Edwards PASCAL Transcatheter Valve Repair System Pivotal Clinical Trial

Tricuspid Regurgitation Clinical Trial

— CLASP II TR  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04097145
• Other study ID #: 2019-07
• Status: Recruiting
• Phase: N/A
• Start date: December 11, 2019
• Est. completion date: March 31, 2029

Study information

• Verified date: May 2024
• Source: Edwards Lifesciences
• Contact: Edwards TMTT Clinical Affairs
• Phone: (949) 250-2500
• Email: TMTT_Clinical[@]edwards.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 870
• Est. completion date: March 31, 2029
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Tricuspid Regurgitation
• Tricuspid Valve Disease
• Tricuspid Valve Insufficiency

Intervention

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

Locations

Country	Name	City	State
Canada	Hamilton Health Services	Hamilton	Ontario
Canada	University of Ottawa Heart Institute	Ottawa	Ontario
Canada	Institut universitaire de cardiologie et de pneumologie de Québec - Université Laval	Québec City	Quebec
Canada	St. Michael's Hospital	Toronto	Ontario
Canada	St. Paul's Hospital	Vancouver	British Columbia
United States	University of Michigan	Ann Arbor	Michigan
United States	Emory University Hospital Midtown / Emory University - St. Joseph's Hospital	Atlanta	Georgia
United States	Piedmont Healthcare, Inc.	Atlanta	Georgia
United States	Johns Hopkins	Baltimore	Maryland
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Montefiore Medical Center / Arts Pavilion / Hutchinson Metro Center Clinic / Weiler Hospital / Moses Hospital	Bronx	New York
United States	State University of New York at Buffalo	Buffalo	New York
United States	Cooper Health Systems	Camden	New Jersey
United States	University of North Carolina	Chapel Hill	North Carolina
United States	Medical University of South Carolina	Charleston	South Carolina
United States	University of Virginia Health System	Charlottesville	Virginia
United States	Erlanger Health System	Chattanooga	Tennessee
United States	Northwestern University	Chicago	Illinois
United States	The Christ Hospital	Cincinnati	Ohio
United States	TriHealth-Bethesda North Hospital	Cincinnati	Ohio
United States	The Ohio State University	Columbus	Ohio
United States	St. Joseph Hospital	Denver	Colorado
United States	Henry Ford Hospital	Detroit	Michigan
United States	Sanford Medical Center Fargo	Fargo	North Dakota
United States	The Cardiac and Vascular Institute Research Foundation	Gainesville	Florida
United States	Penn State Hershey	Hershey	Pennsylvania
United States	Baylor College of Medicine St. Luke's Medical Center	Houston	Texas
United States	HCA Houston Healthcare Medical Center	Houston	Texas
United States	The University of Texas Health Science Center at Houston	Houston	Texas
United States	UTHealth/Memorial Hermann Hospital	Houston	Texas
United States	Ascension St. Vincent Heart Center Cardiovascular Research Institute	Indianapolis	Indiana
United States	University of Iowa Hospitals & Clinics	Iowa City	Iowa
United States	University of California, Irvine	Irvine	California
United States	Saint Luke's Hospital of Kansas City	Kansas City	Missouri
United States	SCPMG - Kaiser San Diego	La Jolla	California
United States	Dartmouth-Hitchcock Medical Center	Lebanon	New Hampshire
United States	Cedars Sinai Medical Center	Los Angeles	California
United States	UCLA Medical Center	Los Angeles	California
United States	Medical Center of the Rockies	Loveland	Colorado
United States	Fairview Health Services	Maplewood	Minnesota
United States	Mount Sinai Medical Center	Miami Beach	Florida
United States	Medical College of Wisconsin	Milwaukee	Wisconsin
United States	Providence St. Patrick Hospital	Missoula	Montana
United States	Morristown Medical Center	Morristown	New Jersey
United States	Intermountain Medical Center	Murray	Utah
United States	NCH Healthcare System	Naples	Florida
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	Rutgers Robert Wood Johnson Medical School	New Brunswick	New Jersey
United States	Ochsner Medical Center	New Orleans	Louisiana
United States	Columbia University Irving Medical Center/NYPH	New York	New York
United States	Lenox Hill Hospital, Northwell Health /Northshore University Hospital Manhasset	New York	New York
United States	Weill Cornell Medicine	New York	New York
United States	Integris Baptist Medical Center	Oklahoma City	Oklahoma
United States	Oklahoma Cardiovascular Research Group	Oklahoma City	Oklahoma
United States	Pennsylvania Presbyterian Medical Center / Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania
United States	Banner University Medical Center Phoenix	Phoenix	Arizona
United States	Baylor Scott & White - The Heart Hospital - Plano	Plano	Texas
United States	Oregon Health & Science University	Portland	Oregon
United States	Virginia Commonwealth University	Richmond	Virginia
United States	Carilion Medical Center	Roanoke	Virginia
United States	Mayo Clinic	Rochester	Minnesota
United States	Rochester General Hospital	Rochester	New York
United States	St. Francis Hospital	Roslyn	New York
United States	William Beaumont Hospital - Royal Oak	Royal Oak	Michigan
United States	St. Mary's of Ascension Research	Saginaw	Michigan
United States	St. George Regional Hospital	Saint George	Utah
United States	Washington University School of Medicine	Saint Louis	Missouri
United States	Kaiser Permanente San Francisco	San Francisco	California
United States	University of California, San Francisco	San Francisco	California
United States	Sarasota Memorial Health Care System	Sarasota	Florida
United States	Swedish Medical Center	Seattle	Washington
United States	Virginia Mason Medical Center	Seattle	Washington
United States	Stanford University	Stanford	California
United States	Tallahassee Research Institute	Tallahassee	Florida
United States	Tucson Medical Center Healthcare	Tucson	Arizona
United States	Oklahoma Heart Institute at Hillcrest Medical Center	Tulsa	Oklahoma
United States	Pinnacle Health Cardiovascular Institute/UPMC Pinnacle	Wormleysburg	Pennsylvania
United States	Lankenau Heart Institute	Wynnewood	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Edwards Lifesciences

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

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