Safety and Efficacy Continued Access Study of the Medtronic CoreValve® System in the Treatment of Symptomatic Severe Aortic Stenosis in Very High Risk Subjects and High Risk Subjects Who Need Aortic Valve Replacement
NCT ID: NCT01531374
Last Updated: 2022-10-25
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
2777 participants
INTERVENTIONAL
2012-02-21
2019-11-18
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Safety & Efficacy Study of the Medtronic CoreValve® System-Treatment of Symptomatic Severe Aortic Stenosis With Significant Comorbidities in Extreme Risk Subjects Who Need Aortic Valve Replacement
NCT01675440
Safety and Efficacy Study of the Medtronic CoreValve® System in the Treatment of Severe, Symptomatic Aortic Stenosis in Intermediate Risk Subjects Who Need Aortic Valve Replacement (SURTAVI).
NCT01586910
CoreValve Advance International Post Market Study
NCT01074658
Assessment of Arrhythmias in Patients Undergoing Transcatheter Aortic Valve Implantation Using a Small Insertable Cardiac Monitoring Device
NCT02559011
Medtronic Evolut Transcatheter Aortic Valve Replacement in Low Risk Patients
NCT02701283
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Extreme Risk: TAVI Iliofemoral
Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Iliofemoral Access
Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
Extreme Risk: TAVI Non-Iliofemoral
Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Non-Iliofemoral Access
Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
High Risk: TAVI
High Risk Surgical Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
OR
Extreme Risk: Subject must have co-morbidities such that one cardiologist and two cardiac surgeons agree that medical factors preclude operation, based on a conclusion that the probability of death or serious morbidity exceeds the probability of meaningful improvement. Specifically, the predicted operative risk of death or serious, irreversible morbidity is ≥ 50% at 30 days.
2. Subject has senile degenerative aortic valve stenosis with:
* Mean gradient \> 40 mmHg, or jet velocity greater than 4.0 m/sec by either resting or dobutamine stress echocardiogram, or simultaneous pressure recordings at cardiac catheterization (either resting or dobutamine stress), AND
* An initial aortic valve area of ≤ 0.8 cm2 (or aortic valve area index ≤ 0.5 cm2/m2) by resting echocardiogram or simultaneous pressure recordings at cardiac catheterization
3. Subject is symptomatic from his/her aortic valve stenosis, as demonstrated by New York Heart Association (NYHA) Functional Class II or greater.
4. The subject or the subject's legal representative has been informed of the nature of the trial, agrees to its provisions and has provided written informed consent as approved by the 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
1. Evidence of an acute myocardial infarction ≤ 30 days before the intended treatment.
2. Any percutaneous coronary or peripheral interventional procedure performed within 30 days prior to the MCS TAVI procedure including bare metal and drug eluting stents.
3. Blood dyscrasias as defined: leukopenia (WBC \< 1000mm3), thrombocytopenia (platelet count \<50,000 cells/mm3), history of bleeding diathesis or coagulopathy.
4. Untreated clinically significant coronary artery disease requiring revascularization.
5. Cardiogenic shock manifested by low cardiac output, vasopressor dependence, or mechanical hemodynamic support.
6. Need for emergency surgery for any reason.
7. Severe ventricular dysfunction with left ventricular ejection fraction (LVEF) \< 20% as measured by resting echocardiogram.
8. Recent (within 6 months) cerebrovascular accident (CVA) or transient ischemic attack (TIA).
9. End stage renal disease requiring chronic dialysis or creatinine clearance \< 20 cc/min.
10. Active GI bleeding that would preclude anticoagulation.
11. A known hypersensitivity or contraindication to any of the following which cannot be adequately pre-medicated:
* Aspirin
* Heparin (HIT/HITTS) and bivalirudin
* Nitinol (titanium or nickel)
* Ticlopidine and clopidogrel
* Contrast media
12. Ongoing sepsis, including active endocarditis.
13. Subject refuses a blood transfusion.
14. Life expectancy \< 12 months due to associated non-cardiac co-morbid conditions.
15. Other medical, social, or psychological conditions that in the opinion of an Investigator precludes the subject from appropriate consent.
