomized Controlled Trial Safety: All Cause Mortality or All Stroke Rate at 12 Months, Continued Access Study	4.3 Percent of participants (K-M rate)	6.3 Percent of participants (K-M rate)	5.7 Percent of participants (K-M rate)

SECONDARY outcome

Timeframe: 30 days

Population: As treated set

Randomized Controlled Trial: Combined clinical efficacy after 30 days was defined as the composite of all-cause mortality, disabling stroke, life-threatening bleed, major vascular complication, or AKI (II or III) Continued Access Study: Combined clinical efficacy after 30 days was defined as the composite of all-cause mortality, all stroke, life-threatening bleed, or major vascular complication

Outcome measures

Outcome measures
Measure	Randomized Controlled Trial - Medtronic TAVR Systems n=730 Participants Treatment with Medtronic CoreValve, Evolut R, and Evolut PRO systems in the Randomized Controlled Trial	Randomized Controlled Trial - SAVR n=684 Participants Surgical Aortic Valve Replacement (SAVR) in the Randomized Controlled Trial	Continued Access Study - Medtronic TAVR Systems n=745 Participants Treatment with Medtronic Evolut R and Evolut PRO systems in the Continued Access Study
RCT: Composite of Death, Disabling Stroke, Life-threatening Bleed, Major Vascular Complication, or AKI (II or III) at 30 Days CAS: Composite of Death, All Stroke, Life-threatening Bleed, or Major Vascular Complication at 30 Days Composite event	5.3 Percent of participants (K-M rate)	10.8 Percent of participants (K-M rate)	6.6 Percent of participants (K-M rate)
RCT: Composite of Death, Disabling Stroke, Life-threatening Bleed, Major Vascular Complication, or AKI (II or III) at 30 Days CAS: Composite of Death, All Stroke, Life-threatening Bleed, or Major Vascular Complication at 30 Days Death	0.4 Percent of participants (K-M rate)	1.2 Percent of participants (K-M rate)	0.7 Percent of participants (K-M rate)
RCT: Composite of Death, Disabling Stroke, Life-threatening Bleed, Major Vascular Complication, or AKI (II or III) at 30 Days CAS: Composite of Death, All Stroke, Life-threatening Bleed, or Major Vascular Complication at 30 Days Disabling stroke	0.4 Percent of participants (K-M rate)	1.6 Percent of participants (K-M rate)	NA Percent of participants (K-M rate) The 30 day composite endpoint for the Continued Access Study included all strokes, not disabling strokes separately.
RCT: Composite of Death, Disabling Stroke, Life-threatening Bleed, Major Vascular Complication, or AKI (II or III) at 30 Days CAS: Composite of Death, All Stroke, Life-threatening Bleed, or Major Vascular Complication at 30 Days Life-threatening or disabling bleed	2.5 Percent of participants (K-M rate)	7.5 Percent of participants (K-M rate)	3.4 Percent of participants (K-M rate)
RCT: Composite of Death, Disabling Stroke, Life-threatening Bleed, Major Vascular Complication, or AKI (II or III) at 30 Days CAS: Composite of Death, All Stroke, Life-threatening Bleed, or Major Vascular Complication at 30 Days Major vascular complication	3.7 Percent of participants (K-M rate)	3.1 Percent of participants (K-M rate)	0.4 Percent of participants (K-M rate)
RCT: Composite of Death, Disabling Stroke, Life-threatening Bleed, Major Vascular Complication, or AKI (II or III) at 30 Days CAS: Composite of Death, All Stroke, Life-threatening Bleed, or Major Vascular Complication at 30 Days AKI (II or III)	0.8 Percent of participants (K-M rate)	2.8 Percent of participants (K-M rate)	NA Percent of participants (K-M rate) AKI (II or III) was not assessed for the Continued Access Study
RCT: Composite of Death, Disabling Stroke, Life-threatening Bleed, Major Vascular Complication, or AKI (II or III) at 30 Days CAS: Composite of Death, All Stroke, Life-threatening Bleed, or Major Vascular Complication at 30 Days All Stroke	NA Percent of participants (K-M rate) The 30 day composite endpoint for the Randomized Controlled Trial included disabling strokes, not all strokes as a component.	NA Percent of participants (K-M rate) The 30 day composite endpoint for the Randomized Controlled Trial included disabling strokes, not all strokes as a component.	2.7 Percent of participants (K-M rate)

SECONDARY outcome

Timeframe: 30 days

Population: Randomized Controlled Trial - As treated set Continued Access Study - Attempted implant set

The rate of new permanent pacemaker implant at 30 days

Outcome measures

Outcome measures
Measure	Randomized Controlled Trial - Medtronic TAVR Systems n=730 Participants Treatment with Medtronic CoreValve, Evolut R, and Evolut PRO systems in the Randomized Controlled Trial	Randomized Controlled Trial - SAVR n=684 Participants Surgical Aortic Valve Replacement (SAVR) in the Randomized Controlled Trial	Continued Access Study - Medtronic TAVR Systems n=745 Participants Treatment with Medtronic Evolut R and Evolut PRO systems in the Continued Access Study
New Pacemaker Implantation at 30 Days	17.7 Percent of participants (K-M rate)	6.3 Percent of participants (K-M rate)	15.0 Percent of participants (K-M rate)

SECONDARY outcome

Timeframe: 1 year

Population: Randomized Controlled Trial - As treated set Continued Access Study - Attempted implant set

The rate of prosthetic valve endocarditis at 1 year

Outcome measures

Outcome measures
Measure	Randomized Controlled Trial - Medtronic TAVR Systems n=730 Participants Treatment with Medtronic CoreValve, Evolut R, and Evolut PRO systems in the Randomized Controlled Trial	Randomized Controlled Trial - SAVR n=684 Participants Surgical Aortic Valve Replacement (SAVR) in the Randomized Controlled Trial	Continued Access Study - Medtronic TAVR Systems n=745 Participants Treatment with Medtronic Evolut R and Evolut PRO systems in the Continued Access Study
Prosthetic Valve Endocarditis at 1 Year	0.1 Percent of participants (K-M rate)	0.5 Percent of participants (K-M rate)	0.4 Percent of participants (K-M rate)

SECONDARY outcome

Timeframe: 1 year

Population: Randomized Controlled Trial - As treated set Continued Access Study - Attempted implant set

The rate of prosthetic valve thrombosis at 1 year

Outcome measures

Outcome measures
Measure	Randomized Controlled Trial - Medtronic TAVR Systems n=730 Participants Treatment with Medtronic CoreValve, Evolut R, and Evolut PRO systems in the Randomized Controlled Trial	Randomized Controlled Trial - SAVR n=684 Participants Surgical Aortic Valve Replacement (SAVR) in the Randomized Controlled Trial	Continued Access Study - Medtronic TAVR Systems n=745 Participants Treatment with Medtronic Evolut R and Evolut PRO systems in the Continued Access Study
Prosthetic Valve Thrombosis at 1 Year	0.3 Percent of participants (K-M rate)	0.2 Percent of participants (K-M rate)	0.0 Percent of participants (K-M rate)

SECONDARY outcome

Timeframe: 1 year

Population: Randomized Controlled Trial - As treated set Continued Access Study - Attempted implant set

The rate of all stroke (disabling and non-disabling) at 1 year

Outcome measures

Outcome measures
Measure	Randomized Controlled Trial - Medtronic TAVR Systems n=730 Participants Treatment with Medtronic CoreValve, Evolut R, and Evolut PRO systems in the Randomized Controlled Trial	Randomized Controlled Trial - SAVR n=684 Participants Surgical Aortic Valve Replacement (SAVR) in the Randomized Controlled Trial	Continued Access Study - Medtronic TAVR Systems n=745 Participants Treatment with Medtronic Evolut R and Evolut PRO systems in the Continued Access Study
All Stroke (Disabling and Non-disabling) at 1 Year	4.3 Percent of participants (K-M rate)	4.3 Percent of participants (K-M rate)	3.6 Percent of participants (K-M rate)

SECONDARY outcome

Timeframe: 1 year

Population: Randomized Controlled Trial - As treated set Continued Access Study - Attempted implant set

The rate of life-threatening bleeding at 1 year

Outcome measures

Outcome measures
Measure	Randomized Controlled Trial - Medtronic TAVR Systems n=730 Participants Treatment with Medtronic CoreValve, Evolut R, and Evolut PRO systems in the Randomized Controlled Trial	Randomized Controlled Trial - SAVR n=684 Participants Surgical Aortic Valve Replacement (SAVR) in the Randomized Controlled Trial	Continued Access Study - Medtronic TAVR Systems n=745 Participants Treatment with Medtronic Evolut R and Evolut PRO systems in the Continued Access Study
Life-threatening Bleeding at 1 Year	3.6 Percent of participants (K-M rate)	8.7 Percent of participants (K-M rate)	3.8 Percent of participants (K-M rate)

SECONDARY outcome

Timeframe: 1 year

Population: Randomized Controlled Trial - As treated set Continued Access Study - Attempted implant set

The rate of valve-related dysfunction requiring repeat procedure at 1 year

Outcome measures

Outcome measures
Measure	Randomized Controlled Trial - Medtronic TAVR Systems n=730 Participants Treatment with Medtronic CoreValve, Evolut R, and Evolut PRO systems in the Randomized Controlled Trial	Randomized Controlled Trial - SAVR n=684 Participants Surgical Aortic Valve Replacement (SAVR) in the Randomized Controlled Trial	Continued Access Study - Medtronic TAVR Systems n=745 Participants Treatment with Medtronic Evolut R and Evolut PRO systems in the Continued Access Study
Valve-related Dysfunction Requiring Repeat Procedure at 1 Year	0.6 Percent of participants (K-M rate)	0.4 Percent of participants (K-M rate)	0.8 Percent of participants (K-M rate)

SECONDARY outcome

Timeframe: 1 year

Population: Implanted

Stenosis (moderate or severe) Any of the following: 1. Peak aortic velocity \>4 m/s OR mean aortic gradient \>40 mmHg, AND EOA \<0.8 cm2 2. Peak aortic velocity \>4 m/s OR mean aortic gradient \>40 mmHg, AND EOA ≥0.8 cm2, and DVI \<0.25 3. Peak aortic velocity ≤4 m/s and mean aortic gradient ≤ 40 mmHg, AND EOA \<0.8 cm2, and DVI \<0.25 Regurgitation (moderate or severe) Any of the following: 1. Moderate or Severe Total Regurgitation 2. Moderate or Severe Paravalvular Regurgitation 3. Moderate or Severe Transvalvular Regurgitation

Outcome measures

Outcome measures
Measure	Randomized Controlled Trial - Medtronic TAVR Systems n=727 Participants Treatment with Medtronic CoreValve, Evolut R, and Evolut PRO systems in the Randomized Controlled Trial	Randomized Controlled Trial - SAVR n=686 Participants Surgical Aortic Valve Replacement (SAVR) in the Randomized Controlled Trial	Continued Access Study - Medtronic TAVR Systems Treatment with Medtronic Evolut R and Evolut PRO systems in the Continued Access Study
Valve-related Dysfunction (Moderate or Severe Stenosis or Regurgitation) at 1 Year, Randomized Controlled Trial Moderate or severe stenosis	0.2 Percent of participants	0.4 Percent of participants	—
Valve-related Dysfunction (Moderate or Severe Stenosis or Regurgitation) at 1 Year, Randomized Controlled Trial Moderate or severe regurgitation	4.3 Percent of participants	1.3 Percent of participants	—

SECONDARY outcome

Timeframe: Randomized Controlled Trial - 30 days and 1 year Continued Access Study - 1 year

Population: Randomized Controlled Trial - As treated set Continued Access Study - Attempted implant set

Quality of life summary scores and change from baseline using the following measures: KCCQ: Quantifies physical function, symptoms, social function, self-efficacy and knowledge, and quality of life. Scores are transformed to a range of 0-100, in which higher scores reflect better health status.

Outcome measures

Outcome measures
Measure	Randomized Controlled Trial - Medtronic TAVR Systems n=730 Participants Treatment with Medtronic CoreValve, Evolut R, and Evolut PRO systems in the Randomized Controlled Trial	Randomized Controlled Trial - SAVR n=684 Participants Surgical Aortic Valve Replacement (SAVR) in the Randomized Controlled Trial	Continued Access Study - Medtronic TAVR Systems n=745 Participants Treatment with Medtronic Evolut R and Evolut PRO systems in the Continued Access Study
Randomized Controlled Trial - Health-related Quality of Life as Assessed by Kansas City Cardiomyopathy Questionnaire (KCCQ) at 30 Days and 1 Year Continued Access Study - Health-related Quality of Life as Assessed by KCCQ at 1 Year 30 day KCCQ - Overall	88.6 Score on a scale Standard Deviation 14.2	78.7 Score on a scale Standard Deviation 18.8	NA Score on a scale Standard Deviation NA 30 day KCCQ scores were not an endpoint measure for the Continued Access Study
Randomized Controlled Trial - Health-related Quality of Life as Assessed by Kansas City Cardiomyopathy Questionnaire (KCCQ) at 30 Days and 1 Year Continued Access Study - Health-related Quality of Life as Assessed by KCCQ at 1 Year 30 day change from baseline - Overall	20.0 Score on a scale Standard Deviation 21.1	9.2 Score on a scale Standard Deviation 22.3	NA Score on a scale Standard Deviation NA 30 day KCCQ scores were not an endpoint measure for the Continued Access Study
Randomized Controlled Trial - Health-related Quality of Life as Assessed by Kansas City Cardiomyopathy Questionnaire (KCCQ) at 30 Days and 1 Year Continued Access Study - Health-related Quality of Life as Assessed by KCCQ at 1 Year 30 day KCCQ - Clinical	89.7 Score on a scale Standard Deviation 13.4	82.6 Score on a scale Standard Deviation 16.9	NA Score on a scale Standard Deviation NA 30 day KCCQ scores were not an endpoint measure for the Continued Access Study
Randomized Controlled Trial - Health-related Quality of Life as Assessed by Kansas City Cardiomyopathy Questionnaire (KCCQ) at 30 Days and 1 Year Continued Access Study - Health-related Quality of Life as Assessed by KCCQ at 1 Year 30 day change from baseline - Clinical	15.4 Score on a scale Standard Deviation 19.6	7.5 Score on a scale Standard Deviation 20.5	NA Score on a scale Standard Deviation NA 30 day KCCQ scores were not an endpoint measure for the Continued Access Study
Randomized Controlled Trial - Health-related Quality of Life as Assessed by Kansas City Cardiomyopathy Questionnaire (KCCQ) at 30 Days and 1 Year Continued Access Study - Health-related Quality of Life as Assessed by KCCQ at 1 Year 1 year KCCQ - Overall	90.6 Score on a scale Standard Deviation 12.7	90.5 Score on a scale Standard Deviation 12.4	91.1 Score on a scale Standard Deviation 13.8
Randomized Controlled Trial - Health-related Quality of Life as Assessed by Kansas City Cardiomyopathy Questionnaire (KCCQ) at 30 Days and 1 Year Continued Access Study - Health-related Quality of Life as Assessed by KCCQ at 1 Year 1 year change from baseline - Overall	21.6 Score on a scale Standard Deviation 20.6	20.7 Score on a scale Standard Deviation 20.3	24.7 Score on a scale Standard Deviation 22.8
Randomized Controlled Trial - Health-related Quality of Life as Assessed by Kansas City Cardiomyopathy Questionnaire (KCCQ) at 30 Days and 1 Year Continued Access Study - Health-related Quality of Life as Assessed by KCCQ at 1 Year 1 year KCCQ - Clinical	89.9 Score on a scale Standard Deviation 13.4	90.2 Score on a scale Standard Deviation 12.8	NA Score on a scale Standard Deviation NA KCCQ Clinical score was not calculated for the Continued Access Study
Randomized Controlled Trial - Health-related Quality of Life as Assessed by Kansas City Cardiomyopathy Questionnaire (KCCQ) at 30 Days and 1 Year Continued Access Study - Health-related Quality of Life as Assessed by KCCQ at 1 Year 1 year change from baseline - Clinical	15.3 Score on a scale Standard Deviation 18.9	14.8 Score on a scale Standard Deviation 18.9	NA Score on a scale Standard Deviation NA KCCQ Clinical score was not calculated for the Continued Access Study

SECONDARY outcome

Timeframe: 1 year

Population: As treated set

The rate of repeat hospitalization for aortic valve disease at 1 year

Outcome measures

Outcome measures
Measure	Randomized Controlled Trial - Medtronic TAVR Systems n=730 Participants Treatment with Medtronic CoreValve, Evolut R, and Evolut PRO systems in the Randomized Controlled Trial	Randomized Controlled Trial - SAVR n=684 Participants Surgical Aortic Valve Replacement (SAVR) in the Randomized Controlled Trial	Continued Access Study - Medtronic TAVR Systems Treatment with Medtronic Evolut R and Evolut PRO systems in the Continued Access Study
Repeat Hospitalization for Aortic Valve Disease at 1 Year, Randomized Controlled Trial	3.5 Percent of participants (K-M rate)	5.8 Percent of participants (K-M rate)	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 1 year

Population: Implanted

Reporting of prosthetic valve hemodynamic performance by degree of total prosthetic valve regurgitation

Outcome measures

Outcome measures
Measure	Randomized Controlled Trial - Medtronic TAVR Systems n=727 Participants Treatment with Medtronic CoreValve, Evolut R, and Evolut PRO systems in the Randomized Controlled Trial	Randomized Controlled Trial - SAVR n=686 Participants Surgical Aortic Valve Replacement (SAVR) in the Randomized Controlled Trial	Continued Access Study - Medtronic TAVR Systems Treatment with Medtronic Evolut R and Evolut PRO systems in the Continued Access Study
Hemodynamic Performance Metrics by Doppler Echocardiography: Percent of Participants With Degrees of Total Prosthetic Valve Regurgitation at 1 Year, Randomized Controlled Trial None	39.4 Percent of participants	72.2 Percent of participants	—
Hemodynamic Performance Metrics by Doppler Echocardiography: Percent of Participants With Degrees of Total Prosthetic Valve Regurgitation at 1 Year, Randomized Controlled Trial Trace	23.5 Percent of participants	19.3 Percent of participants	—
Hemodynamic Performance Metrics by Doppler Echocardiography: Percent of Participants With Degrees of Total Prosthetic Valve Regurgitation at 1 Year, Randomized Controlled Trial Mild/Mild to Moderate	32.9 Percent of participants	7.2 Percent of participants	—
Hemodynamic Performance Metrics by Doppler Echocardiography: Percent of Participants With Degrees of Total Prosthetic Valve Regurgitation at 1 Year, Randomized Controlled Trial Moderate/Moderate to Severe	4.1 Percent of participants	1.3 Percent of participants	—
Hemodynamic Performance Metrics by Doppler Echocardiography: Percent of Participants With Degrees of Total Prosthetic Valve Regurgitation at 1 Year, Randomized Controlled Trial Severe	0.1 Percent of participants	0.0 Percent of participants	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 1 year

Population: Implanted

Reporting of prosthetic valve hemodynamic performance by EOA

Outcome measures

Outcome measures
Measure	Randomized Controlled Trial - Medtronic TAVR Systems n=727 Participants Treatment with Medtronic CoreValve, Evolut R, and Evolut PRO systems in the Randomized Controlled Trial	Randomized Controlled Trial - SAVR n=686 Participants Surgical Aortic Valve Replacement (SAVR) in the Randomized Controlled Trial	Continued Access Study - Medtronic TAVR Systems Treatment with Medtronic Evolut R and Evolut PRO systems in the Continued Access Study
Hemodynamic Performance Metrics by Doppler Echocardiography at 1 Year, Randomized Controlled Trial Effective Orifice Area (EOA) at 1 Year	2.23 cm2 Standard Deviation 0.63	1.96 cm2 Standard Deviation 0.57	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 1 year

Population: As treated set

Quality of life summary scores and change from baseline using the following measures: EQ-5D: Measures 5 domains (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) that can be converted to utilities using an algorithm. Utilities range from 0 to 1, with 1 representing perfect health, and 0 corresponding to the worst imaginable health state

Outcome measures

Outcome measures
Measure	Randomized Controlled Trial - Medtronic TAVR Systems n=730 Participants Treatment with Medtronic CoreValve, Evolut R, and Evolut PRO systems in the Randomized Controlled Trial	Randomized Controlled Trial - SAVR n=684 Participants Surgical Aortic Valve Replacement (SAVR) in the Randomized Controlled Trial	Continued Access Study - Medtronic TAVR Systems Treatment with Medtronic Evolut R and Evolut PRO systems in the Continued Access Study
Health-related Quality of Life as Assessed by European QoL (EQ-5D) at 1 Year, Randomized Controlled Trial EQ-5D Index Score at 1 year	0.81 Score on a scale Standard Deviation 0.21	0.81 Score on a scale Standard Deviation 0.19	—
Health-related Quality of Life as Assessed by European QoL (EQ-5D) at 1 Year, Randomized Controlled Trial 1 year change from baseline EQ-5D Index Score	0.09 Score on a scale Standard Deviation 0.24	0.08 Score on a scale Standard Deviation 0.24	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 1 year

Population: As treated set

Reporting of NYHA classification at 1 year NYHA Classification criteria: Class I: Subjects with cardiac disease but without resulting limitations of physical activity Class I: 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

Outcome measures
Measure	Randomized Controlled Trial - Medtronic TAVR Systems n=730 Participants Treatment with Medtronic CoreValve, Evolut R, and Evolut PRO systems in the Randomized Controlled Trial	Randomized Controlled Trial - SAVR n=684 Participants Surgical Aortic Valve Replacement (SAVR) in the Randomized Controlled Trial	Continued Access Study - Medtronic TAVR Systems Treatment with Medtronic Evolut R and Evolut PRO systems in the Continued Access Study
New York Heart Association (NYHA) Functional Classification at 1 Year, Randomized Controlled Trial NYHA Class I	80.6 Percent of participants	79.5 Percent of participants	—
New York Heart Association (NYHA) Functional Classification at 1 Year, Randomized Controlled Trial NYHA Class II	15.8 Percent of participants	15.7 Percent of participants	—
New York Heart Association (NYHA) Functional Classification at 1 Year, Randomized Controlled Trial NYHA Class III	1.1 Percent of participants	1.4 Percent of participants	—
New York Heart Association (NYHA) Functional Classification at 1 Year, Randomized Controlled Trial NYHA Class IV	0.4 Percent of participants	0.3 Percent of participants	—
New York Heart Association (NYHA) Functional Classification at 1 Year, Randomized Controlled Trial Died prior to visit	2.1 Percent of participants	3.0 Percent of participants	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 1 year

Population: Implanted

Reporting of prosthetic valve hemodynamic performance by transvalvular mean aortic gradient

Outcome measures

Outcome measures
Measure	Randomized Controlled Trial - Medtronic TAVR Systems n=727 Participants Treatment with Medtronic CoreValve, Evolut R, and Evolut PRO systems in the Randomized Controlled Trial	Randomized Controlled Trial - SAVR n=686 Participants Surgical Aortic Valve Replacement (SAVR) in the Randomized Controlled Trial	Continued Access Study - Medtronic TAVR Systems Treatment with Medtronic Evolut R and Evolut PRO systems in the Continued Access Study
Hemodynamic Performance Metrics by Doppler Echocardiography at 1 Year, Randomized Controlled Trial Mean Aortic Gradient at 1 Year	8.74 mmHG Standard Deviation 3.58	11.27 mmHG Standard Deviation 4.81	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Hospital discharge or 7 days post-procedure (whichever occurs first)

Population: Randomized Controlled Trial - Implanted set. Per the Clinical Investigational Plan, the incidence estimate is provided for the TAVR group only. Continued Access Study - Attempted implant set.

