Medtronic CoreValve Evolut R U.S. Clinical Study

Percentage of patients that died by any cause at 30 days

Time frame: Assessed at 30 days post-implantation

Population: All subjects who are brought into the procedure room and any of the following have occurred: anesthesia administered, vascular line placed, TEE placed, or any monitoring line placed.

Stroke Diagnostic Criteria: \> Acute episode of focal or global neurological deficit with at least 2 of the following: * change in level of consciousness \> * hemiplegia, hemiparesis * numbness or sensory loss affecting 1 side \> * dysphasia or aphasia * hemianopia * amaurosis fugax \> * other neurological signs or symptoms consistent with stroke 2.) No other readily identifiable non-stroke cause or the clinical presentation, to be determined by or in conjunctions with the designated neurologist 3.) Confirmation of the diagnosis by at least 1 of the following: * Neurological specialist \> * Neuroimaging procedure, or on clincial grounds alone \> Stroke: durations of neural deficit \> 24 h if available neuroimaging documents a new hemofrrhage or infarct; or the neurological deficit results in death Defined by VARC II: \> An mRS (Modified Rankin Score) of 2 or more at 90 days and an increase in at least 1 mRS category from pre-stroke baseline

Time frame: Assessed at 30 days post-implantation

Population: All subjects who are brought into the procedure room and any of the following have occurred: anesthesia administered, vascular line placed, TEE placed, or any monitoring line placed.

Percentage of patience with none, trace or mild total prosthetic regurgitation at early post procedure echo cardiogram (24 hours to 7 days) as evaluated by echo core lab.

Time frame: Assessed at 24 hours to 7 days post implantation

Population: Subset includes all subjects who are implanted with the Evolut R TAV, defined as the Evolut R TAV is placed in the aortic annulus and completely released from the Enveo catheter delivery system

Percentage of patients with Device Success defined as: * Absence of procedural mortality, AND * Correct positioning of a single Evolut R valve into the proper anatomical location, AND * Absence of patient-prosthesis mismatch, and mean gradient , 20 mm Hg (or peak velocity \< 3m/sec, AND * Absence of moderate or severe prosthetic valve regurgitation

Time frame: Assessed at 24 hours to seven days post implantation

Population: All subjects implanted with the Evolut R TAV, defined as the Evolut R TAV is placed in the aortic annulus and completely released from the Enveo catheter delivery system

Angiographic or echocardiographic evidence of a new, partial or complete, obstruction of a coronary ostium, either by the Evolut R prosthesis itself, the native leaflets, calcifications, or dissection, occurring during or after the TAVI procedure.

Time frame: Assessed at 30 days post-implantation

Population: All subjects who are brought into the procedure room and any of the following have occurred: anesthesia administered, vascular line placed, TEE placed, or any monitoring line placed.

Hemodynamic performance by Doppler echocardiography - Aortic Valve Area cm2

Time frame: Assessed at baseline, 30 days, 6 months, and 1 year

Population: The hemodynamic performance subset includes all subjects implanted with the Evolut R TAV for more than 24 hours post implantation - only subjects with echo can be analyzed.

Mean gradient by Doppler echocardiography.

Time frame: Assessed at baseline, 30 days, 6 months, and 1 year

Population: The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the Evolut R system. Only subjects with echo can be analyzed.

Hemodynamic performance: the percent of patients who have a degree of total prosthetic valve regurgitation that is moderate or severe.

Time frame: Assessed at 30 days, 6 months, and 1 year

Population: The hemodynamic performance subset includes all subjects implanted with the Evolut R TAV for more than 24 hours post implantation. Only subjects with echo can be analyzed.

Percentage of patients with any valve dysfunction that requires repeat procedure (e.g. balloon valvuloplasty, TAVI, or surgical AVR), per VARC II definition.

Time frame: Assessed at 30 days post-implantation

Population: The safety subset includes all subjects who are brought into the procedure room and any of the following have occurred: anesthesia administered, vascular line placed, or any monitoring line placed.