16. Severe dementia (resulting in either inability to provide informed consent for the trial/procedure, prevents independent lifestyle outside of a chronic care facility, or will fundamentally complicate rehabilitation from the procedure or compliance with follow-up visits).
17. Currently participating in an investigational drug or another device trial.
18. Symptomatic carotid or vertebral artery disease.
Anatomical
19. High Risk:Native aortic annulus size \< 20 mm or \> 29 mm per the baseline diagnostic imaging (until 23mm valve enrollment completion/closure in the CoreValve® US Pivotal Trial-High Risk Cohort)
OR
Extreme Risk: Native aortic annulus size \< 18 mm or \> 29 mm per the baseline diagnostic imaging. (High risk and extreme risk upon 23mm valve enrollment completion/closure in the CoreValve® US Pivotal Trial-High Risk Cohort)
20. Pre-existing prosthetic heart valve any position.
21. Mixed aortic valve disease (aortic stenosis and aortic regurgitation with predominant aortic regurgitation (3-4+)).
22. Moderate to severe (3-4+) or severe (4+) mitral or severe (4+) tricuspid regurgitation.
23. Moderate to severe mitral stenosis.
24. Hypertrophic obstructive cardiomyopathy.
25. Echocardiographic evidence of new or untreated intracardiac mass, thrombus or vegetation.
26. Severe basal septal hypertrophy with an outflow gradient.
27. Aortic root angulation (angle between plane of aortic valve annulus and horizontal plane/vertebrae) \> 70° (for femoral and left subclavian/axillary access) and \> 30° (for right subclavian/axillary access).
28. Ascending aorta diameter \>43 mm if the aortic annulus diameter is 23-29 mm; ascending aortic diameter \> 40 mm if the aortic annulus diameter is 20-23 mm; or an ascending aorta diameter \> 34 mm if the aortic annulus diameter is 18-20 mm (Extreme Risk only until 23 mm valve enrollment completion/closure in the CoreValve® US Pivotal Trial-High Risk Cohort).
29. Congenital bicuspid or unicuspid valve verified by echocardiography.
30. Sinus of valsalva anatomy that would prevent adequate coronary perfusion.
Vascular
31. Transarterial access not able to accommodate an 18Fr sheath.
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Medtronic Cardiovascular
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
David H Adams, MD
Role: PRINCIPAL_INVESTIGATOR
Icahn School of Medicine at Mount Sinai
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Banner Good Samaritan
Phoenix, Arizona, United States
University of Southern California University Hospital
Los Angeles, California, United States
Kaiser Permanente - Los Angeles Medical Center
Los Angeles, California, United States
El Camino Hospital
Mountain View, California, United States
VA Palo Alto Health Care System
Palo Alto, California, United States
Hartford Hospital
Hartford, Connecticut, United States
Yale New Haven Hospital
New Haven, Connecticut, United States
Washington Hospital Center / Georgetown Hospital
Washington D.C., District of Columbia, United States
University of Miami Health System / Jackson Memorial Hospital
Miami, Florida, United States
Mount Sinai Medical Center
Miami Beach, Florida, United States
Piedmont Heart Institute
Atlanta, Georgia, United States
Saint Joseph's Hospital of Atlanta
Atlanta, Georgia, United States
Loyola University Medical Center
Maywood, Illinois, United States
St. Vincent Heart Center of Indiana
Indianapolis, Indiana, United States
Iowa Heart Center
Des Moines, Iowa, United States
University of Kansas Hospital
Kansas City, Kansas, United States
Cardiovascular Institute of the South/Terrebonne General
Houma, Louisiana, United States
Johns Hopkins Hospital
Baltimore, Maryland, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
University of Michigan Health Systems
Ann Arbor, Michigan, United States
Detroit Medical Center Cardiovascular Institute
Detroit, Michigan, United States
St. John Hospital and Medical Center
