NCT04153292ClinicalTrials.gov

The ENCIRCLE Trial

SAPIEN M3 System Transcatheter Mitral Valve Replacement Via Transseptal Access

RecruitingTaking participants now, according to the registry record.

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In brief

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…

Interventional900 participants sought68 sites6 countries

Registered in 1 registry

ClinicalTrials.govNCT04153292Open this record at ClinicalTrials.govSynced 2 months ago

One study can be registered in several registries. We show it once and link every record we hold.

Trial information is shown as published by the registry, in its original language.

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How this study is set up

The points below are drawn from the public registry record for this study. Each one cites the field or sentence it came from. A dash (—) means the record does not state something — not that it is missing or wrong. Many well-run studies, especially small ones, leave some of these blank.

Present: Registered before enrolment beganFirst posted 2019-11-06; recorded start 2020-11-12
Present: Has a defined primary outcomeA primary outcome measure is listed in the record
Present: The primary outcome states a time frameThe primary outcome measure records a time frame
Not stated: Participants are not randomly assignedAllocation is recorded as non-randomised
Present: Has a comparison groupThe record lists a placebo or comparator arm, or more than one study arm
Not stated: Open label (no blinding)Masking is recorded as none (open label)
Not stated: An ethics committee is not stated in the registry recordThis registry's ingested record has no ethics-committee field
Not stated: Regulatory oversight (such as an IND or IDE) is not stated in the registry recordThis registry's ingested record has no regulatory-authorisation field
Not stated: A data monitoring committee is not stated in the registry recordThis registry's ingested record has no data-monitoring-committee fieldA data monitoring committee is not required for many smaller studies, and its absence here is not unusual.
Present: No cost to participants is mentioned in the recordChecked the summary, description and eligibility text; no cost-to-participant phrase found
Present: Sponsor has 47 other studies in this databaseCounted from the lead sponsor named in the record (Edwards Lifesciences)
Present: Sponsor has posted results for at least one studyBased on the sponsor’s studies in this database

The record lists 2 conditions.
Lead sponsor type recorded as: industry.

These are facts from the public registry record, not a judgement about the study. Discuss any trial with your own doctor before taking part.

What these facts mean, and what to ask · ruleset v1

Trial stature

Three independent measures of this study, described from its registry record — not a recommendation about it. A rigorous study by investigators nobody has heard of is better evidence than a weak study led by a famous one. How these are scored.

Methodological rigourMODERATE

A moderately rigorous design for a study of this type, judged from its ClinicalTrials.gov record.

How this score is built

Randomised allocation0/20
Non-randomised allocation
Blinding0/20
Open-label
Control arm0/15
No comparator arm stated in the record
Primary-outcome specificity10/10
Named primary outcome with a defined time frame
Endpoint type10/10
Mortality / MACE endpoint (hard clinical outcome)
Multi-centre8/8
Multi-centre: 68 sites
Data monitoring committee7/7
A data monitoring committee is in place
Prospective registration5/5
Registered before the study start date
Protocol / SAP posted0/5
No protocol or SAP posted to the registry

ScaleLARGE

A large study, international in scope: 900 participants (target), run at 68 sites, across 6 countries.

How this score is built

Enrolment29/40
900 participants (target)
Site count21/25
68 sites
Country count12/15
6 countries
Planned duration10/10
Planned over about 125 months
Sponsor scale6/10
Edwards Lifesciences has led 47 trials in our corpus

Investigator standingUNKNOWN

We have no verifiable track record for the investigator named on this trial. That is common for early-career investigators and for records held outside ClinicalTrials.gov — it is not a negative signal.

How this score is built

Investigator standing0/100
No investigator recorded in the registry for this trial

These describe the registry record only, and today we hold ClinicalTrials.gov data. Absent fields lower a score, and absence often reflects registration practice rather than study quality. A high-stature trial is not necessarily safer or a better choice for you — enrolling in a large definitive trial can mean a higher chance of receiving placebo, while a small early-phase study may be the only route to a new therapy.

Summary

This is a prospective single-arm, multicenter study.

Conditions

Mitral Regurgitation
Mitral Valve Insufficiency

Eligibility

Eligibility
Sex	All
Ages	18 Years – No maximum
Healthy volunteers	No

Eligibility as written in the registry

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

Eligibility in plain statements

This record's criteria have not been broken into separate statements yet. The registry text above is complete and is the authoritative version.

Study design

Study design
Study type	Interventional
Phase	Not applicable
Allocation	Non-randomised
Intervention model	SINGLE_GROUP
Primary purpose	TREATMENT
Masking	NONE (0)
Enrolment	900 participants sought

Sponsor and collaborators

Edwards Lifesciences Sponsor

Arms and interventions

TMVR - Main CohortEXPERIMENTAL
Subjects for whom commercially available surgical or transcatheter treatment options are deemed unsuitable will have transcatheter mitral valve replacement (TMVR).
TMVR - Failed TEER RegistryEXPERIMENTAL
Subjects who have had an attempted but failed transcatheter edge-to-edge repair (TEER) procedure will have TMVR.
TMVR - MAC RegistryEXPERIMENTAL
Subjects with mitral annular calcification (MAC) will have TMVR.

