Huntsville, ALNCT04153292Now EnrollingIRB Ready

Mitral Regurgitation Clinical Trial in Huntsville, AL

Access cutting-edge mitral regurgitation treatment through this clinical trial at a research site in Huntsville. Study-provided care at no cost to qualified participants.

Sponsored by Edwards Lifesciences

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Expert Care in Huntsville

Access mitral regurgitation specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related mitral regurgitation treatment provided free

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Check if you qualify for this mitral regurgitation clinical trial in Huntsville, AL

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Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Local to Huntsville

    Convenient for AL residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit Huntsville site if eligible
  4. 4Begin participation

About This Mitral Regurgitation Study in Huntsville

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.

Sponsor: Edwards Lifesciences

Who Can Participate

Inclusion Criteria

18 years of age or older
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

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Huntsville?

Yes, this clinical trial (NCT04153292) has an active research site in Huntsville, AL that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Mitral Regurgitation Treatment Options in Huntsville, AL

If you're searching for mitral regurgitation treatment options in Huntsville, AL, this clinical trial (NCT04153292) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Huntsville research site is actively enrolling participants for this clinical trial. You'll receive care from experienced mitral regurgitation specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all mitral regurgitation clinical trials near you to find additional studies recruiting in your area.

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