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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT04153292




Registration number
NCT04153292
Ethics application status
Date submitted
4/11/2019
Date registered
6/11/2019
Date last updated
19/04/2024

Titles & IDs
Public title
The ENCIRCLE Trial
Scientific title
SAPIEN M3 System Transcatheter Mitral Valve Replacement Via Transseptal Access
Secondary ID [1] 0 0
2018-19
Universal Trial Number (UTN)
Trial acronym
ENCIRCLE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mitral Regurgitation 0 0
Mitral Valve Insufficiency 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - SAPIEN M3 valve and dock

Experimental: TMVR - Main Cohort - Subjects for whom commercially available surgical or transcatheter treatment options are deemed unsuitable will have transcatheter mitral valve replacement (TMVR).

Experimental: TMVR - Failed TEER Registry - Subjects who have had an attempted but failed transcatheter edge-to-edge repair (TEER) procedure will have TMVR.

Experimental: TMVR - MAC Registry - Subjects with mitral annular calcification (MAC) will have TMVR.


Treatment: Devices: SAPIEN M3 valve and dock
During the procedure a SAPIEN M3 dock and a SAPIEN M3 valve will be implanted via transseptal approach.
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Non-hierarchical composite of death and heart failure rehospitalization
Timepoint [1] 0 0
1 year
Secondary outcome [1] 0 0
Improvement in NYHA functional class compared to baseline
Timepoint [1] 0 0
1 year
Secondary outcome [2] 0 0
Improvement in KCCQ Overall Score compared to baseline
Timepoint [2] 0 0
1 year
Secondary outcome [3] 0 0
Improvement in MR compared to baseline
Timepoint [3] 0 0
1 year
Secondary outcome [4] 0 0
Decrease in LVEDVi compared to baseline
Timepoint [4] 0 0
1 year

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
12/11/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/02/2031
Actual
Sample size
Target
900
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
The Prince Charles Hospital - Chermside
Recruitment hospital [2] 0 0
Royal Prince Alfred Hospital - Camperdown
Recruitment postcode(s) [1] 0 0
4032 - Chermside
Recruitment postcode(s) [2] 0 0
NSW2050 - Camperdown
Recruitment outside Australia
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United States of America
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Alabama
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Arizona
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California
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Florida
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Georgia
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Illinois
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Indiana
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Kansas
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Louisiana
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Maryland
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Massachusetts
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Michigan
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Minnesota
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Missouri
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Montana
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New Hampshire
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New Jersey
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New York
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North Carolina
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Ohio
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Oklahoma
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Pennsylvania
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Tennessee
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Texas
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Utah
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Virginia
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Washington
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Wisconsin
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Canada
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Quebec
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Canada
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Toronto
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Canada
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Vancouver
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Israel
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Jerusalem
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Israel
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Petah Tikva
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Israel
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Ramat Gan
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Netherlands
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South Holland
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United Kingdom
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London
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United Kingdom
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Oxford

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Edwards Lifesciences
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT04153292
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
John Webb, MD
Address 0 0
St. Paul's Hospital
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Edwards THV Clinical Affairs
Address 0 0
Country 0 0
Phone 0 0
+1 (949) 250-2500
Fax 0 0
Email 0 0
THV_CT.gov@Edwards.com
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT04153292