Trial Outcomes & Findings for The Medtronic CoreValve™ Evolut R™ CE Mark Clinical Study (NCT NCT01876420)

NCT ID: NCT01876420

Last Updated: 2018-08-22

Results Overview

The All-cause mortality rate at 30 days per the VARC II recommendation of clinical endpoints for TAVI. More specifically: Cardiovascular mortality (Any of the following criteria) * Death due to proximate cardiac cause (e.g. myocardial infarction, cardiac tamponade, worsening heart failure) * Death caused by non-coronary vascular conditions such as neurological events, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular disease * All procedure-related deaths, including those related to a complication of the procedure or treatment for a complication of the procedure * All valve-related deaths including structural or non-structural valve dysfunction or other valve-related adverse events * Sudden or unwitnessed death * Death of unknown cause Non-cardiovascular mortality * Any death in which the primary cause of death is clearly related to another condition (e.g. trauma, cancer, suicide)

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 60 participants
• Primary outcome timeframe: 30 days
• Results posted on: 2018-08-22

Participant Flow

Participant milestones

Measure	All Implanted Subjects Sixty subjects were implanted with the Evolut R valve from six centers in Australia, the United Kingdom, and New Zealand.
Overall Study STARTED	60
Overall Study COMPLETED	59
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Measure	All Implanted Subjects Sixty subjects were implanted with the Evolut R valve from six centers in Australia, the United Kingdom, and New Zealand.
Overall Study Missed 30 day visit	1

Baseline Characteristics

The Medtronic CoreValve™ Evolut R™ CE Mark Clinical Study

Baseline characteristics by cohort

Measure	The CoreValve™ Evolut R TAV™ System n=60 Participants CoreValve™ Evolut R™ System which consists of the Evolut R™ Transcatheter Aortic Valve (26 \& 29 mm sizes), EnVeo R™ Delivery Catheter System with Enveo InLine™ Sheath, and EnVeo R™ Loading System The CoreValve™ Evolut R TAV™ system: CoreValve™ Evolut R™ System which consists of the Evolut R™ Transcatheter Aortic Valve (26 \& 29 mm sizes), EnVeo R™ Delivery Catheter System with Enveo InLine™ Sheath, and EnVeo R™ Loading System
Age, Continuous	82.8 years STANDARD_DEVIATION 6.1 • n=5 Participants
Sex: Female, Male Female	40 Participants n=5 Participants
Sex: Female, Male Male	20 Participants n=5 Participants
Region of Enrollment New Zealand	6 participants n=5 Participants
Region of Enrollment United Kingdom	29 participants n=5 Participants
Region of Enrollment Australia	25 participants n=5 Participants
NYHA Class NYHA I	0 participants n=5 Participants
NYHA Class NYHA II	19 participants n=5 Participants
NYHA Class NYHA III	36 participants n=5 Participants
NYHA Class NYHA IV	5 participants n=5 Participants
STS Score	7.0 percent of risk for cardiac surgery STANDARD_DEVIATION 3.7 • n=5 Participants
Logistic EuroScore	20.5 percent risk for cardiac surgery STANDARD_DEVIATION 12.5 • n=5 Participants
Body Surface Area (BSA)	1.7 m² STANDARD_DEVIATION 0.2 • n=5 Participants

PRIMARY outcome

Timeframe: 30 days

Population: All implanted subjects at 30 days.

The All-cause mortality rate at 30 days per the VARC II recommendation of clinical endpoints for TAVI. More specifically:

Cardiovascular mortality (Any of the following criteria)

• Death due to proximate cardiac cause (e.g. myocardial infarction, cardiac tamponade, worsening heart failure)
• Death caused by non-coronary vascular conditions such as neurological events, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular disease
• All procedure-related deaths, including those related to a complication of the procedure or treatment for a complication of the procedure
• All valve-related deaths including structural or non-structural valve dysfunction or other valve-related adverse events
• Sudden or unwitnessed death
• Death of unknown cause Non-cardiovascular mortality
• Any death in which the primary cause of death is clearly related to another condition (e.g. trauma, cancer, suicide)

Outcome measures

Measure	All Implanted Subjects n=60 Participants Sixty subjects were implanted with the Evolut R valve from six centers in Australia, the United Kingdom, and New Zealand.
All-cause Mortality Rate at 30 Days	0.0 percentage of participants

PRIMARY outcome

Timeframe: 30 days

Population: All implanted subjects at 30 days.

