BridgeMD
New treatment option for Tricuspid Regurgitation
Official title EFS of the DUO System for Tricuspid Regurgitation
ClinicalTrials.gov ID: NCT05913908
What this study is testing
- What it's testing
- The study is an early feasibility study to measure individual patient clinical outcomes and effectiveness, evaluate the safety and function of the DUO Transcatheter Tricuspid Coaptation Valve System (DUO System).
- Which group you join is decided by chance.
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
- Presence of severe or greater tricuspid regurgitation as determined by the Echo Core Lab.
- Patient is symptomatic despite medical therapy.
- The local Site Heart Team determines the Patient is appropriate for transcatheter valve intervention.
- The Patient's anatomy is suitable in the judgment of the Patient Selection Committee.
- Age ≥18 years
You likely can't join if
- Patient is currently participating in another clinical investigation that could affect the outcome of this trial.
- Any previous tricuspid valve intervention that would interfere with the placement of the investigational device.
- Moderate or greater tricuspid valve stenosis.
- Severe aortic, mitral and/or pulmonic valve stenosis and/or regurgitation
- Pacemaker or implantable cardioverter-defibrillator (ICD) leads that would prevent appropriate placement of the investigational device.
- Need for concomitant surgical or treatment procedure, known at the time of screening (e.g., CABG, Atrial Septal Defect (ASD) repair).
See the full eligibility criteria
- Presence of severe or greater tricuspid regurgitation as determined by the Echo Core Lab.
- Patient is symptomatic despite medical therapy.
- The local Site Heart Team determines the Patient is appropriate for transcatheter valve intervention.
- The Patient's anatomy is suitable in the judgment of the Patient Selection Committee.
- Age ≥18 years
- The Patient has been informed of the nature of the study and agrees to its provisions and has provided written Informed Consent.
- Patient is currently participating in another clinical investigation that could affect the outcome of this trial.
- Any previous tricuspid valve intervention that would interfere with the placement of the investigational device.
- Moderate or greater tricuspid valve stenosis.
- Severe aortic, mitral and/or pulmonic valve stenosis and/or regurgitation
- Pacemaker or implantable cardioverter-defibrillator (ICD) leads that would prevent appropriate placement of the investigational device.
- Need for concomitant surgical or treatment procedure, known at the time of screening (e.g., CABG, Atrial Septal Defect (ASD) repair).
- Ejection Fraction (EF) \<25%
- Echocardiographic evidence of unstable intracardiac mass, thrombus or vegetation
- Patient has Systolic Pulmonary Pressure (sPAP) \>60 mm Hg
- Severe hemodynamic instability: cardiogenic shock or the need for inotropic support or Intra-Aortic Balloon Pump (IABP) or other percutaneous ventricular assist devices
- Severe respiratory instability with continuous use of home oxygen
- Severe right ventricular dysfunction
- Untreated clinically significant coronary or carotid artery disease requiring revascularization surgical or treatment PCI.
- Stroke or transient ischemic event within 90 days prior to the index procedure
- Acute myocardial infarction within 30 days before the index procedure
- Renal insufficiency (eGFR \<25 ml/min) or currently on chronic dialysis
- Active endocarditis within 6 months of the index procedure
- Pulmonary embolism or deep vein thrombosis within the last 6 months
- Any surgical, treatment, or transcatheter procedure within 30 days prior to the index procedure
- Hypertrophic cardiomyopathy, restrictive cardiomyopathy or constrictive pericarditis
- Life expectancy \<1 year
- Active infections requiring current antibiotic therapy
- Known severe liver disease
- Is on the waiting list for a transplant or has had a prior heart or lung transplant
- Known active peptic ulcer or active GI bleed
- Unable to take anticoagulant therapy
- Any known major coagulation abnormalities, thrombocytopenia, platelets \< 50,000/ml or severe anemia Hb \<8 g/dl
- Known patient is actively abusing drugs
- Any known sensitivities or allergies to contrast (that cannot be adequately premedicated) and/or the device materials, including nickel and titanium
- Patients who are pregnant or intend to become pregnant
- Any condition making it unlikely the Patient will be able to complete all protocol procedures (including compliance with optimal medical therapy and immobility that would prevent completion of 6MWT), follow-up visits...
The study team makes the final eligibility decision.
Where it's taking place
- Phoenix, Arizona, United States
- Thousand Oaks, California, United States
- Atlanta, Georgia, United States
- Chicago, Illinois, United States
- Wichita, Kansas, United States
- Minneapolis, Minnesota, United States
- New York, New York, United States
- Columbus, Ohio, United States
- Harrisburg, Pennsylvania, United States
- San Antonio, Texas, United States
- Salt Lake City, Utah, United States
- Seattle, Washington, United States
- Poznan, Poznan, Poland
- Warsaw, Warsaw, Poland
- Katowice, Poland
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 Phoenix, Arizona, United States; Thousand Oaks, California, United States; Atlanta, Georgia, United States; Chicago, Illinois, United States; Wichita, Kansas, United States; Minneapolis, Minnesota, United States and 9 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.