- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04097145
Edwards PASCAL Transcatheter Valve Repair System Pivotal Clinical Trial (CLASP II TR)
May 27, 2026 updated by: Edwards Lifesciences
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
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
Study Overview
Status
Recruiting
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 Type
Interventional
Enrollment (Estimated)
1270
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Edwards TMTT Clinical Affairs
- Phone Number: (949) 250-2500
- Email: TMTT_Clinical@edwards.com
Study Locations
-
-
British Columbia
-
Vancouver, British Columbia, Canada, V6Z 1Y6
- Active, not recruiting
- St. Paul's Hospital
-
-
Ontario
-
Hamilton, Ontario, Canada, L8L 2X2
- Active, not recruiting
- Hamilton Health Services
-
Ottawa, Ontario, Canada, K1Y 4Q7
- Active, not recruiting
- University of Ottawa Heart Institute
-
Toronto, Ontario, Canada, M4N 3M5
- Active, not recruiting
- Sunnybrook Health Sciences Centre
-
Toronto, Ontario, Canada, M5B 1W8
- Active, not recruiting
- St. Michael's Hospital
-
-
Quebec
-
Québec, Quebec, Canada, G1V 4G5
- Active, not recruiting
- Institut universitaire de cardiologie et de pneumologie de Quebec - Universite Laval
-
-
-
-
Arizona
-
Phoenix, Arizona, United States, 85006
- Active, not recruiting
- Banner University Medical Center Phoenix
-
Tucson, Arizona, United States, 85712
- Active, not recruiting
- Tucson Medical Center Healthcare
-
-
California
-
Irvine, California, United States, 92868
- Recruiting
- University of California, Irvine
-
Principal Investigator:
- Antonio Frangieh, MD
-
La Jolla, California, United States, 92037
- Active, not recruiting
- SCPMG - Kaiser San Diego
-
Los Angeles, California, United States, 90048
- Active, not recruiting
- Cedars Sinai Medical Center
-
Los Angeles, California, United States, 90095
- Active, not recruiting
- UCLA Medical Center
-
San Francisco, California, United States, 94143
- Recruiting
- University of California, San Francisco
-
Principal Investigator:
- Sammy Elmariah, MD
-
San Francisco, California, United States, 94118
- Active, not recruiting
- Kaiser Permanente San Francisco
-
Stanford, California, United States, 94305
- Active, not recruiting
- Stanford University
-
-
Colorado
-
Denver, Colorado, United States, 80218
- Recruiting
- St. Joseph Hospital
-
Principal Investigator:
- Jake Chanin, MD
-
Loveland, Colorado, United States, 80538
- Active, not recruiting
- Medical Center of the Rockies
-
-
Florida
-
Gainesville, Florida, United States, 32605
- Recruiting
- The Cardiac and Vascular Institute Research Foundation
-
Principal Investigator:
- Ilie Barb, MD
-
Principal Investigator:
- Charles Klodell, MD
-
Miami Beach, Florida, United States, 33140
- Recruiting
- Mount Sinai Medical Center
-
Principal Investigator:
- Nirat Beohar, MD
-
Principal Investigator:
- Steve Xydas, MD
-
Naples, Florida, United States, 34102
- Recruiting
- NCH Healthcare System
-
Principal Investigator:
- Robert Cubeddu, MD
-
Sarasota, Florida, United States, 34239
- Recruiting
- Sarasota Memorial Health Care System
-
Principal Investigator:
- Ricardo A. Yaryura, MD
-
Tallahassee, Florida, United States, 32308
- Active, not recruiting
- Tallahassee Research Institute
-
-
Georgia
-
Atlanta, Georgia, United States, 30308
- Recruiting
- Emory University Hospital Midtown / Emory University - St. Joseph's Hospital
-
Principal Investigator:
- Adam Greenbaum, MD
-
Atlanta, Georgia, United States, 30309
- Active, not recruiting
- Piedmont Healthcare, Inc.
