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TRISCEND II Pivotal Trial

Primary Purpose

Tricuspid Valve Regurgitation, Tricuspid Valve Insufficiency, Tricuspid Valve Disease

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

About this trial

This is an interventional treatment trial for Tricuspid Valve Regurgitation

Eligibility Criteria

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

Inclusion Criteria:

  • Symptomatic tricuspid regurgitation (TR) despite medical therapy
  • TR graded as severe or greater
  • Appropriate for transcatheter tricuspid valve replacement per the local heart team

Exclusion Criteria:

  • Tricuspid valve anatomic contraindications
  • Need for emergent or urgent surgery or any planned cardiac surgery within the next 12 months
  • Hemodynamic instability
  • Refractory heart failure requiring advanced intervention
  • Currently participating in another investigational study

Sites / Locations

  • SJHMC Heart and Vascular InstituteRecruiting
  • Tucson Medical CenterRecruiting
  • Scripps Memorial Hospital La JollaRecruiting
  • Cedars-Sinai Medical CenterRecruiting
  • UC Davis Medical CenterRecruiting
  • Kaiser Permanente San FranciscoRecruiting
  • University of California San FranciscoRecruiting
  • Stanford UniversityRecruiting
  • Medical Center of the Rockies
  • Florida Heart & Vascular Care - JFKRecruiting
  • The Cardiac & Vascular Institute Research FoundationRecruiting
  • NCH Heart InstituteRecruiting
  • Emory UniversityRecruiting
  • Piedmont Heart InstituteRecruiting
  • Northwestern UniversityRecruiting
  • St. Vincent Heart Center of IndianaRecruiting
  • Kansas University Medical CenterRecruiting
  • Cardiovascular Research Institute of KansasRecruiting
  • University of MarylandRecruiting
  • Johns Hopkins Hospital
  • Massachusetts General HospitalRecruiting
  • Brigham and Women's HospitalRecruiting
  • Beth Israel Deaconess Medical CenterRecruiting
  • University of Michigan Hospital and Health SystemsRecruiting
  • Henry Ford Health SystemRecruiting
  • Mayo ClinicRecruiting
  • Saint Luke's Hospital of Kansas CityRecruiting
  • Washington University Barnes-Jewish Hospital
  • Morristown Medical CenterRecruiting
  • Rutgers Robert Wood Johnson Medical SchoolRecruiting
  • Montefiore Medical CenterRecruiting
  • State University of New York at BuffaloRecruiting
  • North Shore University HospitalRecruiting
  • NYU Langone HealthRecruiting
  • Weill Cornell Medicine-New York Presbyterian HospitalRecruiting
  • Columbia University Medical Center/NYPHRecruiting
  • Lenox Hill HospitalRecruiting
  • Rochester General Hospital
  • St. Francis HospitalRecruiting
  • University of North Carolina - Chapel HillRecruiting
  • Carolinas Medical CenterRecruiting
  • The Christ HospitalRecruiting
  • Cleveland ClinicRecruiting
  • Oklahoma Heart InstituteRecruiting
  • Oregon Health & Science UniversityRecruiting
  • University of PennsylvaniaRecruiting
  • Lankenau Heart InstituteRecruiting
  • Saint Thomas HealthRecruiting
  • Vanderbilt University Medical CenterRecruiting
  • HCA Houston HealthcareRecruiting
  • The University of Texas Health Science Center at HoustonRecruiting
  • Baylor Heart Hopsital PlanoRecruiting
  • Intermountain Medical CenterRecruiting
  • University of Virginia Health SystemRecruiting
  • Sentara Norfolk General HospitalRecruiting
  • Virginia Mason Franciscan HealthRecruiting
  • Swedish Medical CenterRecruiting
  • University of WashingtonRecruiting
  • Herz- und Diabeteszentrum NRW, Bad Oeynhausen
  • Herzzentrum Universitätsklinik Bonn
  • Herzzentrum Dresden Universitätsklinik
  • Herzzentrum der Uniklinik Köln
  • Herzzentrum Leipzig GmbH
  • Johannes Gutenberg-Universität Mainz
  • Klinikum der Universität München - Großhadern

