Edwards PASCAL Transcatheter Valve Repair System Pivotal Clinical Trial (CLASP II TR)

March 13, 2024 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

Conditions

Intervention / Treatment

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)

870

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

Study Locations

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V6Z 1Y6
        • Recruiting
        • St. Paul's Hospital
        • Principal Investigator:
          • Robert Boone, MD
    • Ontario
      • Hamilton, Ontario, Canada, L8L 2X2
        • Recruiting
        • Hamilton Health Services
        • Principal Investigator:
          • Shamir Mehta, MD
      • Ottawa, Ontario, Canada, K1Y 4Q7
        • Recruiting
        • University of Ottawa Heart Institute
        • Principal Investigator:
          • Marino Labinaz, MD
      • Toronto, Ontario, Canada, M5B 1W8
        • Recruiting
        • St. Michael's Hospital
        • Principal Investigator:
          • Neil Fam, MD
    • Quebec
      • Québec City, Quebec, Canada, G1V 4G5
        • Recruiting
        • Institut Universitaire de Cardiologie et de Pneumologie de Quebec - Université Laval
        • Principal Investigator:
          • Josep Rodés-Cabau, MD
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85006
        • Recruiting
        • Banner University Medical Center Phoenix
        • Principal Investigator:
          • Marvin Eng, MD
      • Tucson, Arizona, United States, 85712
        • Recruiting
        • Tucson Medical Center Healthcare
        • Principal Investigator:
          • Thomas Waggoner, DO
    • California
      • Irvine, California, United States, 92868
        • Recruiting
        • University of California, Irvine
        • Principal Investigator:
          • Antonio Frangieh, MD
      • La Jolla, California, United States, 92037
        • Recruiting
        • SCPMG - Kaiser San Diego
        • Principal Investigator:
          • Bahram Khadivi, MD
      • Los Angeles, California, United States, 90048
        • Recruiting
        • Cedars Sinai Medical Center
        • Principal Investigator:
          • Raj Makkar, MD
      • Los Angeles, California, United States, 90095
        • Recruiting
        • UCLA Medical Center
        • Principal Investigator:
          • Marcella Press, MD
      • San Francisco, California, United States, 94143
        • Recruiting
        • University of California, San Francisco
        • Principal Investigator:
          • Sammy Elmariah, MD
      • San Francisco, California, United States, 94118
        • Recruiting
        • Kaiser Permanente San Francisco
        • Principal Investigator:
          • Jacob Mishell, MD
        • Principal Investigator:
          • Andrew Rassi, MD
      • Stanford, California, United States, 94305
        • Recruiting
        • Stanford University
        • Principal Investigator:
          • Rahul Sharma, MD
    • Colorado
      • Denver, Colorado, United States, 80218
        • Recruiting
        • St. Joseph Hospital
        • Principal Investigator:
          • Jake Chanin, MD
      • Loveland, Colorado, United States, 80538
        • Recruiting
        • Medical Center of the Rockies
        • Principal Investigator:
          • Mohamad Lazkani, MD
    • 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
        • Recruiting
        • Tallahassee Research Institute
        • Principal Investigator:
          • Thomas Noel
    • 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
        • Recruiting
        • Piedmont Healthcare, Inc.
        • Principal Investigator:
          • Vinod Thourani, MD
        • Contact:
          • Pradeep Yadav, MD
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Recruiting
        • Northwestern University
        • Principal Investigator:
          • Charles Davidson, MD
    • 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
        • Recruiting
        • University of Iowa Hospitals & Clinics
        • Principal Investigator:
          • Phillip A. Horwitz, MD
    • 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
        • Recruiting
        • William Beaumont Hospital - Royal Oak
        • Principal Investigator:
          • Ivan Hanson, MD
      • Saginaw, Michigan, United States, 48601
        • Recruiting
        • St. Mary's of Ascension Research
        • Principal Investigator:
          • Safwan Kassas, MD
    • Minnesota
      • Maplewood, Minnesota, United States, 55109
        • Recruiting
        • Fairview Health Services
        • Principal Investigator:
          • Marat Yanavitski, MD
      • Rochester, Minnesota, United States, 55905
        • Recruiting
        • Mayo Clinic
        • Principal Investigator:
          • Mackram Eleid, MD
    • Missouri
      • Kansas City, Missouri, United States, 64111
        • Recruiting
        • Saint Luke's Hospital of Kansas City
        • Principal Investigator:
          • Adnan Chhatriwalla, MD
      • Saint Louis, Missouri, United States, 63110
        • Recruiting
        • Washington University School of Medicine
        • Principal Investigator:
          • Alan Zajarias, MD
        • Principal Investigator:
          • Puja Kachroo, MD
    • Montana
      • Missoula, Montana, United States, 59802
        • Recruiting
        • Providence St. Patrick Hospital
        • Principal Investigator:
          • James Maddux, MD
        • Principal Investigator:
          • Daniel Spoon, MD
    • 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:
          • Robert Kipperman, MD
      • New Brunswick, New Jersey, United States, 08901
        • Recruiting
        • Rutgers Robert Wood Johnson Medical School
        • Principal Investigator:
          • Mark Russo, MD
    • New York
      • 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
      • 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:
          • Mark Reisman, 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:
          • Chad Kliger, MD
        • Principal Investigator:
          • Bruce Rutkin, MD
      • Rochester, New York, United States, 14621
        • Recruiting
        • Rochester General Hospital
        • Principal Investigator:
          • Jeremiah Depta, MD
      • Roslyn, New York, United States, 11576
        • Recruiting
        • St. Francis Hospital
        • Principal Investigator:
          • George A. Petrossian, MD
        • Principal Investigator:
          • Newell B. Robinson, MD
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27517
        • Recruiting
        • University of North Carolina
        • Principal Investigator:
          • John Vavalle, MD
    • North Dakota
      • Fargo, North Dakota, United States, 58104
        • Recruiting
        • Sanford Medical Center Fargo
        • Principal Investigator:
          • Thomas Haldis, DO
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • Recruiting
        • The Christ Hospital
        • Principal Investigator:
          • Santiago Garcia, MD
      • Cincinnati, Ohio, United States, 45242
        • Recruiting
        • TriHealth-Bethesda North Hospital
        • Principal Investigator:
          • Mohammed Al-Amoodi, MD
        • Contact:
          • Sateesh Kesari, MD
      • Columbus, Ohio, United States, 43210
        • Recruiting
        • The Ohio State University
        • Principal Investigator:
          • Scott Lilly, MD
        • Principal Investigator:
          • Konstantinos Boudoulas, MD
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73112
        • Recruiting
        • Integris Baptist Medical Center
        • Principal Investigator:
          • Jeffrey Sparling, MD
      • Oklahoma City, Oklahoma, United States, 73120
        • Recruiting
        • Oklahoma Cardiovascular Research Group
        • Principal Investigator:
          • Mohammad Ghani, MD
      • Tulsa, Oklahoma, United States, 74104
        • Recruiting
        • Oklahoma Heart Institute at Hillcrest Medical Center
        • Principal Investigator:
          • Kamran Muhammad, MD
    • Oregon
      • Portland, Oregon, United States, 97239
        • Recruiting
        • Oregon Health & Science University
        • Principal Investigator:
          • Scott Chadderdon, MD
        • Principal Investigator:
          • Firas Zahr, MD
    • Pennsylvania
      • 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:
          • Hemal Gada, MD
        • Principal Investigator:
          • Mubashir Mumtaz, MD
      • Wynnewood, Pennsylvania, United States, 19096
        • Recruiting
        • Lankenau Heart Institute
        • Principal Investigator:
          • William Gray, MD
    • South Carolina
      • Charleston, South Carolina, United States, 29245
        • Recruiting
        • Medical University of South Carolina
        • Principal Investigator:
          • Nicholas Amoroso, MD
    • Tennessee
      • Chattanooga, Tennessee, United States, 37403
        • Active, not recruiting
        • Erlanger Health System
      • Nashville, Tennessee, United States, 37212
        • Recruiting
        • Vanderbilt University Medical Center
        • Principal Investigator:
          • Brian R. Lindman, MD
        • Principal Investigator:
          • Colin Barker, MD
    • Texas
      • 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
    • Utah
      • Murray, Utah, United States, 84107
        • Recruiting
        • Intermountain Medical Center
        • Principal Investigator:
          • Brian Whisenant, MD
      • Saint George, Utah, United States, 84790
        • Recruiting
        • St. George Regional Hospital
        • Principal Investigator:
          • Blake Gardner, MD
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • Recruiting
        • University of Virginia Health System
        • Principal Investigator:
          • Scott Lim, MD
      • Richmond, Virginia, United States, 23298
        • Recruiting
        • Virginia Commonwealth University
        • Principal Investigator:
          • Zachary Gertz, MD
      • Roanoke, Virginia, United States, 24014
        • Recruiting
        • Carilion Medical Center
        • Principal Investigator:
          • Jason Foerst, MD
    • Washington
      • Seattle, Washington, United States, 98122
        • Recruiting
        • Swedish Medical Center
        • Principal Investigator:
          • Sameer Gafoor, MD
      • Seattle, Washington, United States, 98101
        • Recruiting
        • Virginia Mason Medical Center
        • Principal Investigator:
          • Ming Zhang, MD
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Recruiting
        • Medical College of Wisconsin
        • Principal Investigator:
          • Peter Mason, MD, MPH

