2019-06 TRISCEND Study

• ClinicalTrials.gov Identifier: NCT04221490
• Recruitment Status: Recruiting
• First Posted: January 9, 2020
• Last Update Posted: December 3, 2020
• Sponsor: Edwards Lifesciences
• Information provided by (Responsible Party): Edwards Lifesciences

Study Description

Brief Summary:

Early feasibility study to assess safety and performance of the Edwards EVOQUE Tricuspid Valve Replacement System

Condition or disease	Intervention/treatment	Phase
Tricuspid Valve Regurgitation; Heart Valve Diseases; Cardiovascular Diseases	Device: Transcatheter Tricuspid Valve Replacement	Not Applicable

Detailed Description:

The study is a multi-center, prospective, single arm study designed to evaluate the safety and performance of the Edwards EVOQUE Tricuspid Valve Replacement System

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 200 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Edwards Transcatheter Tricuspid Valve Replacement: Investigation of Safety and Clinical Efficacy Using a Novel Device
• Actual Study Start Date: May 6, 2020
• Estimated Primary Completion Date: October 2025
• Estimated Study Completion Date: December 2025

Arms and Interventions

Arm	Intervention/treatment
Experimental: Treatment; Treatment with the Edwards EVOQUE Tricuspid Transcatheter Valve Replacement System	Device: Transcatheter Tricuspid Valve Replacement; Replacement of the tricuspid valve through a transcatheter approach; Other Name: Edwards EVOQUE Tricuspid Valve Replacement System

Outcome Measures

Primary Outcome Measures :

1. Freedom from device or procedure-related adverse events [ Time Frame: 30 days ]
   Freedom from device or procedure-related adverse events

Secondary Outcome Measures :

1. NYHA Functional Class [ Time Frame: 30 days, 6 months, 12 months, annual for five years ]
   Number of patients with improvement in NYHA class
2. Six minute walk test [ Time Frame: 30 days, 6 months, 12 months, annual for five years ]
   Change in distance (m) from baseline
3. Reduction in TR grade [ Time Frame: 30 days, 6 months, 12 months, annual for five years ]
   Number of patients with reduction in TR from baseline
4. Health Status - KCCQ [ Time Frame: 30 days, 6 months, 12 months, annual for five years ]
   Number of points of improvement in health status as measured by Kansas City Cardiomyopathy Questionnaire
5. Health Status - SF-36 [ Time Frame: 30 days, 6 months, 12 months, annual for five years ]
   Number of points of improvement in health status as measured by 36 item short form survey (SF-36)

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• Functional or degenerative TR moderate or greater
• Symptomatic despite medical therapy
• The Local Site Heart Team determines that the patient is appropriate for transcatheter tricuspid valve replacement

Exclusion Criteria:

• Unsuitable anatomy
• Previous tricuspid valve repair or replacement
• Comorbid condition(s) that, in the opinion of the investigator, could limit the patient's ability to participate in the study, including compliance with follow- up requirements, or that could impact the scientific integrity of the study.

