Boston, MANCT05452720Now EnrollingIRB Ready

Tetrology of Fallot Clinical Trial in Boston, MA

Access cutting-edge tetrology of fallot treatment through this clinical trial at a research site in Boston. Study-provided care at no cost to qualified participants.

Sponsored by PECA Labs

Quick Self-Assessment

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Expert Care in Boston

Access tetrology of fallot specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related tetrology of fallot treatment provided free

Apply for This Boston Location

Check if you qualify for this tetrology of fallot clinical trial in Boston, MA

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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 Boston

    Convenient for MA 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 Boston site if eligible
  4. 4Begin participation

About This Tetrology of Fallot Study in Boston

The MASA Valve Early Feasibility Study (MVEFS) multi-site interventional clinical trial within the United States of America with each center following a common protocol.The objective of the trial is to evaluate the safety and probable benefit of MASA Valve in the indicated subset of patients requiring Right Ventricular Outflow Tract Reconstruction (RVOTR). As an early feasibility study, the purpose is determine the feasibility of success of the device in order to gather early data towards a future pivotal study and/or regulatory clearance submission.

Sponsor: PECA Labs

Who Can Participate

Inclusion Criteria

At least one of the following: Right Ventricular to Pulmonary Artery mean gradient \> 35mm Hg, moderate or severe Pulmonary regurgitation (≥3+), or clinical indication for replacement of their native or prosthetic pulmonary valve with a prosthesis.
Age \< 22 years
Patient is geographically stable and willing to return for 1 year follow-up for the trial.
Patient's legal guardian should be willing to provide informed consent (IC) at the hospital location where they are being enrolled.
The patient, and the patient's parent / legal representative where appropriate, and the treating physician agree that the subject will return for all required post-procedure follow up visits and the subject will comply with clinical investigation plan required follow-up visits.

Exclusion Criteria

Patient is in need of or has presence of a prosthetic heart valve at any other position
Patient has a need for concomitant surgical procedures (non-cardiac)
Patients with previously implanted pacemaker (including defibrillators) or mechanical valves
Patient has an active bacterial or viral infection or requiring current antibiotic therapy (if temporary illness, patient may be a candidate 4 weeks after discontinuation of antibiotics)
Patient has an active endocarditis
Leukopenia, according to local laboratory evaluation of white blood cell count
Acute or chronic anemia, according to local laboratory evaluation of hemoglobin Patients can be transfused to meet eligibility criteria
Thrombocytopenia, defined as Platelet count \< 150,000/mm3 Patients can be transfused to meet eligibility criteria
Severe chest wall deformity, which would preclude placement of the PV conduit
Known hypersensitivity to anticoagulants and antiplatelet drugs and to the device materials
Immunocompromised patient defined as: autoimmune disease, patients receiving immunosuppressant drugs or immune stimulant drugs
Patient has chronic inflammatory / autoimmune disease
Need for emergency cardiac or vascular surgery or intervention
Major or progressive non-cardiac disease (liver failure, renal failure, cancer) that has a life expectancy of less than one year
Currently participating, or participated within the last 30 days, in an investigational drug or device study
Alcohol or drug abuse as defined by DSM IV-TR criteria for substance abuse - this includes the illicit use of cannabis within the last 12 months
Patient has medical, social or psychosocial factors that, in the opinion of the Investigator, could have impact on safety or compliance

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 Boston?

Yes, this clinical trial (NCT05452720) has an active research site in Boston, MA 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.

Tetrology of Fallot Treatment Options in Boston, MA

If you're searching for tetrology of fallot treatment options in Boston, MA, this clinical trial (NCT05452720) 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 Boston research site is actively enrolling participants for this clinical trial. You'll receive care from experienced tetrology of fallot 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 tetrology of fallot clinical trials near you to find additional studies recruiting in your area.

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