Assessment of procedural effectiveness by meeting all of the following device success criteria: * Absence of procedural mortality, AND * Correct positioning of a single prosthetic heart valve into the proper anatomical location, AND * Absence of moderate or severe total prosthetic valve regurgitation (at 18 hours to 7 days)

Outcome measures

Outcome measures
Measure	Randomized Controlled Trial - Medtronic TAVR Systems n=727 Participants Treatment with Medtronic CoreValve, Evolut R, and Evolut PRO systems in the Randomized Controlled Trial	Randomized Controlled Trial - SAVR n=745 Participants Surgical Aortic Valve Replacement (SAVR) in the Randomized Controlled Trial	Continued Access Study - Medtronic TAVR Systems Treatment with Medtronic Evolut R and Evolut PRO systems in the Continued Access Study
Efficacy: Device Success Rate	85.3 Percent of participants Interval 82.1 to 88.1	98.1 Percent of participants Interval 96.9 to 99.0	—

Adverse Events

Randomized Controlled Trial - Medtronic TAVR Systems

Serious events: 459 serious events

Other events: 474 other events

Deaths: 25 deaths

Randomized Controlled Trial - SAVR

Serious events: 495 serious events

Other events: 571 other events

Deaths: 29 deaths

Continued Access Study - Medtronic TAVR Systems

Serious events: 429 serious events

Other events: 0 other events

Deaths: 19 deaths

Serious adverse events

Other adverse events

Additional Information

Kristin Smith, Clinical Research Manager

Medtronic Structural Heart & Aortic Clinical Research & Medical Science

Phone: 763-526-3095

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Within 60 days of receipt Medtronic (MDT) will verify presence of Confidential Information (CI) \& won't censor or interfere with presentation/conclusions except to protect CI (other than Study Data) \& its rights in patentable or copyrightable materials, \& check technical accuracy of MDT data. If told by MDT that Publication contains CI or technical errors of MDT data, PI will make requested changes before publishing/presenting. PI will delay publication up to 90 more days, if requested.
Publication restrictions are in place

Restriction type: OTHER

Measure	Randomized Controlled Trial - Medtronic TAVR Systems n=730 Participants Treatment with Medtronic CoreValve, Evolut R, and Evolut PRO systems in the Randomized Controlled Trial	Randomized Controlled Trial - SAVR n=684 Participants Surgical Aortic Valve Replacement (SAVR) in the Randomized Controlled Trial	Continued Access Study - Medtronic TAVR Systems n=745 Participants Treatment with Medtronic Evolut R and Evolut PRO systems in the Continued Access Study	Total n=2159 Participants Total of all reporting groups
Age, Continuous	74.1 Years STANDARD_DEVIATION 5.8 • n=5 Participants	73.7 Years STANDARD_DEVIATION 5.9 • n=7 Participants	74.9 Years STANDARD_DEVIATION 5.9 • n=5 Participants	73.9 Years STANDARD_DEVIATION 5.9 • n=4 Participants
Sex: Female, Male Female	266 Participants n=5 Participants	233 Participants n=7 Participants	246 Participants n=5 Participants	745 Participants n=4 Participants
Sex: Female, Male Male	464 Participants n=5 Participants	451 Participants n=7 Participants	499 Participants n=5 Participants	1414 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	NA Participants n=5 Participants	NA Participants n=7 Participants	25 Participants n=5 Participants	NA Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	NA Participants n=5 Participants	NA Participants n=7 Participants	705 Participants n=5 Participants	NA Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	NA Participants n=5 Participants	NA Participants n=7 Participants	15 Participants n=5 Participants	NA Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	NA Participants n=5 Participants	NA Participants n=7 Participants	3 Participants n=5 Participants	NA Participants n=4 Participants
Race (NIH/OMB) Asian	NA Participants n=5 Participants	NA Participants n=7 Participants	4 Participants n=5 Participants	NA Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	NA Participants n=5 Participants	NA Participants n=7 Participants	1 Participants n=5 Participants	NA Participants n=4 Participants
Race (NIH/OMB) Black or African American	NA Participants n=5 Participants	NA Participants n=7 Participants	15 Participants n=5 Participants	NA Participants n=4 Participants
Race (NIH/OMB) White	NA Participants n=5 Participants	NA Participants n=7 Participants	707 Participants n=5 Participants	NA Participants n=4 Participants
Race (NIH/OMB) More than one race	NA Participants n=5 Participants	NA Participants n=7 Participants	0 Participants n=5 Participants	NA Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	NA Participants n=5 Participants	NA Participants n=7 Participants	15 Participants n=5 Participants	NA Participants n=4 Participants
Subject characteristic - subject age	74.1 Years STANDARD_DEVIATION 5.8 • n=5 Participants	73.7 Years STANDARD_DEVIATION 5.9 • n=7 Participants	74.9 Years STANDARD_DEVIATION 5.9 • n=5 Participants	73.9 Years STANDARD_DEVIATION 5.9 • n=4 Participants
Subject characteristic - body surface area	2.0 m^2 STANDARD_DEVIATION 0.2 • n=5 Participants	2.0 m^2 STANDARD_DEVIATION 0.2 • n=7 Participants	2.0 m^2 STANDARD_DEVIATION 0.2 • n=5 Participants	2.0 m^2 STANDARD_DEVIATION 0.2 • n=4 Participants
Subject characteristic - SYNTAX Score I, Randomized Controlled Trial	1.9 Scores on a scale STANDARD_DEVIATION 3.7 • n=5 Participants	2.1 Scores on a scale STANDARD_DEVIATION 3.9 • n=7 Participants	NA Scores on a scale STANDARD_DEVIATION NA • n=5 Participants	2.0 Scores on a scale STANDARD_DEVIATION 3.8 • n=4 Participants
Society of Thoracic Surgeons (STS) score	2.0 Scores on a scale STANDARD_DEVIATION 0.7 • n=5 Participants	1.9 Scores on a scale STANDARD_DEVIATION 0.7 • n=7 Participants	1.6 Scores on a scale STANDARD_DEVIATION 0.6 • n=5 Participants	1.9 Scores on a scale STANDARD_DEVIATION 0.7 • n=4 Participants
STS factors STS Factors Diabetes	31.4 Percent of participants n=5 Participants	30.7 Percent of participants n=7 Participants	30.4 Percent of participants n=5 Participants	31 Percent of participants n=4 Participants
STS factors STS Factors Serum Creatinine >2 mg/dl	0.4 Percent of participants n=5 Participants	0.1 Percent of participants n=7 Participants	0.4 Percent of participants n=5 Participants	0.3 Percent of participants n=4 Participants
STS factors STS Factors Dialysis	0.0 Percent of participants n=5 Participants	0.1 Percent of participants n=7 Participants	NA Percent of participants n=5 Participants	0.1 Percent of participants n=4 Participants
STS factors STS Factors Hypertension	84.8 Percent of participants n=5 Participants	82.4 Percent of participants n=7 Participants	85.0 Percent of participants n=5 Participants	83.6 Percent of participants n=4 Participants
STS factors STS Factors Endocarditis	0.0 Percent of participants n=5 Participants	0.0 Percent of participants n=7 Participants	0.0 Percent of participants n=5 Participants	0.0 Percent of participants n=4 Participants
STS factors STS Factors Chronic Lung Disease (COPD)	15.1 Percent of participants n=5 Participants	18.0 Percent of participants n=7 Participants	20.3 Percent of participants n=5 Participants	16.5 Percent of participants n=4 Participants
STS factors STS Factors Immunosuppressive Therapy	2.1 Percent of participants n=5 Participants	1.0 Percent of participants n=7 Participants	1.1 Percent of participants n=5 Participants	1.6 Percent of participants n=4 Participants
STS factors STS Factors Peripheral Arterial Disease	7.5 Percent of participants n=5 Participants	8.2 Percent of participants n=7 Participants	8.7 Percent of participants n=5 Participants	7.8 Percent of participants n=4 Participants
STS factors STS Factors Cerebrovascular Disease	10.1 Percent of participants n=5 Participants	12.0 Percent of participants n=7 Participants	2.0 Percent of participants n=5 Participants	11.0 Percent of participants n=4 Participants
STS factors STS Factors Previous CABG	2.5 Percent of participants n=5 Participants	2.0 Percent of participants n=7 Participants	2.6 Percent of participants n=5 Participants	2.3 Percent of participants n=4 Participants
STS factors STS Factors Previous Valve Surgery	0.0 Percent of participants n=5 Participants	0.0 Percent of participants n=7 Participants	0.0 Percent of participants n=5 Participants	0.0 Percent of participants n=4 Participants
STS factors STS Factors Previous PCI	14.1 Percent of participants n=5 Participants	12.9 Percent of participants n=7 Participants	18.3 Percent of participants n=5 Participants	13.5 Percent of participants n=4 Participants
STS factors STS Factors Previous MI	6.6 Percent of participants n=5 Participants	4.8 Percent of participants n=7 Participants	8.1 Percent of participants n=5 Participants	5.7 Percent of participants n=4 Participants
STS factors STS Factors Atrial Fibrillation/ Atrial Flutter	15.3 Percent of participants n=5 Participants	14.4 Percent of participants n=7 Participants	15.2 Percent of participants n=5 Participants	14.8 Percent of participants n=4 Participants
New York Heart Association Classification NYHA I	10.4 Percent of participants n=5 Participants	9.2 Percent of participants n=7 Participants	7.2 Percent of participants n=5 Participants	9.8 Percent of participants n=4 Participants
New York Heart Association Classification NYHA II	64.7 Percent of participants n=5 Participants	62.6 Percent of participants n=7 Participants	64.5 Percent of participants n=5 Participants	63.6 Percent of participants n=4 Participants
New York Heart Association Classification NYHA III	24.8 Percent of participants n=5 Participants	27.8 Percent of participants n=7 Participants	27.7 Percent of participants n=5 Participants	26.2 Percent of participants n=4 Participants
New York Heart Association Classification NYHA IV	0.1 Percent of participants n=5 Participants	0.4 Percent of participants n=7 Participants	0.5 Percent of participants n=5 Participants	0.3 Percent of participants n=4 Participants
Subject heart conduction disturbances	3.3 Percent of participants n=5 Participants	3.8 Percent of participants n=7 Participants	4.2 Percent of participants n=5 Participants	3.5 Percent of participants n=4 Participants
Modified Rankin Score (mRS), Randomized Controlled Trial mRS 0	83.8 Percent of participants n=5 Participants	85.0 Percent of participants n=7 Participants	NA Percent of participants n=5 Participants	84.4 Percent of participants n=4 Participants
Modified Rankin Score (mRS), Randomized Controlled Trial mRS1	9.6 Percent of participants n=5 Participants	8.1 Percent of participants n=7 Participants	NA Percent of participants n=5 Participants	8.9 Percent of participants n=4 Participants
Modified Rankin Score (mRS), Randomized Controlled Trial mRS 2	5.6 Percent of participants n=5 Participants	6.2 Percent of participants n=7 Participants	NA Percent of participants n=5 Participants	5.9 Percent of participants n=4 Participants
Modified Rankin Score (mRS), Randomized Controlled Trial mRS 3	1.0 Percent of participants n=5 Participants	0.7 Percent of participants n=7 Participants	NA Percent of participants n=5 Participants	0.9 Percent of participants n=4 Participants
Modified Rankin Score (mRS), Randomized Controlled Trial mRS 4	0.0 Percent of participants n=5 Participants	0.0 Percent of participants n=7 Participants	NA Percent of participants n=5 Participants	0.0 Percent of participants n=4 Participants
Modified Rankin Score (mRS), Randomized Controlled Trial mRS 5	0.0 Percent of participants n=5 Participants	0.0 Percent of participants n=7 Participants	NA Percent of participants n=5 Participants	0.0 Percent of participants n=4 Participants
Modified Rankin Score (mRS), Randomized Controlled Trial mRS 6	0.0 Percent of participants n=5 Participants	0.0 Percent of participants n=7 Participants	NA Percent of participants n=5 Participants	0.0 Percent of participants n=4 Participants
Mean aortic gradient	46.9 mmHG STANDARD_DEVIATION 12.2 • n=5 Participants	46.5 mmHG STANDARD_DEVIATION 12.2 • n=7 Participants	45.5 mmHG STANDARD_DEVIATION 12.5 • n=5 Participants	46.7 mmHG STANDARD_DEVIATION 12.2 • n=4 Participants
Max aortic valve velocity	4.4 m/sec STANDARD_DEVIATION 0.5 • n=5 Participants	4.4 m/sec STANDARD_DEVIATION 0.5 • n=7 Participants	4.3 m/sec STANDARD_DEVIATION 0.5 • n=5 Participants	4.4 m/sec STANDARD_DEVIATION 0.5 • n=4 Participants
Aortic valve area (AVA)	0.8 cm2 STANDARD_DEVIATION 0.2 • n=5 Participants	0.8 cm2 STANDARD_DEVIATION 0.2 • n=7 Participants	0.8 cm2 STANDARD_DEVIATION 0.2 • n=5 Participants	0.8 cm2 STANDARD_DEVIATION 0.2 • n=4 Participants
Left Ventricular Ejection Fraction (LVEF)	61.7 Percentage of blood ejected STANDARD_DEVIATION 7.9 • n=5 Participants	61.9 Percentage of blood ejected STANDARD_DEVIATION 7.7 • n=7 Participants	61.8 Percentage of blood ejected STANDARD_DEVIATION 8.0 • n=5 Participants	61.8 Percentage of blood ejected STANDARD_DEVIATION 7.8 • n=4 Participants

