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

  • STATUS
    Recruiting
  • End date
    Feb 25, 2028
  • participants needed
    500
  • sponsor
    Edwards Lifesciences
Updated on 25 October 2022
Investigator
Edwards THV Clinical Affairs
Primary Contact
CentraCare (2.1 mi away) Contact
+56 other location
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 IdentifierNCT04153292
SponsorEdwards Lifesciences
Last Modified on25 October 2022

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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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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