Naples, FLNCT07454980Now EnrollingIRB Ready

Tricuspid Regurgitation (TR) Clinical Trial in Naples, FL

Access cutting-edge tricuspid regurgitation (tr) treatment through this clinical trial at a research site in Naples. Study-provided care at no cost to qualified participants.

Sponsored by Jenscare Innovation Inc.

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Expert Care in Naples

Access tricuspid regurgitation (tr) specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related tricuspid regurgitation (tr) treatment provided free

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Check if you qualify for this tricuspid regurgitation (tr) clinical trial in Naples, FL

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Why Participate?

  • No-Cost Study Care

  • Local to Naples

    Convenient for FL 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 Naples site if eligible
  4. 4Begin participation

About This Tricuspid Regurgitation (TR) Study in Naples

The goal of this clinical trial is to learn if LuX-Valve Plus system works to treat symptomatic subjects with at least severe tricuspid regurgitation (TR). It will also learn about the safety of LuX-Valve Plus system. Researchers will compare LuX-Valve Plus system to a conventional device called EVOQUE to see if LuX-Valve Plus system works to treat subjects with at least severe tricuspid regurgitation. Participants will: Undergo one procedure using the LuX-Valve Plus system or EVOQUE after passing screening and enrolling in the trial; Complete follow-up visits and examinations as required by the trial protocol; Report any adverse events

Sponsor: Jenscare Innovation Inc.

Who Can Participate

Inclusion Criteria

For the randomized study:
Subject is at least 21 years of age at time of consent.
Subject (or legal guardian) understands trial requirements and treatment procedures and is able to provide written informed consent.
Severe or greater TR as assessed on transthoracic echocardiography by core lab.
New York Heart Association (NYHA) Class II-IV.
On optimal medical therapy (OMT) for TR at the time of baseline assessment per site Heart Team. OMT includes stable oral diuretic medications unless patient has a documented history of intolerance.
The site Heart Team concurs that the patient is a good candidate for transcatheter tricuspid valve replacement and suitable for LuX-Valve Plus system by core lab.
The commercial sponsor for EVOQUE deems that the patient is a good candidate for EVOQUE valve (control arm). For single arm cohort ("Not Suitable for Conventional TTVI")
Meets all criteria 1-6 above
The EVOQUE commercial sponsor deems the anatomy unsuitable for EVOQUE tricuspid valve replacement, or the annular perimeter is smaller or greaterthan EVOQUE commercial Instructions for Use (IFU), as determined by the clinical site
Two independent Structural Cardiologists determine the patient "Not Suitable" for Triluminate edge to edge repair

Exclusion Criteria

Left ventricular ejection fraction (LVEF) \<35%.
Pulmonary arterial systolic pressure (PASP) \>60 mmHg by echo Doppler (unless right heart catheterization \[RHC\] demonstrates PASP ≤60mmHg); in case RHC is performed, PASP \>2/3 systemic BP with PVR \>5 Wood units after vasodilator challenge, in the absence of symptomatic hypotension or systolic BP \<90 mmHg.
Evidence of intracardiac mass, thrombus, or vegetation.
Ebstein Anomaly or congenital right ventricular dysplasia.
Surgical or interventional correction is indicated for other concomitant valvular diseases (subjects with concomitant valvular disease may treat their respective valve first and wait 2 months before being reassessed for the trial).
Subjects with valve prostheses implanted in the tricuspid valve.
Pre-existing prosthetic valve(s) (other than tricuspid ones) with clinically significant prosthetic dysfunction.
Active infection, infective endocarditis or sepsis within 3 months, or infections requiring antibiotics treatment within two weeks prior to planned procedure.
Untreated clinically significant coronary artery disease requiring revascularization.
Acute myocardial infarction or unstable ischemia-related angina within 30 days prior to the planned procedure.
Any percutaneous coronary, intracardiac or carotid intervention within 30 days prior to the planned procedure.
Cerebrovascular stroke (ischemic or bleeding) within 3 months prior to enrollment.
Active peptic ulcer or active gastrointestinal bleeding within 3 months prior to enrollment.
Blood dyscrasias as defined: leukopenia (WBC \<1000 mm3), thrombocytopenia (platelet count \<50,000 cells/mm3), history of bleeding diathesis, or coagulopathy.
Inability to tolerate anticoagulation or antiplatelet therapy.
Renal insufficiency (eGFR\< 30ml/min \[per the CKD-EPI formula\] and/or renal replacement therapy).
Patients with hepatic insufficiency or cirrhosis with Child-Pugh score class C
Pregnancy or intent to become pregnant prior to completion of all protocol follow-up requirements.
Severe Chronic Obstructive Pulmonary Disease requiring steroids or requiring continuous home oxygen.
Untreatable hypersensitivity or contraindication to any of the following: all antiplatelets, all anticoagulants, nitinol alloys (nickel and titanium), bovine tissue, glutaraldehyde, or contrast media.
Estimated life expectancy \<12 months.
Subjects currently participating in another clinical trial of an investigational drug or device that has not yet completed its primary endpoint.
Subjects with current history of illicit drug use.
Any other condition making it unlikely the patient will be able to complete all protocol procedure and follow-ups determined by the investigator.

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 Naples?

Yes, this clinical trial (NCT07454980) has an active research site in Naples, FL 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 (TR) Treatment Options in Naples, FL

If you're searching for tricuspid regurgitation (tr) treatment options in Naples, FL, this clinical trial (NCT07454980) 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 Naples research site is actively enrolling participants for this clinical trial. You'll receive care from experienced tricuspid regurgitation (tr) 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 (tr) clinical trials near you to find additional studies recruiting in your area.

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