- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01876420
The Medtronic CoreValve™ Evolut R™ CE Mark Clinical Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Victoria
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Melbourne, Victoria, Australia, 3004
- Epworth Hospital
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Melbourne, Victoria, Australia
- Monash Medical Center
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Hamilton, New Zealand
- Waikato Hospital
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Belfast, United Kingdom, BT12 6BA
- Royal Victoria Hospital
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Leeds, United Kingdom, LS1 3EX
- Leeds General Infirmary
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London, United Kingdom
- St. George's Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Severe aortic stenosis, defined as aortic valve area of < 1.0 cm2 (or aortic valve area index of < 0.6 cm2/m2) by the continuity equation, AND mean gradient > 40 mmHg or maximal aortic valve velocity > 4.0 m/sec by resting echocardiogram.
- Estimated 30 day mortality risk of > 15% by study center Heart Team assessment,33 OR at least two cardiovascular surgeons from the study center deny surgery because of prohibitive operative risk, estimated to be a combined >50% risk of irreversible mortality or morbidity.
- Symptoms of aortic stenosis, and NYHA Functional Class II or greater.
- The subject meets the legal minimum age to provide informed consent based on local regulatory requirements, and has provided written informed consent as approved by the EC/IRB of the respective clinical site.
The subject and the treating physician agree that the subject will return for all required post-procedure follow-up visits.
Exclusion Criteria:
Clinical exclusion criteria:
- Subject has been offered SAVR but has declined.
- Any condition considered a contraindication for placement of a bioprosthetic valve (e.g. subject is indicated for mechanical prosthetic valve).
- Known hypersensitivity or contraindication to Nitinol.
- Blood dyscrasias as defined: leukopenia (WBC <1000 mm3), thrombocytopenia (platelet count <50,000 cells/mm3), history of bleeding diathesis or coagulopathy, or hypercoagulable states.
- Untreated clinically significant coronary artery disease requiring revascularization.
- Severe left ventricular dysfunction with left ventricular ejection fraction (LVEF) <20% by echocardiography, contrast ventriculography, or radionuclide ventriculography.
- End stage renal disease requiring chronic dialysis of creatinine clearance < 20 cc/min.
- Ongoing sepsis, including active endocarditis.
- Any condition considered a contraindication to extracorporeal assistance.
- Any percutaneous coronary or peripheral interventional procedure with a bare metal stent performed within 30 days prior to Heart Team assessment, or within six months prior to Heart Team assessment for procedures with a drug eluting stents.
- Symptomatic carotid or vertebral artery disease or successful treatment of carotid stenosis within eight weeks of Heart Team Assessment .
- Cardiogenic shock manifested by low cardiac output, vasopressor dependence, or mechanical hemodynamic support.
- Recent (within 6 months of Heart Team assessment) cerebrovascular accident (CVA) or transient ischemic attack (TIA).
- Gastrointestinal (GI) bleeding that would preclude anticoagulation.
- Subject refuses a blood transfusion.
- Severe dementia (resulting in either inability to provide informed consent for the study/procedure, prevents independent lifestyle outside of a chronic care facility, or will fundamentally complicate rehabilitation from the procedure or compliance with follow-up visits).
- Estimated life expectancy of less than 12 months due to associated non-cardiac co-morbid conditions.
- Other medical, social, or psychological conditions that in the opinion of the Investigator precludes the subject from appropriate consent or adherence to the protocol required follow-ups exams.
- Currently participating in an investigational drug or another device study (excluding registries).
- Evidence of an acute myocardial infarction ≤30 days before the index procedure.
- Need for emergency surgery for any reason.
- Liver failure (Child-C).
Subject is pregnant or breast feeding.
Anatomical exclusion criteria:
- Pre-existing prosthetic heart valve in any position.
- Mixed aortic valve disease (aortic stenosis with moderate or severe aortic regurgitation).
- Severe mitral regurgitation.
- Severe tricuspid regurgitation.
- Moderate or severe mitral stenosis.
- Hypertrophic obstructive cardiomyopathy.
- Echocardiographic or Multi-Slice Computed Tomography (MSCT) evidence of intracardiac mass thrombus or vegetation.
- Congenital bicuspid or unicuspid valve verified by echocardiography.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: 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
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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
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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All-cause Mortality Rate at 30 Days
Time Frame: 30 days
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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)
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30 days
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Stroke Rate (Disabling and Non-disabling) at 30 Days
Time Frame: 30 days
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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.
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30 days
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Device Success Rate at 24 Hours to Seven Days
Time Frame: 24 hours to seven days
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24 hours to seven days
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
VARC II Combined Safety Endpoint at 30 Days
Time Frame: 30 days
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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.
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30 days
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Event Rates of the Individual Components of the VARC II Composite Safety Endpoint at 30 Days
Time Frame: 30 days
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The Individual components of the VARC II composite safety endpoint at 30 days per the Kaplan Meier Event Rate (%).
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30 days
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Hemodynamic Performance Metrics at 30 Days by Doppler Echocardiography - Mean Gradient
Time Frame: 30 days
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The hemodynamic performance will be measured by the Mean Prosthetic Valve Gradient for 59 subjects, measured with the Doppler echocardiography.
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30 days
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Hemodynamic Performance Metrics at 30 Days by Doppler Echocardiography - • Effective Orifice Area (EOA)
Time Frame: 30 days
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Effective orifice area
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30 days
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Hemodynamic Performance Metrics at 30 Days by Doppler Echocardiography - Total Aortic Regurgitation (Transvalvular & Paravalvular)
Time Frame: 30 days
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Degree of Total prosthetic valve regurgitation (transvalvular & paravalvular)
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30 days
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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.
Time Frame: Day 1
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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.
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Day 1
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Eric Vang, PhD, Director Clinical Research Structural Heart
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MDT10093773DOC
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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