1. Any aortic dissection, aortic rupture, annulus rupture, left ventricle perforation, or new apical aneurysm/pseudoaneurysm OR \> 2. Access-related vascular injury (dissection, stenosis, perforation, rupture, arterio-venous fistula, pseudoaneurysm, hematoma, irreversible nerve injury, compartment syndrome, percutaneous closure device failure) leading to death, life-threatening or major bleeding, visceral ischemia, or neurological impairment OR \> 3. Distal embolization (noncerebral) from a vascular source requiring surgery or resulting in amputation or irreversible end-organ damage OR \> 4. The use of unplanned endovascular or surgery associated with death, major bleeding, visceral ischemia or neurological impairment OR \> 5. Any new ipsilateral lower extremity ischemia documented by patient symptoms, physical exam, and/or decreased or absent blood flow on lower extremity angiogram OR \> 6. Surgery for access site nerve injury OR \> 7. Permanent access related nerve injury

Time frame: Assessed at 30 days post-implantation

Population: The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the Evolut R system.

1. Fatal bleeding (BARC type 5) OR \> 2. Bleeding in a critical organs, such as intracranial, intraspinal, \> intraocular, or pericardial necessitating pericardiocentesis, or intramuscular with compartment syndrome (BARC type 3b and 3c) OR \> 3. Bleeding causing hypovolemic shock or severe hypotension requiring vasopressors or surgery (BARC type 3b) OR \> 4. Overt source of bleeding with drop in hemoglobin ≥5 g/dL or whole blood or packed red blood cells (RBCs) transfusion ≥4 units\* \> (BARC type 3b)

Time frame: Assessed at 30 days post-implantation

Population: All subjects who are brought into the procedure room and any of the following have occurred: anesthesia administered, vascular line placed, TEE placed, or any monitoring line placed.

Stage 2 1. Increase in serum creatinine to 200%-299% (2.0%-2.99% increase compared with baseline) OR \> 2. Urine output \<0.5 mL/kg/h for \>12 but \<24 h \> Stage 3 \> 1\) Increase in serum creatinine to ≥300% (\>3 x increase compared with baseline) OR serum creatinine of ≥4.0 mg/dL (≥354 mmol/L) with an acute increase of at least 0.5 mg/dL (44 mmol/L) OR * Urine output \<0.3 ml/kg/h for ≥24 h OR \> * Anuria for ≥12 h

Time frame: Assessed at 30 days post-implantation

Population: All subjects who are brought into the procedure room and any of the following have occurred: anesthesia administered, vascular line placed, TEE placed, or any monitoring line placed.

Percent of patients who underwent implantation of new permanent pacemaker or ICD during or after index procedure

Time frame: Assessed at 30 days

Population: All subjects who are brought into the procedure room and any of the following have occurred: anesthesia administered, vascular line placed, TEE placed, or any monitoring line placed. Additionally, these patients did NOT have ICD or PPM at the time of the index procedure.

Resheath or recapture success rate (where attempted) where a successful resheath is defined as the intended portion of the Evolut R is resheathed into the capsule of the delivery catheter to the intended amount, as verified by flouroscopy; and a successful recapture is defined as the entire Evolut R TAV (including the frame) is full resheathed into the capsule of the delivery catheter until there is no gap between the capsule and the tip , as verified by flouroscopy. Resheath or recapture wa attempted in a subset of patients. Success rate is calculated as successful resheath or recaputure events in the number of total events. Resheath anad recapture is only possible during the index procedure.

Time frame: Assessed intra-procedurally

Population: 65 patients had resheath or recapture feature used during the 241 attempted procedures.

VARC II composite safety endpoint rate includes percent freedom from the following components: * All-cause mortality * All stroke (disabling and non-disabling) * Life-threatening bleeding * Acute kidney injury: stage 2 or 3 (including renal replacement therapy). * Coronary artery obstruction requiring intervention. * Major vascular complication. * Valve-related dysfunction requiring repeat procedure (BAV, TAVI, or SAVR)

Time frame: Assessed at 30 days post-implantation

Population: All subjects who are brought into the procedure room and any of the following have occurred: anesthesia administered, vascular line placed, TEE placed, or any monitoring line placed.