Is NCT05848284 recruiting in Detriot, MI?

Yes, NCT05848284 is currently recruiting participants at its Detriot, MI location. This tricuspid regurgitation clinical trial is actively enrolling qualified participants.

How do I join the tricuspid regurgitation clinical trial in Detriot?

To join this clinical trial in Detriot, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Detriot clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Tricuspid Regurgitation Clinical Trial in Detriot, MI

Who Can Participate

Inclusion Criteria

Symptomatic severe tricuspid valve regurgitation of primary or secondary etiology.

NYHA class ≥ II. If NYHA Class IV, patient must be ambulatory.

Subject is adequately treated with medical therapy for heart failure ≥ 30 days prior to

index procedure, including a diuretic.

Heart Team determines patient is a recommended candidate for the VDyne System.

Age \>18 years at time of index procedure.

Clinical Screening Committee (CSC) and Imaging Core Labs confirm suitability for treatment with the VDyne System.

Exclusion Criteria

Patient anatomy (cardiac and vascular) is not suitable for VDyne System as assessed by Imaging Core Labs, Sponsor or Clinical Screening Committee (CSC)

Intolerance to procedural anticoagulation or post-procedural antiplatelet/ anticoagulation regimen that cannot be medically managed

Hypersensitivity to nickel or titanium

Left Ventricular Ejection Fraction (LVEF) \<30%.

Severe RV dysfunction.

Significant abnormalities of the tricuspid valve and sub-valvular apparatus.

Sepsis including active infective endocarditis (IE) (within last 6 months).

Right ventricular, atrial thrombus, vegetation or mass on tricuspid valve.

Severe tricuspid annular or leaflets calcification.

Systolic pulmonary hypertension with systolic pulmonary artery pressure \>70 mmHg.

History or rheumatic fever

Significant coronary artery disease requiring treatment such as symptomatic, unresolved multi-vessel or unprotected left main coronary artery disease.

Any planned surgery or interventional procedure within 30 days prior to or 30 days following the implant procedure. This includes any planned concomitant cardiovascular procedure such as CABG, PCI, pulmonary vein ablation, left atrial appendage occlusion, septal defect repair, etc.

Unresolved severe symptomatic carotid stenosis (\> 70% by ultrasound).

Cardiac resynchronization therapy device or implantable pulse generator implanted within 60 days of planned implant procedure.

Permanent pacing leads that will interfere with delivery or implantation of the VDyne Valve.

Cardiogenic shock or hemodynamic instability requiring inotropes or mechanical support devices at the time of planned implant procedure.

Prior tricuspid valve surgery or catheter-based therapy with permanent residual device(s) implanted that would preclude delivery or implantation of the VDyne Valve (e.g. valve replacement, edge to edge repair, etc.).

Significant valvular heart disease requiring intervention other than the tricuspid valve.

Known significant intracardiac shunt (e.g. septal defect)

Cerebrovascular accident (stroke, TIA) within 6 months of treatment procedure.

Severe lung disease (severe COPD or continuous use of home oxygen or oral steroids).

Acute myocardial infarction (AMI) within 30 days.

Significant renal dysfunction (eGFR\<30 ml/min/1.73m2) or on dialysis.

End-stage liver disease (MELD \> 11 / CHILD class C).

Bleeding requiring transfusion within prior 30 days.

Coagulopathy or other clotting disorder that cannot be medically managed.

Chronic immunosuppression or other condition that could impair healing response.

Any of the following: leukopenia, chronic anemia (Hgb \< 9), thrombocytopenia, history of bleeding diathesis, or coagulopathy.

Unwilling to receive blood products.

Known hypersensitivity or contraindication to procedural or post-procedural medications (e.g., contrast solution) which cannot be adequately managed medically.

Life expectancy less than 12 months due to non-cardiac comorbidities.

Treatment is not expected to provide benefit (futile).

Current IV Drug user (must be free drug abuse for \> 1 year).

Pregnant, lactating or planning pregnancy within next 12 months.

Vulnerable patient groups (minors, cognitively impaired persons, prisoners, persons whose willingness to volunteer could be unduly influenced by the expectation of benefits associated with participation or of retaliatory response from senior members of a hierarchy in case of refusal to participate, such as students, residents, and employees).

Currently participating in an investigational drug or device trial that has not reached its primary endpoint or is likely to interfere with this study.

Patient (or legal guardian) unable or unwilling to provide written, informed consent before study enrollment.

Patient unable or unwilling to comply with study required testing and follow-up visits

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 Detriot?

Yes, this clinical trial (NCT05848284) has an active research site in Detriot, MI 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.

Tricuspid Regurgitation Treatment Options in Detriot, MI

If you're searching for tricuspid regurgitation treatment options in Detriot, MI, this clinical trial (NCT05848284) 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 Detriot research site is actively enrolling participants for this clinical trial. You'll receive care from experienced tricuspid 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 tricuspid regurgitation clinical trials near you to find additional studies recruiting in your area.

Tricuspid Regurgitation Clinical Trial in Detriot, MI

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