Edwards PASCAL Transcatheter Valve Repair System Pivotal Clinical Trial

Not Applicable

Recruiting

• Conditions: Tricuspid Valve Insufficiency; Tricuspid Regurgitation; Tricuspid Valve Disease
• Interventions: Device: Edwards PASCAL System; Drug: Optimal Medical Therapy

• Registration Number: NCT04097145
• Lead Sponsor: Edwards Lifesciences

Brief 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

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.

Study Timeline

• Study First Submitted: 2019-09-18
• Study First Submitted QC: 2019-09-18
• Study First Posted: 2019-09-20
• Study Start: 2019-12-11
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-07
• Last Update Posted: 2025-07-09
• Primary Completion: 2027-12-31
• Study Completion: 2031-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 870

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Edwards PASCAL System & OMT	Edwards PASCAL System	Transcatheter tricuspid valve repair with the Edwards PASCAL system in patients on optimal medical therapy (OMT) with tricuspid regurgitation
Optimal Medical Therapy (OMT)	Optimal Medical Therapy	Optimal medical therapy (OMT) alone in patients with tricuspid regurgitation
Single-Arm Registry	Edwards PASCAL System	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
Continued Access Study	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

Name	Time	Method
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)	12 months	Comparison of number of participants with composite endpoint events between experimental and active comparator arms

Secondary Outcome Measures

Name	Time	Method
Quality of Life (QOL) as Measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ)	3, 6, and 12 months	Change in KCCQ score from baseline
All Cause Mortality	12 months, 24 months	Total number of deaths from any cause
Death and Heart Failure Hospitalizations	12 months	Total number of deaths and hospital admissions due to heart failure
All-cause Hospitalization	12 months	Total number of hospitalizations due to any cause
Right ventricular end-diastolic diameter (RVEDD mid)	12 months	Change in right ventricular end-diastolic diameter (RVEDD mid)
Major Adverse Events (MAEs)	30 days	Overall rate of Major Adverse Events (MAEs)
Reduction in TR grade	Intraprocedural post-implantation	Reduction in TR severity as assessed by TEE pre- and post-implantation
All-Cause Mortality	12 months, annually through 5 years	Total number of deaths from any cause
Heart failure hospitalizations	12 months, annually through 5 years	Total number of hospital admissions due to heart failure
Non-elective tricuspid valve re-intervenitions (percutaneous or surgical)	12 months, annually through 5 years	Total number of non-elective tricuspid valve re-interventions
Durable RVAD implantation or heart transplant	12 months, annually through 5 years	Total number of patients requiring RVAD impantantion or heart transplant
Need for paracentesis	12 months, annually through 5 years	Total nunber of patients who required paracentesis
All cause mortality or the first heart failure hospitalization for patients with massive or torrential TR at baseline	12, 24 months	Time to death or first heart failure hospitalization
1 Grade Reduction in TR Severity	6, 12 months	Total number of participants with at least 1 grade reduction in TR severity

Trial Locations

Locations (79)

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

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