Clinical trial NCT04153292: The ENCIRCLE Trial
Official title: SAPIEN M3 System Transcatheter Mitral Valve Replacement Via Transseptal Access
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Mitral Regurgitation
Mitral Valve Insufficiency
Lead sponsor: Edwards Lifesciences
Sponsor class: INDUSTRY
First posted: 2019-11-06
Enrollment: 900
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed description: This is a prospective single-arm, multicenter study.

Eligibility criteria: 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

Primary outcomes:
measure: Non-hierarchical composite of death and heart failure rehospitalization
timeFrame: 1 year
Secondary outcomes:
measure: Improvement in NYHA functional class compared to baseline
timeFrame: 1 year
measure: Improvement in KCCQ Overall Score compared to baseline
timeFrame: 1 year
measure: Improvement in MR compared to baseline
timeFrame: 1 year
measure: Decrease in LVEDVi compared to baseline
timeFrame: 1 year
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: Heart Center Hospital
state: Alabama
city: Phoenix
country: United States
facility: Banner University Medical Center
state: Arizona
city: Phoenix
country: United States
facility: Arizona Cardiovascular Research Center
state: Arizona
city: Tucson
country: United States
facility: TMC Healthcare
state: Arizona
city: La Jolla
country: United States
facility: Scripps Health
state: California
city: Los Angeles
country: United States
facility: Good Samaritan Hospital
state: California
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
city: Los Angeles
country: United States
facility: Kaiser Sunset LA
state: California
city: Orange
country: United States
facility: Saint Joseph Hospital
state: California
city: San Francisco
country: United States
facility: California Pacific Medical Center
state: California
city: Loveland
country: United States
facility: UC Health Northern Colorado (Medical Center of the Rockies)
state: Colorado
city: Delray Beach
country: United States
facility: Delray Medical Center
state: Florida
city: Gainesville
country: United States
facility: Cardiac & Vascular Institute Foundation
state: Florida
city: Jacksonville
country: United States
facility: Ascension St. Vincent's Hospital
state: Florida
city: Naples
country: United States
facility: Naples Community Hospital
state: Florida
city: Sarasota
country: United States
facility: Sarasota Memorial Hospital
state: Florida
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Atlanta
country: United States
facility: Piedmont Healthcare
state: Georgia
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Glenview
country: United States
facility: Northshore University Health System
state: Illinois
city: Indianapolis
country: United States
facility: St. Vincent Heart Center of Indiana
state: Indiana
city: Kansas City
country: United States
facility: University of Kansas
state: Kansas
city: Wichita
country: United States
facility: Cardiovascular Research Institute of Kansas (CRIOK)
state: Kansas
city: Baton Rouge
country: United States
facility: Our Lady of the Lake Regional Medical Center
state: Louisiana
city: Baltimore
country: United States
facility: Medstar Union Memorial Hospital
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Brigham & Women's
state: Massachusetts
city: Detroit
country: United States
facility: Henry Ford
state: Michigan
city: Minneapolis
country: United States
facility: Minneapolis Heart
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Saint Cloud
country: United States
facility: CentraCare
state: Minnesota
city: Kansas City
country: United States
facility: Saint Luke's Kansas City
state: Missouri
city: Missoula
country: United States
facility: St. Patrick Hospital
state: Montana
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock Medical Center
state: New Hampshire
city: Morristown
country: United States
facility: Morristown Medical Center
state: New Jersey
city: New Brunswick
country: United States
facility: Robert Wood Johnson University Hospital
state: New Jersey
city: Buffalo
country: United States
facility: University of Buffalo
state: New York
city: New York
country: United States
facility: Weill Cornell Medicine
state: New York
city: Charlotte
country: United States
facility: Carolinas Medical Center
state: North Carolina
city: Charlotte
country: United States
facility: Novant Health and Vascular Institute
state: North Carolina
city: Cincinnati
country: United States
facility: The Christ Hospital
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
city: Columbus
country: United States
facility: Mount Carmel East Hospital
state: Ohio
city: Oklahoma City
country: United States
facility: Oklahoma Heart Hospital
state: Oklahoma
city: Tulsa
country: United States
facility: Oklahoma Heart Institute
state: Oklahoma
city: Mechanicsburg
country: United States
facility: UPMC Heart and Vascular Institute
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Alleghany General Hospital
state: Pennsylvania
city: Nashville
country: United States
facility: Saint Thomas Health
state: Tennessee
city: Austin
country: United States
facility: Austin Heart
state: Texas
city: Houston
country: United States
facility: HCA Houston Healthcare Medical (SCRI)
state: Texas
city: Houston
country: United States
facility: UT Memorial Hermann
state: Texas
city: Murray
country: United States
facility: Intermountain Medical Center
state: Utah
city: Norfolk
country: United States
facility: Sentara Norfolk
state: Virginia
city: Roanoke
country: United States
facility: Carilion Roanoke Memorial Hospital
state: Virginia
city: Seattle
country: United States
facility: University of Washington Seattle
state: Washington
city: Madison
country: United States
facility: University of Wisconsin
state: Wisconsin
city: Chermside
country: Australia
facility: The Prince Charles Hospital
state: Queensland
city: Camperdown
country: Australia
facility: Royal Prince Alfred Hospital
city: Quebec City
country: Canada
facility: Laval University
state: Quebec
city: Toronto
country: Canada
facility: St. Michael's
city: Vancouver
country: Canada
facility: St. Pauls
city: Jerusalem
country: Israel
facility: Shaare Zedek Medical Center
city: Petah Tikva
country: Israel
facility: Rabin Medical Center
city: Ramat Gan
country: Israel
facility: Sheba Medical Center
city: Leiden
country: Netherlands
facility: Leiden University Medical Center
state: South Holland
city: Rotterdam
country: Netherlands
facility: Rotterdam Erasmus MC
state: South Holland
city: London
country: United Kingdom
facility: Saint Thomas Hospital
city: Oxford
country: United Kingdom
facility: Saint Bartholomew's Medical Center
Study officials:
affiliation: St. Paul's Hospital
name: John Webb, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Mayo Clinic
name: Mayra Guerrero, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: California Pacific Medical Center
name: David Daniels, MD
role: PRINCIPAL_INVESTIGATOR
References: