The Medtronic CoreValve™ Evolut R™ CE Mark Clinical Study

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)

Time frame: 30 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).

Time frame: 24 hours to seven 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.

Time frame: 30 days

Population: All implanted subjects at 30 days.

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

Time frame: 30 days

Population: The number of subjects analyzed at 30 days.

Effective orifice area

Time frame: 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.

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

Time frame: 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.

Degree of Total prosthetic valve regurgitation (transvalvular & paravalvular)

Time frame: 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.

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.

Time frame: 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.

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.

Time frame: 30 days