Serious adverse events
Measure	Randomized Controlled Trial - Medtronic TAVR Systems n=730 participants at risk Treatment with Medtronic CoreValve, Evolut R, and Evolut PRO systems in the Randomized Controlled Trial	Randomized Controlled Trial - SAVR n=684 participants at risk Surgical Aortic Valve Replacement (SAVR) in the Randomized Controlled Trial	Continued Access Study - Medtronic TAVR Systems n=745 participants at risk Treatment with Medtronic Evolut R and Evolut PRO systems in the Continued Access Study
Blood and lymphatic system disorders Anaemia	3.0% 22/730 • Randomized Controlled Trial - Adverse events (AEs) were collected from study enrollment through the 24 month follow-up visit. Adverse event data are currently available and reported for up to 24 months. Continued Access Study - Adverse events (AEs) were collected from study enrollment through the 12 month follow-up visit. Adverse event data are currently available and reported for up to 12 months. Randomized Controlled Trial - All new or worsening AEs were collected through 24 months. After 24 months only serious and device-related events will be collected. Continued Access Study - All new or worsening AEs were collected through 12 months. Note, any AE that is entered as 0 for this portion of the study does not imply that the AE did not occur, rather it is not collected in the TVT Registry. There are no events entered in the 'Other' table as TVT-R does not distinguish seriousness.	8.8% 60/684 • Randomized Controlled Trial - Adverse events (AEs) were collected from study enrollment through the 24 month follow-up visit. Adverse event data are currently available and reported for up to 24 months. Continued Access Study - Adverse events (AEs) were collected from study enrollment through the 12 month follow-up visit. Adverse event data are currently available and reported for up to 12 months. Randomized Controlled Trial - All new or worsening AEs were collected through 24 months. After 24 months only serious and device-related events will be collected. Continued Access Study - All new or worsening AEs were collected through 12 months. Note, any AE that is entered as 0 for this portion of the study does not imply that the AE did not occur, rather it is not collected in the TVT Registry. There are no events entered in the 'Other' table as TVT-R does not distinguish seriousness.	0.00% 0/745 • Randomized Controlled Trial - Adverse events (AEs) were collected from study enrollment through the 24 month follow-up visit. Adverse event data are currently available and reported for up to 24 months. Continued Access Study - Adverse events (AEs) were collected from study enrollment through the 12 month follow-up visit. Adverse event data are currently available and reported for up to 12 months. Randomized Controlled Trial - All new or worsening AEs were collected through 24 months. After 24 months only serious and device-related events will be collected. Continued Access Study - All new or worsening AEs were collected through 12 months. Note, any AE that is entered as 0 for this portion of the study does not imply that the AE did not occur, rather it is not collected in the TVT Registry. There are no events entered in the 'Other' table as TVT-R does not distinguish seriousness.
Blood and lymphatic system disorders Blood Loss Anaemia	0.14% 1/730 • Randomized Controlled Trial - Adverse events (AEs) were collected from study enrollment through the 24 month follow-up visit. Adverse event data are currently available and reported for up to 24 months. Continued Access Study - Adverse events (AEs) were collected from study enrollment through the 12 month follow-up visit. Adverse event data are currently available and reported for up to 12 months. Randomized Controlled Trial - All new or worsening AEs were collected through 24 months. After 24 months only serious and device-related events will be collected. Continued Access Study - All new or worsening AEs were collected through 12 months. Note, any AE that is entered as 0 for this portion of the study does not imply that the AE did not occur, rather it is not collected in the TVT Registry. There are no events entered in the 'Other' table as TVT-R does not distinguish seriousness.	3.1% 21/684 • Randomized Controlled Trial - Adverse events (AEs) were collected from study enrollment through the 24 month follow-up visit. Adverse event data are currently available and reported for up to 24 months. Continued Access Study - Adverse events (AEs) were collected from study enrollment through the 12 month follow-up visit. Adverse event data are currently available and reported for up to 12 months. Randomized Controlled Trial - All new or worsening AEs were collected through 24 months. After 24 months only serious and device-related events will be collected. Continued Access Study - All new or worsening AEs were collected through 12 months. Note, any AE that is entered as 0 for this portion of the study does not imply that the AE did not occur, rather it is not collected in the TVT Registry. There are no events entered in the 'Other' table as TVT-R does not distinguish seriousness.	0.00% 0/745 • Randomized Controlled Trial - Adverse events (AEs) were collected from study enrollment through the 24 month follow-up visit. Adverse event data are currently available and reported for up to 24 months. Continued Access Study - Adverse events (AEs) were collected from study enrollment through the 12 month follow-up visit. Adverse event data are currently available and reported for up to 12 months. Randomized Controlled Trial - All new or worsening AEs were collected through 24 months. After 24 months only serious and device-related events will be collected. Continued Access Study - All new or worsening AEs were collected through 12 months. Note, any AE that is entered as 0 for this portion of the study does not imply that the AE did not occur, rather it is not collected in the TVT Registry. There are no events entered in the 'Other' table as TVT-R does not distinguish seriousness.
Blood and lymphatic system disorders Coagulopathy	0.00% 0/730 • Randomized Controlled Trial - Adverse events (AEs) were collected from study enrollment through the 24 month follow-up visit. Adverse event data are currently available and reported for up to 24 months. Continued Access Study - Adverse events (AEs) were collected from study enrollment through the 12 month follow-up visit. Adverse event data are currently available and reported for up to 12 months. Randomized Controlled Trial - All new or worsening AEs were collected through 24 months. After 24 months only serious and device-related events will be collected. Continued Access Study - All new or worsening AEs were collected through 12 months. Note, any AE that is entered as 0 for this portion of the study does not imply that the AE did not occur, rather it is not collected in the TVT Registry. There are no events entered in the 'Other' table as TVT-R does not distinguish seriousness.	1.0% 7/684 • Randomized Controlled Trial - Adverse events (AEs) were collected from study enrollment through the 24 month follow-up visit. Adverse event data are currently available and reported for up to 24 months. Continued Access Study - Adverse events (AEs) were collected from study enrollment through the 12 month follow-up visit. Adverse event data are currently available and reported for up to 12 months. Randomized Controlled Trial - All new or worsening AEs were collected through 24 months. After 24 months only serious and device-related events will be collected. Continued Access Study - All new or worsening AEs were collected through 12 months. Note, any AE that is entered as 0 for this portion of the study does not imply that the AE did not occur, rather it is not collected in the TVT Registry. There are no events entered in the 'Other' table as TVT-R does not distinguish seriousness.	0.00% 0/745 • Randomized Controlled Trial - Adverse events (AEs) were collected from study enrollment through the 24 month follow-up visit. Adverse event data are currently available and reported for up to 24 months. Continued Access Study - Adverse events (AEs) were collected from study enrollment through the 12 month follow-up visit. Adverse event data are currently available and reported for up to 12 months. Randomized Controlled Trial - All new or worsening AEs were collected through 24 months. After 24 months only serious and device-related events will be collected. Continued Access Study - All new or worsening AEs were collected through 12 months. Note, any AE that is entered as 0 for this portion of the study does not imply that the AE did not occur, rather it is not collected in the TVT Registry. There are no events entered in the 'Other' table as TVT-R does not distinguish seriousness.
Blood and lymphatic system disorders Disseminated Intravascular Coagulation	0.14% 1/730 • Randomized Controlled Trial - Adverse events (AEs) were collected from study enrollment through the 24 month follow-up visit. Adverse event data are currently available and reported for up to 24 months. Continued Access Study - Adverse events (AEs) were collected from study enrollment through the 12 month follow-up visit. Adverse event data are currently available and reported for up to 12 months. Randomized Controlled Trial - All new or worsening AEs were collected through 24 months. After 24 months only serious and device-related events will be collected. Continued Access Study - All new or worsening AEs were collected through 12 months. Note, any AE that is entered as 0 for this portion of the study does not imply that the AE did not occur, rather it is not collected in the TVT Registry. There are no events entered in the 'Other' table as TVT-R does not distinguish seriousness.	0.00% 0/684 • Randomized Controlled Trial - Adverse events (AEs) were collected from study enrollment through the 24 month follow-up visit. Adverse event data are currently available and reported for up to 24 months. Continued Access Study - Adverse events (AEs) were collected from study enrollment through the 12 month follow-up visit. Adverse event data are currently available and reported for up to 12 months. Randomized Controlled Trial - All new or worsening AEs were collected through 24 months. After 24 months only serious and device-related events will be collected. Continued Access Study - All new or worsening AEs were collected through 12 months. Note, any AE that is entered as 0 for this portion of the study does not imply that the AE did not occur, rather it is not collected in the TVT Registry. There are no events entered in the 'Other' table as TVT-R does not distinguish seriousness.	0.00% 0/745 • Randomized Controlled Trial - Adverse events (AEs) were collected from study enrollment through the 24 month follow-up visit. Adverse event data are currently available and reported for up to 24 months. Continued Access Study - Adverse events (AEs) were collected from study enrollment through the 12 month follow-up visit. Adverse event data are currently available and reported for up to 12 months. Randomized Controlled Trial - All new or worsening AEs were collected through 24 months. After 24 months only serious and device-related events will be collected. Continued Access Study - All new or worsening AEs were collected through 12 months. Note, any AE that is entered as 0 for this portion of the study does not imply that the AE did not occur, rather it is not collected in the TVT Registry. There are no events entered in the 'Other' table as TVT-R does not distinguish seriousness.
Blood and lymphatic system disorders Heparin-Induced Thrombocytopenia	0.00% 0/730 • Randomized Controlled Trial - Adverse events (AEs) were collected from study enrollment through the 24 month follow-up visit. Adverse event data are currently available and reported for up to 24 months. Continued Access Study - Adverse events (AEs) were collected from study enrollment through the 12 month follow-up visit. Adverse event data are currently available and reported for up to 12 months. Randomized Controlled Trial - All new or worsening AEs were collected through 24 months. After 24 months only serious and device-related events will be collected. Continued Access Study - All new or worsening AEs were collected through 12 months. Note, any AE that is entered as 0 for this portion of the study does not imply that the AE did not occur, rather it is not collected in the TVT Registry. There are no events entered in the 'Other' table as TVT-R does not distinguish seriousness.	0.29% 2/684 • Randomized Controlled Trial - Adverse events (AEs) were collected from study enrollment through the 24 month follow-up visit. Adverse event data are currently available and reported for up to 24 months. Continued Access Study - Adverse events (AEs) were collected from study enrollment through the 12 month follow-up visit. Adverse event data are currently available and reported for up to 12 months. Randomized Controlled Trial - All new or worsening AEs were collected through 24 months. After 24 months only serious and device-related events will be collected. Continued Access Study - All new or worsening AEs were collected through 12 months. Note, any AE that is entered as 0 for this portion of the study does not imply that the AE did not occur, rather it is not collected in the TVT Registry. There are no events entered in the 'Other' table as TVT-R does not distinguish seriousness.	0.00% 0/745 • Randomized Controlled Trial - Adverse events (AEs) were collected from study enrollment through the 24 month follow-up visit. Adverse event data are currently available and reported for up to 24 months. Continued Access Study - Adverse events (AEs) were collected from study enrollment through the 12 month follow-up visit. Adverse event data are currently available and reported for up to 12 months. Randomized Controlled Trial - All new or worsening AEs were collected through 24 months. After 24 months only serious and device-related events will be collected. Continued Access Study - All new or worsening AEs were collected through 12 months. Note, any AE that is entered as 0 for this portion of the study does not imply that the AE did not occur, rather it is not collected in the TVT Registry. There are no events entered in the 'Other' table as TVT-R does not distinguish seriousness.
Blood and lymphatic system disorders Hypergammaglobulinaemia	0.14% 1/730 • Randomized Controlled Trial - Adverse events (AEs) were collected from study enrollment through the 24 month follow-up visit. Adverse event data are currently available and reported for up to 24 months. Continued Access Study - Adverse events (AEs) were collected from study enrollment through the 12 month follow-up visit. Adverse event data are currently available and reported for up to 12 months. Randomized Controlled Trial - All new or worsening AEs were collected through 24 months. After 24 months only serious and device-related events will be collected. Continued Access Study - All new or worsening AEs were collected through 12 months. Note, any AE that is entered as 0 for this portion of the study does not imply that the AE did not occur, rather it is not collected in the TVT Registry. There are no events entered in the 'Other' table as TVT-R does not distinguish seriousness.	0.00% 0/684 • Randomized Controlled Trial - Adverse events (AEs) were collected from study enrollment through the 24 month follow-up visit. Adverse event data are currently available and reported for up to 24 months. Continued Access Study - Adverse events (AEs) were collected from study enrollment through the 12 month follow-up visit. Adverse event data are currently available and reported for up to 12 months. Randomized Controlled Trial - All new or worsening AEs were collected through 24 months. After 24 months only serious and device-related events will be collected. Continued Access Study - All new or worsening AEs were collected through 12 months. Note, any AE that is entered as 0 for this portion of the study does not imply that the AE did not occur, rather it is not collected in the TVT Registry. There are no events entered in the 'Other' table as TVT-R does not distinguish seriousness.	0.00% 0/745 • Randomized Controlled Trial - Adverse events (AEs) were collected from study enrollment through the 24 month follow-up visit. Adverse event data are currently available and reported for up to 24 months. Continued Access Study - Adverse events (AEs) were collected from study enrollment through the 12 month follow-up visit. Adverse event data are currently available and reported for up to 12 months. Randomized Controlled Trial - All new or worsening AEs were collected through 24 months. After 24 months only serious and device-related events will be collected. Continued Access Study - All new or worsening AEs were collected through 12 months. Note, any AE that is entered as 0 for this portion of the study does not imply that the AE did not occur, rather it is not collected in the TVT Registry. There are no events entered in the 'Other' table as TVT-R does not distinguish seriousness.
Blood and lymphatic system disorders Iron Deficiency Anaemia	0.14% 1/730 • Randomized Controlled Trial - Adverse events (AEs) were collected from study enrollment through the 24 month follow-up visit. Adverse event data are currently available and reported for up to 24 months. Continued Access Study - Adverse events (AEs) were collected from study enrollment through the 12 month follow-up visit. Adverse event data are currently available and reported for up to 12 months. Randomized Controlled Trial - All new or worsening AEs were collected through 24 months. After 24 months only serious and device-related events will be collected. Continued Access Study - All new or worsening AEs were collected through 12 months. Note, any AE that is entered as 0 for this portion of the study does not imply that the AE did not occur, rather it is not collected in the TVT Registry. There are no events entered in the 'Other' table as TVT-R does not distinguish seriousness.	0.00% 0/684 • Randomized Controlled Trial - Adverse events (AEs) were collected from study enrollment through the 24 month follow-up visit. Adverse event data are currently available and reported for up to 24 months. Continued Access Study - Adverse events (AEs) were collected from study enrollment through the 12 month follow-up visit. Adverse event data are currently available and reported for up to 12 months. Randomized Controlled Trial - All new or worsening AEs were collected through 24 months. After 24 months only serious and device-related events will be collected. Continued Access Study - All new or worsening AEs were collected through 12 months. Note, any AE that is entered as 0 for this portion of the study does not imply that the AE did not occur, rather it is not collected in the TVT Registry. There are no events entered in the 'Other' table as TVT-R does not distinguish seriousness.	0.00% 0/745 • Randomized Controlled Trial - Adverse events (AEs) were collected from study enrollment through the 24 month follow-up visit. Adverse event data are currently available and reported for up to 24 months. Continued Access Study - Adverse events (AEs) were collected from study enrollment through the 12 month follow-up visit. Adverse event data are currently available and reported for up to 12 months. Randomized Controlled Trial - All new or worsening AEs were collected through 24 months. After 24 months only serious and device-related events will be collected. Continued Access Study - All new or worsening AEs were collected through 12 months. Note, any AE that is entered as 0 for this portion of the study does not imply that the AE did not occur, rather it is not collected in the TVT Registry. There are no events entered in the 'Other' table as TVT-R does not distinguish seriousness.
Blood and lymphatic system disorders Leukocytosis	0.14% 1/730 • Randomized Controlled Trial - Adverse events (AEs) were collected from study enrollment through the 24 month follow-up visit. Adverse event data are currently available and reported for up to 24 months. Continued Access Study - Adverse events (AEs) were collected from study enrollment through the 12 month follow-up visit. Adverse event data are currently available and reported for up to 12 months. Randomized Controlled Trial - All new or worsening AEs were collected through 24 months. After 24 months only serious and device-related events will be collected. Continued Access Study - All new or worsening AEs were collected through 12 months. Note, any AE that is entered as 0 for this portion of the study does not imply that the AE did not occur, rather it is not collected in the TVT Registry. There are no events entered in the 'Other' table as TVT-R does not distinguish seriousness.	0.58% 4/684 • Randomized Controlled Trial - Adverse events (AEs) were collected from study enrollment through the 24 month follow-up visit. Adverse event data are currently available and reported for up to 24 months. Continued Access Study - Adverse events (AEs) were collected from study enrollment through the 12 month follow-up visit. Adverse event data are currently available and reported for up to 12 months. Randomized Controlled Trial - All new or worsening AEs were collected through 24 months. After 24 months only serious and device-related events will be collected. Continued Access Study - All new or worsening AEs were collected through 12 months. Note, any AE that is entered as 0 for this portion of the study does not imply that the AE did not occur, rather it is not collected in the TVT Registry. There are no events entered in the 'Other' table as TVT-R does not distinguish seriousness.	0.00% 0/745 • Randomized Controlled Trial - Adverse events (AEs) were collected from study enrollment through the 24 month follow-up visit. Adverse event data are currently available and reported for up to 24 months. Continued Access Study - Adverse events (AEs) were collected from study enrollment through the 12 month follow-up visit. Adverse event data are currently available and reported for up to 12 months. Randomized Controlled Trial - All new or worsening AEs were collected through 24 months. After 24 months only serious and device-related events will be collected. Continued Access Study - All new or worsening AEs were collected through 12 months. Note, any AE that is entered as 0 for this portion of the study does not imply that the AE did not occur, rather it is not collected in the TVT Registry. There are no events entered in the 'Other' table as TVT-R does not distinguish seriousness.
Blood and lymphatic system disorders Thrombocytopenia	0.27% 2/730 • Randomized Controlled Trial - Adverse events (AEs) were collected from study enrollment through the 24 month follow-up visit. Adverse event data are currently available and reported for up to 24 months. Continued Access Study - Adverse events (AEs) were collected from study enrollment through the 12 month follow-up visit. Adverse event data are currently available and reported for up to 12 months. Randomized Controlled Trial - All new or worsening AEs were collected through 24 months. After 24 months only serious and device-related events will be collected. Continued Access Study - All new or worsening AEs were collected through 12 months. Note, any AE that is entered as 0 for this portion of the study does not imply that the AE did not occur, rather it is not collected in the TVT Registry. There are no events entered in the 'Other' table as TVT-R does not distinguish seriousness.	3.9% 27/684 • Randomized Controlled Trial - Adverse events (AEs) were collected from study enrollment through the 24 month follow-up visit. Adverse event data are currently available and reported for up to 24 months. Continued Access Study - Adverse events (AEs) were collected from study enrollment through the 12 month follow-up visit. Adverse event data are currently available and reported for up to 12 months. Randomized Controlled Trial - All new or worsening AEs were collected through 24 months. After 24 months only serious and device-related events will be collected. Continued Access Study - All new or worsening AEs were collected through 12 months. Note, any AE that is entered as 0 for this portion of the study does not imply that the AE did not occur, rather it is not collected in the TVT Registry. There are no events entered in the 'Other' table as TVT-R does not distinguish seriousness.	0.00% 0/745 • Randomized Controlled Trial - Adverse events (AEs) were collected from study enrollment through the 24 month follow-up visit. Adverse event data are currently available and reported for up to 24 months. Continued Access Study - Adverse events (AEs) were collected from study enrollment through the 12 month follow-up visit. Adverse event data are currently available and reported for up to 12 months. Randomized Controlled Trial - All new or worsening AEs were collected through 24 months. After 24 months only serious and device-related events will be collected. Continued Access Study - All new or worsening AEs were collected through 12 months. Note, any AE that is entered as 0 for this portion of the study does not imply that the AE did not occur, rather it is not collected in the TVT Registry. There are no events entered in the 'Other' table as TVT-R does not distinguish seriousness.
Cardiac disorders Acquired Cardiac Septal Defect	0.00% 0/730 • Randomized Controlled Trial - Adverse events (AEs) were collected from study enrollment through the 24 month follow-up visit. Adverse event data are currently available and reported for up to 24 months. Continued Access Study - Adverse events (AEs) were collected from study enrollment through the 12 month follow-up visit. Adverse event data are currently available and reported for up to 12 months. Randomized Controlled Trial - All new or worsening AEs were collected through 24 months. After 24 months only serious and device-related events will be collected. Continued Access Study - All new or worsening AEs were collected through 12 months. Note, any AE that is entered as 0 for this portion of the study does not imply that the AE did not occur, rather it is not collected in the TVT Registry. There are no events entered in the 'Other' table as TVT-R does not distinguish seriousness.	0.15% 1/684 • Randomized Controlled Trial - Adverse events (AEs) were collected from study enrollment through the 24 month follow-up visit. Adverse event data are currently available and reported for up to 24 months. Continued Access Study - Adverse events (AEs) were collected from study enrollment through the 12 month follow-up visit. Adverse event data are currently available and reported for up to 12 months. Randomized Controlled Trial - All new or worsening AEs were collected through 24 months. After 24 months only serious and device-related events will be collected. Continued Access Study - All new or worsening AEs were collected through 12 months. Note, any AE that is entered as 0 for this portion of the study does not imply that the AE did not occur, rather it is not collected in the TVT Registry. There are no events entered in the 'Other' table as TVT-R does not distinguish seriousness.	0.00% 0/745 • Randomized Controlled Trial - Adverse events (AEs) were collected from study enrollment through the 24 month follow-up visit. Adverse event data are currently available and reported for up to 24 months. Continued Access Study - Adverse events (AEs) were collected from study enrollment through the 12 month follow-up visit. Adverse event data are currently available and reported for up to 12 months. Randomized Controlled Trial - All new or worsening AEs were collected through 24 months. After 24 months only serious and device-related events will be collected. Continued Access Study - All new or worsening AEs were collected through 12 months. Note, any AE that is entered as 0 for this portion of the study does not imply that the AE did not occur, rather it is not collected in the TVT Registry. There are no events entered in the 'Other' table as TVT-R does not distinguish seriousness.
