RECRUITING

The ENCIRCLE Trial

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Conditions

Mitral RegurgitationMitral Valve Insufficiency

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This study will establish the safety and effectiveness of the SAPIEN M3 System in subjects with symptomatic, at least 3+ mitral regurgitation (MR) for whom commercially available surgical or transcatheter treatment options are deemed unsuitable. Following completion of enrollment, subjects will be eligible for enrollment in the continued access phase of the trial.

Official Title

SAPIEN M3 System Transcatheter Mitral Valve Replacement Via Transseptal Access

Quick Facts

Study Start:2020-11-12
Study Completion:2031-02
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04153292

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. 18 years of age or older
  2. 2. MR ≥ 3+
  3. 3. NYHA functional class ≥ II
  4. 4. Per the Heart Team, commercially available surgical or transcatheter treatment options are deemed unsuitable due to clinical, anatomic or technical considerations.
  5. 5. Subject's heart failure management has been optimized based on subject characteristics and applicable guidelines, and stable for at least 30 days prior to enrollment.
  6. 6. The subject or subject's legal representative has been informed of the nature of the study, agrees to its provisions and has provided written informed consent.
  1. 1. Mitral/cardiac anatomy that would preclude appropriate delivery and deployment of the SAPIEN M3 dock or valve
  2. 2. Inappropriate anatomy for femoral introduction and delivery of the SAPIEN M3 dock and valve
  3. 3. Presence of any device that will contact or interfere with the SAPIEN M3 System during delivery or after implantation
  4. 4. Left ventricular ejection fraction \<25%
  5. 5. Severe right ventricular dysfunction
  6. 6. Need for aortic, tricuspid or pulmonic valve intervention within the next 12 months
  7. 7. History of heart transplant
  8. 8. Cardiac imaging evidence of intracardiac mass, thrombus or vegetation
  9. 9. Active bacterial endocarditis within 180 days of the procedure
  10. 10. Hemodynamic instability requiring inotropic or mechanical support within 30 days of the procedure
  11. 11. Myocardial infarction within 30 days of the procedure
  12. 12. Clinically significant untreated coronary artery disease requiring revascularization
  13. 13. Any percutaneous cardiovascular intervention, cardiovascular surgery, or carotid surgery within 30 days of the procedure
  14. 14. Stroke or transient ischemic attack within 90 days of the procedure
  15. 15. Irreversible, severe pulmonary hypertension
  16. 16. Chronic obstructive pulmonary disease requiring home oxygen therapy or chronic outpatient oral steroid use
  17. 17. Renal insufficiency or receiving renal replacement therapy
  18. 18. Liver disease
  19. 19. Planned surgery within the next 12 months
  20. 20. Inability to tolerate or a medical condition precluding treatment with antithrombotic therapy, including heparin administration during the procedure
  21. 21. Active infection requiring current antibiotic therapy
  22. 22. Active SARS-CoV-2 infection (Coronavirus-19 \[COVID-19\]) or previously diagnosed with COVID-19 with sequelae that could confound endpoint assessments
  23. 23. Leukopenia, anemia, thrombocytopenia, history of bleeding diathesis or coagulopathy or hypercoagulable states
  24. 24. Refusal of blood products
  25. 25. Female who is pregnant or lactating
  26. 26. Estimated life expectancy \<12 months due to non-cardiac conditions
  27. 27. Participating in another investigational drug or device study that has not reached its primary endpoint
  28. 28. Subject considered to be part of a vulnerable population

Contacts and Locations

Study Contact

Edwards THV Clinical Affairs
CONTACT
+1 (949) 250-2500
THV_CT.gov@Edwards.com

Principal Investigator

John Webb, MD
PRINCIPAL_INVESTIGATOR
St. Paul's Hospital
Mayra Guerrero, MD
PRINCIPAL_INVESTIGATOR
Mayo Clinic
David Daniels, MD
PRINCIPAL_INVESTIGATOR
California Pacific Medical Center

Study Locations (Sites)