Interventions

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

Outcome measures

Primary outcome
Non-hierarchical composite of death and heart failure rehospitalization
Number of subjects with death and/or heart failure rehospitalization
Time frame 1 year
Secondary outcome
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.
Time frame 1 year
Secondary outcome
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.
Time frame 1 year
Secondary outcome
Improvement in MR compared to baseline
Number of subjects with improved MR compared to baseline
Time frame 1 year
Secondary outcome
Decrease in LVEDVi compared to baseline
Number of subjects with decreased left ventricular end-diastolic volume index (LVEDVi) compared to baseline
Time frame 1 year

Dates

Dates
Start date	November 12, 2020 (actual)
Primary completion	February 28, 2027 (estimated)
Completion	February 28, 2031 (estimated)
First posted	November 6, 2019 (actual)
Last updated	February 25, 2026
Results posted	Not stated in the registry record
Status last verified	February 2026

Actual means the event happened. Estimated means the sponsor expects it. The two mean different things.

Locations

3 sites are recruiting

Australia

Australia
Facility	City	State or region	Status
Royal Prince Alfred Hospital	Camperdown		Active, not recruiting
The Prince Charles Hospital	Chermside	Queensland	Active, not recruiting

Canada

Canada
Facility	City	State or region	Status
Laval University	Québec	Quebec	Recruiting
St. Michael's	Toronto		Recruiting
St. Pauls	Vancouver		Recruiting

Israel

Israel
Facility	City	Status
Shaare Zedek Medical Center	Jerusalem	Withdrawn
Rabin Medical Center	Petah Tikva	Active, not recruiting
Sheba Medical Center	Ramat Gan	Withdrawn

Netherlands

Netherlands
Facility	City	State or region	Status
Leiden University Medical Center	Leiden		Active, not recruiting
Rotterdam Erasmus MC	Rotterdam		Active, not recruiting

United Kingdom

United Kingdom
Facility	City	State or region	Status
Saint Thomas Hospital	London		Active, not recruiting
Saint Bartholomew's Medical Center	London		Active, not recruiting

United States

United States
Facility	City	State or region	Status
Piedmont Healthcare	Atlanta	Georgia	Active, not recruiting
Emory University	Atlanta	Georgia	Active, not recruiting
Austin Heart	Austin	Texas	Active, not recruiting
Medstar Union Memorial Hospital	Baltimore	Maryland	Active, not recruiting
Our Lady of the Lake Regional Medical Center	Baton Rouge	Louisiana	Active, not recruiting
Brigham & Women's	Boston	Massachusetts	Withdrawn
Massachusetts General Hospital	Boston	Massachusetts	Active, not recruiting
University of Buffalo	Buffalo	New York	Active, not recruiting
Novant Health and Vascular Institute	Charlotte	North Carolina	Active, not recruiting
Carolinas Medical Center	Charlotte	North Carolina	Withdrawn
Rush University Medical Center	Chicago	Illinois	Withdrawn
The Christ Hospital	Cincinnati	Ohio	Active, not recruiting
Cleveland Clinic Foundation	Cleveland	Ohio	Active, not recruiting
Mount Carmel East Hospital	Columbus	Ohio	Active, not recruiting
Delray Medical Center	Delray Beach	Florida	Withdrawn
Henry Ford	Detroit	Michigan	Active, not recruiting
Cardiac & Vascular Institute Foundation	Gainesville	Florida	Active, not recruiting
Northshore University Health System	Glenview	Illinois	Active, not recruiting
UT Memorial Hermann	Houston	Texas	Active, not recruiting
HCA Houston Healthcare Medical (SCRI)	Houston	Texas	Active, not recruiting
Heart Center Hospital	Huntsville	Alabama	Active, not recruiting
St. Vincent Heart Center of Indiana	Indianapolis	Indiana	Withdrawn
Ascension St. Vincent's Hospital	Jacksonville	Florida	Active, not recruiting
University of Kansas	Kansas City	Kansas	Active, not recruiting
Saint Luke's Kansas City	Kansas City	Missouri	Active, not recruiting
Scripps Health	La Jolla	California	Active, not recruiting
Dartmouth-Hitchcock Medical Center	Lebanon	New Hampshire	Active, not recruiting
Good Samaritan Hospital	Los Angeles	California	Active, not recruiting
Kaiser Sunset LA	Los Angeles	California	Active, not recruiting
Cedars-Sinai Medical Center	Los Angeles	California	Active, not recruiting
UC Health Northern Colorado (Medical Center of the Rockies)	Loveland	Colorado	Active, not recruiting
University of Wisconsin	Madison	Wisconsin	Withdrawn
UPMC Heart and Vascular Institute	Mechanicsburg	Pennsylvania	Active, not recruiting
Minneapolis Heart	Minneapolis	Minnesota	Withdrawn
St. Patrick Hospital	Missoula	Montana	Withdrawn
Morristown Medical Center	Morristown	New Jersey	Withdrawn
Intermountain Medical Center	Murray	Utah	Active, not recruiting
Naples Community Hospital	Naples	Florida	Active, not recruiting

18 further sites are listed in the registry record.

Study documents

No documents are linked in this registry record.

Changes over time

No changes have been recorded since we first ingested this record.

A change is recorded each time the sponsor updates the registry record. Status, dates, enrolment and sites appear here as they move.

Registry: ClinicalTrials.gov · NCT########

https://xmedica.io/trials/ctgov/NCT04153292

Categories

Registered in 1 registry

Interested in this study?

How this study is set up

Summary

Conditions

Eligibility

Eligibility as written in the registry

Eligibility in plain statements

Study design

Sponsor and collaborators

Arms and interventions

Interventions

Outcome measures

Dates

Locations

Australia

Canada

Israel

Netherlands

United Kingdom

United States

Study documents

Changes over time