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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	ClinicalTrials.gov
Last refreshed on:	29 April 2024
Main ID:	NCT04153292
Date of registration:	04/11/2019
Prospective Registration:	Yes
Primary sponsor:	Edwards Lifesciences
Public title:	The ENCIRCLE Trial ENCIRCLE
Scientific title:	SAPIEN M3 System Transcatheter Mitral Valve Replacement Via Transseptal Access
Date of first enrolment:	November 12, 2020
Target sample size:	900
Recruitment status:	Recruiting
URL:	https://clinicaltrials.gov/ct2/show/NCT04153292
Study type:	Interventional
Study design:	Allocation: Non-Randomized. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
Phase:	N/A

Countries of recruitment
Australia	Canada	Israel	Netherlands	United Kingdom	United States

Contacts

Name:	John Webb, MD
Address:
Telephone:
Email:
Affiliation:	St. Paul's Hospital

Name:	David Daniels, MD
Address:
Telephone:
Email:
Affiliation:	California Pacific Medical Center

Name:	Edwards THV Clinical Affairs
Address:
Telephone:	+1 (949) 250-2500
Email:	THV_CT.gov@Edwards.com
Affiliation:

Name:	Mayra Guerrero, MD
Address:
Telephone:
Email:
Affiliation:	Mayo Clinic

Key inclusion & exclusion 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

Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Mitral Regurgitation

Mitral Valve Insufficiency

Intervention(s)

Device: SAPIEN M3 valve and dock

Primary Outcome(s)

Non-hierarchical composite of death and heart failure rehospitalization [Time Frame: 1 year]

Secondary Outcome(s)

Improvement in MR compared to baseline [Time Frame: 1 year]

Improvement in NYHA functional class compared to baseline [Time Frame: 1 year]

Improvement in KCCQ Overall Score compared to baseline [Time Frame: 1 year]

Decrease in LVEDVi compared to baseline [Time Frame: 1 year]

Secondary ID(s)

2018-19

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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