The Stroke rate (disabling and non-disabling) at 30 days per the VARC II definitions. Stroke is defined as an acute episode of focal or global neurological dysfunction caused by the brain, spinal cord, or retinal vascular injury as a result of haemorrhage or infarction. Stroke may be classified as ischaemic or haemorrhagic with appropriate subdefinitions. Ischaemic stroke is defined as an acute episode of focal cerebral, spinal, or retinal dysfunction caused by infarction of central nervous system tissue. Haemorrhagic stroke is defined as an acute episode of focal or global cerebral or spinal dysfunction caused by intraparenchymal, intraventricular, or subarachnoid haemorrhage. A stroke may be classified as 'undetermined' if there is insufficient information to allow the categorization as ischaemic or haemorrhagic.

Outcome measures

Measure	All Implanted Subjects n=60 Participants Sixty subjects were implanted with the Evolut R valve from six centers in Australia, the United Kingdom, and New Zealand.
Stroke Rate (Disabling and Non-disabling) at 30 Days	0.0 percentage of participants

PRIMARY outcome

Timeframe: 24 hours to seven days

Population: All implanted subjects at 30 days.

1. Device success rate at 24 hours to seven days, defined as:

• Absence of procedural mortality, AND
• Correct positioning of a single prosthetic heart valve into the proper anatomical location, AND
• Intended performance of the prosthetic heart valve, defined as the absence of patient-prosthesis-mismatch and mean aortic valve gradient less than 20 mmHg (or peak velocity < 3 m/sec), AND absence of moderate or severe prosthetic valve regurgitation.

2. The percentage of subjects with no more than mild aortic regurgitation at early post procedure echocardiogram (24 hours through seven days).

Outcome measures

Measure	All Implanted Subjects n=60 Participants Sixty subjects were implanted with the Evolut R valve from six centers in Australia, the United Kingdom, and New Zealand.
Device Success Rate at 24 Hours to Seven Days Overall Device Success	78.6 percentage of participants
Device Success Rate at 24 Hours to Seven Days Absence of Procedural Mortality	100.0 percentage of participants
Device Success Rate at 24 Hours to Seven Days Correct Positioning of Single Valve	98.3 percentage of participants
Device Success Rate at 24 Hours to Seven Days Intended Performance of Prosthetic Heart Valve	80.0 percentage of participants
Device Success Rate at 24 Hours to Seven Days Absence of Patient Prosthesis Mismatch	83.6 percentage of participants
Device Success Rate at 24 Hours to Seven Days Mean Gradient < 20mmHg or Peak Velocity < 3m/sec	98.3 percentage of participants
Device Success Rate at 24 Hours to Seven Days Absence of Mod. or Severe Prosthetic Regurgitation	93.3 percentage of participants

SECONDARY outcome

Timeframe: 30 days

The VARC II Combined Safety Endpoint at 30 days includes the following components: All-Cause Mortality, All Stroke, Life Threatening or Disabling Bleeding, Acute Kidney Injury: Stage 2 or 3, Coronary Artery Obstruction, Major Vascular Complication, and Valve-Related Dysfunction Requiring Repeat Procedure.

Outcome measures

Measure	All Implanted Subjects n=60 Participants Sixty subjects were implanted with the Evolut R valve from six centers in Australia, the United Kingdom, and New Zealand.
VARC II Combined Safety Endpoint at 30 Days	13.3 percentage probability

SECONDARY outcome

Timeframe: 30 days

Population: The number of subjects analyzed at 30 days.

The Individual components of the VARC II composite safety endpoint at 30 days per the Kaplan Meier Event Rate (%).

Outcome measures

Measure	All Implanted Subjects n=60 Participants Sixty subjects were implanted with the Evolut R valve from six centers in Australia, the United Kingdom, and New Zealand.
Event Rates of the Individual Components of the VARC II Composite Safety Endpoint at 30 Days Combined Safety Endpoint	13.3 percentage of probability
Event Rates of the Individual Components of the VARC II Composite Safety Endpoint at 30 Days All Cause Mortality	0.0 percentage of probability
Event Rates of the Individual Components of the VARC II Composite Safety Endpoint at 30 Days All Stroke	0.0 percentage of probability
Event Rates of the Individual Components of the VARC II Composite Safety Endpoint at 30 Days Life Threatening or Disabling Bleeding	5.0 percentage of probability
Event Rates of the Individual Components of the VARC II Composite Safety Endpoint at 30 Days Acute Kidney Injury: Stage 2 or 3	1.7 percentage of probability
Event Rates of the Individual Components of the VARC II Composite Safety Endpoint at 30 Days Coronary Artery Obstruction	0.0 percentage of probability
Event Rates of the Individual Components of the VARC II Composite Safety Endpoint at 30 Days Major Vascular Complication	8.3 percentage of probability
Event Rates of the Individual Components of the VARC II Composite Safety Endpoint at 30 Days Valve-Related Dysfunct. Requiring Repeat Procedure	0.0 percentage of probability

SECONDARY outcome

Timeframe: 30 days

Population: All implanted subjects who had echos at the 30 day visit, which were 58 subjects, only 57 of the echos were able to measure the Mean Gradient for those subjects.