Cardiac disorders Acute Coronary Syndrome	0.14% 1/730 • Randomized Controlled Trial - Adverse events (AEs) were collected from study enrollment through the 24 month follow-up visit. Adverse event data are currently available and reported for up to 24 months. Continued Access Study - Adverse events (AEs) were collected from study enrollment through the 12 month follow-up visit. Adverse event data are currently available and reported for up to 12 months. Randomized Controlled Trial - All new or worsening AEs were collected through 24 months. After 24 months only serious and device-related events will be collected. Continued Access Study - All new or worsening AEs were collected through 12 months. Note, any AE that is entered as 0 for this portion of the study does not imply that the AE did not occur, rather it is not collected in the TVT Registry. There are no events entered in the 'Other' table as TVT-R does not distinguish seriousness.	0.15% 1/684 • Randomized Controlled Trial - Adverse events (AEs) were collected from study enrollment through the 24 month follow-up visit. Adverse event data are currently available and reported for up to 24 months. Continued Access Study - Adverse events (AEs) were collected from study enrollment through the 12 month follow-up visit. Adverse event data are currently available and reported for up to 12 months. Randomized Controlled Trial - All new or worsening AEs were collected through 24 months. After 24 months only serious and device-related events will be collected. Continued Access Study - All new or worsening AEs were collected through 12 months. Note, any AE that is entered as 0 for this portion of the study does not imply that the AE did not occur, rather it is not collected in the TVT Registry. There are no events entered in the 'Other' table as TVT-R does not distinguish seriousness.	0.00% 0/745 • Randomized Controlled Trial - Adverse events (AEs) were collected from study enrollment through the 24 month follow-up visit. Adverse event data are currently available and reported for up to 24 months. Continued Access Study - Adverse events (AEs) were collected from study enrollment through the 12 month follow-up visit. Adverse event data are currently available and reported for up to 12 months. Randomized Controlled Trial - All new or worsening AEs were collected through 24 months. After 24 months only serious and device-related events will be collected. Continued Access Study - All new or worsening AEs were collected through 12 months. Note, any AE that is entered as 0 for this portion of the study does not imply that the AE did not occur, rather it is not collected in the TVT Registry. There are no events entered in the 'Other' table as TVT-R does not distinguish seriousness.
Cardiac disorders Acute Left Ventricular Failure	0.41% 3/730 • Randomized Controlled Trial - Adverse events (AEs) were collected from study enrollment through the 24 month follow-up visit. Adverse event data are currently available and reported for up to 24 months. Continued Access Study - Adverse events (AEs) were collected from study enrollment through the 12 month follow-up visit. Adverse event data are currently available and reported for up to 12 months. Randomized Controlled Trial - All new or worsening AEs were collected through 24 months. After 24 months only serious and device-related events will be collected. Continued Access Study - All new or worsening AEs were collected through 12 months. Note, any AE that is entered as 0 for this portion of the study does not imply that the AE did not occur, rather it is not collected in the TVT Registry. There are no events entered in the 'Other' table as TVT-R does not distinguish seriousness.	0.29% 2/684 • Randomized Controlled Trial - Adverse events (AEs) were collected from study enrollment through the 24 month follow-up visit. Adverse event data are currently available and reported for up to 24 months. Continued Access Study - Adverse events (AEs) were collected from study enrollment through the 12 month follow-up visit. Adverse event data are currently available and reported for up to 12 months. Randomized Controlled Trial - All new or worsening AEs were collected through 24 months. After 24 months only serious and device-related events will be collected. Continued Access Study - All new or worsening AEs were collected through 12 months. Note, any AE that is entered as 0 for this portion of the study does not imply that the AE did not occur, rather it is not collected in the TVT Registry. There are no events entered in the 'Other' table as TVT-R does not distinguish seriousness.	0.00% 0/745 • Randomized Controlled Trial - Adverse events (AEs) were collected from study enrollment through the 24 month follow-up visit. Adverse event data are currently available and reported for up to 24 months. Continued Access Study - Adverse events (AEs) were collected from study enrollment through the 12 month follow-up visit. Adverse event data are currently available and reported for up to 12 months. Randomized Controlled Trial - All new or worsening AEs were collected through 24 months. After 24 months only serious and device-related events will be collected. Continued Access Study - All new or worsening AEs were collected through 12 months. Note, any AE that is entered as 0 for this portion of the study does not imply that the AE did not occur, rather it is not collected in the TVT Registry. There are no events entered in the 'Other' table as TVT-R does not distinguish seriousness.
Cardiac disorders Acute Myocardial Infarction	1.1% 8/730 • Randomized Controlled Trial - Adverse events (AEs) were collected from study enrollment through the 24 month follow-up visit. Adverse event data are currently available and reported for up to 24 months. Continued Access Study - Adverse events (AEs) were collected from study enrollment through the 12 month follow-up visit. Adverse event data are currently available and reported for up to 12 months. Randomized Controlled Trial - All new or worsening AEs were collected through 24 months. After 24 months only serious and device-related events will be collected. Continued Access Study - All new or worsening AEs were collected through 12 months. Note, any AE that is entered as 0 for this portion of the study does not imply that the AE did not occur, rather it is not collected in the TVT Registry. There are no events entered in the 'Other' table as TVT-R does not distinguish seriousness.	0.73% 5/684 • Randomized Controlled Trial - Adverse events (AEs) were collected from study enrollment through the 24 month follow-up visit. Adverse event data are currently available and reported for up to 24 months. Continued Access Study - Adverse events (AEs) were collected from study enrollment through the 12 month follow-up visit. Adverse event data are currently available and reported for up to 12 months. Randomized Controlled Trial - All new or worsening AEs were collected through 24 months. After 24 months only serious and device-related events will be collected. Continued Access Study - All new or worsening AEs were collected through 12 months. Note, any AE that is entered as 0 for this portion of the study does not imply that the AE did not occur, rather it is not collected in the TVT Registry. There are no events entered in the 'Other' table as TVT-R does not distinguish seriousness.	0.54% 4/745 • Randomized Controlled Trial - Adverse events (AEs) were collected from study enrollment through the 24 month follow-up visit. Adverse event data are currently available and reported for up to 24 months. Continued Access Study - Adverse events (AEs) were collected from study enrollment through the 12 month follow-up visit. Adverse event data are currently available and reported for up to 12 months. Randomized Controlled Trial - All new or worsening AEs were collected through 24 months. After 24 months only serious and device-related events will be collected. Continued Access Study - All new or worsening AEs were collected through 12 months. Note, any AE that is entered as 0 for this portion of the study does not imply that the AE did not occur, rather it is not collected in the TVT Registry. There are no events entered in the 'Other' table as TVT-R does not distinguish seriousness.
Cardiac disorders Angina Pectoris	0.27% 2/730 • Randomized Controlled Trial - Adverse events (AEs) were collected from study enrollment through the 24 month follow-up visit. Adverse event data are currently available and reported for up to 24 months. Continued Access Study - Adverse events (AEs) were collected from study enrollment through the 12 month follow-up visit. Adverse event data are currently available and reported for up to 12 months. Randomized Controlled Trial - All new or worsening AEs were collected through 24 months. After 24 months only serious and device-related events will be collected. Continued Access Study - All new or worsening AEs were collected through 12 months. Note, any AE that is entered as 0 for this portion of the study does not imply that the AE did not occur, rather it is not collected in the TVT Registry. There are no events entered in the 'Other' table as TVT-R does not distinguish seriousness.	0.44% 3/684 • Randomized Controlled Trial - Adverse events (AEs) were collected from study enrollment through the 24 month follow-up visit. Adverse event data are currently available and reported for up to 24 months. Continued Access Study - Adverse events (AEs) were collected from study enrollment through the 12 month follow-up visit. Adverse event data are currently available and reported for up to 12 months. Randomized Controlled Trial - All new or worsening AEs were collected through 24 months. After 24 months only serious and device-related events will be collected. Continued Access Study - All new or worsening AEs were collected through 12 months. Note, any AE that is entered as 0 for this portion of the study does not imply that the AE did not occur, rather it is not collected in the TVT Registry. There are no events entered in the 'Other' table as TVT-R does not distinguish seriousness.	0.00% 0/745 • Randomized Controlled Trial - Adverse events (AEs) were collected from study enrollment through the 24 month follow-up visit. Adverse event data are currently available and reported for up to 24 months. Continued Access Study - Adverse events (AEs) were collected from study enrollment through the 12 month follow-up visit. Adverse event data are currently available and reported for up to 12 months. Randomized Controlled Trial - All new or worsening AEs were collected through 24 months. After 24 months only serious and device-related events will be collected. Continued Access Study - All new or worsening AEs were collected through 12 months. Note, any AE that is entered as 0 for this portion of the study does not imply that the AE did not occur, rather it is not collected in the TVT Registry. There are no events entered in the 'Other' table as TVT-R does not distinguish seriousness.
Cardiac disorders Angina Unstable	0.00% 0/730 • Randomized Controlled Trial - Adverse events (AEs) were collected from study enrollment through the 24 month follow-up visit. Adverse event data are currently available and reported for up to 24 months. Continued Access Study - Adverse events (AEs) were collected from study enrollment through the 12 month follow-up visit. Adverse event data are currently available and reported for up to 12 months. Randomized Controlled Trial - All new or worsening AEs were collected through 24 months. After 24 months only serious and device-related events will be collected. Continued Access Study - All new or worsening AEs were collected through 12 months. Note, any AE that is entered as 0 for this portion of the study does not imply that the AE did not occur, rather it is not collected in the TVT Registry. There are no events entered in the 'Other' table as TVT-R does not distinguish seriousness.	0.15% 1/684 • Randomized Controlled Trial - Adverse events (AEs) were collected from study enrollment through the 24 month follow-up visit. Adverse event data are currently available and reported for up to 24 months. Continued Access Study - Adverse events (AEs) were collected from study enrollment through the 12 month follow-up visit. Adverse event data are currently available and reported for up to 12 months. Randomized Controlled Trial - All new or worsening AEs were collected through 24 months. After 24 months only serious and device-related events will be collected. Continued Access Study - All new or worsening AEs were collected through 12 months. Note, any AE that is entered as 0 for this portion of the study does not imply that the AE did not occur, rather it is not collected in the TVT Registry. There are no events entered in the 'Other' table as TVT-R does not distinguish seriousness.	0.00% 0/745 • Randomized Controlled Trial - Adverse events (AEs) were collected from study enrollment through the 24 month follow-up visit. Adverse event data are currently available and reported for up to 24 months. Continued Access Study - Adverse events (AEs) were collected from study enrollment through the 12 month follow-up visit. Adverse event data are currently available and reported for up to 12 months. Randomized Controlled Trial - All new or worsening AEs were collected through 24 months. After 24 months only serious and device-related events will be collected. Continued Access Study - All new or worsening AEs were collected through 12 months. Note, any AE that is entered as 0 for this portion of the study does not imply that the AE did not occur, rather it is not collected in the TVT Registry. There are no events entered in the 'Other' table as TVT-R does not distinguish seriousness.
Cardiac disorders Aortic Valve Calcification	0.00% 0/730 • Randomized Controlled Trial - Adverse events (AEs) were collected from study enrollment through the 24 month follow-up visit. Adverse event data are currently available and reported for up to 24 months. Continued Access Study - Adverse events (AEs) were collected from study enrollment through the 12 month follow-up visit. Adverse event data are currently available and reported for up to 12 months. Randomized Controlled Trial - All new or worsening AEs were collected through 24 months. After 24 months only serious and device-related events will be collected. Continued Access Study - All new or worsening AEs were collected through 12 months. Note, any AE that is entered as 0 for this portion of the study does not imply that the AE did not occur, rather it is not collected in the TVT Registry. There are no events entered in the 'Other' table as TVT-R does not distinguish seriousness.	0.15% 1/684 • Randomized Controlled Trial - Adverse events (AEs) were collected from study enrollment through the 24 month follow-up visit. Adverse event data are currently available and reported for up to 24 months. Continued Access Study - Adverse events (AEs) were collected from study enrollment through the 12 month follow-up visit. Adverse event data are currently available and reported for up to 12 months. Randomized Controlled Trial - All new or worsening AEs were collected through 24 months. After 24 months only serious and device-related events will be collected. Continued Access Study - All new or worsening AEs were collected through 12 months. Note, any AE that is entered as 0 for this portion of the study does not imply that the AE did not occur, rather it is not collected in the TVT Registry. There are no events entered in the 'Other' table as TVT-R does not distinguish seriousness.	0.00% 0/745 • Randomized Controlled Trial - Adverse events (AEs) were collected from study enrollment through the 24 month follow-up visit. Adverse event data are currently available and reported for up to 24 months. Continued Access Study - Adverse events (AEs) were collected from study enrollment through the 12 month follow-up visit. Adverse event data are currently available and reported for up to 12 months. Randomized Controlled Trial - All new or worsening AEs were collected through 24 months. After 24 months only serious and device-related events will be collected. Continued Access Study - All new or worsening AEs were collected through 12 months. Note, any AE that is entered as 0 for this portion of the study does not imply that the AE did not occur, rather it is not collected in the TVT Registry. There are no events entered in the 'Other' table as TVT-R does not distinguish seriousness.
Cardiac disorders Aortic Valve Incompetence	0.82% 6/730 • Randomized Controlled Trial - Adverse events (AEs) were collected from study enrollment through the 24 month follow-up visit. Adverse event data are currently available and reported for up to 24 months. Continued Access Study - Adverse events (AEs) were collected from study enrollment through the 12 month follow-up visit. Adverse event data are currently available and reported for up to 12 months. Randomized Controlled Trial - All new or worsening AEs were collected through 24 months. After 24 months only serious and device-related events will be collected. Continued Access Study - All new or worsening AEs were collected through 12 months. Note, any AE that is entered as 0 for this portion of the study does not imply that the AE did not occur, rather it is not collected in the TVT Registry. There are no events entered in the 'Other' table as TVT-R does not distinguish seriousness.	0.29% 2/684 • Randomized Controlled Trial - Adverse events (AEs) were collected from study enrollment through the 24 month follow-up visit. Adverse event data are currently available and reported for up to 24 months. Continued Access Study - Adverse events (AEs) were collected from study enrollment through the 12 month follow-up visit. Adverse event data are currently available and reported for up to 12 months. Randomized Controlled Trial - All new or worsening AEs were collected through 24 months. After 24 months only serious and device-related events will be collected. Continued Access Study - All new or worsening AEs were collected through 12 months. Note, any AE that is entered as 0 for this portion of the study does not imply that the AE did not occur, rather it is not collected in the TVT Registry. There are no events entered in the 'Other' table as TVT-R does not distinguish seriousness.	0.00% 0/745 • Randomized Controlled Trial - Adverse events (AEs) were collected from study enrollment through the 24 month follow-up visit. Adverse event data are currently available and reported for up to 24 months. Continued Access Study - Adverse events (AEs) were collected from study enrollment through the 12 month follow-up visit. Adverse event data are currently available and reported for up to 12 months. Randomized Controlled Trial - All new or worsening AEs were collected through 24 months. After 24 months only serious and device-related events will be collected. Continued Access Study - All new or worsening AEs were collected through 12 months. Note, any AE that is entered as 0 for this portion of the study does not imply that the AE did not occur, rather it is not collected in the TVT Registry. There are no events entered in the 'Other' table as TVT-R does not distinguish seriousness.
Cardiac disorders Aortic Valve Stenosis	0.00% 0/730 • Randomized Controlled Trial - Adverse events (AEs) were collected from study enrollment through the 24 month follow-up visit. Adverse event data are currently available and reported for up to 24 months. Continued Access Study - Adverse events (AEs) were collected from study enrollment through the 12 month follow-up visit. Adverse event data are currently available and reported for up to 12 months. Randomized Controlled Trial - All new or worsening AEs were collected through 24 months. After 24 months only serious and device-related events will be collected. Continued Access Study - All new or worsening AEs were collected through 12 months. Note, any AE that is entered as 0 for this portion of the study does not imply that the AE did not occur, rather it is not collected in the TVT Registry. There are no events entered in the 'Other' table as TVT-R does not distinguish seriousness.	0.15% 1/684 • Randomized Controlled Trial - Adverse events (AEs) were collected from study enrollment through the 24 month follow-up visit. Adverse event data are currently available and reported for up to 24 months. Continued Access Study - Adverse events (AEs) were collected from study enrollment through the 12 month follow-up visit. Adverse event data are currently available and reported for up to 12 months. Randomized Controlled Trial - All new or worsening AEs were collected through 24 months. After 24 months only serious and device-related events will be collected. Continued Access Study - All new or worsening AEs were collected through 12 months. Note, any AE that is entered as 0 for this portion of the study does not imply that the AE did not occur, rather it is not collected in the TVT Registry. There are no events entered in the 'Other' table as TVT-R does not distinguish seriousness.	0.00% 0/745 • Randomized Controlled Trial - Adverse events (AEs) were collected from study enrollment through the 24 month follow-up visit. Adverse event data are currently available and reported for up to 24 months. Continued Access Study - Adverse events (AEs) were collected from study enrollment through the 12 month follow-up visit. Adverse event data are currently available and reported for up to 12 months. Randomized Controlled Trial - All new or worsening AEs were collected through 24 months. After 24 months only serious and device-related events will be collected. Continued Access Study - All new or worsening AEs were collected through 12 months. Note, any AE that is entered as 0 for this portion of the study does not imply that the AE did not occur, rather it is not collected in the TVT Registry. There are no events entered in the 'Other' table as TVT-R does not distinguish seriousness.
Cardiac disorders Arrhythmia	0.41% 3/730 • Randomized Controlled Trial - Adverse events (AEs) were collected from study enrollment through the 24 month follow-up visit. Adverse event data are currently available and reported for up to 24 months. Continued Access Study - Adverse events (AEs) were collected from study enrollment through the 12 month follow-up visit. Adverse event data are currently available and reported for up to 12 months. Randomized Controlled Trial - All new or worsening AEs were collected through 24 months. After 24 months only serious and device-related events will be collected. Continued Access Study - All new or worsening AEs were collected through 12 months. Note, any AE that is entered as 0 for this portion of the study does not imply that the AE did not occur, rather it is not collected in the TVT Registry. There are no events entered in the 'Other' table as TVT-R does not distinguish seriousness.	0.15% 1/684 • Randomized Controlled Trial - Adverse events (AEs) were collected from study enrollment through the 24 month follow-up visit. Adverse event data are currently available and reported for up to 24 months. Continued Access Study - Adverse events (AEs) were collected from study enrollment through the 12 month follow-up visit. Adverse event data are currently available and reported for up to 12 months. Randomized Controlled Trial - All new or worsening AEs were collected through 24 months. After 24 months only serious and device-related events will be collected. Continued Access Study - All new or worsening AEs were collected through 12 months. Note, any AE that is entered as 0 for this portion of the study does not imply that the AE did not occur, rather it is not collected in the TVT Registry. There are no events entered in the 'Other' table as TVT-R does not distinguish seriousness.	0.00% 0/745 • Randomized Controlled Trial - Adverse events (AEs) were collected from study enrollment through the 24 month follow-up visit. Adverse event data are currently available and reported for up to 24 months. Continued Access Study - Adverse events (AEs) were collected from study enrollment through the 12 month follow-up visit. Adverse event data are currently available and reported for up to 12 months. Randomized Controlled Trial - All new or worsening AEs were collected through 24 months. After 24 months only serious and device-related events will be collected. Continued Access Study - All new or worsening AEs were collected through 12 months. Note, any AE that is entered as 0 for this portion of the study does not imply that the AE did not occur, rather it is not collected in the TVT Registry. There are no events entered in the 'Other' table as TVT-R does not distinguish seriousness.
Cardiac disorders Arteriospasm Coronary	0.14% 1/730 • Randomized Controlled Trial - Adverse events (AEs) were collected from study enrollment through the 24 month follow-up visit. Adverse event data are currently available and reported for up to 24 months. Continued Access Study - Adverse events (AEs) were collected from study enrollment through the 12 month follow-up visit. Adverse event data are currently available and reported for up to 12 months. Randomized Controlled Trial - All new or worsening AEs were collected through 24 months. After 24 months only serious and device-related events will be collected. Continued Access Study - All new or worsening AEs were collected through 12 months. Note, any AE that is entered as 0 for this portion of the study does not imply that the AE did not occur, rather it is not collected in the TVT Registry. There are no events entered in the 'Other' table as TVT-R does not distinguish seriousness.	0.00% 0/684 • Randomized Controlled Trial - Adverse events (AEs) were collected from study enrollment through the 24 month follow-up visit. Adverse event data are currently available and reported for up to 24 months. Continued Access Study - Adverse events (AEs) were collected from study enrollment through the 12 month follow-up visit. Adverse event data are currently available and reported for up to 12 months. Randomized Controlled Trial - All new or worsening AEs were collected through 24 months. After 24 months only serious and device-related events will be collected. Continued Access Study - All new or worsening AEs were collected through 12 months. Note, any AE that is entered as 0 for this portion of the study does not imply that the AE did not occur, rather it is not collected in the TVT Registry. There are no events entered in the 'Other' table as TVT-R does not distinguish seriousness.	0.00% 0/745 • Randomized Controlled Trial - Adverse events (AEs) were collected from study enrollment through the 24 month follow-up visit. Adverse event data are currently available and reported for up to 24 months. Continued Access Study - Adverse events (AEs) were collected from study enrollment through the 12 month follow-up visit. Adverse event data are currently available and reported for up to 12 months. Randomized Controlled Trial - All new or worsening AEs were collected through 24 months. After 24 months only serious and device-related events will be collected. Continued Access Study - All new or worsening AEs were collected through 12 months. Note, any AE that is entered as 0 for this portion of the study does not imply that the AE did not occur, rather it is not collected in the TVT Registry. There are no events entered in the 'Other' table as TVT-R does not distinguish seriousness.