Heart Center Hospital
Huntsville, Alabama, 35801
United States
Banner University Medical Center
Phoenix, Arizona, 85006
United States
Arizona Cardiovascular Research Center
Phoenix, Arizona, 85016
United States
TMC Healthcare
Tucson, Arizona, 85712
United States
Scripps Health
La Jolla, California, 92037
United States
Good Samaritan Hospital
Los Angeles, California, 90017
United States
Cedars-Sinai Medical Center
Los Angeles, California, 90048
United States
Kaiser Sunset LA
Los Angeles, California, 90071
United States
Saint Joseph Hospital
Orange, California, 92868
United States
California Pacific Medical Center
San Francisco, California, 94109
United States
UC Health Northern Colorado (Medical Center of the Rockies)
Loveland, Colorado, 80538
United States
Delray Medical Center
Delray Beach, Florida, 33484
United States
Cardiac & Vascular Institute Foundation
Gainesville, Florida, 32605
United States
Ascension St. Vincent's Hospital
Jacksonville, Florida, 32204
United States
Naples Community Hospital
Naples, Florida, 34102
United States
Sarasota Memorial Hospital
Sarasota, Florida, 34239
United States
Emory University
Atlanta, Georgia, 30308
United States
Piedmont Healthcare
Atlanta, Georgia, 30309
United States
Rush University Medical Center
Chicago, Illinois, 60612
United States
Northshore University Health System
Evanston, Illinois, 60201
United States
St. Vincent Heart Center of Indiana
Indianapolis, Indiana, 46290
United States
University of Kansas
Kansas City, Kansas, 66160
United States
Cardiovascular Research Institute of Kansas (CRIOK)
Wichita, Kansas, 67226
United States
Our Lady of the Lake Regional Medical Center
Baton Rouge, Louisiana, 70808
United States
Medstar Union Memorial Hospital
Baltimore, Maryland, 21218
United States
Massachusetts General Hospital
Boston, Massachusetts, 02114
United States
Brigham & Women's
Boston, Massachusetts, 02115
United States
Henry Ford
Detroit, Michigan, 48202
United States
Minneapolis Heart
Minneapolis, Minnesota, 55407
United States
Mayo Clinic
Rochester, Minnesota, 55905
United States
CentraCare
Saint Cloud, Minnesota, 56303
United States
Saint Luke's Kansas City
Kansas City, Missouri, 64111
United States
St. Patrick Hospital
Missoula, Montana, 59802
United States
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756
United States
Morristown Medical Center
Morristown, New Jersey, 07962
United States
Robert Wood Johnson University Hospital
New Brunswick, New Jersey, 08901
United States
University of Buffalo
Buffalo, New York, 14203
United States
Weill Cornell Medicine
New York, New York, 10007
United States
Carolinas Medical Center
Charlotte, North Carolina, 28203
United States
Novant Health and Vascular Institute
Charlotte, North Carolina, 28204
United States
The Christ Hospital
Cincinnati, Ohio, 45219
United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44122
United States
Mount Carmel East Hospital
Columbus, Ohio, 43123
United States
Oklahoma Heart Hospital
Oklahoma City, Oklahoma, 73120
United States
Oklahoma Heart Institute
Tulsa, Oklahoma, 74104
United States
UPMC Heart and Vascular Institute
Mechanicsburg, Pennsylvania, 17050
United States
Alleghany General Hospital
Pittsburgh, Pennsylvania, 15212
United States
Saint Thomas Health
Nashville, Tennessee, 37205
United States
Austin Heart
Austin, Texas, 78705
United States
HCA Houston Healthcare Medical (SCRI)
Houston, Texas, 77004
United States
UT Memorial Hermann
Houston, Texas, 77030
United States
Intermountain Medical Center
Murray, Utah, 84107
United States
Sentara Norfolk
Norfolk, Virginia, 23507
United States
Carilion Roanoke Memorial Hospital
Roanoke, Virginia, 24014
United States
University of Washington Seattle
Seattle, Washington, 98195
United States
University of Wisconsin
Madison, Wisconsin, 53792-3248
United States

Collaborators and Investigators

Sponsor: Edwards Lifesciences

  • John Webb, MD, PRINCIPAL_INVESTIGATOR, St. Paul's Hospital
  • Mayra Guerrero, MD, PRINCIPAL_INVESTIGATOR, Mayo Clinic
  • David Daniels, MD, PRINCIPAL_INVESTIGATOR, California Pacific Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-11-12
Study Completion Date2031-02

Study Record Updates

Study Start Date2020-11-12
Study Completion Date2031-02

Terms related to this study

Additional Relevant MeSH Terms

  • Mitral Regurgitation
  • Mitral Valve Insufficiency