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

Primary Purpose

Tricuspid Regurgitation, Tricuspid Valve Insufficiency, Tricuspid Valve Disease

Status
Recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Edwards PASCAL System
Optimal Medical Therapy
Edwards PASCAL System
Sponsored by
Edwards Lifesciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tricuspid Regurgitation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 core lab assessment
  • Deep vein thrombosis (DVT) or pulmonary embolism (PE) in the last 180 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 or recent infection requiring antibiotic therapy
  • Chronic obstructive pulmonary disease (COPD) requiring continuous home oxygen
  • Pregnant or planning pregnancy within the next 12 months
  • 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

Sites / Locations

  • Banner University Medical Center PhoenixRecruiting
  • Tucson Medical Center HealthcareRecruiting
  • University of California, IrvineRecruiting
  • SCPMG - Kaiser San DiegoRecruiting
  • Cedars Sinai Medical CenterRecruiting
  • UCLA Medical CenterRecruiting
  • Kaiser Permanente San FranciscoRecruiting
  • University of California, San FranciscoRecruiting
  • Stanford UniversityRecruiting
  • St. Joseph HospitalRecruiting
  • Medical Center of the RockiesRecruiting
  • The Cardiac and Vascular Institute Research FoundationRecruiting
  • Mount Sinai Medical CenterRecruiting
  • NCH Healthcare SystemRecruiting
  • Sarasota Memorial Health Care SystemRecruiting
  • Emory University Hospital Midtown / Emory University - St. Joseph's HospitalRecruiting
  • Piedmont Healthcare, Inc.Recruiting
  • Northwestern UniversityRecruiting
  • Ascension St. Vincent Heart Center Cardiovascular Research InstituteRecruiting
  • University of Iowa Hospitals & ClinicsRecruiting
  • Ochsner Medical CenterRecruiting
  • Johns HopkinsRecruiting
  • Massachusetts General HospitalRecruiting
  • University of MichiganRecruiting
  • Henry Ford HospitalRecruiting
  • William Beaumont Hospital - Royal OakRecruiting
  • St. Mary's of Ascension ResearchRecruiting
  • Fairview Health ServicesRecruiting
  • Mayo ClinicRecruiting
  • Saint Luke's Hospital of Kansas CityRecruiting
  • Washington University School of MedicineRecruiting
  • Providence St. Patrick HospitalRecruiting
  • Dartmouth-Hitchcock Medical CenterRecruiting
  • Cooper Health SystemsRecruiting
  • Morristown Medical CenterRecruiting
  • Rutgers Robert Wood Johnson Medical SchoolRecruiting
  • Montefiore Medical Center / Arts Pavilion / Hutchinson Metro Center Clinic / Weiler Hospital / Moses HospitalRecruiting
  • State University of New York at BuffaloRecruiting
  • Columbia University Irving Medical Center/NYPHRecruiting
  • Weill Cornell MedicineRecruiting
  • Lenox Hill Hospital, Northwell Health /Northshore University Hospital ManhassetRecruiting
  • Rochester General HospitalRecruiting
  • St. Francis HospitalRecruiting
  • University of North CarolinaRecruiting
  • Sanford Medical Center FargoRecruiting
  • The Christ HospitalRecruiting
  • TriHealth-Bethesda North HospitalRecruiting
  • The Ohio State UniversityRecruiting
  • Integris Baptist Medical CenterRecruiting
  • Oklahoma Cardiovascular Research GroupRecruiting
  • Oklahoma Heart Institute at Hillcrest Medical CenterRecruiting
  • Oregon Health & Science UniversityRecruiting
  • Penn State HersheyRecruiting
  • Pennsylvania Presbyterian Medical Center / Hospital of the University of PennsylvaniaRecruiting
  • Pinnacle Health Cardiovascular Institute/UPMC PinnacleRecruiting
  • Lankenau Heart InstituteRecruiting
  • Medical University of South CarolinaRecruiting
  • Erlanger Health SystemRecruiting
  • Vanderbilt University Medical CenterRecruiting
  • HCA Houston Healthcare Medical CenterRecruiting
  • Baylor College of Medicine St. Luke's Medical CenterRecruiting
  • The University of Texas Health Science Center at HoustonRecruiting
  • UTHealth/Memorial Hermann HospitalRecruiting
  • Baylor Scott & White - The Heart Hospital - PlanoRecruiting
  • University of Virginia Health SystemRecruiting
  • Virginia Commonwealth UniversityRecruiting
  • Carilion Medical CenterRecruiting
  • Virginia Mason Medical CenterRecruiting
  • Swedish Medical CenterRecruiting
  • Medical College of WisconsinRecruiting
  • St. Paul's HospitalRecruiting
  • Hamilton Health ServicesRecruiting
  • University of Ottawa Heart InstituteRecruiting
  • St. Michael's HospitalRecruiting
  • Institut universitaire de cardiologie et de pneumologie de Québec - Université LavalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Experimental