Cardiac disorders Atrial Fibrillation	5.2% 38/730 • Randomized Controlled Trial - Adverse events (AEs) were collected from study enrollment through the 24 month follow-up visit. Adverse event data are currently available and reported for up to 24 months. Continued Access Study - Adverse events (AEs) were collected from study enrollment through the 12 month follow-up visit. Adverse event data are currently available and reported for up to 12 months. Randomized Controlled Trial - All new or worsening AEs were collected through 24 months. After 24 months only serious and device-related events will be collected. Continued Access Study - All new or worsening AEs were collected through 12 months. Note, any AE that is entered as 0 for this portion of the study does not imply that the AE did not occur, rather it is not collected in the TVT Registry. There are no events entered in the 'Other' table as TVT-R does not distinguish seriousness.	19.7% 135/684 • Randomized Controlled Trial - Adverse events (AEs) were collected from study enrollment through the 24 month follow-up visit. Adverse event data are currently available and reported for up to 24 months. Continued Access Study - Adverse events (AEs) were collected from study enrollment through the 12 month follow-up visit. Adverse event data are currently available and reported for up to 12 months. Randomized Controlled Trial - All new or worsening AEs were collected through 24 months. After 24 months only serious and device-related events will be collected. Continued Access Study - All new or worsening AEs were collected through 12 months. Note, any AE that is entered as 0 for this portion of the study does not imply that the AE did not occur, rather it is not collected in the TVT Registry. There are no events entered in the 'Other' table as TVT-R does not distinguish seriousness.	1.6% 12/745 • Randomized Controlled Trial - Adverse events (AEs) were collected from study enrollment through the 24 month follow-up visit. Adverse event data are currently available and reported for up to 24 months. Continued Access Study - Adverse events (AEs) were collected from study enrollment through the 12 month follow-up visit. Adverse event data are currently available and reported for up to 12 months. Randomized Controlled Trial - All new or worsening AEs were collected through 24 months. After 24 months only serious and device-related events will be collected. Continued Access Study - All new or worsening AEs were collected through 12 months. Note, any AE that is entered as 0 for this portion of the study does not imply that the AE did not occur, rather it is not collected in the TVT Registry. There are no events entered in the 'Other' table as TVT-R does not distinguish seriousness.
Cardiac disorders Atrial Flutter	0.82% 6/730 • Randomized Controlled Trial - Adverse events (AEs) were collected from study enrollment through the 24 month follow-up visit. Adverse event data are currently available and reported for up to 24 months. Continued Access Study - Adverse events (AEs) were collected from study enrollment through the 12 month follow-up visit. Adverse event data are currently available and reported for up to 12 months. Randomized Controlled Trial - All new or worsening AEs were collected through 24 months. After 24 months only serious and device-related events will be collected. Continued Access Study - All new or worsening AEs were collected through 12 months. Note, any AE that is entered as 0 for this portion of the study does not imply that the AE did not occur, rather it is not collected in the TVT Registry. There are no events entered in the 'Other' table as TVT-R does not distinguish seriousness.	2.9% 20/684 • Randomized Controlled Trial - Adverse events (AEs) were collected from study enrollment through the 24 month follow-up visit. Adverse event data are currently available and reported for up to 24 months. Continued Access Study - Adverse events (AEs) were collected from study enrollment through the 12 month follow-up visit. Adverse event data are currently available and reported for up to 12 months. Randomized Controlled Trial - All new or worsening AEs were collected through 24 months. After 24 months only serious and device-related events will be collected. Continued Access Study - All new or worsening AEs were collected through 12 months. Note, any AE that is entered as 0 for this portion of the study does not imply that the AE did not occur, rather it is not collected in the TVT Registry. There are no events entered in the 'Other' table as TVT-R does not distinguish seriousness.	0.00% 0/745 • Randomized Controlled Trial - Adverse events (AEs) were collected from study enrollment through the 24 month follow-up visit. Adverse event data are currently available and reported for up to 24 months. Continued Access Study - Adverse events (AEs) were collected from study enrollment through the 12 month follow-up visit. Adverse event data are currently available and reported for up to 12 months. Randomized Controlled Trial - All new or worsening AEs were collected through 24 months. After 24 months only serious and device-related events will be collected. Continued Access Study - All new or worsening AEs were collected through 12 months. Note, any AE that is entered as 0 for this portion of the study does not imply that the AE did not occur, rather it is not collected in the TVT Registry. There are no events entered in the 'Other' table as TVT-R does not distinguish seriousness.
Cardiac disorders Atrial Tachycardia	0.14% 1/730 • Randomized Controlled Trial - Adverse events (AEs) were collected from study enrollment through the 24 month follow-up visit. Adverse event data are currently available and reported for up to 24 months. Continued Access Study - Adverse events (AEs) were collected from study enrollment through the 12 month follow-up visit. Adverse event data are currently available and reported for up to 12 months. Randomized Controlled Trial - All new or worsening AEs were collected through 24 months. After 24 months only serious and device-related events will be collected. Continued Access Study - All new or worsening AEs were collected through 12 months. Note, any AE that is entered as 0 for this portion of the study does not imply that the AE did not occur, rather it is not collected in the TVT Registry. There are no events entered in the 'Other' table as TVT-R does not distinguish seriousness.	0.15% 1/684 • Randomized Controlled Trial - Adverse events (AEs) were collected from study enrollment through the 24 month follow-up visit. Adverse event data are currently available and reported for up to 24 months. Continued Access Study - Adverse events (AEs) were collected from study enrollment through the 12 month follow-up visit. Adverse event data are currently available and reported for up to 12 months. Randomized Controlled Trial - All new or worsening AEs were collected through 24 months. After 24 months only serious and device-related events will be collected. Continued Access Study - All new or worsening AEs were collected through 12 months. Note, any AE that is entered as 0 for this portion of the study does not imply that the AE did not occur, rather it is not collected in the TVT Registry. There are no events entered in the 'Other' table as TVT-R does not distinguish seriousness.	0.00% 0/745 • Randomized Controlled Trial - Adverse events (AEs) were collected from study enrollment through the 24 month follow-up visit. Adverse event data are currently available and reported for up to 24 months. Continued Access Study - Adverse events (AEs) were collected from study enrollment through the 12 month follow-up visit. Adverse event data are currently available and reported for up to 12 months. Randomized Controlled Trial - All new or worsening AEs were collected through 24 months. After 24 months only serious and device-related events will be collected. Continued Access Study - All new or worsening AEs were collected through 12 months. Note, any AE that is entered as 0 for this portion of the study does not imply that the AE did not occur, rather it is not collected in the TVT Registry. There are no events entered in the 'Other' table as TVT-R does not distinguish seriousness.
Cardiac disorders Atrial Thrombosis	0.00% 0/730 • Randomized Controlled Trial - Adverse events (AEs) were collected from study enrollment through the 24 month follow-up visit. Adverse event data are currently available and reported for up to 24 months. Continued Access Study - Adverse events (AEs) were collected from study enrollment through the 12 month follow-up visit. Adverse event data are currently available and reported for up to 12 months. Randomized Controlled Trial - All new or worsening AEs were collected through 24 months. After 24 months only serious and device-related events will be collected. Continued Access Study - All new or worsening AEs were collected through 12 months. Note, any AE that is entered as 0 for this portion of the study does not imply that the AE did not occur, rather it is not collected in the TVT Registry. There are no events entered in the 'Other' table as TVT-R does not distinguish seriousness.	0.29% 2/684 • Randomized Controlled Trial - Adverse events (AEs) were collected from study enrollment through the 24 month follow-up visit. Adverse event data are currently available and reported for up to 24 months. Continued Access Study - Adverse events (AEs) were collected from study enrollment through the 12 month follow-up visit. Adverse event data are currently available and reported for up to 12 months. Randomized Controlled Trial - All new or worsening AEs were collected through 24 months. After 24 months only serious and device-related events will be collected. Continued Access Study - All new or worsening AEs were collected through 12 months. Note, any AE that is entered as 0 for this portion of the study does not imply that the AE did not occur, rather it is not collected in the TVT Registry. There are no events entered in the 'Other' table as TVT-R does not distinguish seriousness.	0.00% 0/745 • Randomized Controlled Trial - Adverse events (AEs) were collected from study enrollment through the 24 month follow-up visit. Adverse event data are currently available and reported for up to 24 months. Continued Access Study - Adverse events (AEs) were collected from study enrollment through the 12 month follow-up visit. Adverse event data are currently available and reported for up to 12 months. Randomized Controlled Trial - All new or worsening AEs were collected through 24 months. After 24 months only serious and device-related events will be collected. Continued Access Study - All new or worsening AEs were collected through 12 months. Note, any AE that is entered as 0 for this portion of the study does not imply that the AE did not occur, rather it is not collected in the TVT Registry. There are no events entered in the 'Other' table as TVT-R does not distinguish seriousness.
Cardiac disorders Atrioventricular Block	0.27% 2/730 • Randomized Controlled Trial - Adverse events (AEs) were collected from study enrollment through the 24 month follow-up visit. Adverse event data are currently available and reported for up to 24 months. Continued Access Study - Adverse events (AEs) were collected from study enrollment through the 12 month follow-up visit. Adverse event data are currently available and reported for up to 12 months. Randomized Controlled Trial - All new or worsening AEs were collected through 24 months. After 24 months only serious and device-related events will be collected. Continued Access Study - All new or worsening AEs were collected through 12 months. Note, any AE that is entered as 0 for this portion of the study does not imply that the AE did not occur, rather it is not collected in the TVT Registry. There are no events entered in the 'Other' table as TVT-R does not distinguish seriousness.	0.29% 2/684 • Randomized Controlled Trial - Adverse events (AEs) were collected from study enrollment through the 24 month follow-up visit. Adverse event data are currently available and reported for up to 24 months. Continued Access Study - Adverse events (AEs) were collected from study enrollment through the 12 month follow-up visit. Adverse event data are currently available and reported for up to 12 months. Randomized Controlled Trial - All new or worsening AEs were collected through 24 months. After 24 months only serious and device-related events will be collected. Continued Access Study - All new or worsening AEs were collected through 12 months. Note, any AE that is entered as 0 for this portion of the study does not imply that the AE did not occur, rather it is not collected in the TVT Registry. There are no events entered in the 'Other' table as TVT-R does not distinguish seriousness.	0.00% 0/745 • Randomized Controlled Trial - Adverse events (AEs) were collected from study enrollment through the 24 month follow-up visit. Adverse event data are currently available and reported for up to 24 months. Continued Access Study - Adverse events (AEs) were collected from study enrollment through the 12 month follow-up visit. Adverse event data are currently available and reported for up to 12 months. Randomized Controlled Trial - All new or worsening AEs were collected through 24 months. After 24 months only serious and device-related events will be collected. Continued Access Study - All new or worsening AEs were collected through 12 months. Note, any AE that is entered as 0 for this portion of the study does not imply that the AE did not occur, rather it is not collected in the TVT Registry. There are no events entered in the 'Other' table as TVT-R does not distinguish seriousness.
Cardiac disorders Atrioventricular Block Complete	12.2% 89/730 • Randomized Controlled Trial - Adverse events (AEs) were collected from study enrollment through the 24 month follow-up visit. Adverse event data are currently available and reported for up to 24 months. Continued Access Study - Adverse events (AEs) were collected from study enrollment through the 12 month follow-up visit. Adverse event data are currently available and reported for up to 12 months. Randomized Controlled Trial - All new or worsening AEs were collected through 24 months. After 24 months only serious and device-related events will be collected. Continued Access Study - All new or worsening AEs were collected through 12 months. Note, any AE that is entered as 0 for this portion of the study does not imply that the AE did not occur, rather it is not collected in the TVT Registry. There are no events entered in the 'Other' table as TVT-R does not distinguish seriousness.	5.3% 36/684 • Randomized Controlled Trial - Adverse events (AEs) were collected from study enrollment through the 24 month follow-up visit. Adverse event data are currently available and reported for up to 24 months. Continued Access Study - Adverse events (AEs) were collected from study enrollment through the 12 month follow-up visit. Adverse event data are currently available and reported for up to 12 months. Randomized Controlled Trial - All new or worsening AEs were collected through 24 months. After 24 months only serious and device-related events will be collected. Continued Access Study - All new or worsening AEs were collected through 12 months. Note, any AE that is entered as 0 for this portion of the study does not imply that the AE did not occur, rather it is not collected in the TVT Registry. There are no events entered in the 'Other' table as TVT-R does not distinguish seriousness.	0.00% 0/745 • Randomized Controlled Trial - Adverse events (AEs) were collected from study enrollment through the 24 month follow-up visit. Adverse event data are currently available and reported for up to 24 months. Continued Access Study - Adverse events (AEs) were collected from study enrollment through the 12 month follow-up visit. Adverse event data are currently available and reported for up to 12 months. Randomized Controlled Trial - All new or worsening AEs were collected through 24 months. After 24 months only serious and device-related events will be collected. Continued Access Study - All new or worsening AEs were collected through 12 months. Note, any AE that is entered as 0 for this portion of the study does not imply that the AE did not occur, rather it is not collected in the TVT Registry. There are no events entered in the 'Other' table as TVT-R does not distinguish seriousness.
Cardiac disorders Atrioventricular Block First Degree	1.6% 12/730 • Randomized Controlled Trial - Adverse events (AEs) were collected from study enrollment through the 24 month follow-up visit. Adverse event data are currently available and reported for up to 24 months. Continued Access Study - Adverse events (AEs) were collected from study enrollment through the 12 month follow-up visit. Adverse event data are currently available and reported for up to 12 months. Randomized Controlled Trial - All new or worsening AEs were collected through 24 months. After 24 months only serious and device-related events will be collected. Continued Access Study - All new or worsening AEs were collected through 12 months. Note, any AE that is entered as 0 for this portion of the study does not imply that the AE did not occur, rather it is not collected in the TVT Registry. There are no events entered in the 'Other' table as TVT-R does not distinguish seriousness.	0.15% 1/684 • Randomized Controlled Trial - Adverse events (AEs) were collected from study enrollment through the 24 month follow-up visit. Adverse event data are currently available and reported for up to 24 months. Continued Access Study - Adverse events (AEs) were collected from study enrollment through the 12 month follow-up visit. Adverse event data are currently available and reported for up to 12 months. Randomized Controlled Trial - All new or worsening AEs were collected through 24 months. After 24 months only serious and device-related events will be collected. Continued Access Study - All new or worsening AEs were collected through 12 months. Note, any AE that is entered as 0 for this portion of the study does not imply that the AE did not occur, rather it is not collected in the TVT Registry. There are no events entered in the 'Other' table as TVT-R does not distinguish seriousness.	0.00% 0/745 • Randomized Controlled Trial - Adverse events (AEs) were collected from study enrollment through the 24 month follow-up visit. Adverse event data are currently available and reported for up to 24 months. Continued Access Study - Adverse events (AEs) were collected from study enrollment through the 12 month follow-up visit. Adverse event data are currently available and reported for up to 12 months. Randomized Controlled Trial - All new or worsening AEs were collected through 24 months. After 24 months only serious and device-related events will be collected. Continued Access Study - All new or worsening AEs were collected through 12 months. Note, any AE that is entered as 0 for this portion of the study does not imply that the AE did not occur, rather it is not collected in the TVT Registry. There are no events entered in the 'Other' table as TVT-R does not distinguish seriousness.
Cardiac disorders Atrioventricular Block Second Degree	1.8% 13/730 • Randomized Controlled Trial - Adverse events (AEs) were collected from study enrollment through the 24 month follow-up visit. Adverse event data are currently available and reported for up to 24 months. Continued Access Study - Adverse events (AEs) were collected from study enrollment through the 12 month follow-up visit. Adverse event data are currently available and reported for up to 12 months. Randomized Controlled Trial - All new or worsening AEs were collected through 24 months. After 24 months only serious and device-related events will be collected. Continued Access Study - All new or worsening AEs were collected through 12 months. Note, any AE that is entered as 0 for this portion of the study does not imply that the AE did not occur, rather it is not collected in the TVT Registry. There are no events entered in the 'Other' table as TVT-R does not distinguish seriousness.	0.73% 5/684 • Randomized Controlled Trial - Adverse events (AEs) were collected from study enrollment through the 24 month follow-up visit. Adverse event data are currently available and reported for up to 24 months. Continued Access Study - Adverse events (AEs) were collected from study enrollment through the 12 month follow-up visit. Adverse event data are currently available and reported for up to 12 months. Randomized Controlled Trial - All new or worsening AEs were collected through 24 months. After 24 months only serious and device-related events will be collected. Continued Access Study - All new or worsening AEs were collected through 12 months. Note, any AE that is entered as 0 for this portion of the study does not imply that the AE did not occur, rather it is not collected in the TVT Registry. There are no events entered in the 'Other' table as TVT-R does not distinguish seriousness.	0.00% 0/745 • Randomized Controlled Trial - Adverse events (AEs) were collected from study enrollment through the 24 month follow-up visit. Adverse event data are currently available and reported for up to 24 months. Continued Access Study - Adverse events (AEs) were collected from study enrollment through the 12 month follow-up visit. Adverse event data are currently available and reported for up to 12 months. Randomized Controlled Trial - All new or worsening AEs were collected through 24 months. After 24 months only serious and device-related events will be collected. Continued Access Study - All new or worsening AEs were collected through 12 months. Note, any AE that is entered as 0 for this portion of the study does not imply that the AE did not occur, rather it is not collected in the TVT Registry. There are no events entered in the 'Other' table as TVT-R does not distinguish seriousness.
Cardiac disorders Atrioventricular Dissociation	0.14% 1/730 • Randomized Controlled Trial - Adverse events (AEs) were collected from study enrollment through the 24 month follow-up visit. Adverse event data are currently available and reported for up to 24 months. Continued Access Study - Adverse events (AEs) were collected from study enrollment through the 12 month follow-up visit. Adverse event data are currently available and reported for up to 12 months. Randomized Controlled Trial - All new or worsening AEs were collected through 24 months. After 24 months only serious and device-related events will be collected. Continued Access Study - All new or worsening AEs were collected through 12 months. Note, any AE that is entered as 0 for this portion of the study does not imply that the AE did not occur, rather it is not collected in the TVT Registry. There are no events entered in the 'Other' table as TVT-R does not distinguish seriousness.	0.00% 0/684 • Randomized Controlled Trial - Adverse events (AEs) were collected from study enrollment through the 24 month follow-up visit. Adverse event data are currently available and reported for up to 24 months. Continued Access Study - Adverse events (AEs) were collected from study enrollment through the 12 month follow-up visit. Adverse event data are currently available and reported for up to 12 months. Randomized Controlled Trial - All new or worsening AEs were collected through 24 months. After 24 months only serious and device-related events will be collected. Continued Access Study - All new or worsening AEs were collected through 12 months. Note, any AE that is entered as 0 for this portion of the study does not imply that the AE did not occur, rather it is not collected in the TVT Registry. There are no events entered in the 'Other' table as TVT-R does not distinguish seriousness.	0.00% 0/745 • Randomized Controlled Trial - Adverse events (AEs) were collected from study enrollment through the 24 month follow-up visit. Adverse event data are currently available and reported for up to 24 months. Continued Access Study - Adverse events (AEs) were collected from study enrollment through the 12 month follow-up visit. Adverse event data are currently available and reported for up to 12 months. Randomized Controlled Trial - All new or worsening AEs were collected through 24 months. After 24 months only serious and device-related events will be collected. Continued Access Study - All new or worsening AEs were collected through 12 months. Note, any AE that is entered as 0 for this portion of the study does not imply that the AE did not occur, rather it is not collected in the TVT Registry. There are no events entered in the 'Other' table as TVT-R does not distinguish seriousness.
Cardiac disorders Bradycardia	1.2% 9/730 • Randomized Controlled Trial - Adverse events (AEs) were collected from study enrollment through the 24 month follow-up visit. Adverse event data are currently available and reported for up to 24 months. Continued Access Study - Adverse events (AEs) were collected from study enrollment through the 12 month follow-up visit. Adverse event data are currently available and reported for up to 12 months. Randomized Controlled Trial - All new or worsening AEs were collected through 24 months. After 24 months only serious and device-related events will be collected. Continued Access Study - All new or worsening AEs were collected through 12 months. Note, any AE that is entered as 0 for this portion of the study does not imply that the AE did not occur, rather it is not collected in the TVT Registry. There are no events entered in the 'Other' table as TVT-R does not distinguish seriousness.	0.73% 5/684 • Randomized Controlled Trial - Adverse events (AEs) were collected from study enrollment through the 24 month follow-up visit. Adverse event data are currently available and reported for up to 24 months. Continued Access Study - Adverse events (AEs) were collected from study enrollment through the 12 month follow-up visit. Adverse event data are currently available and reported for up to 12 months. Randomized Controlled Trial - All new or worsening AEs were collected through 24 months. After 24 months only serious and device-related events will be collected. Continued Access Study - All new or worsening AEs were collected through 12 months. Note, any AE that is entered as 0 for this portion of the study does not imply that the AE did not occur, rather it is not collected in the TVT Registry. There are no events entered in the 'Other' table as TVT-R does not distinguish seriousness.	0.00% 0/745 • Randomized Controlled Trial - Adverse events (AEs) were collected from study enrollment through the 24 month follow-up visit. Adverse event data are currently available and reported for up to 24 months. Continued Access Study - Adverse events (AEs) were collected from study enrollment through the 12 month follow-up visit. Adverse event data are currently available and reported for up to 12 months. Randomized Controlled Trial - All new or worsening AEs were collected through 24 months. After 24 months only serious and device-related events will be collected. Continued Access Study - All new or worsening AEs were collected through 12 months. Note, any AE that is entered as 0 for this portion of the study does not imply that the AE did not occur, rather it is not collected in the TVT Registry. There are no events entered in the 'Other' table as TVT-R does not distinguish seriousness.
