Triscuspid Regurgitation: Edwards PASCAL TranScatheter Valve Repair System

What is the Purpose of this Study?

The purpose of this study is to evaluate the safety and effectiveness of an experimental device called the PASCAL System with optimal medical therapy (OMT) compared to OMT alone in patients with symptomatic severe tricuspid regurgitation. Tricuspid regurgitation is a condition in which the heart’s tricuspid valve does not close tightly, causing blood to flow backwards. If left untreated, it can increase the risk of heart failure. The PASCAL Device implant is an artificial device covered in polyester fabric. The main components of the PASCAL Implant System are the PASCAL Device implant, steerable catheter, and implant catheter. Participants will be randomly assigned to be in one of two groups in a 2:1 ratio (meaning participants will be twice as likely to receive treatment with the PASCAL device with optimal medical therapy as compared to optimal medical therapy alone). The PASCAL Device with Optimal Medical Therapy (OMT) Group will have a procedure to repair their tricuspid valve using the PASCAL System plus optimal medical therapy. The Optimal Medical Therapy (OMT) Alone Group will be treated with optimal medical therapy alone.

Eligibility

* 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

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

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Where can I participate?

Beverly

More about this Clinical Trial

What is the full name of this clinical trial?

Edwards PASCAL TrAnScatheter Valve RePair System Pivotal Clinical Trial : 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 compared to OMT alone in patients with tricuspid regurgitation

Study Details

Disease Type/Condition

Other

Principal Investigator

Makkar, Rajendra

Co-Investigators

Aamir Shah, Mamoo Nakamura, Tarun Chakravarty, Wen Cheng

Age Group

Adult

Phase

Not Available

IRB Number

STUDY00000548

ClinicalTrials.gov ID

NCT04097145

Key Eligibility

ClinicalTrials.gov

How do I learn more about this study?

clinicaltrials@cshs.org