SAPIEN M3 System TransCatheter Mitral Valve ReplaCement via Transseptal Access

What is the Purpose of this Study?

The purpose of this study is to examine the safety and effectiveness of the investigational SAPIEN M3 System, a mitral valave replacement system, in patients with blood backflow (mitral regurgitation) across the mitral valve. The study focuses on individuals whose doctor have determined that they have moderate-severe to severe mitral regurgitation and are unsuitable for other commercial treatment options.

Since participants in this study are not candidates for open chest surgery, researchers believe that treatment with the study device could be a better way to improve their condition when compared to standard-of-care medical treatment. The standard medical treatments available to patients with mitral regurgitation who do not undergo surgery may temporarily reduce some symptoms but will not permanently improve their condition or cure mitral regurgitation.

Eligibility

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.

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

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Where can I participate?

Beverly

More about this Clinical Trial

What is the full name of this clinical trial?

The ENCIRCLE High-Risk Trial SAPIEN M3 System TransCatheter MItral Valve ReplaCement via TransseptaL AccEss

Study Details

Disease Type/Condition

Mitral Valve Regurgitation

Principal Investigator

Makkar, Rajendra

Age Group

Adult

Phase

II/III

IRB Number

STUDY00001173

ClinicalTrials.gov ID

NCT04153292

Key Eligibility

ClinicalTrials.gov

How do I learn more about this study?

clinicaltrials@cshs.org