The hemodynamic performance will be measured by the Mean Prosthetic Valve Gradient for 59 subjects, measured with the Doppler echocardiography.

Outcome measures

Measure	All Implanted Subjects n=57 Participants Sixty subjects were implanted with the Evolut R valve from six centers in Australia, the United Kingdom, and New Zealand.
Hemodynamic Performance Metrics at 30 Days by Doppler Echocardiography - Mean Gradient	8.1 mmHg Standard Deviation 3.3

SECONDARY outcome

Timeframe: 30 days

Population: All implanted subjects who had echos at the 30 day visit, which were 58 subjects, only 54 of the echos were able to measure the EOA for those subjects.

Effective orifice area

Outcome measures

Measure	All Implanted Subjects n=54 Participants Sixty subjects were implanted with the Evolut R valve from six centers in Australia, the United Kingdom, and New Zealand.
Hemodynamic Performance Metrics at 30 Days by Doppler Echocardiography - • Effective Orifice Area (EOA)	1.9 cm² Standard Deviation 0.5

SECONDARY outcome

Timeframe: 30 days

Population: All implanted subjects who had echos at the 30 day visit, which were 58 subjects, and 58 of the echos were able to measure the Total Aortic Regurgitation for those subjects.

Degree of Total prosthetic valve regurgitation (transvalvular & paravalvular)

Outcome measures

Measure	All Implanted Subjects n=58 Participants Sixty subjects were implanted with the Evolut R valve from six centers in Australia, the United Kingdom, and New Zealand.
Hemodynamic Performance Metrics at 30 Days by Doppler Echocardiography - Total Aortic Regurgitation (Transvalvular & Paravalvular) None	8.6 percentage of participants
Hemodynamic Performance Metrics at 30 Days by Doppler Echocardiography - Total Aortic Regurgitation (Transvalvular & Paravalvular) Trace	22.4 percentage of participants
Hemodynamic Performance Metrics at 30 Days by Doppler Echocardiography - Total Aortic Regurgitation (Transvalvular & Paravalvular) Mild	63.8 percentage of participants
Hemodynamic Performance Metrics at 30 Days by Doppler Echocardiography - Total Aortic Regurgitation (Transvalvular & Paravalvular) Moderate	5.2 percentage of participants
Hemodynamic Performance Metrics at 30 Days by Doppler Echocardiography - Total Aortic Regurgitation (Transvalvular & Paravalvular) Severe	0.0 percentage of participants

SECONDARY outcome

Timeframe: Day 1

Population: Subjects who had either a resheath or recapture attempt at implant and the success rate for each resheathing, or recapturing attempts of the valve at the implant.

Resheath or Recapture success rate (when attempted), where successful recapture is defined as Evolut R™ TAV (including the frame) is fully resheathed into the capsule of the delivery catheter, as verified by fluoroscopy. Resheathing or recapturing of the TAV was attempted on 15 subjects.

Outcome measures

Measure	All Implanted Subjects n=22 Research recapture attempts Sixty subjects were implanted with the Evolut R valve from six centers in Australia, the United Kingdom, and New Zealand.
Resheath or Recapture Success Rate (When Attempted), Where Successful Recapture is Defined as Evolut R™ TAV (Including the Frame) is Fully Resheathed Into the Capsule of the Delivery Catheter, as Verified by Fluoroscopy. Success rate for Resheath or Recapture	100.0 percentage of successful attempts
Resheath or Recapture Success Rate (When Attempted), Where Successful Recapture is Defined as Evolut R™ TAV (Including the Frame) is Fully Resheathed Into the Capsule of the Delivery Catheter, as Verified by Fluoroscopy. Success rate for Resheath	100.0 percentage of successful attempts
Resheath or Recapture Success Rate (When Attempted), Where Successful Recapture is Defined as Evolut R™ TAV (Including the Frame) is Fully Resheathed Into the Capsule of the Delivery Catheter, as Verified by Fluoroscopy. Success rate for Recapture	100.0 percentage of successful attempts