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Experimental

Experimental

Arm Label

Edwards EVOQUE System & OMT

Optimal Medical Therapy (OMT)

Single-Arm Registry

Continued Access Study

Arm Description

Transcatheter tricuspid valve replacement with the Edwards EVOQUE System in conjunction with optimal medical therapy (OMT) in patients with tricuspid regurgitation

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

Transcatheter tricuspid valve replacement with the Edwards EVOQUE System in conjunction with optimal medical therapy (OMT) in patients with tricuspid regurgitation who are not eligible for randomization

Provides continued access to transcatheter tricuspid valve replacement with the Edwards EVOQUE System in conjunction with optimal medical therapy (OMT) in patients with tricuspid regurgitation.

Outcomes

Primary Outcome Measures

TR Grade reduction and composite endpoint including: Kansas City Cardiomyopathy Questionnaire (KCCQ) improvement, New York Heart Association (NYHA) functional class improvement, and 6-minute walk test distance improvement
Comparison of number of participants with reduction in TR and composite endpoint event improvement between experimental and active comparator arms
Rate of Major Adverse Events (MAE)
Rate of Major Adverse Events (MAE) in experimental arm
Composite endpoint including all-cause mortality, RVAD implantation or heart transplant, tricuspid valve intervention, heart failure hospitalizations, KCCQ improvement, NYHA functional class improvement, and 6-minute walk distance improvement
Comparison of number of participants with composite endpoint events between experimental and active comparator arms

Secondary Outcome Measures

Composite endpoint including reduction in TR grade, change in QOL from baseline, death and heart failure hospitalization, all-cause hospitalization, all-cause mortality, and change in right ventricular end diastolic volume index
Hierarchical comparison of number of participants with composite endpoint events between experimental and active comparator arms

Full Information

First Posted
July 9, 2020
Last Updated
June 5, 2023
Sponsor
Edwards Lifesciences
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1. Study Identification

Unique Protocol Identification Number
NCT04482062
Brief Title
TRISCEND II Pivotal Trial
Official Title
Edwards EVOQUE Transcatheter Tricuspid Valve Replacement: Pivotal Clinical Investigation of Safety and Clinical Efficacy Using a Novel Device
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 9, 2021 (Actual)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
December 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
Pivotal trial to evaluate the safety and effectiveness of the Edwards EVOQUE tricuspid valve replacement system
Detailed Description
The study is a prospective, multi-center, randomized controlled pivotal clinical trial to evaluate the safety and effectiveness of the EVOQUE System with optimal medical therapy (OMT) compared to OMT alone in the treatment of patients with at least severe tricuspid regurgitation. Subjects will be followed 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 Valve Regurgitation, Tricuspid Valve Insufficiency, Tricuspid Valve Disease, Heart Valve Diseases, Cardiovascular Diseases, Heart Failure