Arm Label

Edwards PASCAL System & OMT

Optimal Medical Therapy (OMT)

Single-Arm Registry

Arm Description

Transcatheter tricuspid valve repair with the Edwards PASCAL system in patients on optimal medical therapy (OMT) with tricuspid regurgitation

Optimal medical therapy (OMT) alone in patients with tricuspid regurgitation

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
September 18, 2019
Last Updated
October 11, 2023
Sponsor
Edwards Lifesciences
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1. Study Identification

Unique Protocol Identification Number
NCT04097145
Brief Title
Edwards PASCAL Transcatheter Valve Repair System Pivotal Clinical Trial
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 11, 2019 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
March 31, 2029 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Edwards Lifesciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tricuspid Regurgitation, Tricuspid Valve Insufficiency, Tricuspid Valve Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
870 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Edwards PASCAL System & OMT
Arm Type
Experimental
Arm Description
Transcatheter tricuspid valve repair with the Edwards PASCAL system in patients on optimal medical therapy (OMT) with tricuspid regurgitation
Arm Title
Optimal Medical Therapy (OMT)
Arm Type
Active Comparator
Arm Description
Optimal medical therapy (OMT) alone in patients with tricuspid regurgitation
Arm Title
Single-Arm Registry
Arm Type
Experimental
Arm Description
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
Intervention Type
Device
Intervention Name(s)
Edwards PASCAL System
Other Intervention Name(s)
Transcatheter tricuspid valve repair (TTVr)
Intervention Description
Transcatheter tricuspid valve repair with the Edwards PASCAL System in patients on optimal medical therapy
Intervention Type
Drug
Intervention Name(s)
Optimal Medical Therapy
Intervention Description
Optimal Medical Therapy alone in patients with tricuspid regurgitation
Intervention Type
Device
Intervention Name(s)
Edwards PASCAL System
Intervention Description
Transcatheter tricuspid valve repair with the Edwards PASCAL System in conjunction with OMT
Primary Outcome Measure Information:
Title
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)
Description
Comparison of number of participants with composite endpoint events between experimental and active comparator arms
Time Frame
24 months
Secondary Outcome Measure Information:
Title
1 Grade Reduction in TR Severity
Description
Total number of participants with at least 1 grade reduction in TR severity
Time Frame
12 months
Title
Quality of Life (QOL) as Measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ)
Description
Change in KCCQ score from baseline
Time Frame
12 months
Title
All Cause Mortality
Description
Total number of deaths from any cause
Time Frame
12 months, 24 months
Title
Death and Heart Failure Hospitalizations
Description
Total number of deaths and hospital admissions due to heart failure
Time Frame
12 months
Title
All-cause Hospitalization
Description
Total number of hospitalizations due to any cause
Time Frame
12 months
Title
Right ventricular end-diastolic diameter (RVEDD mid)
Description
Change in right ventricular end-diastolic diameter (RVEDD mid)
Time Frame
12 months
Title
Major Adverse Events (MAEs)
Description
Overall rate of Major Adverse Events (MAEs)
Time Frame
30 days
Title
Reduction in TR grade
Description
Reduction in TR severity as assessed by TEE pre- and post-implantation
Time Frame
Intraprocedural post-implantation
Title
All-Cause Mortality
Description
Total number of deaths from any cause
Time Frame
12 months, annually through 5 years
Title
Heart failure hospitalizations
Description
Total number of hospital admissions due to heart failure
Time Frame
12 months, annually through 5 years
Title
Non-elective tricuspid valve re-intervenitions (percutaneous or surgical)
Description
Total number of non-elective tricuspid valve re-interventions
Time Frame
12 months, annually through 5 years
Title
Durable RVAD implantation or heart transplant
Description
Total number of patients requiring RVAD impantantion or heart transplant
Time Frame
12 months, annually through 5 years
Title
Need for paracentesis
Description
Total nunber of patients who required paracentesis
Time Frame
12 months, annually through 5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Edwards TMTT Clinical Affairs
Phone
(949) 250-2500
Email
TMTT_Clinical@edwards.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martin B. Leon, MD
Organizational Affiliation
Columbia University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Michael J. Mack, MD
Organizational Affiliation
Baylor Scott and White Health
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Charles Davidson, MD
Organizational Affiliation
Northwestern University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Allen Anderson, MD
Organizational Affiliation
UT Health San Antonio
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Gorav Ailawadi, MD
Organizational Affiliation
University of Michigan
Official's Role
Study Chair
Facility Information:
Facility Name
Banner University Medical Center Phoenix
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85006
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marvin Eng, MD
Facility Name
Tucson Medical Center Healthcare
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thomas Waggoner, DO
Facility Name
University of California, Irvine
City
Irvine
State/Province
California
ZIP/Postal Code
92868
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Antonio Frangieh, MD
Facility Name
SCPMG - Kaiser San Diego