Adverse Events

All Attempted Implanted Subjects

Serious events: 40 serious events

Other events: 60 other events

Deaths: 0 deaths

Serious adverse events

Measure	All Attempted Implanted Subjects n=60 participants at risk Sixty subjects were implanted with the Evolut R valve from six centers in Australia, the United Kingdom, and New Zealand.
Blood and lymphatic system disorders Anemia	5.0% 3/60 • Up to 30 days. All SAE should be reported as soon as possible, not later than within ten days of knowledge of the event. All other adverse events should be reported as soon as possible, not later than within three weeks.
Blood and lymphatic system disorders Blood disorder	1.7% 1/60 • Up to 30 days. All SAE should be reported as soon as possible, not later than within ten days of knowledge of the event. All other adverse events should be reported as soon as possible, not later than within three weeks.
Cardiac disorders Cardiac Conduction Disorder	13.3% 8/60 • Up to 30 days. All SAE should be reported as soon as possible, not later than within ten days of knowledge of the event. All other adverse events should be reported as soon as possible, not later than within three weeks.
Cardiac disorders Supraventricular arrythmia	1.7% 1/60 • Up to 30 days. All SAE should be reported as soon as possible, not later than within ten days of knowledge of the event. All other adverse events should be reported as soon as possible, not later than within three weeks.
Cardiac disorders Pulmonary edema	1.7% 1/60 • Up to 30 days. All SAE should be reported as soon as possible, not later than within ten days of knowledge of the event. All other adverse events should be reported as soon as possible, not later than within three weeks.
Cardiac disorders Ischemic Coronary Artery Disorder	1.7% 1/60 • Up to 30 days. All SAE should be reported as soon as possible, not later than within ten days of knowledge of the event. All other adverse events should be reported as soon as possible, not later than within three weeks.
Cardiac disorders Decreased BP	1.7% 1/60 • Up to 30 days. All SAE should be reported as soon as possible, not later than within ten days of knowledge of the event. All other adverse events should be reported as soon as possible, not later than within three weeks.
Gastrointestinal disorders Gastrointestianl Ulcers and Perforation, Site Unspecified	3.3% 2/60 • Up to 30 days. All SAE should be reported as soon as possible, not later than within ten days of knowledge of the event. All other adverse events should be reported as soon as possible, not later than within three weeks.
General disorders General Signs and Symptoms Nec	1.7% 1/60 • Up to 30 days. All SAE should be reported as soon as possible, not later than within ten days of knowledge of the event. All other adverse events should be reported as soon as possible, not later than within three weeks.
Infections and infestations Infections	6.7% 4/60 • Up to 30 days. All SAE should be reported as soon as possible, not later than within ten days of knowledge of the event. All other adverse events should be reported as soon as possible, not later than within three weeks.
Infections and infestations Lower Respiratory Tract And Lung Infections	1.7% 1/60 • Up to 30 days. All SAE should be reported as soon as possible, not later than within ten days of knowledge of the event. All other adverse events should be reported as soon as possible, not later than within three weeks.
Injury, poisoning and procedural complications Complications	20.0% 12/60 • Up to 30 days. All SAE should be reported as soon as possible, not later than within ten days of knowledge of the event. All other adverse events should be reported as soon as possible, not later than within three weeks.
Metabolism and nutrition disorders Diabetes Mellitus	1.7% 1/60 • Up to 30 days. All SAE should be reported as soon as possible, not later than within ten days of knowledge of the event. All other adverse events should be reported as soon as possible, not later than within three weeks.
Renal and urinary disorders Renal Failure and Impairment	1.7% 1/60 • Up to 30 days. All SAE should be reported as soon as possible, not later than within ten days of knowledge of the event. All other adverse events should be reported as soon as possible, not later than within three weeks.
Respiratory, thoracic and mediastinal disorders Upper Respiratory Tract Signs and Symptoms	1.7% 1/60 • Up to 30 days. All SAE should be reported as soon as possible, not later than within ten days of knowledge of the event. All other adverse events should be reported as soon as possible, not later than within three weeks.
Skin and subcutaneous tissue disorders Dermatitis Ascribed to Specific Agent	1.7% 1/60 • Up to 30 days. All SAE should be reported as soon as possible, not later than within ten days of knowledge of the event. All other adverse events should be reported as soon as possible, not later than within three weeks.