-
-
Illinois
-
Chicago, Illinois, United States, 60611
- Recruiting
- Northwestern University
-
Principal Investigator:
- Charles Davidson, MD
-
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Indiana
-
Indianapolis, Indiana, United States, 46290
- Recruiting
- Ascension St. Vincent Heart Center Cardiovascular Research Institute
-
Principal Investigator:
- James Hermiller, MD
-
-
Iowa
-
Iowa City, Iowa, United States, 52242
- Active, not recruiting
- University of Iowa Hospitals & Clinics
-
-
Louisiana
-
New Orleans, Louisiana, United States, 70121
- Active, not recruiting
- Ochsner Medical Center
-
-
Maryland
-
Baltimore, Maryland, United States, 21287
- Recruiting
- Johns Hopkins
-
Principal Investigator:
- Rani Hasan, MD
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02114
- Recruiting
- Massachusetts General Hospital
-
Principal Investigator:
- Nilay Patel, MD
-
Principal Investigator:
- Ignacio Inglessis, MD
-
-
Michigan
-
Ann Arbor, Michigan, United States, 48109
- Recruiting
- University of Michigan
-
Principal Investigator:
- Stanley Chetcuti, MD
-
Detroit, Michigan, United States, 48202
- Recruiting
- Henry Ford Hospital
-
Principal Investigator:
- Brian O' Neill, MD
-
Royal Oak, Michigan, United States, 48073
- Active, not recruiting
- William Beaumont Hospital - Royal Oak
-
Saginaw, Michigan, United States, 48601
- Active, not recruiting
- St. Mary's of Ascension Research
-
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Minnesota
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Maplewood, Minnesota, United States, 55109
- Active, not recruiting
- Fairview Health Services
-
Rochester, Minnesota, United States, 55905
- Recruiting
- Mayo Clinic
-
Principal Investigator:
- Mackram Eleid, MD
-
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Missouri
-
Kansas City, Missouri, United States, 64111
- Recruiting
- Saint Luke's Hospital of Kansas City
-
Principal Investigator:
- Adnan Chhatriwalla, MD
-
St Louis, Missouri, United States, 63110
- Active, not recruiting
- Washington University School of Medicine
-
-
Montana
-
Missoula, Montana, United States, 59802
- Active, not recruiting
- Providence St. Patrick Hospital
-
-
New Hampshire
-
Lebanon, New Hampshire, United States, 03756
- Recruiting
- Dartmouth-Hitchcock Medical Center
-
Principal Investigator:
- Michael Young, MD
-
-
New Jersey
-
Camden, New Jersey, United States, 09103
- Recruiting
- Cooper Health Systems
-
Principal Investigator:
- Sajjad Sabir, MD
-
Morristown, New Jersey, United States, 07962
- Recruiting
- Morristown Medical Center
-
Principal Investigator:
- Gennaro Giustino, MD
-
New Brunswick, New Jersey, United States, 08901
- Recruiting
- Rutgers Robert Wood Johnson Medical School
-
Principal Investigator:
- Mark Russo, MD
-
-
New York
-
Buffalo, New York, United States, 14203
- Recruiting
- State University of New York at Buffalo
-
Principal Investigator:
- Vijay Iyer, MD, PhD
-
New York, New York, United States, 10065
- Recruiting
- Weill Cornell Medicine
-
Principal Investigator:
- Shmuel Chen, MD
-
New York, New York, United States, 10032
- Recruiting
- Columbia University Irving Medical Center/NYPH
-
Principal Investigator:
- Susheel Kodali, MD
-
New York, New York, United States, 10075
- Recruiting
- Lenox Hill Hospital, Northwell Health /Northshore University Hospital Manhasset
-
Principal Investigator:
- Bruce Rutkin, MD
-
Principal Investigator:
- Mei Chau, MD
-
Rochester, New York, United States, 14621
- Active, not recruiting
- Rochester General Hospital
-
Roslyn, New York, United States, 11576
- Recruiting
- St. Francis Hospital
-
Principal Investigator:
- George A. Petrossian, MD
-
Principal Investigator:
- Newell B. Robinson, MD
-
The Bronx, New York, United States, 10467
- Recruiting
- Montefiore Medical Center / Arts Pavilion / Hutchinson Metro Center Clinic / Weiler Hospital / Moses Hospital
-
Principal Investigator:
- Mohamed A. Latib, MD
-
-
North Carolina
-
Chapel Hill, North Carolina, United States, 27517
- Recruiting
- University of North Carolina
-
Principal Investigator:
- John Vavalle, MD
-
-
North Dakota
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Fargo, North Dakota, United States, 58104
- Active, not recruiting
- Sanford Medical Center Fargo
-
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Ohio
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Cincinnati, Ohio, United States, 45219
- Recruiting
- The Christ Hospital
-
Principal Investigator:
- Santiago Garcia, MD
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Cincinnati, Ohio, United States, 45242
- Active, not recruiting
- TriHealth-Bethesda North Hospital
-
Columbus, Ohio, United States, 43210
- Recruiting
- The Ohio State University
-
Principal Investigator:
- Scott Lilly, MD
-
Principal Investigator:
- Konstantinos Boudoulas, MD
-
-
Oklahoma
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Oklahoma City, Oklahoma, United States, 73112
- Active, not recruiting
- INTEGRIS Baptist Medical Center
