Medtronic CoreValve Evolut R U.S. Clinical Study
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02207569|
Recruitment Status : Active, not recruiting
First Posted : August 4, 2014
Results First Posted : December 12, 2017
Last Update Posted : March 3, 2020
|Condition or disease||Intervention/treatment||Phase|
|Aortic Stenosis||Device: CoreValve Evolut R TAVR system||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||241 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Medtronic CoreValve Evolut R United States IDE Clinical Study|
|Study Start Date :||August 2014|
|Actual Primary Completion Date :||August 2015|
|Estimated Study Completion Date :||August 2020|
Experimental: CoreValve Evolut R TAVR system
The CoreValve Evolut R System is a transcatheter aortic valve implantation system comprised of the following three components:
Device: CoreValve Evolut R TAVR system
- All-cause Mortality at 30 Days by Percent [ Time Frame: Assessed at 30 days post-implantation ]Percentage of patients that died by any cause at 30 days
- Percentage of Patients With Disabling Stroke at 30 Days [ Time Frame: 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
- 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
- Percent Device Success Rate Between 24 and 7 Day [ Time Frame: 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 regurgitation
- Percentage of Patients With Less Than Moderate Prosthetic Regurgitation at Early Post Procedure Echocardiogram (24 Hours to 7 Days) [ Time Frame: 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.
- Individual Component of VARC II Safety Endpoint: Percentage of People Requiring Valve-related Dysfunction Requiring Repeat Procedure (BAV, TAVI, or SAVR) [ Time Frame: 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.
- Coronary Artery Obstruction Requiring Intervention. [ Time Frame: 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.
- Percent VARC II Combined Safety Endpoint at 30 Days [ Time Frame: 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). [ Time Frame: Assessed at 30 days post-implantation ]
Increase in serum creatinine to 200%-299% (2.0%-2.99% increase compared with baseline) OR
- 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
- Percentage of Patients With Life-threatening or Disabling Bleeding Event Rate [ Time Frame: Assessed at 30 days post-implantation ]
Fatal bleeding (BARC type 5) OR
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
Bleeding causing hypovolemic shock or severe hypotension requiring vasopressors or surgery (BARC type 3b) OR
- 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 Rate of Patients Who Received New Permanent Pacemaker Implant at 30 Days [ Time Frame: Assessed at 30 days ]Percent of patients who underwent implantation of new permanent pacemaker or ICD during or after index procedure
- Percent Resheath and Recapture Success Rate [ Time Frame: 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 [ Time Frame: Assessed at baseline, 30 days, 6 months, and 1 year ]Mean gradient by Doppler echocardiography.
- Major Vascular Complication [ Time Frame: Assessed at 30 days post-implantation ]
Any aortic dissection, aortic rupture, annulus rupture, left ventricle perforation, or new apical aneurysm/pseudoaneurysm OR
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
Distal embolization (noncerebral) from a vascular source requiring surgery or resulting in amputation or irreversible end-organ damage OR
The use of unplanned endovascular or surgery associated with death, major bleeding, visceral ischemia or neurological impairment OR
Any new ipsilateral lower extremity ischemia documented by patient symptoms, physical exam, and/or decreased or absent blood flow on lower extremity angiogram OR
Surgery for access site nerve injury OR
- Permanent access related nerve injury
- Hemodynamic Performance - Aortic Valve Area [ Time Frame: 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 [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02207569
|Principal Investigator:||Jeffrey J Popma, MD||Beth Israel Deaconess Medical Center|
|Principal Investigator:||Mathew R Williams, MD||New York Langone Medical Center|