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Tests treatment safety and results for Tricuspid Regurgitation Functional
Official title Safety and Feasibility Study: Transcatheter Valve Repair in Severe Symptomatic Functional Tricuspid Regurgitation
ClinicalTrials.gov ID: NCT07140562
What this study is testing
- What it's testing
- The goal of this clinical trial is to evaluate the safety and technical success of the Tangent Tricuspid Annular Therapy System in patients with severe, symptomatic functional tricuspid regurgitation.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 90
You may be able to join if
- 18-90 years old at the time of consent
- Symptomatic functional tricuspid regurgitation (without co-existing degenerative disease) despite being adequately treated with optimal medical...
- Severe, massive or torrential functional tricuspid regurgitation, as determined by qualifying transesophageal echocardiogram (TEE) and/or...
- TEE imaging confirms adequate visualization of valve for TR quantification and procedural guidance
- The Local Heart Team determines the candidate is suitable for transcatheter tricuspid valve repair
You likely can't join if
- Estimated life expectancy of less than 12 months
- Systolic pulmonary artery pressure (sPAP) \>70 mmHg as assessed by TTE or right heart catheterization
- Acutely decompensated, defined as hypotension with SBP \ 180 mmHg within 30 days of the study procedure
- Severe COPD dependent on home oxygen or chronic home oxygen use
- Echocardiographic evidence of severe right ventricular dysfunction
- Severe aortic, mitral and/or pulmonic valve stenosis and/or regurgitation requiring treatment (prior transcatheter or surgical treatment allowable)
See the full eligibility criteria
- 18-90 years old at the time of consent
- Symptomatic functional tricuspid regurgitation (without co-existing degenerative disease) despite being adequately treated with optimal medical therapy by the Local Heart Team for at least 30 days prior to the study...
- Severe, massive or torrential functional tricuspid regurgitation, as determined by qualifying transesophageal echocardiogram (TEE) and/or transthoracic echocardiogram (TTE) using the 5-grade classification
- TEE imaging confirms adequate visualization of valve for TR quantification and procedural guidance
- The Local Heart Team determines the candidate is suitable for transcatheter tricuspid valve repair
- Subject or legally authorized representative has provided informed consent and agrees to return for all required post-procedure follow-up visits
- Estimated life expectancy of less than 12 months
- Systolic pulmonary artery pressure (sPAP) \>70 mmHg as assessed by TTE or right heart catheterization
- Acutely decompensated, defined as hypotension with SBP \ 180 mmHg within 30 days of the study procedure
- Severe COPD dependent on home oxygen or chronic home oxygen use
- Echocardiographic evidence of severe right ventricular dysfunction
- Severe aortic, mitral and/or pulmonic valve stenosis and/or regurgitation requiring treatment (prior transcatheter or surgical treatment allowable)
- Any condition that would interfere with the procedure, such as prior tricuspid valve repair, tricuspid valve leaflet anatomy which may preclude device implantation, pacemaker or Implantable Cardioverter Defibrillator...
- Tricuspid valve stenosis defined as a tricuspid valve orifice of ≤1.0 cm2 and/or mean gradient of ≥5 mmHg
- New or untreated right heart chamber and/or superior vena cava intracardiac mass, thrombus, or vegetation
- Degenerative tricuspid or rheumatic tricuspid valve disease
- Any percutaneous cardiovascular intervention, cardiovascular surgery, or carotid surgery within 30 days of the study procedure
- Implant or revision of any rhythm management device (CRT or CRT-D, ICD, or leadless pacemaker) within 90 days prior to the study procedure
- Known need for emergent, urgent, or planned surgery or intervention within 30 days following the study procedure, or planned or scheduled cardiac surgery within 12 months following the study procedure
- Stroke or other major cerebrovascular event within 90 days prior to the study procedure
- Untreated clinically significant coronary artery disease requiring revascularization, recent (within 30 days of the study procedure) acute coronary syndrome or myocardial infarction
- Active or recent GI bleed within 30 days prior to the study procedure, or patients contraindicated for oral anticoagulation therapy
- Bleeding disorders including thrombocytopenia (platelet count \ 700,000 mm3)
- Transfusion-dependent chronic anemia with Hb \<9/dL
- Current or planned pregnancy within 12 months of the study procedure for women of childbearing potential
- Active or recent endocarditis within 90 days of the study procedure, or sepsis/other systemic infection requiring oral or intravenous antibiotics within 30 days of the study procedure
- Prior tricuspid repair or tricuspid replacement or prosthetic implant that would interfere with successful deployment or functioning of the Tangent Implant
- Participation in another pre-market investigational device study or investigational drug study (for a cardiac-related drug)
- Presence of other anatomic or co-morbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's availability to participate in the clinical...
- Any patient considered to be vulnerable
- Left ventricular ejection fraction (LVEF) \<30%
- Deep vein thrombosis or pulmonary embolism within 6 months of the study procedure
- Child-Pugh C cirrhosis
The study team makes the final eligibility decision.
Where it's taking place
- Asunción, Paraguay
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
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 to 90 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Asunción, Paraguay. 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.