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The ENCIRCLE Trial

RECRUITING

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.

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Study details:

This is a prospective single-arm, multicenter study.

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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

Inclusion criteria

18 years of age or older

MR ≥ 3+

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 enrollment.

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

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

Any percutaneous cardiovascular intervention, cardiovascular surgery, or carotid surgery within 30 days of the procedure

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

Planned surgery within the next 12 months

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 endpoint assessments

Leukopenia, anemia, thrombocytopenia, history of bleeding diathesis or coagulopathy or hypercoagulable states

Refusal of blood products

Female who is pregnant or lactating

Estimated life expectancy <12 months due to non-cardiac conditions

Participating in another investigational drug or device study that has not reached its primary endpoint

Subject considered to be part of a vulnerable population

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Eligibility

Age eligible for study : 18 and older

Healthy volunteers accepted : No

Gender eligible for study: All

Things to know

Study dates

Study start: 2020-11-12

Primary completion: 2027-02-01

Study completion finish: 2031-02-01

Study type

TREATMENT

Phase

Trial ID

NCT04153292

Intervention or treatment

DEVICE: SAPIEN M3 valve and dock

Conditions

• Mitral Regurgitation
• Mitral Valve Insufficiency

Condition: Mitral Regurgitation, Mitral Valve Insufficiency
DEVICE: SAPIEN M3 valve and dock
Chermside, Queensland, Australia and more
Sponsor: Edwards Lifesciences

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Find a site

Closest Location:

The Prince Charles Hospital

Research sites nearby

Select from list below to view details:

The Prince Charles Hospital
Chermside, Queensland, Australia
Royal Prince Alfred Hospital
Camperdown, Not Specified, Australia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: TMVR - Main Cohort Subjects for whom commercially available surgical or transcatheter treatment options are deemed unsuitable will have transcatheter mitral valve replacement (TMVR).	DEVICE: SAPIEN M3 valve and dock During the procedure a SAPIEN M3 dock and a SAPIEN M3 valve will be implanted via transseptal approach.
EXPERIMENTAL: TMVR - Failed TEER Registry Subjects who have had an attempted but failed transcatheter edge-to-edge repair (TEER) procedure will have TMVR.	DEVICE: SAPIEN M3 valve and dock During the procedure a SAPIEN M3 dock and a SAPIEN M3 valve will be implanted via transseptal approach.
EXPERIMENTAL: TMVR - MAC Registry Subjects with mitral annular calcification (MAC) will have TMVR.	DEVICE: SAPIEN M3 valve and dock During the procedure a SAPIEN M3 dock and a SAPIEN M3 valve will be implanted via transseptal approach.

What is the study measuring?

Primary outcome

Primary Outcome Measure	Primary Outcome Description	Primary Outcome Time Frame
Non-hierarchical composite of death and heart failure rehospitalization	Number of subjects with death and/or heart failure rehospitalization	1 year

Secondary outcome

Secondary Outcome Measure	Secondary Outcome Description	Secondary Outcome Time Frame
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.	1 year
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.	1 year
Improvement in MR compared to baseline	Number of subjects with improved MR compared to baseline	1 year
Decrease in LVEDVi compared to baseline	Number of subjects with decreased left ventricular end-diastolic volume index (LVEDVi) compared to baseline	1 year

Frequently Asked Questions

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You may be eligible to participate in this trial based on your search.Apply for study

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References

Clinical Trials Gov: The ENCIRCLE Trial