The ENCIRCLE Trial

Mitral Regurgitation Clinical Trial

— ENCIRCLE  

Official title:

SAPIEN M3 System Transcatheter Mitral Valve Replacement Via Transseptal Access

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04153292
• Other study ID #: 2018-19
• Status: Recruiting
• Phase: N/A
• Start date: November 12, 2020
• Est. completion date: February 2031

Study information

• Verified date: April 2024
• Source: Edwards Lifesciences
• Contact: Edwards THV Clinical Affairs
• Phone: +1 (949) 250-2500
• Email: THV_CT.gov[@]Edwards.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

This is a prospective single-arm, multicenter study.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 900
• Est. completion date: February 2031
• Est. primary completion date: February 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. 18 years of age or older

2. MR = 3+

3. NYHA functional class = II

4. Per the Heart Team, commercially available surgical or transcatheter treatment options are deemed unsuitable due to clinical, anatomic or technical considerations.

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. 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.

Exclusion Criteria:

1. Mitral/cardiac anatomy that would preclude appropriate delivery and deployment of the SAPIEN M3 dock or valve

2. Inappropriate anatomy for femoral introduction and delivery of the SAPIEN M3 dock and valve

3. Presence of any device that will contact or interfere with the SAPIEN M3 System during delivery or after implantation

4. Left ventricular ejection fraction <25%

5. Severe right ventricular dysfunction

6. Need for aortic, tricuspid or pulmonic valve intervention within the next 12 months

7. History of heart transplant

8. Cardiac imaging evidence of intracardiac mass, thrombus or vegetation

9. Active bacterial endocarditis within 180 days of the procedure

10. Hemodynamic instability requiring inotropic or mechanical support within 30 days of the procedure

11. Myocardial infarction within 30 days of the procedure

12. Clinically significant untreated coronary artery disease requiring revascularization

13. Any percutaneous cardiovascular intervention, cardiovascular surgery, or carotid surgery within 30 days of the procedure

14. Stroke or transient ischemic attack within 90 days of the procedure

15. Irreversible, severe pulmonary hypertension

16. Chronic obstructive pulmonary disease requiring home oxygen therapy or chronic outpatient oral steroid use

17. Renal insufficiency or receiving renal replacement therapy

18. Liver disease

19. Planned surgery within the next 12 months

20. Inability to tolerate or a medical condition precluding treatment with antithrombotic therapy, including heparin administration during the procedure

21. Active infection requiring current antibiotic therapy

22. Active SARS-CoV-2 infection (Coronavirus-19 [COVID-19]) or previously diagnosed with COVID-19 with sequelae that could confound endpoint assessments

23. Leukopenia, anemia, thrombocytopenia, history of bleeding diathesis or coagulopathy or hypercoagulable states

24. Refusal of blood products

25. Female who is pregnant or lactating

26. Estimated life expectancy <12 months due to non-cardiac conditions

27. Participating in another investigational drug or device study that has not reached its primary endpoint

28. Subject considered to be part of a vulnerable population

Related Conditions & MeSH terms

• Mitral Regurgitation
• Mitral Valve Insufficiency

Intervention

Device:
• SAPIEN M3 valve and dock
During the procedure a SAPIEN M3 dock and a SAPIEN M3 valve will be implanted via transseptal approach.

