BridgeMD
New treatment option for Tricuspid Regurgitation (TR)
Official title Early Feasibility of 'Pivot Extend' for Tricuspid Regurgitation Treatment
ClinicalTrials.gov ID: NCT06877520
What this study is testing
- What it's testing
- This clinical trial aims to evaluate the safety and demonstrate the efficacy of treatment to improve tricuspid regurgitation (TR) symptoms in patients with severe and clinically symptomatic TR through long-term implantation of an investigational medical device. 1.
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
- Adults 18 years of age or older at the time of screening
- Those with symptoms despite medical therapy (OMT, diuretics/medications) for TR for at least 1 month at screening
- Those who meet the criteria of severe (3+) or worse on the TR grade classification table on echocardiography performed at the screening visit
- Those with clinical symptoms of New York Heart Association (NYHA) class 2 or worse
- Those deemed suitable for percutaneous valve intervention by a Heart Team that includes at least one cardiologist, one cardiac surgeon and one...
You likely can't join if
- Those with blood clots, emboli, masses, or growths in the vascular system of the heart or lungs on an echocardiogram and cardiac CT scan performed at...
- Those with uncorrected blood clotting disorders based on hemanalysis performed at the screening visit
- Those who are unable to use anticoagulant agents (NOAC ex.Xarelto)
- Those who have had major bleeding (not including minor bleeding, such as a nosebleed that can be hemostasized) treated with anticoagulants prior to...
- Those with severe anemia (hemoglobin ≦10g/dL) that requires hospitalization
- Those who have an implanted device such as an implantable cardioverter defibrillator (ICD) or pacemaker prior to participation in this clinical trial
See the full eligibility criteria
Who can join
- Adults 18 years of age or older at the time of screening
- Those with symptoms despite medical therapy (OMT, diuretics/medications) for TR for at least 1 month at screening
- Those who meet the criteria of severe (3+) or worse on the TR grade classification table on echocardiography performed at the screening visit
- Those with clinical symptoms of New York Heart Association (NYHA) class 2 or worse
- Those deemed suitable for percutaneous valve intervention by a Heart Team that includes at least one cardiologist, one cardiac surgeon and one anesthesiologist.
- Those who have voluntarily decided to participate in this clinical trial and have provided written informed consent
- Those who can understand and follow the investigator's instructions and are able to participate for the entire duration of the study
What rules you out
- Those with blood clots, emboli, masses, or growths in the vascular system of the heart or lungs on an echocardiogram and cardiac CT scan performed at the screening visit
- Those with uncorrected blood clotting disorders based on hemanalysis performed at the screening visit
- Those who are unable to use anticoagulant agents (NOAC ex.Xarelto)
- Those who have had major bleeding (not including minor bleeding, such as a nosebleed that can be hemostasized) treated with anticoagulants prior to participation in this clinical trial
- Those with severe anemia (hemoglobin ≦10g/dL) that requires hospitalization
- Those who have an implanted device such as an implantable cardioverter defibrillator (ICD) or pacemaker prior to participation in this clinical trial
- Those whose anatomy, in the opinion of the investigator, is not suitable for implantation of an investigational medical device based on echocardiogram and cardiac CT scan performed at the screening visit
- Those who require surgery or treatment procedures (coronary artery bypass graft (CABG) or surgery for atrial septal defect (ASD)) based on an echocardiogram performed at the screening visit
- Those with a platelet count of 80,000/uL or less based on hemanalysis performed at the screening visit
- Patients with pulmonary arterial hypertension with a TR Vmax greater than 3.5 m/s on echocardiography performed at the screening visit or a pulmonary vascular resistance of more than 3 Wood Units on right heart...
- Those with a left ventricular ejection fraction (LVEF) of less than 50% on echocardiogram performed at the screening visit
- Those who have had active gastrointestinal bleeding or a digestive procedure within 3 months prior to participation in this study (those with the potential for gastrointestinal bleeding)
- Those with a history of cerebrovascular accident (CVA) or transient ischemic attacks (TIA) within 30 days prior to participation in this clinical trial
- Those with a history of myocardial infarction (MI) within 30 days prior to participation in this study
- Those with active endocarditis requiring antibiotic treatment
- Those with malignancies with end-stage renal failure requiring hemodialysis and other chronic conditions who have a life expectancy of less than one year
- Those with moderate or severe aortic, pulmonary artery, or mitral stenosis on echocardiogram performed at the screening visit
- Those with moderate or worse mitral valve regurgitation or severe aortic valve regurgitation on the echocardiogram performed at the screening visit
- Those with calcification of the tricuspid valve lobes affecting the procedure on an echocardiogram performed at the screening visit
- Those who have participated in another clinical trial within 30 days prior to participation in this clinical trial
- Pregnant or nursing women, or women planning to become pregnant during the clinical trial period
- Women of childbearing potential who are not using a medically accepted birth control method
- Those with a coexisting condition, which most likely limits the participant´s life expectancy to less than one year.
- Those with a preexisting pulmonary valve prosthesis or RV to PA conduit.
- Those with clinical findings other than the above that, in the opinion of the investigator, are medically inappropriate for this clinical trial
The study team makes the final eligibility decision.
Where it's taking place
- Tbilisi, K'alak'i T'bilisi, Georgia
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 Tbilisi, K'alak'i T'bilisi, Georgia. 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.