Edwards PASCAL Transcatheter Valve Repair System Pivotal Clinical Trial (CLASP II TR)

Edwards Lifesciences

Status

Enrolling

Conditions

Tricuspid Valve Insufficiency

Tricuspid Valve Disease

Tricuspid Regurgitation

Treatments

Device: Edwards PASCAL System

Drug: Optimal Medical Therapy

Study type

Interventional

Funder types

Industry

Identifiers

NCT04097145

2019-07

Details and patient eligibility

About

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

Full 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.

Enrollment

870 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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:
1. Would prevent proper TR reduction due to interaction of the lead with the leaflets
2. 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:
1. Percutaneous coronary, intracardiac, or endovascular intervention within the last 30 days prior to the point of enrollment
2. Carotid surgery within 30 days prior to the point of enrollment
3. Direct current cardioversion within the last 30 days prior to the point of enrollment
4. Leadless RV pacemaker implant within the last 30 days prior to the point of enrollment
5. 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

870 participants in 4 patient groups

Edwards PASCAL System & OMT

Experimental group

Description:

Transcatheter tricuspid valve repair with the Edwards PASCAL system in patients on optimal medical therapy (OMT) with tricuspid regurgitation

Treatment:

Device: Edwards PASCAL System

Optimal Medical Therapy (OMT)

Active Comparator group

Description:

Optimal medical therapy (OMT) alone in patients with tricuspid regurgitation

Treatment:

Drug: Optimal Medical Therapy

Single-Arm Registry

Experimental group

Description:

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

Treatment:

Device: Edwards PASCAL System

Continued Access Study

Experimental group

Description:

Transcatheter tricuspid valve repair with the Edwards PASCAL system in patients on optimal medical therapy (OMT) with tricuspid regurgitation

Treatment:

Device: Edwards PASCAL System