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:

    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 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
Drug: Optimal Medical Therapy
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
Device: Edwards PASCAL System
Transcatheter tricuspid valve repair with the Edwards PASCAL System in patients on optimal medical therapy
Other Names:
  • Transcatheter tricuspid valve repair (TTVr)
Device: Edwards PASCAL System
Transcatheter tricuspid valve repair with the Edwards PASCAL System in conjunction with OMT
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
Device: Edwards PASCAL System
Transcatheter tricuspid valve repair with the Edwards PASCAL System in patients on optimal medical therapy
Other Names:
  • Transcatheter tricuspid valve repair (TTVr)
Device: Edwards PASCAL System
Transcatheter tricuspid valve repair with the Edwards PASCAL System in conjunction with OMT

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: 24 months
Comparison of number of participants with composite endpoint events between experimental and active comparator arms
24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
1 Grade Reduction in TR Severity
Time Frame: 12 months
Total number of participants with at least 1 grade reduction in TR severity
12 months
Quality of Life (QOL) as Measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ)
Time Frame: 12 months
Change in KCCQ score from baseline
12 months
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
All-cause Hospitalization
Time Frame: 12 months
Total number of hospitalizations due to any cause
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Edwards Lifesciences

Investigators

  • Principal Investigator: Martin B. Leon, MD, Columbia University
  • Principal Investigator: Michael J. Mack, MD, Baylor Scott and White Health
  • Study Chair: Allen Anderson, MD, UT Health San Antonio
  • Study Chair: Gorav Ailawadi, MD, University of Michigan
  • Principal Investigator: Charles Davidson, MD, Northwestern University

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, 2024

Study Completion (Estimated)

March 31, 2029

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)

March 15, 2024

Last Update Submitted That Met QC Criteria

March 13, 2024

Last Verified

March 1, 2024

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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