SAPIEN M3 System Transcatheter Mitral Valve Replacement Via Transseptal Access (ENCIRCLE)

STATUS

Recruiting
End date

Feb 25, 2028
participants needed

500
sponsor

Edwards Lifesciences

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Updated on 25 October 2022

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Edwards THV Clinical Affairs

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CentraCare (2.1 mi away) Contact

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regurgitation

heart failure

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.

Description

This is a prospective single-arm, multicenter study.

Details

Condition	Mitral Regurgitation, Mitral Valve Insufficiency
Treatment	SAPIEN M3 valve and dock
Clinical Study Identifier	NCT04153292
Sponsor	Edwards Lifesciences
Last Modified on	25 October 2022

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Eligibility		Yes	No	Not Sure
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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SAPIEN M3 System Transcatheter Mitral Valve Replacement Via Transseptal Access (ENCIRCLE)

Edwards THV Clinical Affairs

CentraCare (2.1 mi away) Contact