The Medtronic CoreValve™ Evolut R™ CE Mark Clinical Study

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Medtronic
Information provided by (Responsible Party):
Medtronic Cardiovascular
ClinicalTrials.gov Identifier:
NCT01876420
First received: June 5, 2013
Last updated: August 10, 2014
Last verified: August 2014
  Purpose

To assess the safety and clinical performance of the CoreValve™ Evolut R™ System.


Condition Intervention Phase
Aortic Stenosis
Device: The CoreValve™ Evolut R TAV™ system
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Medtronic CoreValve™ Evolut R™ CE Mark Clinical Study

Resource links provided by NLM:


Further study details as provided by Medtronic Cardiovascular:

Primary Outcome Measures:
  • All-cause mortality rate at 30 days [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
    All-cause mortality rate at 30 days

  • Stroke rate (disabling and non-disabling) at 30 days [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
    Stroke rate (disabling and non-disabling) at 30 days

  • Device success rate at 24 hours to seven days [ Time Frame: 24 hours to seven days ] [ Designated as safety issue: Yes ]
    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).


Secondary Outcome Measures:
  • Event rate of the VARC II Combined Safety Endpoint at 30 days [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
    • 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)

  • Event rates of the individual components of the VARC II composite safety endpoint at 30 days [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
    Event rates of the individual components of the VARC II composite safety endpoint at 30 days

  • 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 ] [ Designated as safety issue: No ]
    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.

  • Hemodynamic performance metrics at 30 days by Doppler echocardiography [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    • Mean prosthetic valve gradient
    • Effective orifice area
    • Degree of prosthetic valve regurgitation (transvalvular, paravalvular, and total)


Estimated Enrollment: 60
Study Start Date: October 2013
Estimated Study Completion Date: September 2016
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Device: 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
Other Names:
  • The CoreValve™ Evolut R TAV™ system is a recapturable transcatheter aortic valve implantation (TAVI) system comprised of the following three components:
  • 1) CoreValve™ Evolut R™ Transcatheter Aortic Valve (Evolut R™ TAV)
  • 2) Enveo R™ Delivery Catheter System (DCS) with Enveo InLine™ Sheath
  • 3) EnVeo R™ Loading System (LS)

Detailed Description:

The study objectives are to assess the safety and clinical performance of the CoreValve™ Evolut R™ System in patients with severe symptomatic aortic stenosis who are considered at high through extreme risk for surgical aortic valve replacement. These objectives will be accomplished by a prospective clinical study involving up to 60 implanted subjects among up to six study centers.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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.
  2. 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.
  3. Symptoms of aortic stenosis, and NYHA Functional Class II or greater.
  4. 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.
  5. 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:

  6. Subject has been offered SAVR but has declined.
  7. Any condition considered a contraindication for placement of a bioprosthetic valve (e.g. subject is indicated for mechanical prosthetic valve).
  8. Known hypersensitivity or contraindication to Nitinol.
  9. Blood dyscrasias as defined: leukopenia (WBC <1000 mm3), thrombocytopenia (platelet count <50,000 cells/mm3), history of bleeding diathesis or coagulopathy, or hypercoagulable states.
  10. Untreated clinically significant coronary artery disease requiring revascularization.
  11. Severe left ventricular dysfunction with left ventricular ejection fraction (LVEF) <20% by echocardiography, contrast ventriculography, or radionuclide ventriculography.
  12. End stage renal disease requiring chronic dialysis of creatinine clearance < 20 cc/min.
  13. Ongoing sepsis, including active endocarditis.
  14. Any condition considered a contraindication to extracorporeal assistance.
  15. 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.
  16. Symptomatic carotid or vertebral artery disease or successful treatment of carotid stenosis within eight weeks of Heart Team Assessment .
  17. Cardiogenic shock manifested by low cardiac output, vasopressor dependence, or mechanical hemodynamic support.
  18. Recent (within 6 months of Heart Team assessment) cerebrovascular accident (CVA) or transient ischemic attack (TIA).
  19. Gastrointestinal (GI) bleeding that would preclude anticoagulation.
  20. Subject refuses a blood transfusion.
  21. 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).
  22. Estimated life expectancy of less than 12 months due to associated non-cardiac co-morbid conditions.
  23. 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.
  24. Currently participating in an investigational drug or another device study (excluding registries).
  25. Evidence of an acute myocardial infarction ≤30 days before the index procedure.
  26. Need for emergency surgery for any reason.
  27. Liver failure (Child-C).
  28. Subject is pregnant or breast feeding.

    Anatomical exclusion criteria:

  29. Pre-existing prosthetic heart valve in any position.
  30. Mixed aortic valve disease (aortic stenosis with moderate or severe aortic regurgitation).
  31. Severe mitral regurgitation.
  32. Severe tricuspid regurgitation.
  33. Moderate or severe mitral stenosis.
  34. Hypertrophic obstructive cardiomyopathy.
  35. Echocardiographic or Multi-Slice Computed Tomography (MSCT) evidence of intracardiac mass thrombus or vegetation.
  36. Congenital bicuspid or unicuspid valve verified by echocardiography.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01876420

Locations
Australia, Victoria
Monash Medical Center
Melbourne, Victoria, Australia
Epworth Hospital
Melbourne, Victoria, Australia, 3004
New Zealand
Waikato Hospital
Hamilton, New Zealand
United Kingdom
Royal Victoria Hospital
Belfast, United Kingdom, BT12 6BA
Leeds General Infirmary
Leeds, United Kingdom, LS1 3EX
St. George's Hospital
London, United Kingdom
Sponsors and Collaborators
Medtronic Cardiovascular
Medtronic
Investigators
Study Director: Eric Vang, PhD Director Clinical Research Structural Heart
  More Information

No publications provided

Responsible Party: Medtronic Cardiovascular
ClinicalTrials.gov Identifier: NCT01876420     History of Changes
Other Study ID Numbers: MDT10093773DOC
Study First Received: June 5, 2013
Last Updated: August 10, 2014
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
Australia: Department of Health and Ageing Therapeutic Goods Administration
New Zealand: Medsafe

Additional relevant MeSH terms:
Aortic Valve Stenosis
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction

ClinicalTrials.gov processed this record on August 26, 2014