Cardiac disorders Bundle Branch Block Left	4.0% 29/730 • Randomized Controlled Trial - Adverse events (AEs) were collected from study enrollment through the 24 month follow-up visit. Adverse event data are currently available and reported for up to 24 months. Continued Access Study - Adverse events (AEs) were collected from study enrollment through the 12 month follow-up visit. Adverse event data are currently available and reported for up to 12 months. Randomized Controlled Trial - All new or worsening AEs were collected through 24 months. After 24 months only serious and device-related events will be collected. Continued Access Study - All new or worsening AEs were collected through 12 months. Note, any AE that is entered as 0 for this portion of the study does not imply that the AE did not occur, rather it is not collected in the TVT Registry. There are no events entered in the 'Other' table as TVT-R does not distinguish seriousness.	0.44% 3/684 • Randomized Controlled Trial - Adverse events (AEs) were collected from study enrollment through the 24 month follow-up visit. Adverse event data are currently available and reported for up to 24 months. Continued Access Study - Adverse events (AEs) were collected from study enrollment through the 12 month follow-up visit. Adverse event data are currently available and reported for up to 12 months. Randomized Controlled Trial - All new or worsening AEs were collected through 24 months. After 24 months only serious and device-related events will be collected. Continued Access Study - All new or worsening AEs were collected through 12 months. Note, any AE that is entered as 0 for this portion of the study does not imply that the AE did not occur, rather it is not collected in the TVT Registry. There are no events entered in the 'Other' table as TVT-R does not distinguish seriousness.	0.00% 0/745 • Randomized Controlled Trial - Adverse events (AEs) were collected from study enrollment through the 24 month follow-up visit. Adverse event data are currently available and reported for up to 24 months. Continued Access Study - Adverse events (AEs) were collected from study enrollment through the 12 month follow-up visit. Adverse event data are currently available and reported for up to 12 months. Randomized Controlled Trial - All new or worsening AEs were collected through 24 months. After 24 months only serious and device-related events will be collected. Continued Access Study - All new or worsening AEs were collected through 12 months. Note, any AE that is entered as 0 for this portion of the study does not imply that the AE did not occur, rather it is not collected in the TVT Registry. There are no events entered in the 'Other' table as TVT-R does not distinguish seriousness.
Cardiac disorders Bundle Branch Block Right	0.41% 3/730 • Randomized Controlled Trial - Adverse events (AEs) were collected from study enrollment through the 24 month follow-up visit. Adverse event data are currently available and reported for up to 24 months. Continued Access Study - Adverse events (AEs) were collected from study enrollment through the 12 month follow-up visit. Adverse event data are currently available and reported for up to 12 months. Randomized Controlled Trial - All new or worsening AEs were collected through 24 months. After 24 months only serious and device-related events will be collected. Continued Access Study - All new or worsening AEs were collected through 12 months. Note, any AE that is entered as 0 for this portion of the study does not imply that the AE did not occur, rather it is not collected in the TVT Registry. There are no events entered in the 'Other' table as TVT-R does not distinguish seriousness.	0.15% 1/684 • Randomized Controlled Trial - Adverse events (AEs) were collected from study enrollment through the 24 month follow-up visit. Adverse event data are currently available and reported for up to 24 months. Continued Access Study - Adverse events (AEs) were collected from study enrollment through the 12 month follow-up visit. Adverse event data are currently available and reported for up to 12 months. Randomized Controlled Trial - All new or worsening AEs were collected through 24 months. After 24 months only serious and device-related events will be collected. Continued Access Study - All new or worsening AEs were collected through 12 months. Note, any AE that is entered as 0 for this portion of the study does not imply that the AE did not occur, rather it is not collected in the TVT Registry. There are no events entered in the 'Other' table as TVT-R does not distinguish seriousness.	0.00% 0/745 • Randomized Controlled Trial - Adverse events (AEs) were collected from study enrollment through the 24 month follow-up visit. Adverse event data are currently available and reported for up to 24 months. Continued Access Study - Adverse events (AEs) were collected from study enrollment through the 12 month follow-up visit. Adverse event data are currently available and reported for up to 12 months. Randomized Controlled Trial - All new or worsening AEs were collected through 24 months. After 24 months only serious and device-related events will be collected. Continued Access Study - All new or worsening AEs were collected through 12 months. Note, any AE that is entered as 0 for this portion of the study does not imply that the AE did not occur, rather it is not collected in the TVT Registry. There are no events entered in the 'Other' table as TVT-R does not distinguish seriousness.
Cardiac disorders Cardiac Amyloidosis	0.14% 1/730 • Randomized Controlled Trial - Adverse events (AEs) were collected from study enrollment through the 24 month follow-up visit. Adverse event data are currently available and reported for up to 24 months. Continued Access Study - Adverse events (AEs) were collected from study enrollment through the 12 month follow-up visit. Adverse event data are currently available and reported for up to 12 months. Randomized Controlled Trial - All new or worsening AEs were collected through 24 months. After 24 months only serious and device-related events will be collected. Continued Access Study - All new or worsening AEs were collected through 12 months. Note, any AE that is entered as 0 for this portion of the study does not imply that the AE did not occur, rather it is not collected in the TVT Registry. There are no events entered in the 'Other' table as TVT-R does not distinguish seriousness.	0.00% 0/684 • Randomized Controlled Trial - Adverse events (AEs) were collected from study enrollment through the 24 month follow-up visit. Adverse event data are currently available and reported for up to 24 months. Continued Access Study - Adverse events (AEs) were collected from study enrollment through the 12 month follow-up visit. Adverse event data are currently available and reported for up to 12 months. Randomized Controlled Trial - All new or worsening AEs were collected through 24 months. After 24 months only serious and device-related events will be collected. Continued Access Study - All new or worsening AEs were collected through 12 months. Note, any AE that is entered as 0 for this portion of the study does not imply that the AE did not occur, rather it is not collected in the TVT Registry. There are no events entered in the 'Other' table as TVT-R does not distinguish seriousness.	0.00% 0/745 • Randomized Controlled Trial - Adverse events (AEs) were collected from study enrollment through the 24 month follow-up visit. Adverse event data are currently available and reported for up to 24 months. Continued Access Study - Adverse events (AEs) were collected from study enrollment through the 12 month follow-up visit. Adverse event data are currently available and reported for up to 12 months. Randomized Controlled Trial - All new or worsening AEs were collected through 24 months. After 24 months only serious and device-related events will be collected. Continued Access Study - All new or worsening AEs were collected through 12 months. Note, any AE that is entered as 0 for this portion of the study does not imply that the AE did not occur, rather it is not collected in the TVT Registry. There are no events entered in the 'Other' table as TVT-R does not distinguish seriousness.
Cardiac disorders Cardiac Arrest	1.5% 11/730 • Randomized Controlled Trial - Adverse events (AEs) were collected from study enrollment through the 24 month follow-up visit. Adverse event data are currently available and reported for up to 24 months. Continued Access Study - Adverse events (AEs) were collected from study enrollment through the 12 month follow-up visit. Adverse event data are currently available and reported for up to 12 months. Randomized Controlled Trial - All new or worsening AEs were collected through 24 months. After 24 months only serious and device-related events will be collected. Continued Access Study - All new or worsening AEs were collected through 12 months. Note, any AE that is entered as 0 for this portion of the study does not imply that the AE did not occur, rather it is not collected in the TVT Registry. There are no events entered in the 'Other' table as TVT-R does not distinguish seriousness.	1.6% 11/684 • Randomized Controlled Trial - Adverse events (AEs) were collected from study enrollment through the 24 month follow-up visit. Adverse event data are currently available and reported for up to 24 months. Continued Access Study - Adverse events (AEs) were collected from study enrollment through the 12 month follow-up visit. Adverse event data are currently available and reported for up to 12 months. Randomized Controlled Trial - All new or worsening AEs were collected through 24 months. After 24 months only serious and device-related events will be collected. Continued Access Study - All new or worsening AEs were collected through 12 months. Note, any AE that is entered as 0 for this portion of the study does not imply that the AE did not occur, rather it is not collected in the TVT Registry. There are no events entered in the 'Other' table as TVT-R does not distinguish seriousness.	0.94% 7/745 • Randomized Controlled Trial - Adverse events (AEs) were collected from study enrollment through the 24 month follow-up visit. Adverse event data are currently available and reported for up to 24 months. Continued Access Study - Adverse events (AEs) were collected from study enrollment through the 12 month follow-up visit. Adverse event data are currently available and reported for up to 12 months. Randomized Controlled Trial - All new or worsening AEs were collected through 24 months. After 24 months only serious and device-related events will be collected. Continued Access Study - All new or worsening AEs were collected through 12 months. Note, any AE that is entered as 0 for this portion of the study does not imply that the AE did not occur, rather it is not collected in the TVT Registry. There are no events entered in the 'Other' table as TVT-R does not distinguish seriousness.
Cardiac disorders Cardiac Failure	0.55% 4/730 • Randomized Controlled Trial - Adverse events (AEs) were collected from study enrollment through the 24 month follow-up visit. Adverse event data are currently available and reported for up to 24 months. Continued Access Study - Adverse events (AEs) were collected from study enrollment through the 12 month follow-up visit. Adverse event data are currently available and reported for up to 12 months. Randomized Controlled Trial - All new or worsening AEs were collected through 24 months. After 24 months only serious and device-related events will be collected. Continued Access Study - All new or worsening AEs were collected through 12 months. Note, any AE that is entered as 0 for this portion of the study does not imply that the AE did not occur, rather it is not collected in the TVT Registry. There are no events entered in the 'Other' table as TVT-R does not distinguish seriousness.	0.73% 5/684 • Randomized Controlled Trial - Adverse events (AEs) were collected from study enrollment through the 24 month follow-up visit. Adverse event data are currently available and reported for up to 24 months. Continued Access Study - Adverse events (AEs) were collected from study enrollment through the 12 month follow-up visit. Adverse event data are currently available and reported for up to 12 months. Randomized Controlled Trial - All new or worsening AEs were collected through 24 months. After 24 months only serious and device-related events will be collected. Continued Access Study - All new or worsening AEs were collected through 12 months. Note, any AE that is entered as 0 for this portion of the study does not imply that the AE did not occur, rather it is not collected in the TVT Registry. There are no events entered in the 'Other' table as TVT-R does not distinguish seriousness.	0.00% 0/745 • Randomized Controlled Trial - Adverse events (AEs) were collected from study enrollment through the 24 month follow-up visit. Adverse event data are currently available and reported for up to 24 months. Continued Access Study - Adverse events (AEs) were collected from study enrollment through the 12 month follow-up visit. Adverse event data are currently available and reported for up to 12 months. Randomized Controlled Trial - All new or worsening AEs were collected through 24 months. After 24 months only serious and device-related events will be collected. Continued Access Study - All new or worsening AEs were collected through 12 months. Note, any AE that is entered as 0 for this portion of the study does not imply that the AE did not occur, rather it is not collected in the TVT Registry. There are no events entered in the 'Other' table as TVT-R does not distinguish seriousness.
Cardiac disorders Cardiac Failure Acute	0.41% 3/730 • Randomized Controlled Trial - Adverse events (AEs) were collected from study enrollment through the 24 month follow-up visit. Adverse event data are currently available and reported for up to 24 months. Continued Access Study - Adverse events (AEs) were collected from study enrollment through the 12 month follow-up visit. Adverse event data are currently available and reported for up to 12 months. Randomized Controlled Trial - All new or worsening AEs were collected through 24 months. After 24 months only serious and device-related events will be collected. Continued Access Study - All new or worsening AEs were collected through 12 months. Note, any AE that is entered as 0 for this portion of the study does not imply that the AE did not occur, rather it is not collected in the TVT Registry. There are no events entered in the 'Other' table as TVT-R does not distinguish seriousness.	0.29% 2/684 • Randomized Controlled Trial - Adverse events (AEs) were collected from study enrollment through the 24 month follow-up visit. Adverse event data are currently available and reported for up to 24 months. Continued Access Study - Adverse events (AEs) were collected from study enrollment through the 12 month follow-up visit. Adverse event data are currently available and reported for up to 12 months. Randomized Controlled Trial - All new or worsening AEs were collected through 24 months. After 24 months only serious and device-related events will be collected. Continued Access Study - All new or worsening AEs were collected through 12 months. Note, any AE that is entered as 0 for this portion of the study does not imply that the AE did not occur, rather it is not collected in the TVT Registry. There are no events entered in the 'Other' table as TVT-R does not distinguish seriousness.	0.00% 0/745 • Randomized Controlled Trial - Adverse events (AEs) were collected from study enrollment through the 24 month follow-up visit. Adverse event data are currently available and reported for up to 24 months. Continued Access Study - Adverse events (AEs) were collected from study enrollment through the 12 month follow-up visit. Adverse event data are currently available and reported for up to 12 months. Randomized Controlled Trial - All new or worsening AEs were collected through 24 months. After 24 months only serious and device-related events will be collected. Continued Access Study - All new or worsening AEs were collected through 12 months. Note, any AE that is entered as 0 for this portion of the study does not imply that the AE did not occur, rather it is not collected in the TVT Registry. There are no events entered in the 'Other' table as TVT-R does not distinguish seriousness.
Cardiac disorders Cardiac Failure Chronic	0.00% 0/730 • Randomized Controlled Trial - Adverse events (AEs) were collected from study enrollment through the 24 month follow-up visit. Adverse event data are currently available and reported for up to 24 months. Continued Access Study - Adverse events (AEs) were collected from study enrollment through the 12 month follow-up visit. Adverse event data are currently available and reported for up to 12 months. Randomized Controlled Trial - All new or worsening AEs were collected through 24 months. After 24 months only serious and device-related events will be collected. Continued Access Study - All new or worsening AEs were collected through 12 months. Note, any AE that is entered as 0 for this portion of the study does not imply that the AE did not occur, rather it is not collected in the TVT Registry. There are no events entered in the 'Other' table as TVT-R does not distinguish seriousness.	0.15% 1/684 • Randomized Controlled Trial - Adverse events (AEs) were collected from study enrollment through the 24 month follow-up visit. Adverse event data are currently available and reported for up to 24 months. Continued Access Study - Adverse events (AEs) were collected from study enrollment through the 12 month follow-up visit. Adverse event data are currently available and reported for up to 12 months. Randomized Controlled Trial - All new or worsening AEs were collected through 24 months. After 24 months only serious and device-related events will be collected. Continued Access Study - All new or worsening AEs were collected through 12 months. Note, any AE that is entered as 0 for this portion of the study does not imply that the AE did not occur, rather it is not collected in the TVT Registry. There are no events entered in the 'Other' table as TVT-R does not distinguish seriousness.	0.00% 0/745 • Randomized Controlled Trial - Adverse events (AEs) were collected from study enrollment through the 24 month follow-up visit. Adverse event data are currently available and reported for up to 24 months. Continued Access Study - Adverse events (AEs) were collected from study enrollment through the 12 month follow-up visit. Adverse event data are currently available and reported for up to 12 months. Randomized Controlled Trial - All new or worsening AEs were collected through 24 months. After 24 months only serious and device-related events will be collected. Continued Access Study - All new or worsening AEs were collected through 12 months. Note, any AE that is entered as 0 for this portion of the study does not imply that the AE did not occur, rather it is not collected in the TVT Registry. There are no events entered in the 'Other' table as TVT-R does not distinguish seriousness.
Cardiac disorders Cardiac Failure Congestive	2.2% 16/730 • Randomized Controlled Trial - Adverse events (AEs) were collected from study enrollment through the 24 month follow-up visit. Adverse event data are currently available and reported for up to 24 months. Continued Access Study - Adverse events (AEs) were collected from study enrollment through the 12 month follow-up visit. Adverse event data are currently available and reported for up to 12 months. Randomized Controlled Trial - All new or worsening AEs were collected through 24 months. After 24 months only serious and device-related events will be collected. Continued Access Study - All new or worsening AEs were collected through 12 months. Note, any AE that is entered as 0 for this portion of the study does not imply that the AE did not occur, rather it is not collected in the TVT Registry. There are no events entered in the 'Other' table as TVT-R does not distinguish seriousness.	3.5% 24/684 • Randomized Controlled Trial - Adverse events (AEs) were collected from study enrollment through the 24 month follow-up visit. Adverse event data are currently available and reported for up to 24 months. Continued Access Study - Adverse events (AEs) were collected from study enrollment through the 12 month follow-up visit. Adverse event data are currently available and reported for up to 12 months. Randomized Controlled Trial - All new or worsening AEs were collected through 24 months. After 24 months only serious and device-related events will be collected. Continued Access Study - All new or worsening AEs were collected through 12 months. Note, any AE that is entered as 0 for this portion of the study does not imply that the AE did not occur, rather it is not collected in the TVT Registry. There are no events entered in the 'Other' table as TVT-R does not distinguish seriousness.	0.00% 0/745 • Randomized Controlled Trial - Adverse events (AEs) were collected from study enrollment through the 24 month follow-up visit. Adverse event data are currently available and reported for up to 24 months. Continued Access Study - Adverse events (AEs) were collected from study enrollment through the 12 month follow-up visit. Adverse event data are currently available and reported for up to 12 months. Randomized Controlled Trial - All new or worsening AEs were collected through 24 months. After 24 months only serious and device-related events will be collected. Continued Access Study - All new or worsening AEs were collected through 12 months. Note, any AE that is entered as 0 for this portion of the study does not imply that the AE did not occur, rather it is not collected in the TVT Registry. There are no events entered in the 'Other' table as TVT-R does not distinguish seriousness.
Cardiac disorders Cardiac Tamponade	0.14% 1/730 • Randomized Controlled Trial - Adverse events (AEs) were collected from study enrollment through the 24 month follow-up visit. Adverse event data are currently available and reported for up to 24 months. Continued Access Study - Adverse events (AEs) were collected from study enrollment through the 12 month follow-up visit. Adverse event data are currently available and reported for up to 12 months. Randomized Controlled Trial - All new or worsening AEs were collected through 24 months. After 24 months only serious and device-related events will be collected. Continued Access Study - All new or worsening AEs were collected through 12 months. Note, any AE that is entered as 0 for this portion of the study does not imply that the AE did not occur, rather it is not collected in the TVT Registry. There are no events entered in the 'Other' table as TVT-R does not distinguish seriousness.	0.44% 3/684 • Randomized Controlled Trial - Adverse events (AEs) were collected from study enrollment through the 24 month follow-up visit. Adverse event data are currently available and reported for up to 24 months. Continued Access Study - Adverse events (AEs) were collected from study enrollment through the 12 month follow-up visit. Adverse event data are currently available and reported for up to 12 months. Randomized Controlled Trial - All new or worsening AEs were collected through 24 months. After 24 months only serious and device-related events will be collected. Continued Access Study - All new or worsening AEs were collected through 12 months. Note, any AE that is entered as 0 for this portion of the study does not imply that the AE did not occur, rather it is not collected in the TVT Registry. There are no events entered in the 'Other' table as TVT-R does not distinguish seriousness.	0.00% 0/745 • Randomized Controlled Trial - Adverse events (AEs) were collected from study enrollment through the 24 month follow-up visit. Adverse event data are currently available and reported for up to 24 months. Continued Access Study - Adverse events (AEs) were collected from study enrollment through the 12 month follow-up visit. Adverse event data are currently available and reported for up to 12 months. Randomized Controlled Trial - All new or worsening AEs were collected through 24 months. After 24 months only serious and device-related events will be collected. Continued Access Study - All new or worsening AEs were collected through 12 months. Note, any AE that is entered as 0 for this portion of the study does not imply that the AE did not occur, rather it is not collected in the TVT Registry. There are no events entered in the 'Other' table as TVT-R does not distinguish seriousness.
Cardiac disorders Cardio-Respiratory Arrest	0.27% 2/730 • Randomized Controlled Trial - Adverse events (AEs) were collected from study enrollment through the 24 month follow-up visit. Adverse event data are currently available and reported for up to 24 months. Continued Access Study - Adverse events (AEs) were collected from study enrollment through the 12 month follow-up visit. Adverse event data are currently available and reported for up to 12 months. Randomized Controlled Trial - All new or worsening AEs were collected through 24 months. After 24 months only serious and device-related events will be collected. Continued Access Study - All new or worsening AEs were collected through 12 months. Note, any AE that is entered as 0 for this portion of the study does not imply that the AE did not occur, rather it is not collected in the TVT Registry. There are no events entered in the 'Other' table as TVT-R does not distinguish seriousness.	0.29% 2/684 • Randomized Controlled Trial - Adverse events (AEs) were collected from study enrollment through the 24 month follow-up visit. Adverse event data are currently available and reported for up to 24 months. Continued Access Study - Adverse events (AEs) were collected from study enrollment through the 12 month follow-up visit. Adverse event data are currently available and reported for up to 12 months. Randomized Controlled Trial - All new or worsening AEs were collected through 24 months. After 24 months only serious and device-related events will be collected. Continued Access Study - All new or worsening AEs were collected through 12 months. Note, any AE that is entered as 0 for this portion of the study does not imply that the AE did not occur, rather it is not collected in the TVT Registry. There are no events entered in the 'Other' table as TVT-R does not distinguish seriousness.	0.00% 0/745 • Randomized Controlled Trial - Adverse events (AEs) were collected from study enrollment through the 24 month follow-up visit. Adverse event data are currently available and reported for up to 24 months. Continued Access Study - Adverse events (AEs) were collected from study enrollment through the 12 month follow-up visit. Adverse event data are currently available and reported for up to 12 months. Randomized Controlled Trial - All new or worsening AEs were collected through 24 months. After 24 months only serious and device-related events will be collected. Continued Access Study - All new or worsening AEs were collected through 12 months. Note, any AE that is entered as 0 for this portion of the study does not imply that the AE did not occur, rather it is not collected in the TVT Registry. There are no events entered in the 'Other' table as TVT-R does not distinguish seriousness.

