Medtronic CoreValve Evolut R U.S. Clinical Study
- Conditions
- Aortic Stenosis
- Interventions
- Device: CoreValve Evolut R TAVR system
- Registration Number
- NCT02207569
- Lead Sponsor
- Medtronic Cardiovascular
- Brief Summary
The study objectives are to assess the safety and efficacy of the CoreValve Evolut R transcatheter aortic valve replacement (TAVR) system in patients with severe symptomatic aortic stenosis are considered at high or extreme risk for surgical aortic valve replacement.
- Detailed Description
This objective will be accomplished by a prospective, single arm, historical controlled, multi-site study involving a minimum of 150 implanted subjects with no more than 250 implanted subjects at up to 25 study sites in the United States. Procedural and 30 day safety and efficacy results from this study will be compared to appropriate historical control data for the Medtronic CoreValve System. Subjects will be followed up to 5 years following implantation.
The enrollment phase of the study is estimated to take approximately 6-9 months. As each implanted subject is to be followed up to 5 years, the estimated study duration is approximately 66-69 months, excluding the time required for preparing the final report.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 241
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description CoreValve Evolut R TAVR system CoreValve Evolut R TAVR system The CoreValve Evolut R System is a transcatheter aortic valve implantation system comprised of the following three components: 1. Evolut R Transcatheter Aortic Valve (TAV) 2. EnVeo R Delivery Catheter System (DCS) with EnVeo R InLine Sheath 3. EnVeo R Loading System (LS)
- Primary Outcome Measures
Name Time Method Percentage of Patients With Disabling Stroke at 30 Days Assessed at 30 days post-implantation 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 baselineAll-cause Mortality at 30 Days by Percent Assessed at 30 days post-implantation Percentage of patients that died by any cause at 30 days
Percent Device Success Rate Between 24 and 7 Day Assessed at 24 hours to seven days post implantation 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 regurgitationPercentage of Patients With Less Than Moderate Prosthetic Regurgitation at Early Post Procedure Echocardiogram (24 Hours to 7 Days) Assessed at 24 hours to 7 days post implantation 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.
- Secondary Outcome Measures
Name Time Method Coronary Artery Obstruction Requiring Intervention. Assessed at 30 days post-implantation 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.
Hemodynamic Performance - Aortic Valve Area Assessed at baseline, 30 days, 6 months, and 1 year Hemodynamic performance by Doppler echocardiography - Aortic Valve Area cm2
Hemodynamic Performance: Total Prosthetic Valve Regurgitation Graded as Moderate or Severe Assessed at 30 days, 6 months, and 1 year Hemodynamic performance: the percent of patients who have a degree of total prosthetic valve regurgitation that is moderate or severe.
Individual Component of VARC II Safety Endpoint: Percentage of People Requiring Valve-related Dysfunction Requiring Repeat Procedure (BAV, TAVI, or SAVR) Assessed at 30 days post-implantation Percentage of patients with any valve dysfunction that requires repeat procedure (e.g. balloon valvuloplasty, TAVI, or surgical AVR), per VARC II definition.
Percent VARC II Combined Safety Endpoint at 30 Days Assessed at 30 days post-implantation 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)Percent of Patients With Acute Kidney Injury: Stage 2 or 3 (Including Renal Replacement Therapy). Assessed at 30 days post-implantation 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 hPercent Rate of Patients Who Received New Permanent Pacemaker Implant at 30 Days Assessed at 30 days Percent of patients who underwent implantation of new permanent pacemaker or ICD during or after index procedure
Percentage of Patients With Life-threatening or Disabling Bleeding Event Rate Assessed at 30 days post-implantation 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)Percent Resheath and Recapture Success Rate Assessed intra-procedurally 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.
Hemodynamic Performance -Mean Gradient Assessed at baseline, 30 days, 6 months, and 1 year Mean gradient by Doppler echocardiography.
Major Vascular Complication Assessed at 30 days post-implantation 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
Trial Locations
- Locations (23)
New York Langone Medical Center
🇺🇸New York, New York, United States
The Mount Sinai Medical Center
🇺🇸New York, New York, United States
Columbia University Medical Center
🇺🇸New York, New York, United States
Pinnacle Health
🇺🇸Wormleysburg, Pennsylvania, United States
University of Southern California
🇺🇸Los Angeles, California, United States
St. Vincent Heart Center of Indiana/The Care Group, LLC
🇺🇸Indianapolis, Indiana, United States
Beth Israel Deaconcess Medical Center
🇺🇸Boston, Massachusetts, United States
Detroit Medical Center Cardiovascular Institute
🇺🇸Detroit, Michigan, United States
University of Pittsburg Medical Center
🇺🇸Pittsburgh, Pennsylvania, United States
Banner Good Samaritan Medical Center
🇺🇸Phoenix, Arizona, United States
Washington Hospital Center/Medstar
🇺🇸Washington, District of Columbia, United States
University of Kansas
🇺🇸Kansas City, Kansas, United States
The Johns Hopkins University
🇺🇸Baltimore, Maryland, United States
Morristown Memorial Hospital
🇺🇸Morristown, New Jersey, United States
St. Francis Hospital
🇺🇸Roslyn, New York, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
Riverside Methodist Hospital/Ohio Health Research Institute
🇺🇸Columbus, Ohio, United States
Baylor Heart and Vascular Hospital
🇺🇸Dallas, Texas, United States
Aurora Health Care/St Luke's Medical Center
🇺🇸Milwaukee, Wisconsin, United States
The Methodist DeBakey Heart & Vasc Ctr/The Methodist Hosp
🇺🇸Houston, Texas, United States
Yale New Haven Hospital
🇺🇸New Haven, Connecticut, United States
University of Michigan Health Systems
🇺🇸Ann Arbor, Michigan, United States
Spectrum Health
🇺🇸Grand Rapids, Michigan, United States