BridgeMD
New treatment option for Tricuspid Regurgitation
Official title Trisol System EFS Study
ClinicalTrials.gov ID: NCT04905017
What this study is testing
- What it's testing
- The objective of this early feasibility study is to gain early clinical insight into Trisol system safety and performance to treat patients with moderate or greater tricuspid regurgitation (TR).
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
- Age \>18 years.
- Subject meets the legal minimum age to provide informed consent based on local regulatory requirements.
- Participant has symptomatic, moderate or greater functional or degenerative tricuspid regurgitation (TR) as determined by the Echocardiography Core...
- New York Heart Association (NYHA) Functional Class II to IVa.
- Participant is deemed at high surgical risk or greater for tricuspid valve surgery and appropriate for transcatheter tricuspid valve replacement as...
You likely can't join if
- Previous tricuspid valve repair or replacement which may impede proper study device delivery or deployment.
- Stroke or transient ischemic event within the previous 90 days.
- Acute myocardial infarction within the previous 90 days.
- Hemodynamic instability requiring inotropic therapy or mechanical hemodynamic support devices.
- Untreated clinically significant coronary artery disease requiring revascularization.
- Implant or revision of any rhythm management device (CRT or CRT-D) or implantable cardioverter-defibrillator within the previous 30 days.
See the full eligibility criteria
Who can join
- Age \>18 years.
- Subject meets the legal minimum age to provide informed consent based on local regulatory requirements.
- Participant has symptomatic, moderate or greater functional or degenerative tricuspid regurgitation (TR) as determined by the Echocardiography Core Lab assessment of a qualifying transthoracic echocardiogram (TTE)...
- New York Heart Association (NYHA) Functional Class II to IVa.
- Participant is deemed at high surgical risk or greater for tricuspid valve surgery and appropriate for transcatheter tricuspid valve replacement as determined by the local Heart Team.
- Participant adequately treated based upon medical standards, including for coronary artery disease, mitral regurgitation, and Guideline-Directed Medical Therapy (GDMT) for heart failure for at least 30-days prior to...
- Male or non-pregnant female.
- Participant understands the nature of the procedure and provides written informed consent prior to any study specific assessments.
- Participant is willing and able to comply with the specified study requirements and follow-up evaluations.
- Participant is anatomically suitable for the Trisol system, including trans-jugular access as per imaging requirements, and is approved by the Subject Screening Committee
What rules you out
- Previous tricuspid valve repair or replacement which may impede proper study device delivery or deployment.
- Stroke or transient ischemic event within the previous 90 days.
- Acute myocardial infarction within the previous 90 days.
- Hemodynamic instability requiring inotropic therapy or mechanical hemodynamic support devices.
- Untreated clinically significant coronary artery disease requiring revascularization.
- Implant or revision of any rhythm management device (CRT or CRT-D) or implantable cardioverter-defibrillator within the previous 30 days.
- New or untreated right heart chamber or/and superior vena cava intracardiac mass, thrombus, or vegetation.
- Systolic pulmonary arterial pressure (sPAP) \> 80 mmHg as measured by pulmonary pressure catheter.
- Severe RV dysfunction with RV Stroke Work Index (RVSWI) g/m2/beat \<400 and Pulmonary Artery Pulsatile index (PAPi) \<2.
- Ongoing sepsis, including active endocarditis.
- Active infection requiring current antibiotic therapy.
- Known bleeding diathesis or hypercoagulable state.
- Blood dyscrasias as defined: leukopenia (WBC \<3000 cells/mm3), thrombocytopenia (platelet count \<50,000 cells/mm3).
- Active gastrointestinal (GI) bleeding or history of GI bleed within the previous 60 days that would preclude anticoagulation.
- LVEF \<25% as measured by resting echocardiogram within 30 days prior to index procedure.
- Patients in whom transesophageal echocardiography is contraindicated.
- Aortic, mitral or pulmonary valve disease (severe stenosis or severe regurgitation) requiring intervention or performed within 90 days prior to enrollment.
- Severe tricuspid valve stenosis.
- Need for any percutaneous cardiovascular intervention, cardiovascular surgery, or carotid surgery within 30 days prior to index procedure.
- Need for emergent or urgent non cardiac surgery for any reason.
- Contraindication or known allergy to device components, anticoagulation therapy with a vitamin K antagonist, or to contrast media that cannot be adequately premedicated.
- History of cardiac transplantation, or participant currently listed for urgent transplant (e.g., UNOS Status 1).
- Presence of any known life-threatening non-cardiac disease that will limit the subject's life expectancy to less than one year.
- Contraindication or known hypersensitivity to anticoagulant therapy and/or antiplatelet therapy.
- Venous anatomy unsuitable for implant delivery.
- Pacemaker or ICD lead present that would prevent appropriate valve placement.
- Active COVID-19 infection.
- Comorbid condition(s) that, in the opinion of the investigator, could limit the patient's ability to participate in the study, including compliance with follow-up requirements, or that could impact the scientific...
- Previously enrolled in this study or currently participating in another investigational drug or device study that has not completed the primary endpoint or that clinically interferes with the endpoints of this study.
The study team makes the final eligibility decision.
Where it's taking place
- Los Angeles, California, United States
- Atlanta, Georgia, United States
- New York, New York, United States
- Cleveland, Ohio, United States
- Wynnewood, Pennsylvania, United States
- Nashville, Tennessee, United States
- Charlottesville, Virginia, United States
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 Los Angeles, California, United States; Atlanta, Georgia, United States; New York, New York, United States; Cleveland, Ohio, United States; Wynnewood, Pennsylvania, United States; Nashville, Tennessee, United States and 1 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.