-
Oklahoma City, Oklahoma, United States, 73120
- Recruiting
- Oklahoma Cardiovascular Research Group
-
Principal Investigator:
- Mohammad Ghani, MD
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Tulsa, Oklahoma, United States, 74104
- Recruiting
- Oklahoma Heart Institute at Hillcrest Medical Center
-
Principal Investigator:
- Kamran Muhammad, MD
-
-
Oregon
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Portland, Oregon, United States, 97239
- Recruiting
- Oregon Health & Science University
-
Principal Investigator:
- Scott Chadderdon, MD
-
Principal Investigator:
- Firas Zahr, MD
-
-
Pennsylvania
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Hershey, Pennsylvania, United States, 17033
- Recruiting
- Penn State Hershey
-
Principal Investigator:
- Mark Kozak, MD
-
Philadelphia, Pennsylvania, United States, 19104
- Recruiting
- Pennsylvania Presbyterian Medical Center / Hospital of the University of Pennsylvania
-
Principal Investigator:
- Gene Chang, MD
-
Principal Investigator:
- Wilson Szeto, MD
-
Wormleysburg, Pennsylvania, United States, 17043
- Recruiting
- Pinnacle Health Cardiovascular Institute/UPMC Pinnacle
-
Principal Investigator:
- Mubashir Mumtaz, MD
-
Wynnewood, Pennsylvania, United States, 19096
- Recruiting
- Lankenau Heart Institute
-
Principal Investigator:
- William Gray, MD
-
-
South Carolina
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Charleston, South Carolina, United States, 29245
- Active, not recruiting
- Medical University of South Carolina
-
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Tennessee
-
Chattanooga, Tennessee, United States, 37403
- Active, not recruiting
- Erlanger Health System
-
Nashville, Tennessee, United States, 37212
- Active, not recruiting
- Vanderbilt University Medical Center
-
-
Texas
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Houston, Texas, United States, 77030
- Recruiting
- The University of Texas Health Science Center at Houston
-
Principal Investigator:
- Richard Smalling, MD
-
Principal Investigator:
- Abhijeet Dhoble, MD
-
Houston, Texas, United States, 77004
- Recruiting
- HCA Houston Healthcare Medical Center
-
Principal Investigator:
- Pranav Loyalka, MD
-
Houston, Texas, United States, 77030
- Recruiting
- Baylor College of Medicine St. Luke's Medical Center
-
Principal Investigator:
- Guilherme Silva, MD
-
Houston, Texas, United States, 77030
- Recruiting
- UTHealth/Memorial Hermann Hospital
-
Principal Investigator:
- Biswajit Kar, MD
-
Plano, Texas, United States, 75093
- Recruiting
- Baylor Scott & White - The Heart Hospital - Plano
-
Principal Investigator:
- Molly Szerlip, MD
-
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Utah
-
Murray, Utah, United States, 84107
- Active, not recruiting
- Intermountain Medical Center
-
St. George, Utah, United States, 84790
- Recruiting
- St. George Regional Hospital
-
Principal Investigator:
- Blake Gardner, MD
-
-
Virginia
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Charlottesville, Virginia, United States, 22908
- Recruiting
- University of Virginia Health System
-
Principal Investigator:
- John Saxon, MD
-
Richmond, Virginia, United States, 23298
- Active, not recruiting
- Virginia Commonwealth University
-
Roanoke, Virginia, United States, 24014
- Recruiting
- Carilion Medical Center
-
Principal Investigator:
- Jason Foerst, MD
-
-
Washington
-
Seattle, Washington, United States, 98101
- Recruiting
- Virginia Mason Medical Center
-
Principal Investigator:
- Ming Zhang, MD
-
Seattle, Washington, United States, 98122
- Active, not recruiting
- Swedish Medical Center
-
-
Wisconsin
-
Milwaukee, Wisconsin, United States, 53226
- Recruiting
- Medical College of Wisconsin
-
Principal Investigator:
- Jeremiah Depta, MD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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:
- Would prevent proper TR reduction due to interaction of the lead with the leaflets
- 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:
- Percutaneous coronary, intracardiac, or endovascular intervention within the last 30 days prior to the point of enrollment
- Carotid surgery within 30 days prior to the point of enrollment
- Direct current cardioversion within the last 30 days prior to the point of enrollment
- Leadless RV pacemaker implant within the last 30 days prior to the point of enrollment
- 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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Optimal Medical Therapy (OMT)
Optimal medical therapy (OMT) alone in patients with tricuspid regurgitation
|
Optimal Medical Therapy alone in patients with tricuspid regurgitation
|
|
Experimental: Edwards PASCAL System & OMT
Transcatheter tricuspid valve repair with the Edwards PASCAL system in patients on optimal medical therapy (OMT) with tricuspid regurgitation
|
Transcatheter tricuspid valve repair with the Edwards PASCAL System in patients on optimal medical therapy
Other Names:
Transcatheter tricuspid valve repair with the Edwards PASCAL System in conjunction with OMT
Transcatheter tricuspid valve repair with the Edwards PASCAL system in patients on optimal medical therapy (OMT) with tricuspid regurgitation
|
|
Experimental: Single-Arm Registry
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
|
Transcatheter tricuspid valve repair with the Edwards PASCAL System in patients on optimal medical therapy
Other Names:
Transcatheter tricuspid valve repair with the Edwards PASCAL System in conjunction with OMT
Transcatheter tricuspid valve repair with the Edwards PASCAL system in patients on optimal medical therapy (OMT) with tricuspid regurgitation
|
|
Experimental: Continued Access Study
Transcatheter tricuspid valve repair with the Edwards PASCAL system in patients on optimal medical therapy (OMT) with tricuspid regurgitation
|
Transcatheter tricuspid valve repair with the Edwards PASCAL System in patients on optimal medical therapy
Other Names:
Transcatheter tricuspid valve repair with the Edwards PASCAL System in conjunction with OMT
Transcatheter tricuspid valve repair with the Edwards PASCAL system in patients on optimal medical therapy (OMT) with tricuspid regurgitation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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)
Time Frame: 6 months
|
Comparison of number of participants with composite endpoint events between experimental and active comparator arms
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
All Cause Mortality
Time Frame: 12 months, 24 months
|
Total number of deaths from any cause
|
12 months, 24 months
|
|
Death and Heart Failure Hospitalizations
Time Frame: 12 months
|
Total number of deaths and hospital admissions due to heart failure
|
12 months
|
|
Major Adverse Events (MAEs)
Time Frame: 30 days
|
Overall rate of Major Adverse Events (MAEs)
|
30 days
|
|
Reduction in TR grade
Time Frame: Intraprocedural post-implantation
|
Reduction in TR severity as assessed by TEE pre- and post-implantation
|
Intraprocedural post-implantation
|
|
All-Cause Mortality
Time Frame: 12 months, annually through 5 years
|
Total number of deaths from any cause
|
12 months, annually through 5 years
|
|
Heart failure hospitalizations
Time Frame: 12 months, annually through 5 years
|
Total number of hospital admissions due to heart failure
|
12 months, annually through 5 years
|
|
Non-elective tricuspid valve re-intervenitions (percutaneous or surgical)
Time Frame: 12 months, annually through 5 years
|
Total number of non-elective tricuspid valve re-interventions
|
12 months, annually through 5 years
|
|
Durable RVAD implantation or heart transplant
Time Frame: 12 months, annually through 5 years
|
Total number of patients requiring RVAD impantantion or heart transplant
|
12 months, annually through 5 years
|
|
Need for paracentesis
Time Frame: 12 months, annually through 5 years
|
Total nunber of patients who required paracentesis
|
12 months, annually through 5 years
|
|
Right ventricular end-diastolic diameter (RVEDD mid)
Time Frame: 12 months
|
Change in right ventricular end-diastolic diameter (RVEDD mid)
|
12 months
|
|
1 Grade Reduction in TR Severity
Time Frame: 6, 12 months
|
Total number of participants with at least 1 grade reduction in TR severity
|
6, 12 months
|
|
Quality of Life (QOL) as Measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ)
Time Frame: 3, 6, and 12 months
|
Change in KCCQ score from baseline
|
3, 6, and 12 months
|
|
All cause mortality or the first heart failure hospitalization for patients with massive or torrential TR at baseline
Time Frame: 12, 24 months
|
Time to death or first heart failure hospitalization
|
12, 24 months
|
|
All-cause Mortality, TV Surgery or TV Interventions
Time Frame: 24 months
|
Total number of deaths, TV surgeries or interventions
|
24 months
|
|
All-cause Hospitalizations
Time Frame: 12 months
|
Number of hospitalizations for any cause
|
12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Martin B. Leon, MD, Columbia University
- Principal Investigator: Michael J. Mack, MD, Baylor Scott and White Health
- Study Chair: Gorav Ailawadi, MD, University of Michigan
- Principal Investigator: Charles Davidson, MD, Northwestern University
- Study Chair: Allen Anderson, MD, The University of Texas Health Science Center at San Antonio
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 11, 2019
Primary Completion (Estimated)
December 31, 2027
Study Completion (Estimated)
December 31, 2031
Study Registration Dates
First Submitted
September 18, 2019
First Submitted That Met QC Criteria
September 18, 2019
First Posted (Actual)
September 20, 2019
Study Record Updates
Last Update Posted (Actual)
May 29, 2026
Last Update Submitted That Met QC Criteria
May 27, 2026
Last Verified
May 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2019-07
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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