Detroit, Michigan, United States
Spectrum Health Hospitals
Grand Rapids, Michigan, United States
Morristown Memorial Hospital
Morristown, New Jersey, United States
North Shore University Hospital/ Long Island Jewish Hospital
Manhasset, New York, United States
NYU Langone Medical Center
New York, New York, United States
The Mount Sinai Medical Center
New York, New York, United States
Lenox Hill Hospital
New York, New York, United States
St. Francis Hospital
Roslyn, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
Wake Forest University - Baptist Medical Center
Winston-Salem, North Carolina, United States
University Hospitals - Case Medical Center
Cleveland, Ohio, United States
The Ohio State University Medical Center - The Richard M. Ross Heart Hospital
Columbus, Ohio, United States
Riverside Methodist Hospital
Columbus, Ohio, United States
Geisinger Medical Center
Danville, Pennsylvania, United States
Pinnacle Health
Harrisburg, Pennsylvania, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Baylor Heart and Vascular Hospital
Dallas, Texas, United States
Texas Heart Institute at St. Luke's Episcopal Hospital
Houston, Texas, United States
The Methodist Hospital - The Methodist DeBakey Heart & Vascular Center
Houston, Texas, United States
University of Vermont Medical Center
Burlington, Vermont, United States
Inova Fairfax Hospital
Falls Church, Virginia, United States
Providence Sacred Heart Medical Center
Spokane, Washington, United States
St. Luke's Medical Center - Aurora Health Care
Milwaukee, Wisconsin, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Yakubov SJ, Van Mieghem NM, Oh JK, Ito S, Grubb KJ, O'Hair D, Forrest JK, Gada H, Mumtaz M, Deeb GM, Tang GHL, Rovin JD, Jain R, Windecker S, Skelding KA, Kleiman NS, Chetcuti SJ, Dedrick A, Boatman SV, Popma JJ, Reardon MJ. Impact of Transcatheter or Surgical Aortic Valve Performance on 5-Year Outcomes in Patients at >/= Intermediate Risk. J Am Coll Cardiol. 2025 Apr 8;85(13):1419-1430. doi: 10.1016/j.jacc.2025.02.009. Epub 2025 Mar 9.
Klautz RJM, Rao V, Reardon MJ, Deeb GM, Dagenais F, Moront MG, Little SH, Labrousse L, Patel HJ, Ito S, Li S, Sabik JF 3rd, Oh JK. Examining the typical hemodynamic performance of nearly 3000 modern surgical aortic bioprostheses. Eur J Cardiothorac Surg. 2024 May 3;65(5):ezae122. doi: 10.1093/ejcts/ezae122.
O'Hair D, Yakubov SJ, Grubb KJ, Oh JK, Ito S, Deeb GM, Van Mieghem NM, Adams DH, Bajwa T, Kleiman NS, Chetcuti S, Sondergaard L, Gada H, Mumtaz M, Heiser J, Merhi WM, Petrossian G, Robinson N, Tang GHL, Rovin JD, Little SH, Jain R, Verdoliva S, Hanson T, Li S, Popma JJ, Reardon MJ. Structural Valve Deterioration After Self-Expanding Transcatheter or Surgical Aortic Valve Implantation in Patients at Intermediate or High Risk. JAMA Cardiol. 2023 Feb 1;8(2):111-119. doi: 10.1001/jamacardio.2022.4627.
Butala NM, Song Y, Shen C, Cohen DJ, Yeh RW. Effect of intensive versus limited monitoring on clinical trial conduct and outcomes: A randomized trial. Am Heart J. 2022 Jan;243:77-86. doi: 10.1016/j.ahj.2021.09.002. Epub 2021 Sep 14.
Pineda AM, Kevin Harrison J, Kleiman NS, Reardon MJ, Conte JV, O'Hair DP, Chetcuti SJ, Huang J, Yakubov SJ, Popma JJ, Beohar N. Clinical impact of baseline chronic kidney disease in patients undergoing transcatheter or surgical aortic valve replacement. Catheter Cardiovasc Interv. 2019 Mar 1;93(4):740-748. doi: 10.1002/ccd.27928. Epub 2018 Oct 20.
Kleiman NS, Maini BJ, Reardon MJ, Conte J, Katz S, Rajagopal V, Kauten J, Hartman A, McKay R, Hagberg R, Huang J, Popma J; CoreValve Investigators. Neurological Events Following Transcatheter Aortic Valve Replacement and Their Predictors: A Report From the CoreValve Trials. Circ Cardiovasc Interv. 2016 Sep;9(9):e003551. doi: 10.1161/CIRCINTERVENTIONS.115.003551.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
10037989DOC REV 1C
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.