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1070 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Edwards EVOQUE System & OMT
Arm Type
Experimental
Arm Description
Transcatheter tricuspid valve replacement with the Edwards EVOQUE System in conjunction with optimal medical therapy (OMT) in patients 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 replacement with the Edwards EVOQUE System in conjunction with optimal medical therapy (OMT) in patients with tricuspid regurgitation who are not eligible for randomization
Arm Title
Continued Access Study
Arm Type
Experimental
Arm Description
Provides continued access to transcatheter tricuspid valve replacement with the Edwards EVOQUE System in conjunction with optimal medical therapy (OMT) in patients with tricuspid regurgitation.
Intervention Type
Device
Intervention Name(s)
Edwards EVOQUE System
Other Intervention Name(s)
Transcatheter tricuspid valve replacement
Intervention Description
Transcatheter tricuspid valve replacement with the Edwards EVOQUE System in conjunction with OMT
Intervention Type
Drug
Intervention Name(s)
Optimal Medical Therapy
Intervention Description
Optimal Medical Therapy
Primary Outcome Measure Information:
Title
TR Grade reduction and composite endpoint including: Kansas City Cardiomyopathy Questionnaire (KCCQ) improvement, New York Heart Association (NYHA) functional class improvement, and 6-minute walk test distance improvement
Description
Comparison of number of participants with reduction in TR and composite endpoint event improvement between experimental and active comparator arms
Time Frame
6 months
Title
Rate of Major Adverse Events (MAE)
Description
Rate of Major Adverse Events (MAE) in experimental arm
Time Frame
30 days
Title
Composite endpoint including all-cause mortality, RVAD implantation or heart transplant, tricuspid valve intervention, heart failure hospitalizations, KCCQ improvement, NYHA functional class improvement, and 6-minute walk distance improvement
Description
Comparison of number of participants with composite endpoint events between experimental and active comparator arms
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Composite endpoint including reduction in TR grade, change in QOL from baseline, death and heart failure hospitalization, all-cause hospitalization, all-cause mortality, and change in right ventricular end diastolic volume index
Description
Hierarchical comparison of number of participants with composite endpoint events between experimental and active comparator arms
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Symptomatic tricuspid regurgitation (TR) despite medical therapy TR graded as severe or greater Appropriate for transcatheter tricuspid valve replacement per the local heart team Exclusion Criteria: Tricuspid valve anatomic contraindications Need for emergent or urgent surgery or any planned cardiac surgery within the next 12 months Hemodynamic instability Refractory heart failure requiring advanced intervention Currently participating in another investigational study
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
TMTT Clinical
Phone
949-250-2500 or 800-424-3278
Email
TMTT_Clinical@Edwards.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rebecca Hahn, MD
Organizational Affiliation
Columbia University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Susheel Kodali, MD
Organizational Affiliation
Columbia University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Philipp Lurz, MD
Organizational Affiliation
Herzzentrum Leipzig GmbH
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Vinod Thourani, MD
Organizational Affiliation
Piedmont Heart Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
SJHMC Heart and Vascular Institute
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85013
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hursh Naik, MD
Facility Name
Tucson Medical Center
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
Scripps Memorial Hospital La Jolla
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
Curtiss Stinis, 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
UC Davis Medical Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gagan Singh, 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
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 P Sharma, MBBS
Facility Name
Medical Center of the Rockies
City
Loveland
State/Province
Colorado
ZIP/Postal Code
80538
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Florida Heart & Vascular Care - JFK
City
Atlantis
State/Province
Florida
ZIP/Postal Code
33462
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marcos Nores, MD
Facility Name
The Cardiac & 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
Facility Name
NCH Heart Institute
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
Emory University
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
Vasilis Babaliaros, MD
Facility Name
Piedmont Heart Institute
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
Vinod Thourani, MD
First Name & Middle Initial & Last Name & Degree
Pradeep Yadav, 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
St. Vincent Heart Center of Indiana
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
Kansas University Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Peter Tadros, MD
Facility Name
Cardiovascular Research Institute of Kansas
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67226
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bassem Chehab
Facility Name
University of Maryland
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bradley Taylor, MD
Facility Name
Johns Hopkins Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Individual Site Status