Other adverse events
Measure	Randomized Controlled Trial - Medtronic TAVR Systems n=730 participants at risk Treatment with Medtronic CoreValve, Evolut R, and Evolut PRO systems in the Randomized Controlled Trial	Randomized Controlled Trial - SAVR n=684 participants at risk Surgical Aortic Valve Replacement (SAVR) in the Randomized Controlled Trial	Continued Access Study - Medtronic TAVR Systems n=745 participants at risk Treatment with Medtronic Evolut R and Evolut PRO systems in the Continued Access Study
Blood and lymphatic system disorders Anaemia	6.8% 50/730 • Randomized Controlled Trial - Adverse events (AEs) were collected from study enrollment through the 24 month follow-up visit. Adverse event data are currently available and reported for up to 24 months. Continued Access Study - Adverse events (AEs) were collected from study enrollment through the 12 month follow-up visit. Adverse event data are currently available and reported for up to 12 months. Randomized Controlled Trial - All new or worsening AEs were collected through 24 months. After 24 months only serious and device-related events will be collected. Continued Access Study - All new or worsening AEs were collected through 12 months. Note, any AE that is entered as 0 for this portion of the study does not imply that the AE did not occur, rather it is not collected in the TVT Registry. There are no events entered in the 'Other' table as TVT-R does not distinguish seriousness.	21.2% 145/684 • Randomized Controlled Trial - Adverse events (AEs) were collected from study enrollment through the 24 month follow-up visit. Adverse event data are currently available and reported for up to 24 months. Continued Access Study - Adverse events (AEs) were collected from study enrollment through the 12 month follow-up visit. Adverse event data are currently available and reported for up to 12 months. Randomized Controlled Trial - All new or worsening AEs were collected through 24 months. After 24 months only serious and device-related events will be collected. Continued Access Study - All new or worsening AEs were collected through 12 months. Note, any AE that is entered as 0 for this portion of the study does not imply that the AE did not occur, rather it is not collected in the TVT Registry. There are no events entered in the 'Other' table as TVT-R does not distinguish seriousness.	0.00% 0/745 • Randomized Controlled Trial - Adverse events (AEs) were collected from study enrollment through the 24 month follow-up visit. Adverse event data are currently available and reported for up to 24 months. Continued Access Study - Adverse events (AEs) were collected from study enrollment through the 12 month follow-up visit. Adverse event data are currently available and reported for up to 12 months. Randomized Controlled Trial - All new or worsening AEs were collected through 24 months. After 24 months only serious and device-related events will be collected. Continued Access Study - All new or worsening AEs were collected through 12 months. Note, any AE that is entered as 0 for this portion of the study does not imply that the AE did not occur, rather it is not collected in the TVT Registry. There are no events entered in the 'Other' table as TVT-R does not distinguish seriousness.
Blood and lymphatic system disorders Blood Loss Anaemia	0.00% 0/730 • Randomized Controlled Trial - Adverse events (AEs) were collected from study enrollment through the 24 month follow-up visit. Adverse event data are currently available and reported for up to 24 months. Continued Access Study - Adverse events (AEs) were collected from study enrollment through the 12 month follow-up visit. Adverse event data are currently available and reported for up to 12 months. Randomized Controlled Trial - All new or worsening AEs were collected through 24 months. After 24 months only serious and device-related events will be collected. Continued Access Study - All new or worsening AEs were collected through 12 months. Note, any AE that is entered as 0 for this portion of the study does not imply that the AE did not occur, rather it is not collected in the TVT Registry. There are no events entered in the 'Other' table as TVT-R does not distinguish seriousness.	5.8% 40/684 • Randomized Controlled Trial - Adverse events (AEs) were collected from study enrollment through the 24 month follow-up visit. Adverse event data are currently available and reported for up to 24 months. Continued Access Study - Adverse events (AEs) were collected from study enrollment through the 12 month follow-up visit. Adverse event data are currently available and reported for up to 12 months. Randomized Controlled Trial - All new or worsening AEs were collected through 24 months. After 24 months only serious and device-related events will be collected. Continued Access Study - All new or worsening AEs were collected through 12 months. Note, any AE that is entered as 0 for this portion of the study does not imply that the AE did not occur, rather it is not collected in the TVT Registry. There are no events entered in the 'Other' table as TVT-R does not distinguish seriousness.	0.00% 0/745 • Randomized Controlled Trial - Adverse events (AEs) were collected from study enrollment through the 24 month follow-up visit. Adverse event data are currently available and reported for up to 24 months. Continued Access Study - Adverse events (AEs) were collected from study enrollment through the 12 month follow-up visit. Adverse event data are currently available and reported for up to 12 months. Randomized Controlled Trial - All new or worsening AEs were collected through 24 months. After 24 months only serious and device-related events will be collected. Continued Access Study - All new or worsening AEs were collected through 12 months. Note, any AE that is entered as 0 for this portion of the study does not imply that the AE did not occur, rather it is not collected in the TVT Registry. There are no events entered in the 'Other' table as TVT-R does not distinguish seriousness.
Blood and lymphatic system disorders Leukocytosis	7.8% 57/730 • Randomized Controlled Trial - Adverse events (AEs) were collected from study enrollment through the 24 month follow-up visit. Adverse event data are currently available and reported for up to 24 months. Continued Access Study - Adverse events (AEs) were collected from study enrollment through the 12 month follow-up visit. Adverse event data are currently available and reported for up to 12 months. Randomized Controlled Trial - All new or worsening AEs were collected through 24 months. After 24 months only serious and device-related events will be collected. Continued Access Study - All new or worsening AEs were collected through 12 months. Note, any AE that is entered as 0 for this portion of the study does not imply that the AE did not occur, rather it is not collected in the TVT Registry. There are no events entered in the 'Other' table as TVT-R does not distinguish seriousness.	23.8% 163/684 • Randomized Controlled Trial - Adverse events (AEs) were collected from study enrollment through the 24 month follow-up visit. Adverse event data are currently available and reported for up to 24 months. Continued Access Study - Adverse events (AEs) were collected from study enrollment through the 12 month follow-up visit. Adverse event data are currently available and reported for up to 12 months. Randomized Controlled Trial - All new or worsening AEs were collected through 24 months. After 24 months only serious and device-related events will be collected. Continued Access Study - All new or worsening AEs were collected through 12 months. Note, any AE that is entered as 0 for this portion of the study does not imply that the AE did not occur, rather it is not collected in the TVT Registry. There are no events entered in the 'Other' table as TVT-R does not distinguish seriousness.	0.00% 0/745 • Randomized Controlled Trial - Adverse events (AEs) were collected from study enrollment through the 24 month follow-up visit. Adverse event data are currently available and reported for up to 24 months. Continued Access Study - Adverse events (AEs) were collected from study enrollment through the 12 month follow-up visit. Adverse event data are currently available and reported for up to 12 months. Randomized Controlled Trial - All new or worsening AEs were collected through 24 months. After 24 months only serious and device-related events will be collected. Continued Access Study - All new or worsening AEs were collected through 12 months. Note, any AE that is entered as 0 for this portion of the study does not imply that the AE did not occur, rather it is not collected in the TVT Registry. There are no events entered in the 'Other' table as TVT-R does not distinguish seriousness.
Blood and lymphatic system disorders Thrombocytopenia	7.7% 56/730 • Randomized Controlled Trial - Adverse events (AEs) were collected from study enrollment through the 24 month follow-up visit. Adverse event data are currently available and reported for up to 24 months. Continued Access Study - Adverse events (AEs) were collected from study enrollment through the 12 month follow-up visit. Adverse event data are currently available and reported for up to 12 months. Randomized Controlled Trial - All new or worsening AEs were collected through 24 months. After 24 months only serious and device-related events will be collected. Continued Access Study - All new or worsening AEs were collected through 12 months. Note, any AE that is entered as 0 for this portion of the study does not imply that the AE did not occur, rather it is not collected in the TVT Registry. There are no events entered in the 'Other' table as TVT-R does not distinguish seriousness.	28.7% 196/684 • Randomized Controlled Trial - Adverse events (AEs) were collected from study enrollment through the 24 month follow-up visit. Adverse event data are currently available and reported for up to 24 months. Continued Access Study - Adverse events (AEs) were collected from study enrollment through the 12 month follow-up visit. Adverse event data are currently available and reported for up to 12 months. Randomized Controlled Trial - All new or worsening AEs were collected through 24 months. After 24 months only serious and device-related events will be collected. Continued Access Study - All new or worsening AEs were collected through 12 months. Note, any AE that is entered as 0 for this portion of the study does not imply that the AE did not occur, rather it is not collected in the TVT Registry. There are no events entered in the 'Other' table as TVT-R does not distinguish seriousness.	0.00% 0/745 • Randomized Controlled Trial - Adverse events (AEs) were collected from study enrollment through the 24 month follow-up visit. Adverse event data are currently available and reported for up to 24 months. Continued Access Study - Adverse events (AEs) were collected from study enrollment through the 12 month follow-up visit. Adverse event data are currently available and reported for up to 12 months. Randomized Controlled Trial - All new or worsening AEs were collected through 24 months. After 24 months only serious and device-related events will be collected. Continued Access Study - All new or worsening AEs were collected through 12 months. Note, any AE that is entered as 0 for this portion of the study does not imply that the AE did not occur, rather it is not collected in the TVT Registry. There are no events entered in the 'Other' table as TVT-R does not distinguish seriousness.
Cardiac disorders Atrial Fibrillation	7.5% 55/730 • Randomized Controlled Trial - Adverse events (AEs) were collected from study enrollment through the 24 month follow-up visit. Adverse event data are currently available and reported for up to 24 months. Continued Access Study - Adverse events (AEs) were collected from study enrollment through the 12 month follow-up visit. Adverse event data are currently available and reported for up to 12 months. Randomized Controlled Trial - All new or worsening AEs were collected through 24 months. After 24 months only serious and device-related events will be collected. Continued Access Study - All new or worsening AEs were collected through 12 months. Note, any AE that is entered as 0 for this portion of the study does not imply that the AE did not occur, rather it is not collected in the TVT Registry. There are no events entered in the 'Other' table as TVT-R does not distinguish seriousness.	22.1% 151/684 • Randomized Controlled Trial - Adverse events (AEs) were collected from study enrollment through the 24 month follow-up visit. Adverse event data are currently available and reported for up to 24 months. Continued Access Study - Adverse events (AEs) were collected from study enrollment through the 12 month follow-up visit. Adverse event data are currently available and reported for up to 12 months. Randomized Controlled Trial - All new or worsening AEs were collected through 24 months. After 24 months only serious and device-related events will be collected. Continued Access Study - All new or worsening AEs were collected through 12 months. Note, any AE that is entered as 0 for this portion of the study does not imply that the AE did not occur, rather it is not collected in the TVT Registry. There are no events entered in the 'Other' table as TVT-R does not distinguish seriousness.	0.00% 0/745 • Randomized Controlled Trial - Adverse events (AEs) were collected from study enrollment through the 24 month follow-up visit. Adverse event data are currently available and reported for up to 24 months. Continued Access Study - Adverse events (AEs) were collected from study enrollment through the 12 month follow-up visit. Adverse event data are currently available and reported for up to 12 months. Randomized Controlled Trial - All new or worsening AEs were collected through 24 months. After 24 months only serious and device-related events will be collected. Continued Access Study - All new or worsening AEs were collected through 12 months. Note, any AE that is entered as 0 for this portion of the study does not imply that the AE did not occur, rather it is not collected in the TVT Registry. There are no events entered in the 'Other' table as TVT-R does not distinguish seriousness.
Cardiac disorders Atrioventricular Block First Degree	15.8% 115/730 • Randomized Controlled Trial - Adverse events (AEs) were collected from study enrollment through the 24 month follow-up visit. Adverse event data are currently available and reported for up to 24 months. Continued Access Study - Adverse events (AEs) were collected from study enrollment through the 12 month follow-up visit. Adverse event data are currently available and reported for up to 12 months. Randomized Controlled Trial - All new or worsening AEs were collected through 24 months. After 24 months only serious and device-related events will be collected. Continued Access Study - All new or worsening AEs were collected through 12 months. Note, any AE that is entered as 0 for this portion of the study does not imply that the AE did not occur, rather it is not collected in the TVT Registry. There are no events entered in the 'Other' table as TVT-R does not distinguish seriousness.	17.4% 119/684 • Randomized Controlled Trial - Adverse events (AEs) were collected from study enrollment through the 24 month follow-up visit. Adverse event data are currently available and reported for up to 24 months. Continued Access Study - Adverse events (AEs) were collected from study enrollment through the 12 month follow-up visit. Adverse event data are currently available and reported for up to 12 months. Randomized Controlled Trial - All new or worsening AEs were collected through 24 months. After 24 months only serious and device-related events will be collected. Continued Access Study - All new or worsening AEs were collected through 12 months. Note, any AE that is entered as 0 for this portion of the study does not imply that the AE did not occur, rather it is not collected in the TVT Registry. There are no events entered in the 'Other' table as TVT-R does not distinguish seriousness.	0.00% 0/745 • Randomized Controlled Trial - Adverse events (AEs) were collected from study enrollment through the 24 month follow-up visit. Adverse event data are currently available and reported for up to 24 months. Continued Access Study - Adverse events (AEs) were collected from study enrollment through the 12 month follow-up visit. Adverse event data are currently available and reported for up to 12 months. Randomized Controlled Trial - All new or worsening AEs were collected through 24 months. After 24 months only serious and device-related events will be collected. Continued Access Study - All new or worsening AEs were collected through 12 months. Note, any AE that is entered as 0 for this portion of the study does not imply that the AE did not occur, rather it is not collected in the TVT Registry. There are no events entered in the 'Other' table as TVT-R does not distinguish seriousness.
Cardiac disorders Bundle Branch Block Left	33.7% 246/730 • Randomized Controlled Trial - Adverse events (AEs) were collected from study enrollment through the 24 month follow-up visit. Adverse event data are currently available and reported for up to 24 months. Continued Access Study - Adverse events (AEs) were collected from study enrollment through the 12 month follow-up visit. Adverse event data are currently available and reported for up to 12 months. Randomized Controlled Trial - All new or worsening AEs were collected through 24 months. After 24 months only serious and device-related events will be collected. Continued Access Study - All new or worsening AEs were collected through 12 months. Note, any AE that is entered as 0 for this portion of the study does not imply that the AE did not occur, rather it is not collected in the TVT Registry. There are no events entered in the 'Other' table as TVT-R does not distinguish seriousness.	20.6% 141/684 • Randomized Controlled Trial - Adverse events (AEs) were collected from study enrollment through the 24 month follow-up visit. Adverse event data are currently available and reported for up to 24 months. Continued Access Study - Adverse events (AEs) were collected from study enrollment through the 12 month follow-up visit. Adverse event data are currently available and reported for up to 12 months. Randomized Controlled Trial - All new or worsening AEs were collected through 24 months. After 24 months only serious and device-related events will be collected. Continued Access Study - All new or worsening AEs were collected through 12 months. Note, any AE that is entered as 0 for this portion of the study does not imply that the AE did not occur, rather it is not collected in the TVT Registry. There are no events entered in the 'Other' table as TVT-R does not distinguish seriousness.	0.00% 0/745 • Randomized Controlled Trial - Adverse events (AEs) were collected from study enrollment through the 24 month follow-up visit. Adverse event data are currently available and reported for up to 24 months. Continued Access Study - Adverse events (AEs) were collected from study enrollment through the 12 month follow-up visit. Adverse event data are currently available and reported for up to 12 months. Randomized Controlled Trial - All new or worsening AEs were collected through 24 months. After 24 months only serious and device-related events will be collected. Continued Access Study - All new or worsening AEs were collected through 12 months. Note, any AE that is entered as 0 for this portion of the study does not imply that the AE did not occur, rather it is not collected in the TVT Registry. There are no events entered in the 'Other' table as TVT-R does not distinguish seriousness.
Cardiac disorders Bundle Branch Block Right	0.00% 0/730 • Randomized Controlled Trial - Adverse events (AEs) were collected from study enrollment through the 24 month follow-up visit. Adverse event data are currently available and reported for up to 24 months. Continued Access Study - Adverse events (AEs) were collected from study enrollment through the 12 month follow-up visit. Adverse event data are currently available and reported for up to 12 months. Randomized Controlled Trial - All new or worsening AEs were collected through 24 months. After 24 months only serious and device-related events will be collected. Continued Access Study - All new or worsening AEs were collected through 12 months. Note, any AE that is entered as 0 for this portion of the study does not imply that the AE did not occur, rather it is not collected in the TVT Registry. There are no events entered in the 'Other' table as TVT-R does not distinguish seriousness.	7.0% 48/684 • Randomized Controlled Trial - Adverse events (AEs) were collected from study enrollment through the 24 month follow-up visit. Adverse event data are currently available and reported for up to 24 months. Continued Access Study - Adverse events (AEs) were collected from study enrollment through the 12 month follow-up visit. Adverse event data are currently available and reported for up to 12 months. Randomized Controlled Trial - All new or worsening AEs were collected through 24 months. After 24 months only serious and device-related events will be collected. Continued Access Study - All new or worsening AEs were collected through 12 months. Note, any AE that is entered as 0 for this portion of the study does not imply that the AE did not occur, rather it is not collected in the TVT Registry. There are no events entered in the 'Other' table as TVT-R does not distinguish seriousness.	0.00% 0/745 • Randomized Controlled Trial - Adverse events (AEs) were collected from study enrollment through the 24 month follow-up visit. Adverse event data are currently available and reported for up to 24 months. Continued Access Study - Adverse events (AEs) were collected from study enrollment through the 12 month follow-up visit. Adverse event data are currently available and reported for up to 12 months. Randomized Controlled Trial - All new or worsening AEs were collected through 24 months. After 24 months only serious and device-related events will be collected. Continued Access Study - All new or worsening AEs were collected through 12 months. Note, any AE that is entered as 0 for this portion of the study does not imply that the AE did not occur, rather it is not collected in the TVT Registry. There are no events entered in the 'Other' table as TVT-R does not distinguish seriousness.
Cardiac disorders Pericardial Effusion	0.00% 0/730 • Randomized Controlled Trial - Adverse events (AEs) were collected from study enrollment through the 24 month follow-up visit. Adverse event data are currently available and reported for up to 24 months. Continued Access Study - Adverse events (AEs) were collected from study enrollment through the 12 month follow-up visit. Adverse event data are currently available and reported for up to 12 months. Randomized Controlled Trial - All new or worsening AEs were collected through 24 months. After 24 months only serious and device-related events will be collected. Continued Access Study - All new or worsening AEs were collected through 12 months. Note, any AE that is entered as 0 for this portion of the study does not imply that the AE did not occur, rather it is not collected in the TVT Registry. There are no events entered in the 'Other' table as TVT-R does not distinguish seriousness.	5.4% 37/684 • Randomized Controlled Trial - Adverse events (AEs) were collected from study enrollment through the 24 month follow-up visit. Adverse event data are currently available and reported for up to 24 months. Continued Access Study - Adverse events (AEs) were collected from study enrollment through the 12 month follow-up visit. Adverse event data are currently available and reported for up to 12 months. Randomized Controlled Trial - All new or worsening AEs were collected through 24 months. After 24 months only serious and device-related events will be collected. Continued Access Study - All new or worsening AEs were collected through 12 months. Note, any AE that is entered as 0 for this portion of the study does not imply that the AE did not occur, rather it is not collected in the TVT Registry. There are no events entered in the 'Other' table as TVT-R does not distinguish seriousness.	0.00% 0/745 • Randomized Controlled Trial - Adverse events (AEs) were collected from study enrollment through the 24 month follow-up visit. Adverse event data are currently available and reported for up to 24 months. Continued Access Study - Adverse events (AEs) were collected from study enrollment through the 12 month follow-up visit. Adverse event data are currently available and reported for up to 12 months. Randomized Controlled Trial - All new or worsening AEs were collected through 24 months. After 24 months only serious and device-related events will be collected. Continued Access Study - All new or worsening AEs were collected through 12 months. Note, any AE that is entered as 0 for this portion of the study does not imply that the AE did not occur, rather it is not collected in the TVT Registry. There are no events entered in the 'Other' table as TVT-R does not distinguish seriousness.
General disorders Chest Pain	5.2% 38/730 • Randomized Controlled Trial - Adverse events (AEs) were collected from study enrollment through the 24 month follow-up visit. Adverse event data are currently available and reported for up to 24 months. Continued Access Study - Adverse events (AEs) were collected from study enrollment through the 12 month follow-up visit. Adverse event data are currently available and reported for up to 12 months. Randomized Controlled Trial - All new or worsening AEs were collected through 24 months. After 24 months only serious and device-related events will be collected. Continued Access Study - All new or worsening AEs were collected through 12 months. Note, any AE that is entered as 0 for this portion of the study does not imply that the AE did not occur, rather it is not collected in the TVT Registry. There are no events entered in the 'Other' table as TVT-R does not distinguish seriousness.	0.00% 0/684 • Randomized Controlled Trial - Adverse events (AEs) were collected from study enrollment through the 24 month follow-up visit. Adverse event data are currently available and reported for up to 24 months. Continued Access Study - Adverse events (AEs) were collected from study enrollment through the 12 month follow-up visit. Adverse event data are currently available and reported for up to 12 months. Randomized Controlled Trial - All new or worsening AEs were collected through 24 months. After 24 months only serious and device-related events will be collected. Continued Access Study - All new or worsening AEs were collected through 12 months. Note, any AE that is entered as 0 for this portion of the study does not imply that the AE did not occur, rather it is not collected in the TVT Registry. There are no events entered in the 'Other' table as TVT-R does not distinguish seriousness.	0.00% 0/745 • Randomized Controlled Trial - Adverse events (AEs) were collected from study enrollment through the 24 month follow-up visit. Adverse event data are currently available and reported for up to 24 months. Continued Access Study - Adverse events (AEs) were collected from study enrollment through the 12 month follow-up visit. Adverse event data are currently available and reported for up to 12 months. Randomized Controlled Trial - All new or worsening AEs were collected through 24 months. After 24 months only serious and device-related events will be collected. Continued Access Study - All new or worsening AEs were collected through 12 months. Note, any AE that is entered as 0 for this portion of the study does not imply that the AE did not occur, rather it is not collected in the TVT Registry. There are no events entered in the 'Other' table as TVT-R does not distinguish seriousness.