Other adverse events

Measure	All Attempted Implanted Subjects n=60 participants at risk Sixty subjects were implanted with the Evolut R valve from six centers in Australia, the United Kingdom, and New Zealand.
Blood and lymphatic system disorders Anaemias Nec	8.3% 5/60 • Up to 30 days. All SAE should be reported as soon as possible, not later than within ten days of knowledge of the event. All other adverse events should be reported as soon as possible, not later than within three weeks.
Blood and lymphatic system disorders Thrombocytopenias	3.3% 2/60 • Up to 30 days. All SAE should be reported as soon as possible, not later than within ten days of knowledge of the event. All other adverse events should be reported as soon as possible, not later than within three weeks.
Cardiac disorders Cardiac Conduction Disorders	48.3% 29/60 • Up to 30 days. All SAE should be reported as soon as possible, not later than within ten days of knowledge of the event. All other adverse events should be reported as soon as possible, not later than within three weeks.
Cardiac disorders Cardiac Disorders Nec	20.0% 12/60 • Up to 30 days. All SAE should be reported as soon as possible, not later than within ten days of knowledge of the event. All other adverse events should be reported as soon as possible, not later than within three weeks.
Cardiac disorders Heart Failure Nec	5.0% 3/60 • Up to 30 days. All SAE should be reported as soon as possible, not later than within ten days of knowledge of the event. All other adverse events should be reported as soon as possible, not later than within three weeks.
Cardiac disorders Ischemic Coronary Artery Disorders	3.3% 2/60 • Up to 30 days. All SAE should be reported as soon as possible, not later than within ten days of knowledge of the event. All other adverse events should be reported as soon as possible, not later than within three weeks.
Cardiac disorders Rate and Rhythm Disorders	6.7% 4/60 • Up to 30 days. All SAE should be reported as soon as possible, not later than within ten days of knowledge of the event. All other adverse events should be reported as soon as possible, not later than within three weeks.
Cardiac disorders Supraventricular Arrythmias	6.7% 4/60 • Up to 30 days. All SAE should be reported as soon as possible, not later than within ten days of knowledge of the event. All other adverse events should be reported as soon as possible, not later than within three weeks.
Gastrointestinal disorders Diarrhoea	5.0% 3/60 • Up to 30 days. All SAE should be reported as soon as possible, not later than within ten days of knowledge of the event. All other adverse events should be reported as soon as possible, not later than within three weeks.
Gastrointestinal disorders Gastrointestinal Atonic And Hypomobility	8.3% 5/60 • Up to 30 days. All SAE should be reported as soon as possible, not later than within ten days of knowledge of the event. All other adverse events should be reported as soon as possible, not later than within three weeks.
Gastrointestinal disorders Nausea and Vomiting	1.7% 1/60 • Up to 30 days. All SAE should be reported as soon as possible, not later than within ten days of knowledge of the event. All other adverse events should be reported as soon as possible, not later than within three weeks.
Gastrointestinal disorders Gastrointestinal Atonic And HypomobilitySigns and Symptoms Nec	3.3% 2/60 • Up to 30 days. All SAE should be reported as soon as possible, not later than within ten days of knowledge of the event. All other adverse events should be reported as soon as possible, not later than within three weeks.
General disorders Febrile Disorders	1.7% 1/60 • Up to 30 days. All SAE should be reported as soon as possible, not later than within ten days of knowledge of the event. All other adverse events should be reported as soon as possible, not later than within three weeks.
General disorders Inflammations	1.7% 1/60 • Up to 30 days. All SAE should be reported as soon as possible, not later than within ten days of knowledge of the event. All other adverse events should be reported as soon as possible, not later than within three weeks.
General disorders Complication Associated with Device Nec	1.7% 1/60 • Up to 30 days. All SAE should be reported as soon as possible, not later than within ten days of knowledge of the event. All other adverse events should be reported as soon as possible, not later than within three weeks.
Infections and infestations Infections Nec	10.0% 6/60 • Up to 30 days. All SAE should be reported as soon as possible, not later than within ten days of knowledge of the event. All other adverse events should be reported as soon as possible, not later than within three weeks.
Infections and infestations Urinary Tract Infections	13.3% 8/60 • Up to 30 days. All SAE should be reported as soon as possible, not later than within ten days of knowledge of the event. All other adverse events should be reported as soon as possible, not later than within three weeks.
Injury, poisoning and procedural complications Non-site specific Injuries Nec	10.0% 6/60 • Up to 30 days. All SAE should be reported as soon as possible, not later than within ten days of knowledge of the event. All other adverse events should be reported as soon as possible, not later than within three weeks.