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bahram Khadivi, MD
Facility Name
Cedars Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Raj Makkar, MD
Facility Name
UCLA Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marcella Press, MD
Facility Name
Kaiser Permanente San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94118
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrew Rassi, MD
First Name & Middle Initial & Last Name & Degree
Jacob Mishell, MD
Facility Name
University of California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sammy Elmariah, MD
Facility Name
Stanford University
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rahul Sharma, MD
Facility Name
St. Joseph Hospital
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jake Chanin, MD
Facility Name
Medical Center of the Rockies
City
Loveland
State/Province
Colorado
ZIP/Postal Code
80538
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mohamad Lazkani, MD
Facility Name
The Cardiac and Vascular Institute Research Foundation
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32605
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Charles Klodell, MD
First Name & Middle Initial & Last Name & Degree
Ilie Barb, MD
Facility Name
Mount Sinai Medical Center
City
Miami Beach
State/Province
Florida
ZIP/Postal Code
33140
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nirat Beohar, MD
First Name & Middle Initial & Last Name & Degree
Steve Xydas, MD
Facility Name
NCH Healthcare System
City
Naples
State/Province
Florida
ZIP/Postal Code
34102
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Robert Cubeddu, MD
Facility Name
Sarasota Memorial Health Care System
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34239
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ricardo A. Yaryura, MD
Facility Name
Emory University Hospital Midtown / Emory University - St. Joseph's Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Adam Greenbaum, MD
Facility Name
Piedmont Healthcare, Inc.
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30309
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pradeep Yadav, MD
First Name & Middle Initial & Last Name & Degree
Vinod Thourani, MD
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Charles Davidson, MD
Facility Name
Ascension St. Vincent Heart Center Cardiovascular Research Institute
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46290
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
James Hermiller, MD
Facility Name
University of Iowa Hospitals & Clinics
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Phillip A. Horwitz, MD
Facility Name
Ochsner Medical Center
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
J. Stephen Jenkins, MD
Facility Name
Johns Hopkins
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rani Hasan, MD
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nilay Patel, MD
First Name & Middle Initial & Last Name & Degree
Ignacio Inglessis, MD
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stanley Chetcuti, MD
Facility Name
Henry Ford Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brian O' Neill, MD
Facility Name
William Beaumont Hospital - Royal Oak
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ivan Hanson, MD
Facility Name
St. Mary's of Ascension Research
City
Saginaw
State/Province
Michigan
ZIP/Postal Code
48601
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Safwan Kassas, MD
Facility Name
Fairview Health Services
City
Maplewood
State/Province
Minnesota
ZIP/Postal Code
55109
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marat Yanavitski, MD
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mackram Eleid, MD
Facility Name
Saint Luke's Hospital of Kansas City
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Adnan Chhatriwalla, MD
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alan Zajarias, MD
First Name & Middle Initial & Last Name & Degree
Puja Kachroo, MD
Facility Name
Providence St. Patrick Hospital
City
Missoula
State/Province
Montana
ZIP/Postal Code
59802
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
James Maddux, MD
First Name & Middle Initial & Last Name & Degree
Daniel Spoon, MD
Facility Name
Dartmouth-Hitchcock Medical Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Young, MD
Facility Name
Cooper Health Systems
City
Camden
State/Province
New Jersey
ZIP/Postal Code
09103
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sajjad Sabir, MD
Facility Name
Morristown Medical Center
City
Morristown
State/Province
New Jersey
ZIP/Postal Code
07962
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Robert Kipperman, MD
Facility Name
Rutgers Robert Wood Johnson Medical School
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08901
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mark Russo, MD
Facility Name
Montefiore Medical Center / Arts Pavilion / Hutchinson Metro Center Clinic / Weiler Hospital / Moses Hospital
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mohamed A. Latib, MD
Facility Name
State University of New York at Buffalo
City
Buffalo
State/Province
New York
ZIP/Postal Code
14203
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vijay Iyer, MD, PhD
Facility Name
Columbia University Irving Medical Center/NYPH
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Susheel Kodali, MD
Facility Name
Weill Cornell Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mark Reisman, MD
Facility Name
Lenox Hill Hospital, Northwell Health /Northshore University Hospital Manhasset
City
New York
State/Province
New York
ZIP/Postal Code
10075
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chad Kliger, MD
First Name & Middle Initial & Last Name & Degree
Bruce Rutkin, MD
Facility Name
Rochester General Hospital