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/730 • Randomized Controlled Trial - Adverse events (AEs) were collected from study enrollment through the 24 month follow-up visit. Adverse event data are currently available and reported for up to 24 months. Continued Access Study - Adverse events (AEs) were collected from study enrollment through the 12 month follow-up visit. Adverse event data are currently available and reported for up to 12 months. Randomized Controlled Trial - All new or worsening AEs were collected through 24 months. After 24 months only serious and device-related events will be collected. Continued Access Study - All new or worsening AEs were collected through 12 months. Note, any AE that is entered as 0 for this portion of the study does not imply that the AE did not occur, rather it is not collected in the TVT Registry. There are no events entered in the 'Other' table as TVT-R does not distinguish seriousness.	9.5% 65/684 • Randomized Controlled Trial - Adverse events (AEs) were collected from study enrollment through the 24 month follow-up visit. Adverse event data are currently available and reported for up to 24 months. Continued Access Study - Adverse events (AEs) were collected from study enrollment through the 12 month follow-up visit. Adverse event data are currently available and reported for up to 12 months. Randomized Controlled Trial - All new or worsening AEs were collected through 24 months. After 24 months only serious and device-related events will be collected. Continued Access Study - All new or worsening AEs were collected through 12 months. Note, any AE that is entered as 0 for this portion of the study does not imply that the AE did not occur, rather it is not collected in the TVT Registry. There are no events entered in the 'Other' table as TVT-R does not distinguish seriousness.	0.00% 0/745 • Randomized Controlled Trial - Adverse events (AEs) were collected from study enrollment through the 24 month follow-up visit. Adverse event data are currently available and reported for up to 24 months. Continued Access Study - Adverse events (AEs) were collected from study enrollment through the 12 month follow-up visit. Adverse event data are currently available and reported for up to 12 months. Randomized Controlled Trial - All new or worsening AEs were collected through 24 months. After 24 months only serious and device-related events will be collected. Continued Access Study - All new or worsening AEs were collected through 12 months. Note, any AE that is entered as 0 for this portion of the study does not imply that the AE did not occur, rather it is not collected in the TVT Registry. There are no events entered in the 'Other' table as TVT-R does not distinguish seriousness.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/730 • Randomized Controlled Trial - Adverse events (AEs) were collected from study enrollment through the 24 month follow-up visit. Adverse event data are currently available and reported for up to 24 months. Continued Access Study - Adverse events (AEs) were collected from study enrollment through the 12 month follow-up visit. Adverse event data are currently available and reported for up to 12 months. Randomized Controlled Trial - All new or worsening AEs were collected through 24 months. After 24 months only serious and device-related events will be collected. Continued Access Study - All new or worsening AEs were collected through 12 months. Note, any AE that is entered as 0 for this portion of the study does not imply that the AE did not occur, rather it is not collected in the TVT Registry. There are no events entered in the 'Other' table as TVT-R does not distinguish seriousness.	5.1% 35/684 • Randomized Controlled Trial - Adverse events (AEs) were collected from study enrollment through the 24 month follow-up visit. Adverse event data are currently available and reported for up to 24 months. Continued Access Study - Adverse events (AEs) were collected from study enrollment through the 12 month follow-up visit. Adverse event data are currently available and reported for up to 12 months. Randomized Controlled Trial - All new or worsening AEs were collected through 24 months. After 24 months only serious and device-related events will be collected. Continued Access Study - All new or worsening AEs were collected through 12 months. Note, any AE that is entered as 0 for this portion of the study does not imply that the AE did not occur, rather it is not collected in the TVT Registry. There are no events entered in the 'Other' table as TVT-R does not distinguish seriousness.	0.00% 0/745 • Randomized Controlled Trial - Adverse events (AEs) were collected from study enrollment through the 24 month follow-up visit. Adverse event data are currently available and reported for up to 24 months. Continued Access Study - Adverse events (AEs) were collected from study enrollment through the 12 month follow-up visit. Adverse event data are currently available and reported for up to 12 months. Randomized Controlled Trial - All new or worsening AEs were collected through 24 months. After 24 months only serious and device-related events will be collected. Continued Access Study - All new or worsening AEs were collected through 12 months. Note, any AE that is entered as 0 for this portion of the study does not imply that the AE did not occur, rather it is not collected in the TVT Registry. There are no events entered in the 'Other' table as TVT-R does not distinguish seriousness.
Nervous system disorders Dizziness	8.9% 65/730 • Randomized Controlled Trial - Adverse events (AEs) were collected from study enrollment through the 24 month follow-up visit. Adverse event data are currently available and reported for up to 24 months. Continued Access Study - Adverse events (AEs) were collected from study enrollment through the 12 month follow-up visit. Adverse event data are currently available and reported for up to 12 months. Randomized Controlled Trial - All new or worsening AEs were collected through 24 months. After 24 months only serious and device-related events will be collected. Continued Access Study - All new or worsening AEs were collected through 12 months. Note, any AE that is entered as 0 for this portion of the study does not imply that the AE did not occur, rather it is not collected in the TVT Registry. There are no events entered in the 'Other' table as TVT-R does not distinguish seriousness.	7.2% 49/684 • Randomized Controlled Trial - Adverse events (AEs) were collected from study enrollment through the 24 month follow-up visit. Adverse event data are currently available and reported for up to 24 months. Continued Access Study - Adverse events (AEs) were collected from study enrollment through the 12 month follow-up visit. Adverse event data are currently available and reported for up to 12 months. Randomized Controlled Trial - All new or worsening AEs were collected through 24 months. After 24 months only serious and device-related events will be collected. Continued Access Study - All new or worsening AEs were collected through 12 months. Note, any AE that is entered as 0 for this portion of the study does not imply that the AE did not occur, rather it is not collected in the TVT Registry. There are no events entered in the 'Other' table as TVT-R does not distinguish seriousness.	0.00% 0/745 • Randomized Controlled Trial - Adverse events (AEs) were collected from study enrollment through the 24 month follow-up visit. Adverse event data are currently available and reported for up to 24 months. Continued Access Study - Adverse events (AEs) were collected from study enrollment through the 12 month follow-up visit. Adverse event data are currently available and reported for up to 12 months. Randomized Controlled Trial - All new or worsening AEs were collected through 24 months. After 24 months only serious and device-related events will be collected. Continued Access Study - All new or worsening AEs were collected through 12 months. Note, any AE that is entered as 0 for this portion of the study does not imply that the AE did not occur, rather it is not collected in the TVT Registry. There are no events entered in the 'Other' table as TVT-R does not distinguish seriousness.
Renal and urinary disorders Acute Kidney Injury	0.00% 0/730 • Randomized Controlled Trial - Adverse events (AEs) were collected from study enrollment through the 24 month follow-up visit. Adverse event data are currently available and reported for up to 24 months. Continued Access Study - Adverse events (AEs) were collected from study enrollment through the 12 month follow-up visit. Adverse event data are currently available and reported for up to 12 months. Randomized Controlled Trial - All new or worsening AEs were collected through 24 months. After 24 months only serious and device-related events will be collected. Continued Access Study - All new or worsening AEs were collected through 12 months. Note, any AE that is entered as 0 for this portion of the study does not imply that the AE did not occur, rather it is not collected in the TVT Registry. There are no events entered in the 'Other' table as TVT-R does not distinguish seriousness.	7.9% 54/684 • Randomized Controlled Trial - Adverse events (AEs) were collected from study enrollment through the 24 month follow-up visit. Adverse event data are currently available and reported for up to 24 months. Continued Access Study - Adverse events (AEs) were collected from study enrollment through the 12 month follow-up visit. Adverse event data are currently available and reported for up to 12 months. Randomized Controlled Trial - All new or worsening AEs were collected through 24 months. After 24 months only serious and device-related events will be collected. Continued Access Study - All new or worsening AEs were collected through 12 months. Note, any AE that is entered as 0 for this portion of the study does not imply that the AE did not occur, rather it is not collected in the TVT Registry. There are no events entered in the 'Other' table as TVT-R does not distinguish seriousness.	0.00% 0/745 • Randomized Controlled Trial - Adverse events (AEs) were collected from study enrollment through the 24 month follow-up visit. Adverse event data are currently available and reported for up to 24 months. Continued Access Study - Adverse events (AEs) were collected from study enrollment through the 12 month follow-up visit. Adverse event data are currently available and reported for up to 12 months. Randomized Controlled Trial - All new or worsening AEs were collected through 24 months. After 24 months only serious and device-related events will be collected. Continued Access Study - All new or worsening AEs were collected through 12 months. Note, any AE that is entered as 0 for this portion of the study does not imply that the AE did not occur, rather it is not collected in the TVT Registry. There are no events entered in the 'Other' table as TVT-R does not distinguish seriousness.
Respiratory, thoracic and mediastinal disorders Atelectasis	0.00% 0/730 • Randomized Controlled Trial - Adverse events (AEs) were collected from study enrollment through the 24 month follow-up visit. Adverse event data are currently available and reported for up to 24 months. Continued Access Study - Adverse events (AEs) were collected from study enrollment through the 12 month follow-up visit. Adverse event data are currently available and reported for up to 12 months. Randomized Controlled Trial - All new or worsening AEs were collected through 24 months. After 24 months only serious and device-related events will be collected. Continued Access Study - All new or worsening AEs were collected through 12 months. Note, any AE that is entered as 0 for this portion of the study does not imply that the AE did not occur, rather it is not collected in the TVT Registry. There are no events entered in the 'Other' table as TVT-R does not distinguish seriousness.	10.1% 69/684 • Randomized Controlled Trial - Adverse events (AEs) were collected from study enrollment through the 24 month follow-up visit. Adverse event data are currently available and reported for up to 24 months. Continued Access Study - Adverse events (AEs) were collected from study enrollment through the 12 month follow-up visit. Adverse event data are currently available and reported for up to 12 months. Randomized Controlled Trial - All new or worsening AEs were collected through 24 months. After 24 months only serious and device-related events will be collected. Continued Access Study - All new or worsening AEs were collected through 12 months. Note, any AE that is entered as 0 for this portion of the study does not imply that the AE did not occur, rather it is not collected in the TVT Registry. There are no events entered in the 'Other' table as TVT-R does not distinguish seriousness.	0.00% 0/745 • Randomized Controlled Trial - Adverse events (AEs) were collected from study enrollment through the 24 month follow-up visit. Adverse event data are currently available and reported for up to 24 months. Continued Access Study - Adverse events (AEs) were collected from study enrollment through the 12 month follow-up visit. Adverse event data are currently available and reported for up to 12 months. Randomized Controlled Trial - All new or worsening AEs were collected through 24 months. After 24 months only serious and device-related events will be collected. Continued Access Study - All new or worsening AEs were collected through 12 months. Note, any AE that is entered as 0 for this portion of the study does not imply that the AE did not occur, rather it is not collected in the TVT Registry. There are no events entered in the 'Other' table as TVT-R does not distinguish seriousness.
Respiratory, thoracic and mediastinal disorders Dyspnoea	5.8% 42/730 • Randomized Controlled Trial - Adverse events (AEs) were collected from study enrollment through the 24 month follow-up visit. Adverse event data are currently available and reported for up to 24 months. Continued Access Study - Adverse events (AEs) were collected from study enrollment through the 12 month follow-up visit. Adverse event data are currently available and reported for up to 12 months. Randomized Controlled Trial - All new or worsening AEs were collected through 24 months. After 24 months only serious and device-related events will be collected. Continued Access Study - All new or worsening AEs were collected through 12 months. Note, any AE that is entered as 0 for this portion of the study does not imply that the AE did not occur, rather it is not collected in the TVT Registry. There are no events entered in the 'Other' table as TVT-R does not distinguish seriousness.	0.00% 0/684 • Randomized Controlled Trial - Adverse events (AEs) were collected from study enrollment through the 24 month follow-up visit. Adverse event data are currently available and reported for up to 24 months. Continued Access Study - Adverse events (AEs) were collected from study enrollment through the 12 month follow-up visit. Adverse event data are currently available and reported for up to 12 months. Randomized Controlled Trial - All new or worsening AEs were collected through 24 months. After 24 months only serious and device-related events will be collected. Continued Access Study - All new or worsening AEs were collected through 12 months. Note, any AE that is entered as 0 for this portion of the study does not imply that the AE did not occur, rather it is not collected in the TVT Registry. There are no events entered in the 'Other' table as TVT-R does not distinguish seriousness.	0.00% 0/745 • Randomized Controlled Trial - Adverse events (AEs) were collected from study enrollment through the 24 month follow-up visit. Adverse event data are currently available and reported for up to 24 months. Continued Access Study - Adverse events (AEs) were collected from study enrollment through the 12 month follow-up visit. Adverse event data are currently available and reported for up to 12 months. Randomized Controlled Trial - All new or worsening AEs were collected through 24 months. After 24 months only serious and device-related events will be collected. Continued Access Study - All new or worsening AEs were collected through 12 months. Note, any AE that is entered as 0 for this portion of the study does not imply that the AE did not occur, rather it is not collected in the TVT Registry. There are no events entered in the 'Other' table as TVT-R does not distinguish seriousness.
Respiratory, thoracic and mediastinal disorders Pleural Effusion	0.00% 0/730 • Randomized Controlled Trial - Adverse events (AEs) were collected from study enrollment through the 24 month follow-up visit. Adverse event data are currently available and reported for up to 24 months. Continued Access Study - Adverse events (AEs) were collected from study enrollment through the 12 month follow-up visit. Adverse event data are currently available and reported for up to 12 months. Randomized Controlled Trial - All new or worsening AEs were collected through 24 months. After 24 months only serious and device-related events will be collected. Continued Access Study - All new or worsening AEs were collected through 12 months. Note, any AE that is entered as 0 for this portion of the study does not imply that the AE did not occur, rather it is not collected in the TVT Registry. There are no events entered in the 'Other' table as TVT-R does not distinguish seriousness.	15.9% 109/684 • Randomized Controlled Trial - Adverse events (AEs) were collected from study enrollment through the 24 month follow-up visit. Adverse event data are currently available and reported for up to 24 months. Continued Access Study - Adverse events (AEs) were collected from study enrollment through the 12 month follow-up visit. Adverse event data are currently available and reported for up to 12 months. Randomized Controlled Trial - All new or worsening AEs were collected through 24 months. After 24 months only serious and device-related events will be collected. Continued Access Study - All new or worsening AEs were collected through 12 months. Note, any AE that is entered as 0 for this portion of the study does not imply that the AE did not occur, rather it is not collected in the TVT Registry. There are no events entered in the 'Other' table as TVT-R does not distinguish seriousness.	0.00% 0/745 • Randomized Controlled Trial - Adverse events (AEs) were collected from study enrollment through the 24 month follow-up visit. Adverse event data are currently available and reported for up to 24 months. Continued Access Study - Adverse events (AEs) were collected from study enrollment through the 12 month follow-up visit. Adverse event data are currently available and reported for up to 12 months. Randomized Controlled Trial - All new or worsening AEs were collected through 24 months. After 24 months only serious and device-related events will be collected. Continued Access Study - All new or worsening AEs were collected through 12 months. Note, any AE that is entered as 0 for this portion of the study does not imply that the AE did not occur, rather it is not collected in the TVT Registry. There are no events entered in the 'Other' table as TVT-R does not distinguish seriousness.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.00% 0/730 • Randomized Controlled Trial - Adverse events (AEs) were collected from study enrollment through the 24 month follow-up visit. Adverse event data are currently available and reported for up to 24 months. Continued Access Study - Adverse events (AEs) were collected from study enrollment through the 12 month follow-up visit. Adverse event data are currently available and reported for up to 12 months. Randomized Controlled Trial - All new or worsening AEs were collected through 24 months. After 24 months only serious and device-related events will be collected. Continued Access Study - All new or worsening AEs were collected through 12 months. Note, any AE that is entered as 0 for this portion of the study does not imply that the AE did not occur, rather it is not collected in the TVT Registry. There are no events entered in the 'Other' table as TVT-R does not distinguish seriousness.	5.7% 39/684 • Randomized Controlled Trial - Adverse events (AEs) were collected from study enrollment through the 24 month follow-up visit. Adverse event data are currently available and reported for up to 24 months. Continued Access Study - Adverse events (AEs) were collected from study enrollment through the 12 month follow-up visit. Adverse event data are currently available and reported for up to 12 months. Randomized Controlled Trial - All new or worsening AEs were collected through 24 months. After 24 months only serious and device-related events will be collected. Continued Access Study - All new or worsening AEs were collected through 12 months. Note, any AE that is entered as 0 for this portion of the study does not imply that the AE did not occur, rather it is not collected in the TVT Registry. There are no events entered in the 'Other' table as TVT-R does not distinguish seriousness.	0.00% 0/745 • Randomized Controlled Trial - Adverse events (AEs) were collected from study enrollment through the 24 month follow-up visit. Adverse event data are currently available and reported for up to 24 months. Continued Access Study - Adverse events (AEs) were collected from study enrollment through the 12 month follow-up visit. Adverse event data are currently available and reported for up to 12 months. Randomized Controlled Trial - All new or worsening AEs were collected through 24 months. After 24 months only serious and device-related events will be collected. Continued Access Study - All new or worsening AEs were collected through 12 months. Note, any AE that is entered as 0 for this portion of the study does not imply that the AE did not occur, rather it is not collected in the TVT Registry. There are no events entered in the 'Other' table as TVT-R does not distinguish seriousness.
Vascular disorders Hypertension	10.4% 76/730 • Randomized Controlled Trial - Adverse events (AEs) were collected from study enrollment through the 24 month follow-up visit. Adverse event data are currently available and reported for up to 24 months. Continued Access Study - Adverse events (AEs) were collected from study enrollment through the 12 month follow-up visit. Adverse event data are currently available and reported for up to 12 months. Randomized Controlled Trial - All new or worsening AEs were collected through 24 months. After 24 months only serious and device-related events will be collected. Continued Access Study - All new or worsening AEs were collected through 12 months. Note, any AE that is entered as 0 for this portion of the study does not imply that the AE did not occur, rather it is not collected in the TVT Registry. There are no events entered in the 'Other' table as TVT-R does not distinguish seriousness.	9.1% 62/684 • Randomized Controlled Trial - Adverse events (AEs) were collected from study enrollment through the 24 month follow-up visit. Adverse event data are currently available and reported for up to 24 months. Continued Access Study - Adverse events (AEs) were collected from study enrollment through the 12 month follow-up visit. Adverse event data are currently available and reported for up to 12 months. Randomized Controlled Trial - All new or worsening AEs were collected through 24 months. After 24 months only serious and device-related events will be collected. Continued Access Study - All new or worsening AEs were collected through 12 months. Note, any AE that is entered as 0 for this portion of the study does not imply that the AE did not occur, rather it is not collected in the TVT Registry. There are no events entered in the 'Other' table as TVT-R does not distinguish seriousness.	0.00% 0/745 • Randomized Controlled Trial - Adverse events (AEs) were collected from study enrollment through the 24 month follow-up visit. Adverse event data are currently available and reported for up to 24 months. Continued Access Study - Adverse events (AEs) were collected from study enrollment through the 12 month follow-up visit. Adverse event data are currently available and reported for up to 12 months. Randomized Controlled Trial - All new or worsening AEs were collected through 24 months. After 24 months only serious and device-related events will be collected. Continued Access Study - All new or worsening AEs were collected through 12 months. Note, any AE that is entered as 0 for this portion of the study does not imply that the AE did not occur, rather it is not collected in the TVT Registry. There are no events entered in the 'Other' table as TVT-R does not distinguish seriousness.
Vascular disorders Hypotension	0.00% 0/730 • Randomized Controlled Trial - Adverse events (AEs) were collected from study enrollment through the 24 month follow-up visit. Adverse event data are currently available and reported for up to 24 months. Continued Access Study - Adverse events (AEs) were collected from study enrollment through the 12 month follow-up visit. Adverse event data are currently available and reported for up to 12 months. Randomized Controlled Trial - All new or worsening AEs were collected through 24 months. After 24 months only serious and device-related events will be collected. Continued Access Study - All new or worsening AEs were collected through 12 months. Note, any AE that is entered as 0 for this portion of the study does not imply that the AE did not occur, rather it is not collected in the TVT Registry. There are no events entered in the 'Other' table as TVT-R does not distinguish seriousness.	6.0% 41/684 • Randomized Controlled Trial - Adverse events (AEs) were collected from study enrollment through the 24 month follow-up visit. Adverse event data are currently available and reported for up to 24 months. Continued Access Study - Adverse events (AEs) were collected from study enrollment through the 12 month follow-up visit. Adverse event data are currently available and reported for up to 12 months. Randomized Controlled Trial - All new or worsening AEs were collected through 24 months. After 24 months only serious and device-related events will be collected. Continued Access Study - All new or worsening AEs were collected through 12 months. Note, any AE that is entered as 0 for this portion of the study does not imply that the AE did not occur, rather it is not collected in the TVT Registry. There are no events entered in the 'Other' table as TVT-R does not distinguish seriousness.	0.00% 0/745 • Randomized Controlled Trial - Adverse events (AEs) were collected from study enrollment through the 24 month follow-up visit. Adverse event data are currently available and reported for up to 24 months. Continued Access Study - Adverse events (AEs) were collected from study enrollment through the 12 month follow-up visit. Adverse event data are currently available and reported for up to 12 months. Randomized Controlled Trial - All new or worsening AEs were collected through 24 months. After 24 months only serious and device-related events will be collected. Continued Access Study - All new or worsening AEs were collected through 12 months. Note, any AE that is entered as 0 for this portion of the study does not imply that the AE did not occur, rather it is not collected in the TVT Registry. There are no events entered in the 'Other' table as TVT-R does not distinguish seriousness.