BridgeMD
New treatment option for Mitral Regurgitation
Official title The ENCIRCLE Trial
ClinicalTrials.gov ID: NCT04153292
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- Subject's heart failure management has been optimized based on subject characteristics and applicable guidelines, and stable for at least 30 days...
You likely can't join if
- 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
See the full eligibility 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.
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Huntsville, Alabama, United States
- Phoenix, Arizona, United States
- Tucson, Arizona, United States
- La Jolla, California, United States
- Los Angeles, California, United States
- Orange, California, United States
- San Francisco, California, United States
- Loveland, Colorado, United States
- Delray Beach, Florida, United States
- Gainesville, Florida, United States
- Jacksonville, Florida, United States
- Naples, Florida, United States
- Sarasota, Florida, United States
- Atlanta, Georgia, United States
- Chicago, Illinois, United States
- Glenview, Illinois, United States
- Indianapolis, Indiana, United States
- Kansas City, Kansas, United States
- Wichita, Kansas, United States
- Baton Rouge, Louisiana, United States
+ 40 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Huntsville, Alabama, United States; Phoenix, Arizona, United States; Tucson, Arizona, United States; La Jolla, California, United States; Los Angeles, California, United States; Orange, California, United States and 54 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.