City
Rochester
State/Province
New York
ZIP/Postal Code
14621
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jeremiah Depta, MD
Facility Name
St. Francis Hospital
City
Roslyn
State/Province
New York
ZIP/Postal Code
11576
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
George A. Petrossian, MD
First Name & Middle Initial & Last Name & Degree
Newell B. Robinson, MD
Facility Name
University of North Carolina
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27517
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
John Vavalle, MD
Facility Name
Sanford Medical Center Fargo
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thomas Haldis, DO
Facility Name
The Christ Hospital
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Santiago Garcia, MD
Facility Name
TriHealth-Bethesda North Hospital
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45242
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sateesh Kesari, MD
First Name & Middle Initial & Last Name & Degree
Mohammed Al-Amoodi, MD
Facility Name
The Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Konstantinos Boudoulas, MD
First Name & Middle Initial & Last Name & Degree
Scott Lilly, MD
Facility Name
Integris Baptist Medical Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jeffrey Sparling, MD
Facility Name
Oklahoma Cardiovascular Research Group
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73120
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mohammad Ghani, MD
Facility Name
Oklahoma Heart Institute at Hillcrest Medical Center
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kamran Muhammad, MD
Facility Name
Oregon Health & Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Firas Zahr, MD
First Name & Middle Initial & Last Name & Degree
Scott Chadderdon, MD
Facility Name
Penn State Hershey
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mark Kozak, MD
Facility Name
Pennsylvania Presbyterian Medical Center / Hospital of the University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gene Chang, MD
First Name & Middle Initial & Last Name & Degree
Wilson Szeto, MD
Facility Name
Pinnacle Health Cardiovascular Institute/UPMC Pinnacle
City
Wormleysburg
State/Province
Pennsylvania
ZIP/Postal Code
17043
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mubashir Mumtaz, MD
First Name & Middle Initial & Last Name & Degree
Hemal Gada, MD
Facility Name
Lankenau Heart Institute
City
Wynnewood
State/Province
Pennsylvania
ZIP/Postal Code
19096
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
William Gray, MD
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29245
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nicholas Amoroso, MD
Facility Name
Erlanger Health System
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37403
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Megan Coylewright, MD
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37212
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Colin Barker, MD
First Name & Middle Initial & Last Name & Degree
Brian R. Lindman, MD
Facility Name
HCA Houston Healthcare Medical Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77004
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pranav Loyalka, MD
Facility Name
Baylor College of Medicine St. Luke's Medical Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guilherme Silva, MD
Facility Name
The University of Texas Health Science Center at Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Abhijeet Dhoble, MD
First Name & Middle Initial & Last Name & Degree
Richard Smalling, MD
Facility Name
UTHealth/Memorial Hermann Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Biswajit Kar, MD
Facility Name
Baylor Scott & White - The Heart Hospital - Plano
City
Plano
State/Province
Texas
ZIP/Postal Code
75093
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Molly Szerlip, MD
Facility Name
University of Virginia Health System
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Scott Lim, MD
Facility Name
Virginia Commonwealth University
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zachary Gertz, MD
Facility Name
Carilion Medical Center
City
Roanoke
State/Province
Virginia
ZIP/Postal Code
24014
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jason Foerst, MD
Facility Name
Virginia Mason Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ming Zhang, MD
Facility Name
Swedish Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98122
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sameer Gafoor, MD
Facility Name
Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Peter Mason, MD, MPH
Facility Name
St. Paul's Hospital
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6Z 1Y6
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Robert Boone, MD
Facility Name
Hamilton Health Services
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8L 2X2
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shamir Mehta, MD
Facility Name
University of Ottawa Heart Institute
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1Y 4Q7
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marino Labinaz
Facility Name
St. Michael's Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5B 1W8
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Neil Fam, MD
Facility Name
Institut universitaire de cardiologie et de pneumologie de Québec - Université Laval
City
Québec City
State/Province
Quebec
ZIP/Postal Code
G1V 4G5
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Josep Rodés-Cabau, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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Edwards PASCAL Transcatheter Valve Repair System Pivotal Clinical Trial

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