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New treatment option for Tricuspid Regurgitation
Official title Edwards PASCAL Transcatheter Valve Repair System Pivotal Clinical Trial
ClinicalTrials.gov ID: NCT04097145
What this study is testing
What is Optimal Medical Therapy?
Optimal Medical Therapy is an investigational medicine, being studied as a potential treatment for tricuspid regurgitation.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- To establish the safety and effectiveness of the Edwards PASCAL Transcatheter Repair System in patients with symptomatic severe tricuspid regurgitation who have been determined to be at an intermediate or greater estimated risk of mortality with tricuspid valve surgery by the cardiac surgeon with concurrence by the local Heart Team
- 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
- Eighteen (18) years of age or older
- Despite medical therapy, per the local Heart Team, patient has signs of TR, symptoms from TR, or prior heart failure hospitalization from TR.
- Severe or greater tricuspid regurgitation
- New York Heart Association (NYHA) Class II-IVa or heart failure hospitalization in the prior 12 months
- Patient is at an intermediate or greater estimated risk of mortality with tricuspid valve surgery as determined by the cardiac surgeon with...
You likely can't join if
- Tricuspid valve anatomy not evaluable by TTE or TEE
- Tricuspid valve anatomy precludes proper device deployment and function
- Patient with refractory heart failure requiring, advanced intervention (i.e. patient has or will need left ventricular assist device, or...
- Presence of trans-tricuspid pacemaker or defibrillator leads which meet one of the following:
- Would prevent proper TR reduction due to interaction of the lead with the leaflets
- Were implanted in the RV within the last 90 days prior to the point of enrollment
See the full eligibility criteria
- Eighteen (18) years of age or older
- Despite medical therapy, per the local Heart Team, patient has signs of TR, symptoms from TR, or prior heart failure hospitalization from TR.
- Severe or greater tricuspid regurgitation
- New York Heart Association (NYHA) Class II-IVa or heart failure hospitalization in the prior 12 months
- Patient is at an intermediate or greater estimated risk of mortality with tricuspid valve surgery as determined by the cardiac surgeon with concurrence by the local Heart Team
- Patient is able and willing to give informed consent, follow protocol procedures, and comply with follow-up visit requirements
- Tricuspid valve anatomy not evaluable by TTE or TEE
- Tricuspid valve anatomy precludes proper device deployment and function
- Patient with refractory heart failure requiring, advanced intervention (i.e. patient has or will need left ventricular assist device, or transplantation) (ACC/AHA Stage D heart failure)
- Presence of trans-tricuspid pacemaker or defibrillator leads which meet one of the following:
- Would prevent proper TR reduction due to interaction of the lead with the leaflets
- Were implanted in the RV within the last 90 days prior to the point of enrollment
- Primary non-degenerative tricuspid disease
- Previous tricuspid valve repair or replacement that would interfere with placement of PASCAL
- Clinically significant, untreated coronary artery disease requiring revascularization, unstable angina, evidence of acute coronary syndrome, recent myocardial infarction
- Significant intra-cardiac mass, thrombus, or vegetation per echo core lab assessment
- Deep vein thrombosis (DVT) or pulmonary embolism (PE) in the last 90 days
- Recent Stroke
- Active gastrointestinal (GI) bleeding
- Presence of infiltrative cardiomyopathy or valvulopathy (including carcinoid, amyloidosis, sarcoidosis, hemochromatosis) or significant congenital heart disease, including but not limited to atrial septal defect, RV...
- Need for emergent or urgent surgery for any reason, any planned cardiac surgery within the next 12 months (365 days), or any planned percutaneous cardiac procedure within the next 90 days
- Any of the following cardiovascular procedures:
- Percutaneous coronary, intracardiac, or endovascular intervention within the last 30 days prior to the point of enrollment
- Carotid surgery within 30 days prior to the point of enrollment
- Direct current cardioversion within the last 30 days prior to the point of enrollment
- Leadless RV pacemaker implant within the last 30 days prior to the point of enrollment
- Cardiac surgery within 90 days prior to the point of enrollment
- Severe aortic, mitral and/or pulmonic valve stenosis and/or regurgitation
- Known history of untreated severe symptomatic carotid stenosis or asymptomatic carotid stenosis
- Active endocarditis within the last 90 days or infection requiring antibiotic therapy within the last 14 days
- Patient is oxygen-dependent or requires continuous home oxygen
- Pregnant, breastfeeding, or planning pregnancy within the next 12 months (365 days)
- Concurrent medical condition with a life expectancy of less than 12 months in the judgment of the Investigator
- Patient is currently participating in another investigational biologic, drug, or device clinical study
- Patient has other medical, social, or psychological conditions that preclude appropriate consent and follow-up, or the patient is under guardianship
- Any patient considered to be vulnerable
The study team makes the final eligibility decision.
Where it's taking place
- Phoenix, Arizona, United States
- Tucson, Arizona, United States
- Irvine, California, United States
- La Jolla, California, United States
- Los Angeles, California, United States
- San Francisco, California, United States
- Stanford, California, United States
- Denver, Colorado, United States
- Loveland, Colorado, United States
- Gainesville, Florida, United States
- Miami Beach, Florida, United States
- Naples, Florida, United States
- Sarasota, Florida, United States
- Tallahassee, Florida, United States
- Atlanta, Georgia, United States
- Chicago, Illinois, United States
- Indianapolis, Indiana, United States
- Iowa City, Iowa, United States
- New Orleans, Louisiana, United States
- Baltimore, Maryland, United States
+ 47 more site(s).
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; Tucson, Arizona, United States; Irvine, California, United States; La Jolla, California, United States; Los Angeles, California, United States; San Francisco, California, United States and 61 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.