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Tests treatment safety and results for Tricuspid Regurgitation Functional
Official title Acute Safety and Efficacy of the Pivot Bridge System for Functional Tricuspid Regurgitation
ClinicalTrials.gov ID: NCT07385625
What this study is testing
- What it's testing
- The purpose of this clinical trial is as follows. To assess the safety of the investigational medical device "Pivot Bridge" in participants aged 18 years or older with massive or greater functinal tricuspid regurgitation (TR) who have received medical therapy (diuretics/pharmacological treatment) for at least one month.
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
- people who meet all of the following criteria will be enrolled
- Adults aged 18 years or older at the time of screening
- people who have received appropriate medical treatment (diuretics/medical therapy) for tricuspid regurgitation for at least 1 month prior to...
- people who, at the screening visit, are assessed by transthoracic echocardiography (TTE) to have functional tricuspid regurgitation severity of...
- people who, at the screening visit, are found on TTE or cardiac computed tomography (CT) to have a right ventricle (RV) larger than the left...
You likely can't join if
- people who meet any of the following criteria will be excluded
- people in whom thrombus or embolic material is identified on echocardiography or cardiac computed tomography (CT) performed at the screening visit
- people who have uncorrected coagulation disorders as shown by clinical laboratory tests performed at the screening visit
- people who cannot use anticoagulant agents
- people who, prior to participation in this clinical trial, have experienced major bleeding due to the use of anticoagulants (minor bleeding such as...
- people who, prior to participation in this clinical trial, have had devices such as an implantable cardioverter defibrillator (ICD) or a pacemaker...
See the full eligibility criteria
Who can join
- people who meet all of the following criteria will be enrolled
- Adults aged 18 years or older at the time of screening
- people who have received appropriate medical treatment (diuretics/medical therapy) for tricuspid regurgitation for at least 1 month prior to participation in this clinical trial
- people who, at the screening visit, are assessed by transthoracic echocardiography (TTE) to have functional tricuspid regurgitation severity of Massive (4+) or greater, as defined by Tricuspid Valve Academic Research...
- people who, at the screening visit, are found on TTE or cardiac computed tomography (CT) to have a right ventricle (RV) larger than the left ventricle (LV)
- people who, at the screening visit, are found on cardiac CT to have an annular diameter of 40 mm or greater
- people for whom the Heart Team, consisting of at least one cardiologist (specialist in cardiology) and at least one cardiac surgeon, has determined that surgical treatment for isolated Tricuspid Regurgitation is required
- people who voluntarily decide to participate in this clinical trial and provide written informed consent on the subject consent form
- people who are able to understand and comply with the investigator's instructions and participate throughout the entire clinical trial period
What rules you out
- people who meet any of the following criteria will be excluded
- people in whom thrombus or embolic material is identified on echocardiography or cardiac computed tomography (CT) performed at the screening visit
- people who have uncorrected coagulation disorders as shown by clinical laboratory tests performed at the screening visit
- people who cannot use anticoagulant agents
- people who, prior to participation in this clinical trial, have experienced major bleeding due to the use of anticoagulants (minor bleeding such as controllable epistaxis does not apply) requiring treatment, or who have...
- people who, prior to participation in this clinical trial, have had devices such as an implantable cardioverter defibrillator (ICD) or a pacemaker implanted
- people who, based on echocardiography and cardiac CT performed at the screening visit, are judged by the investigator to have anatomical structures unsuitable for implantation of the investigational medical device
- people who, based on clinical laboratory tests performed at the screening visit, have a platelet count of ≤80,000/µL
- people who, based on echocardiography performed at the screening visit, have pulmonary hypertension with TR Vmax ≥3.5 m/s
- people who, based on echocardiography performed at the screening visit, have left ventricular ejection fraction (LVEF) \<50%
- people who, within 3 months prior to participation in this clinical trial, have had active gastrointestinal bleeding or have undergone gastrointestinal procedures (people with a risk of gastrointestinal bleeding)
- people who, within 30 days prior to participation in this clinical trial, have a history of cerebrovascular accident (CVA) or transient ischemic attack (TIA)
- people who, within 30 days prior to participation in this clinical trial, have a history of myocardial infarction (MI)
- people with active infective endocarditis requiring antibiotic therapy
- people with severe terminal illnesses (e.g., malignant tumors, end-stage pulmonary disease, end-stage liver disease, end-stage renal failure)
- people who, based on echocardiography performed at the screening visit, have moderate or severe aortic, pulmonary, or mitral stenosis
- people who, based on echocardiography performed at the screening visit, are found to have calcification of the tricuspid valve leaflets that would affect the procedure
- people who, based on echocardiography performed at the screening visit, are found to have masses, thrombi, or proliferative lesions in the right heart system, femoral vein, or inferior vena cava
- people who, within 30 days prior to participation in this clinical trial, have participated in another clinical trial
- Pregnant or lactating women, and women planning to become pregnant during the study period
- Women of childbearing potential who are not using medically acceptable methods of contraception
- people who, in addition to the above, are deemed by the investigator to have clinically significant findings that make them inappropriate for participation in this trial
The study team makes the final eligibility decision.
Where it's taking place
- Daegu, Dalseo-gu, South Korea
- Yangsan, Gyeongsangnam-do, South Korea
- Seoul, Seodaemun-gu, South Korea
- Seoul, Songpa-gu, South Korea
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 Daegu, Dalseo-gu, South Korea; Yangsan, Gyeongsangnam-do, South Korea; Seoul, Seodaemun-gu, South Korea; Seoul, Songpa-gu, South Korea. Enter your location above to see the nearest site and check your eligibility.
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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.