Comparing 3 approaches for mitral regurgitation
Official title: The ENCIRCLE Trial
SAPIEN M3 System Transcatheter Mitral Valve Replacement Via Transseptal Access
- 3 groups
- Sites in Toronto, Vancouver and 1 more city
- Recruiting
Interventions
- Medical device
SAPIEN M3 valve and dock
During the procedure a SAPIEN M3 dock and a SAPIEN M3 valve will be implanted via transseptal approach.
Canadian Sites (3)
3 of 3 recruiting
- Recruiting
Laval University
Québec, Quebec
- Recruiting
St. Michael's
Toronto
- Recruiting
St. Pauls
Vancouver
Eligibility Criteria
See who this study is looking for33 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +18 years of age or older
- +NYHA functional class ≥ II
- +Per the Heart Team, commercially available surgical or transcatheter treatment options are deemed unsuitable due to clinical, anatomic or technical considerations.
- +Subject's heart failure management has been optimized based on subject characteristics and applicable guidelines, and stable for at least 30 days prior to enrollmentEnrolmentThe number of participants a study plans to include, or has included.Read more →.
- +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 consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more →.
Exclusion
- −Mitral/cardiac anatomy that would preclude appropriate delivery and deployment of the SAPIEN M3 dock or valve
- −Inappropriate anatomy for femoral introduction and delivery of the SAPIEN M3 dock and valve
- −Presence of any device that will contact or interfere with the SAPIEN M3 System during delivery or after implantation
- −Left ventricular ejection fraction \<25%
- −Severe right ventricular dysfunction
- −Need for aortic, tricuspid or pulmonic valve intervention within the next 12 months
- −History of heart transplant
- −Cardiac imaging evidence of intracardiac mass, thrombus or vegetation
- −Active bacterial endocarditis within 180 days of the procedure
- −Hemodynamic instability requiring inotropic or mechanical support within 30 days of the procedure
- −Myocardial infarction within 30 days of the procedure
- −Clinically significant untreated coronary artery disease requiring revascularization
- −Stroke or transient ischemic attack within 90 days of the procedure
- −Irreversible, severe pulmonary hypertension
- −Chronic obstructive pulmonary disease requiring home oxygen therapy or chronic outpatient oral steroid use
- −Renal insufficiency or receiving renal replacement therapy
- −Liver disease
- −Inability to tolerate or a medical condition precluding treatment with antithrombotic therapy, including heparin administration during the procedure
- −Active infection requiring current antibiotic therapy
- −Active SARS-CoV-2 infection (Coronavirus-19 \[COVID-19\]) or previously diagnosed with COVID-19 with sequelae that could confound endpointEndpointThe specific thing a study measures to answer its question.Read more → assessments
- −Leukopenia, anemia, thrombocytopenia, history of bleeding diathesis or coagulopathy or hypercoagulable states
- −Refusal of blood products
- −Estimated life expectancy \<12 months due to non-cardiac conditions
- −Participating in another investigational drug or device study that has not reached its primary endpointPrimary endpointThe single main question the study is designed to answer.Read more →
- −Subject considered to be part of a vulnerable population
- −Female who is pregnant or lactating
- −Any percutaneous cardiovascular intervention, cardiovascular surgery, or carotid surgery within 30 days of the procedure
- −Planned surgery within the next 12 months
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
This study is not organised into the usual phase numbers — that is common for device, behavioural, and diagnostic research.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
Who receives what
There are 3 groups in this study.
Groups A, B and C receive SAPIEN M3 valve and dock.
Registry label: A: TMVR - Main Cohort · B: TMVR - Failed TEER Registry · C: TMVR - MAC Registry
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].label
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
How the study is run
Groups are assigned by the study team using set rules, rather than by chance.
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for
The study lists a minimum age of 18 years, with no upper limit given.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 900 people.
The study is currently expected to finish around February 2031.
The main measurement is taken over: 1 year.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Non-hierarchical composite of death and heart failure rehospitalization — measured over 1 year.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT04153292 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About SAPIEN M3 valve and dockDevice
During the procedure a SAPIEN M3 dock and a SAPIEN M3 valve will be implanted via transseptal approach.
From the trial registry — its own words, unedited.
What a device is here: A physical instrument, implant, app or piece of equipment being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: a minimum age of 18 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
Groups are assigned by the study team using set rules, rather than by chance.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists a minimum age of 18 years, with no upper limit given.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: 1 year.
The study as a whole is currently expected to finish around 2031-02-28.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 900 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists 11 locations, including: Toronto, Canada; Vancouver, Canada; Québec, Quebec, Canada; Detroit, Michigan, United States; Minneapolis, Minnesota, United States; Rochester, Minnesota, United States, and 5 more.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
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.
Other Sites (8)
Henry Ford
Detroit, Michigan, United States
Minneapolis Heart
Minneapolis, Minnesota, United States
Mayo Clinic
Rochester, Minnesota, United States
CentraCare
Saint Cloud, Minnesota, United States
St. Patrick Hospital
Missoula, Montana, United States
University of Buffalo
Buffalo, New York, United States
Weill Cornell Medicine
New York, New York, United States
University of Washington Seattle
Seattle, Washington, United States
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See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.