Injury, poisoning and procedural complications Non-site specific Procedural Complications	13.3% 8/60 • Up to 30 days. All SAE should be reported as soon as possible, not later than within ten days of knowledge of the event. All other adverse events should be reported as soon as possible, not later than within three weeks.
Metabolism and nutrition disorders General Nutrition Disorders	28.3% 17/60 • Up to 30 days. All SAE should be reported as soon as possible, not later than within ten days of knowledge of the event. All other adverse events should be reported as soon as possible, not later than within three weeks.
Nervous system disorders Headach Nec	3.3% 2/60 • Up to 30 days. All SAE should be reported as soon as possible, not later than within ten days of knowledge of the event. All other adverse events should be reported as soon as possible, not later than within three weeks.
Nervous system disorders Neurological Signs And Symptoms Nec	1.7% 1/60 • Up to 30 days. All SAE should be reported as soon as possible, not later than within ten days of knowledge of the event. All other adverse events should be reported as soon as possible, not later than within three weeks.
Psychiatric disorders Depressive Disorders	1.7% 1/60 • Up to 30 days. All SAE should be reported as soon as possible, not later than within ten days of knowledge of the event. All other adverse events should be reported as soon as possible, not later than within three weeks.
Psychiatric disorders Mental Disorder	6.7% 4/60 • Up to 30 days. All SAE should be reported as soon as possible, not later than within ten days of knowledge of the event. All other adverse events should be reported as soon as possible, not later than within three weeks.
Renal and urinary disorders Renal Failure and Impairment	3.3% 2/60 • Up to 30 days. All SAE should be reported as soon as possible, not later than within ten days of knowledge of the event. All other adverse events should be reported as soon as possible, not later than within three weeks.
Renal and urinary disorders Urinary Abnormalities	3.3% 2/60 • Up to 30 days. All SAE should be reported as soon as possible, not later than within ten days of knowledge of the event. All other adverse events should be reported as soon as possible, not later than within three weeks.
Reproductive system and breast disorders Vulvovaginal Disorder Nec	1.7% 1/60 • Up to 30 days. All SAE should be reported as soon as possible, not later than within ten days of knowledge of the event. All other adverse events should be reported as soon as possible, not later than within three weeks.
Respiratory, thoracic and mediastinal disorders Coughing And Associated Symptoms	1.7% 1/60 • Up to 30 days. All SAE should be reported as soon as possible, not later than within ten days of knowledge of the event. All other adverse events should be reported as soon as possible, not later than within three weeks.
Respiratory, thoracic and mediastinal disorders Pneumothorax And Pleural Effusions	6.7% 4/60 • Up to 30 days. All SAE should be reported as soon as possible, not later than within ten days of knowledge of the event. All other adverse events should be reported as soon as possible, not later than within three weeks.
Skin and subcutaneous tissue disorders Dermatitis And Eczema	1.7% 1/60 • Up to 30 days. All SAE should be reported as soon as possible, not later than within ten days of knowledge of the event. All other adverse events should be reported as soon as possible, not later than within three weeks.
Skin and subcutaneous tissue disorders Subcutaneous Tissue Ulcerations	5.0% 3/60 • Up to 30 days. All SAE should be reported as soon as possible, not later than within ten days of knowledge of the event. All other adverse events should be reported as soon as possible, not later than within three weeks.
Skin and subcutaneous tissue disorders Skin injuries And Mechanical Dermatoses	6.7% 4/60 • Up to 30 days. All SAE should be reported as soon as possible, not later than within ten days of knowledge of the event. All other adverse events should be reported as soon as possible, not later than within three weeks.
Vascular disorders Vascular Hypotensive Disorders	6.7% 4/60 • Up to 30 days. All SAE should be reported as soon as possible, not later than within ten days of knowledge of the event. All other adverse events should be reported as soon as possible, not later than within three weeks.
Cardiac disorders Aortic Valvular Disorders	3.3% 2/60 • Up to 30 days. All SAE should be reported as soon as possible, not later than within ten days of knowledge of the event. All other adverse events should be reported as soon as possible, not later than within three weeks.
Cardiac disorders Ventricular Arrythmias	1.7% 1/60 • Up to 30 days. All SAE should be reported as soon as possible, not later than within ten days of knowledge of the event. All other adverse events should be reported as soon as possible, not later than within three weeks.

Additional Information

Terry Noel

Medtronic

Phone: 763-526-0309

Results disclosure agreements

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