Edwards PASCAL Transcatheter Valve Repair System Pivotal Clinical Trial

Official title

A Prospective, Multicenter, Randomized, Controlled Pivotal Trial to Evaluate the Safety and Effectiveness of Transcatheter Tricuspid Valve Repair With the Edwards PASCAL Transcatheter Valve Repair System and Optimal Medical Therapy (OMT) Compared to OMT Alone in Patients With Tricuspid Regurgitation

Overview

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

Detailed description

A Prospective, multicenter, randomized, controlled pivotal trial to evaluate the safety and effectiveness of transcatheter tricuspid valve repair with the Edwards PASCAL Transcatheter Valve Repair System and optimal medical therapy (OMT) compared to OMT alone in patients with tricuspid regurgitation. Patients will be seen for follow-up visits at discharge, 30 days, 3 months, 6 months, and annually through 5 years.

Interventions

• Device Edwards PASCAL System
  Transcatheter tricuspid valve repair with the Edwards PASCAL System in patients on optimal medical therapy
• Drug Optimal Medical Therapy
  Optimal Medical Therapy alone in patients with tricuspid regurgitation
• Device Edwards PASCAL System
  Transcatheter tricuspid valve repair with the Edwards PASCAL System in conjunction with OMT
• Device Edwards PASCAL System
  Transcatheter tricuspid valve repair with the Edwards PASCAL system in patients on optimal medical therapy (OMT) with tricuspid regurgitation

Primary outcome measures

• Composite endpoint including all-cause mortality, RVAD implantation or heart transplant, tricuspid valve intervention, heart failure hospitalizations, and Quality of Life improvement (measured by KCCQ score) [Time frame: 6 months]

Secondary outcome measures (12)

• 1 Grade Reduction in TR Severity [Time frame: 6, 12 months]
• Quality of Life (QOL) as Measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ) [Time frame: 3, 6, and 12 months]
• All Cause Mortality [Time frame: 12 months, 24 months]
• Death and Heart Failure Hospitalizations [Time frame: 12 months]
• All-cause Mortality, TV Surgery or TV Interventions [Time frame: 24 months]
• Right ventricular end-diastolic diameter (RVEDD mid) [Time frame: 12 months]
• Major Adverse Events (MAEs) [Time frame: 30 days]
• Reduction in TR grade [Time frame: Intraprocedural post-implantation]
• All-Cause Mortality [Time frame: 12 months, annually through 5 years]
• Heart failure hospitalizations [Time frame: 12 months, annually through 5 years]
• Non-elective tricuspid valve re-intervenitions (percutaneous or surgical) [Time frame: 12 months, annually through 5 years]
• Durable RVAD implantation or heart transplant [Time frame: 12 months, annually through 5 years]

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 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 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 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

United States · 73 centers

• Banner University Medical Center Phoenix — Phoenix
• Tucson Medical Center Healthcare — Tucson
• University of California, Irvine — Irvine
• SCPMG - Kaiser San Diego — La Jolla
• Cedars Sinai Medical Center — Los Angeles
• UCLA Medical Center — Los Angeles
• Kaiser Permanente San Francisco — San Francisco
• University of California, San Francisco — San Francisco
• … and 65 more centers

Canada · 6 centers

• St. Paul's Hospital — Vancouver
• Hamilton Health Services — Hamilton
• University of Ottawa Heart Institute — Ottawa
• Sunnybrook Health Sciences Centre — Toronto
• St. Michael's Hospital — Toronto
• Institut universitaire de cardiologie et de pneumologie de Québec - Université Laval — Québec

Identifiers

NCT: NCT04097145 · 2019-07

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