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

Plain English Summary

Edwards PASCAL Transcatheter Valve Repair System Pivotal Clinical Trial is a Not Applicable clinical trial sponsored by Edwards Lifesciences studying Tricuspid Regurgitation, Tricuspid Valve Insufficiency, Tricuspid Valve Disease. This trial tests a new device called the Edwards PASCAL System to repair a leaky tricuspid valve. It is for adults with severe tricuspid regurgitation who are at moderate or high risk for traditional surgery. Participants will either receive the new valve repair device along with standard medical care or just standard medical care. The alternative for some patients might be open-heart surgery to repair or replace the valve. The trial aims to enroll 870 participants.

Official Summary

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

Who Can Participate

Here is what you need to know about eligibility for this trial. Adults 18 years or older with severe leakage of the tricuspid valve. Patients experiencing symptoms like shortness of breath or fatigue, or who have been hospitalized for heart failure due to the leaky valve. Individuals considered at moderate to high risk for open-heart surgery. People whose tricuspid valve anatomy is suitable for the device and who do not have other severe heart valve problems. This trial is studying Tricuspid Regurgitation, Tricuspid Valve Insufficiency, Tricuspid Valve Disease, so participants generally need a confirmed diagnosis. The trial is currently accepting new participants.

What They're Measuring

The main goal is to see if the new device can significantly reduce valve leakage and improve patients' quality of life, reduce hospitalizations, and potentially avoid the need for further intervention The specific primary outcome measures are: 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) (6 months). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.

About This Phase

This study does not have a traditional clinical phase designation. It may be an observational study that follows patients without intervening in their care, an expanded access or compassionate use program, or other non-interventional research. These studies contribute valuable data about disease progression, treatment patterns, and patient outcomes.

Why This Trial Matters

This trial addresses a significant unmet need for patients with severe tricuspid regurgitation who are not good candidates for surgery, offering a less invasive repair option. This research targets Tricuspid Regurgitation, Tricuspid Valve Insufficiency, Tricuspid Valve Disease, where improved treatment options are needed.

Investor Insight

This trial evaluates a novel transcatheter solution for tricuspid regurgitation, a growing market driven by an aging population and increased diagnosis, with potential for significant patient benefit The large enrollment target of 870 participants suggests significant investment in this program.

Is This Trial Right for Me?

Ask your doctor if your tricuspid valve leakage is severe and if you are a candidate for this trial. Understand that you will be randomly assigned to receive either the new device or standard care. Participation involves regular clinic visits, tests, and potential hospitalizations for the procedure and follow-up. This trial is currently recruiting participants. The trial is being conducted at 20 sites. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.

AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.

Study Design

• Study Type: INTERVENTIONAL
• Allocation: RANDOMIZED
• Model: PARALLEL
• Masking: NONE
• Enrollment: 870 participants

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 Outcomes

• 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) (6 months)

Secondary Outcomes

• 1 Grade Reduction in TR Severity (6, 12 months)
• Quality of Life (QOL) as Measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ) (3, 6, and 12 months)
• All Cause Mortality (12 months, 24 months)
• Death and Heart Failure Hospitalizations (12 months)
• All-cause Mortality, TV Surgery or TV Interventions (24 months)

Full 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:

  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 Locations

• Banner University Medical Center Phoenix, Phoenix, Arizona, United States
• Tucson Medical Center Healthcare, Tucson, Arizona, United States
• University of California, Irvine, Irvine, California, United States
• SCPMG - Kaiser San Diego, La Jolla, California, United States
• Cedars Sinai Medical Center, Los Angeles, California, United States
• UCLA Medical Center, Los Angeles, California, United States
• Kaiser Permanente San Francisco, San Francisco, California, United States
• University of California, San Francisco, San Francisco, California, United States
• Stanford University, Stanford, California, United States
• St. Joseph Hospital, Denver, Colorado, United States
• ...and 10 more locations

Frequently Asked Questions

Related Conditions

• Tricuspid Regurgitation
• Tricuspid Valve Insufficiency
• Tricuspid Valve Disease
• Heart Failure
• Congestive Heart Failure
• Pulmonary Hypertension
• Atrial Fibrillation
• Cardiomyopathy
• Valvular Heart Disease
• Congenital Heart Defects

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