Withdrawn
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
Ignacio Inglessis, MD
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pinak B Shah, MD
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Roger Laham, MD
Facility Name
University of Michigan Hospital and Health Systems
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
Gorav Ailawadi, MD
First Name & Middle Initial & Last Name & Degree
Stanley Chetcuti, MD
Facility Name
Henry Ford Health System
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
William O'Neill, 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 Barnes-Jewish Hospital
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Individual Site Status
Withdrawn
Facility Name
Morristown Medical Center
City
Morristown
State/Province
New Jersey
ZIP/Postal Code
07960
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
08903
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mark Russo, MD
Facility Name
Montefiore Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
M. Azeem 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
Facility Name
North Shore University Hospital
City
Manhasset
State/Province
New York
ZIP/Postal Code
11030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bruce Rutkin, MD
Facility Name
NYU Langone Health
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mathew Williams, MD
First Name & Middle Initial & Last Name & Degree
Cezar S. Staniloae, MD
Facility Name
Weill Cornell Medicine-New York Presbyterian Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mark Reisman, MD
Facility Name
Columbia University 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
Lenox Hill Hospital
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
Facility Name
Rochester General Hospital
City
Rochester
State/Province
New York
ZIP/Postal Code
14621
Country
United States
Individual Site Status
Withdrawn
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
Facility Name
University of North Carolina - Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
John Paul Vavalle, MD
Facility Name
Carolinas Medical Center
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28203
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mike Rinaldi, MD
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
Joseph Choo, MD
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Samir Kapadia, MD
Facility Name
Oklahoma Heart Institute
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
97293
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
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
Howard Hermann, 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
Saint Thomas Health
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37205
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Morse, MD
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
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 Lindman, MD
Facility Name
HCA Houston Healthcare
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
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
Facility Name
Baylor Heart Hopsital 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
Robert Smith, MD
First Name & Middle Initial & Last Name & Degree
Molly Szerlip, MD
Facility Name
Intermountain Medical Center
City
Murray
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brian Whisenant, 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
Sentara Norfolk General Hospital
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Paul Mahoney, MD
Facility Name
Virginia Mason Franciscan Health
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
University of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
James McCabe, MD
Facility Name
Herz- und Diabeteszentrum NRW, Bad Oeynhausen
City
Bad Oeynhausen
ZIP/Postal Code
32545
Country
Germany
Individual Site Status
Active, not recruiting
Facility Name
Herzzentrum Universitätsklinik Bonn
City
Bonn
ZIP/Postal Code
53105
Country
Germany
Individual Site Status
Active, not recruiting
Facility Name
Herzzentrum Dresden Universitätsklinik
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Individual Site Status
Active, not recruiting
Facility Name
Herzzentrum der Uniklinik Köln
City
Köln
ZIP/Postal Code
50937
Country
Germany
Individual Site Status
Active, not recruiting
Facility Name
Herzzentrum Leipzig GmbH
City
Leipzig
ZIP/Postal Code
04289
Country
Germany
Individual Site Status
Active, not recruiting
Facility Name
Johannes Gutenberg-Universität Mainz
City
Mainz
ZIP/Postal Code
55131
Country
Germany
Individual Site Status
Active, not recruiting
Facility Name
Klinikum der Universität München - Großhadern
City
München
ZIP/Postal Code
81377
Country
Germany
Individual Site Status
Active, not recruiting

12. IPD Sharing Statement

Citations:
PubMed Identifier
35272771
Citation
Kodali S, Hahn RT, George I, Davidson CJ, Narang A, Zahr F, Chadderdon S, Smith R, Grayburn PA, O'Neill WW, Wang DD, Herrmann H, Silvestry F, Elmariah S, Inglessis I, Passeri J, Lim DS, Salerno M, Makar M, Mack MJ, Leon MB, Makkar R; TRISCEND Investigators. Transfemoral Tricuspid Valve Replacement in Patients With Tricuspid Regurgitation: TRISCEND Study 30-Day Results. JACC Cardiovasc Interv. 2022 Mar 14;15(5):471-480. doi: 10.1016/j.jcin.2022.01.016.
Results Reference
derived
PubMed Identifier
34112461
Citation
Lurz P, Kresoja KP. Tricuspid Valve Therapies: Closing the Gap. JACC Cardiovasc Interv. 2021 Jun 14;14(11):1241-1242. doi: 10.1016/j.jcin.2021.04.008. No abstract available.
Results Reference
derived

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TRISCEND II Pivotal Trial

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