Locations

Country	Name	City	State
Australia	Royal Prince Alfred Hospital	Camperdown
Australia	The Prince Charles Hospital	Chermside	Queensland
Canada	Laval University	Quebec City	Quebec
Canada	St. Michael's	Toronto
Canada	St. Pauls	Vancouver
Israel	Shaare Zedek Medical Center	Jerusalem
Israel	Rabin Medical Center	Petah Tikva
Israel	Sheba Medical Center	Ramat Gan
Netherlands	Leiden University Medical Center	Leiden	South Holland
Netherlands	Rotterdam Erasmus MC	Rotterdam	South Holland
United Kingdom	Saint Thomas Hospital	London
United Kingdom	Saint Bartholomew's Medical Center	Oxford
United States	Emory University	Atlanta	Georgia
United States	Piedmont Healthcare	Atlanta	Georgia
United States	Austin Heart	Austin	Texas
United States	Medstar Union Memorial Hospital	Baltimore	Maryland
United States	Our Lady of the Lake Regional Medical Center	Baton Rouge	Louisiana
United States	Brigham & Women's	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	University of Buffalo	Buffalo	New York
United States	Carolinas Medical Center	Charlotte	North Carolina
United States	Novant Health and Vascular Institute	Charlotte	North Carolina
United States	Rush University Medical Center	Chicago	Illinois
United States	The Christ Hospital	Cincinnati	Ohio
United States	Cleveland Clinic Foundation	Cleveland	Ohio
United States	Mount Carmel East Hospital	Columbus	Ohio
United States	Delray Medical Center	Delray Beach	Florida
United States	Henry Ford	Detroit	Michigan
United States	Northshore University Health System	Evanston	Illinois
United States	Cardiac & Vascular Institute Foundation	Gainesville	Florida
United States	HCA Houston Healthcare Medical (SCRI)	Houston	Texas
United States	UT Memorial Hermann	Houston	Texas
United States	Heart Center Hospital	Huntsville	Alabama
United States	St. Vincent Heart Center of Indiana	Indianapolis	Indiana
United States	Ascension St. Vincent's Hospital	Jacksonville	Florida
United States	Saint Luke's Kansas City	Kansas City	Missouri
United States	University of Kansas	Kansas City	Kansas
United States	Scripps Health	La Jolla	California
United States	Dartmouth-Hitchcock Medical Center	Lebanon	New Hampshire
United States	Cedars-Sinai Medical Center	Los Angeles	California
United States	Good Samaritan Hospital	Los Angeles	California
United States	Kaiser Sunset LA	Los Angeles	California
United States	UC Health Northern Colorado (Medical Center of the Rockies)	Loveland	Colorado
United States	University of Wisconsin	Madison	Wisconsin
United States	UPMC Heart and Vascular Institute	Mechanicsburg	Pennsylvania
United States	Minneapolis Heart	Minneapolis	Minnesota
United States	St. Patrick Hospital	Missoula	Montana
United States	Morristown Medical Center	Morristown	New Jersey
United States	Intermountain Medical Center	Murray	Utah
United States	Naples Community Hospital	Naples	Florida
United States	Saint Thomas Health	Nashville	Tennessee
United States	Robert Wood Johnson University Hospital	New Brunswick	New Jersey
United States	Weill Cornell Medicine	New York	New York
United States	Sentara Norfolk	Norfolk	Virginia
United States	Oklahoma Heart Hospital	Oklahoma City	Oklahoma
United States	Saint Joseph Hospital	Orange	California
United States	Arizona Cardiovascular Research Center	Phoenix	Arizona
United States	Banner University Medical Center	Phoenix	Arizona
United States	Alleghany General Hospital	Pittsburgh	Pennsylvania
United States	Carilion Roanoke Memorial Hospital	Roanoke	Virginia
United States	Mayo Clinic	Rochester	Minnesota
United States	CentraCare	Saint Cloud	Minnesota
United States	California Pacific Medical Center	San Francisco	California
United States	Sarasota Memorial Hospital	Sarasota	Florida
United States	University of Washington Seattle	Seattle	Washington
United States	TMC Healthcare	Tucson	Arizona
United States	Oklahoma Heart Institute	Tulsa	Oklahoma
United States	Cardiovascular Research Institute of Kansas (CRIOK)	Wichita	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Edwards Lifesciences

Countries where clinical trial is conducted

United States,  Australia,  Canada,  Israel,  Netherlands,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Non-hierarchical composite of death and heart failure rehospitalization	Number of subjects with death and/or heart failure rehospitalization	1 year
Secondary	Improvement in NYHA functional class compared to baseline	New York Heart Association (NYHA) functional classification of heart failure is based on how much a patient is limited during physical activity. The rating ranges from I-IV. I = no limitations of physical activity; II = slight limitations of physical activity, ordinary physical activity results in fatigue, palpitation, shortness of breath; III = marked limitations of physical activity, less than ordinary activity causes fatigue, palpitation, or shortness of breath; IV = unable to carry on any physical activity without discomfort, symptoms of heart failure at rest.	1 year
Secondary	Improvement in KCCQ Overall Score compared to baseline	The Kansas City Cardiomyopathy Questionnaire (KCCQ) is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life. An overall summary score can be derived from the physical function, symptom (frequency and severity), social function and quality of life domains. Scores are transformed to a range of 0-100, in which higher scores reflect better health status.	1 year
Secondary	Improvement in MR compared to baseline	Number of subjects with improved MR compared to baseline	1 year
Secondary	Decrease in LVEDVi compared to baseline	Number of subjects with decreased left ventricular end-diastolic volume index (LVEDVi) compared to baseline	1 year