Edwards PASCAL Transcatheter Valve Repair System Pivotal Clinical Trial (CLASP II TR)
Tricuspid Regurgitation, Tricuspid Valve Insufficiency, Tricuspid Valve Disease
About this trial
This is an interventional treatment trial for Tricuspid Regurgitation
Eligibility Criteria
Inclusion 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
Exclusion Criteria:
- 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 core lab assessment
- Deep vein thrombosis (DVT) or pulmonary embolism (PE) in the last 180 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 dysplasia, and arrhythmogenic 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 or recent infection requiring antibiotic therapy
- Chronic obstructive pulmonary disease (COPD) requiring continuous home oxygen
- Pregnant or planning pregnancy within the next 12 months
- 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
Sites / Locations
- Banner University Medical Center PhoenixRecruiting
- Tucson Medical Center HealthcareRecruiting
- University of California, IrvineRecruiting
- SCPMG - Kaiser San DiegoRecruiting
- Cedars Sinai Medical CenterRecruiting
- UCLA Medical CenterRecruiting
- Kaiser Permanente San FranciscoRecruiting
- University of California, San FranciscoRecruiting
- Stanford UniversityRecruiting
- St. Joseph HospitalRecruiting
- Medical Center of the RockiesRecruiting
- The Cardiac and Vascular Institute Research FoundationRecruiting
- Mount Sinai Medical CenterRecruiting
- NCH Healthcare SystemRecruiting
- Sarasota Memorial Health Care SystemRecruiting
- Emory University Hospital Midtown / Emory University - St. Joseph's HospitalRecruiting
- Piedmont Healthcare, Inc.Recruiting
- Northwestern UniversityRecruiting
- Ascension St. Vincent Heart Center Cardiovascular Research InstituteRecruiting
- University of Iowa Hospitals & ClinicsRecruiting
- Ochsner Medical CenterRecruiting
- Johns HopkinsRecruiting
- Massachusetts General HospitalRecruiting
- University of MichiganRecruiting
- Henry Ford HospitalRecruiting
- William Beaumont Hospital - Royal OakRecruiting
- St. Mary's of Ascension ResearchRecruiting
- Fairview Health ServicesRecruiting
- Mayo ClinicRecruiting
- Saint Luke's Hospital of Kansas CityRecruiting
- Washington University School of MedicineRecruiting
- Providence St. Patrick HospitalRecruiting
- Dartmouth-Hitchcock Medical CenterRecruiting
- Cooper Health SystemsRecruiting
- Morristown Medical CenterRecruiting
- Rutgers Robert Wood Johnson Medical SchoolRecruiting
- Montefiore Medical Center / Arts Pavilion / Hutchinson Metro Center Clinic / Weiler Hospital / Moses HospitalRecruiting
- State University of New York at BuffaloRecruiting
- Columbia University Irving Medical Center/NYPHRecruiting
- Weill Cornell MedicineRecruiting
- Lenox Hill Hospital, Northwell Health /Northshore University Hospital ManhassetRecruiting
- Rochester General HospitalRecruiting
- St. Francis HospitalRecruiting
- University of North CarolinaRecruiting
- Sanford Medical Center FargoRecruiting
- The Christ HospitalRecruiting
- TriHealth-Bethesda North HospitalRecruiting
- The Ohio State UniversityRecruiting
- Integris Baptist Medical CenterRecruiting
- Oklahoma Cardiovascular Research GroupRecruiting
- Oklahoma Heart Institute at Hillcrest Medical CenterRecruiting
- Oregon Health & Science UniversityRecruiting
- Penn State HersheyRecruiting
- Pennsylvania Presbyterian Medical Center / Hospital of the University of PennsylvaniaRecruiting
- Pinnacle Health Cardiovascular Institute/UPMC PinnacleRecruiting
- Lankenau Heart InstituteRecruiting
- Medical University of South CarolinaRecruiting
- Erlanger Health SystemRecruiting
- Vanderbilt University Medical CenterRecruiting
- HCA Houston Healthcare Medical CenterRecruiting
- Baylor College of Medicine St. Luke's Medical CenterRecruiting
- The University of Texas Health Science Center at HoustonRecruiting
- UTHealth/Memorial Hermann HospitalRecruiting
- Baylor Scott & White - The Heart Hospital - PlanoRecruiting
- University of Virginia Health SystemRecruiting
- Virginia Commonwealth UniversityRecruiting
- Carilion Medical CenterRecruiting
- Virginia Mason Medical CenterRecruiting
- Swedish Medical CenterRecruiting
- Medical College of WisconsinRecruiting
- St. Paul's HospitalRecruiting
- Hamilton Health ServicesRecruiting
- University of Ottawa Heart InstituteRecruiting
- St. Michael's HospitalRecruiting
- Institut universitaire de cardiologie et de pneumologie de Québec - Université LavalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Active Comparator
Experimental
Edwards PASCAL System & OMT
Optimal Medical Therapy (OMT)
Single-Arm Registry
Transcatheter tricuspid valve repair with the Edwards PASCAL system in patients on optimal medical therapy (OMT) with tricuspid regurgitation
Optimal medical therapy (OMT) alone in patients with tricuspid regurgitation
Transcatheter tricuspid valve repair with the Edwards PASCAL System in conjunction with optimal medical therapy (OMT) in patients with tricuspid regurgitation who are not eligible for randomization