Contacts and Locations

Contacts

Contact: TMTT Clinical; 949-250-2500; TMTT_Clinical@Edwards.com

Locations

United States, California

Cedars-Sinai Medical Center; Recruiting

Los Angeles, California, United States, 90048

Contact: Mitch Gheorghiu 310-423-6152 mitch.gheorghiu@cshs.org

Contact: Khaled Alsabaawi 310-423-6226 khaled.alsabaawi@cshs.org

Principal Investigator: Raj Makkar, MD

Sub-Investigator: Michelle Hamilton, MD

Sub-Investigator: Siddharth Singh, MD

Sub-Investigator: Tarun Chakravarty, MD

Sub-Investigator: Wen Cheng, MD

Sub-Investigator: Mamoo Nakamura, MD

Sub-Investigator: Moody Makar, MD

Sub-Investigator: David Chang, MD

Sub-Investigator: John Friedman, MD

Sub-Investigator: Luke Oakley, MD

Stanford University; Recruiting

Stanford, California, United States, 94305

Contact: Research Nurse 650-725-2687 mkasle@stanford.edu

Contact: Research Nurse 650-725-2687 leigh1@stanford.edu

Principal Investigator: Rahul Sharma, MD

Sub-Investigator: David Lee, MD

Sub-Investigator: David Liang, MD

Sub-Investigator: Jack Boyd, MD

Sub-Investigator: Christiane Haeffele, MD

Sub-Investigator: Shirin Jimenez, MD

Sub-Investigator: John MacArthur, MD

Sub-Investigator: Mirela Tuzovic, MD

Sub-Investigator: Dominik Fleischmann, MD

Sub-Investigator: Mayil Krishnam, MD

United States, Georgia

Emory University; Recruiting

Atlanta, Georgia, United States, 30308

Contact: Elizabeth Charles 404-686-1249 elizabeth.z.charles@emory.edu

Contact: Kristy Pitts 404-686-5775 klpitts@emory.edu

Principal Investigator: Vasilis Babaliaros, MD

Sub-Investigator: Adam Greenbaum, MD

Sub-Investigator: Kendra Grubb, MD

Sub-Investigator: Patrick Gleason, MD

Sub-Investigator: Divya Gupta, MD

Sub-Investigator: Chandan Devireddy, MD

Sub-Investigator: Robert Guyton, MD

Sub-Investigator: Gaetano Paone, MD

Sub-Investigator: Lucia Alvarez, MD

Sub-Investigator: Isida Byku, MD

Piedmont Heart Institute; Recruiting

Atlanta, Georgia, United States, 30309

Contact: Kashaine Gray 404-605-2958 kashaine.gray@piedmont.org

Contact: Kimi Wang 404-605-2986 kimi.wang@piedmont.org

Principal Investigator: Pradeep Yadav, MD

Principal Investigator: Vinod Thourani, MD

United States, Illinois

Northwestern University; Recruiting

Evanston, Illinois, United States, 60208

Contact: Christina Arroyo 312-926-7078 Christina.Arroyo@nm.org

Contact: Elizabeth McCloskey 312-926-0840 Elizabeth.McCloskey@nm.org

Principal Investigator: Charles Davidson, MD

United States, Maryland

University of Maryland; Recruiting

Baltimore, Maryland, United States, 21201

Contact: Freshta Akbari 410-328-4562 fakbari@som.umaryland.edu

Contact: Emily Fleischmann 410-328-0993 efleischmann@som.umaryland.edu

Principal Investigator: James Gammie, MD

Sub-Investigator: Mark Vesely, MD

United States, Massachusetts

Massachusetts General Hospital Boston; Recruiting

Boston, Massachusetts, United States, 02114

Contact: Lina Fu 617-643-1371 lfu2@partners.org

Contact: Alexandra Moses amoses5@mgh.harvard.edu

Principal Investigator: Sammy Elmariah, MD

Sub-Investigator: Ignacio Inglessis, MD

Sub-Investigator: Nathaniel Langer, MD

Sub-Investigator: Jonathan Passeri, MD

Brigham and Women's Hospital; Recruiting

Boston, Massachusetts, United States, 02115

Contact: Lisa Downey 617-732-4812 Ldowney2@bwh.harvard.edu

Contact: Sinead Coyle 617-525-7479 Scoyle3@bwh.harvard.edu

Principal Investigator: Pinak Bipin Shah, MD

Principal Investigator: Tsuyoshi Kaneko, MD

United States, Michigan

Henry Ford Hospital; Recruiting

Detroit, Michigan, United States, 48202

Contact: Ardit Kacorri 313-916-7452 Akacorr1@hfhs.org

Contact: Ashish Solanki 313-916-3571 Asolank2@hfhs.org

Principal Investigator: William O'Neill, MD

Sub-Investigator: Marvin Eng, MD

Sub-Investigator: Tiberio Frisoli, MD

Sub-Investigator: Dimitrios Apostolou, MD

Sub-Investigator: Dee Dee Wang, MD

Sub-Investigator: Raed Alnajjar, MD

Sub-Investigator: Daizo Tanaka, MD

Sub-Investigator: Pedro Villablanca, MD

Sub-Investigator: Hassan Nemeh, MD

Sub-Investigator: Brian O'Neill, MD

United States, New York

Montefiore Medical Center; Recruiting

Bronx, New York, United States, 10467

Contact: Kara Booth 718-920-6523 kbooth@montefiore.org

Contact: Nadia Persaud 718-920-8576 napersaud@montefiore.org

Principal Investigator: Mohamed Latib, MD

Sub-Investigator: Mei Chau, MD

Sub-Investigator: Ythan Goldberg, MD

Sub-Investigator: Edwin Ho, MD

Sub-Investigator: Ulrich Jorde, MD

Sub-Investigator: Patricia Chavez, MD

Sub-Investigator: Sandhya Murthy, MD

Columbia University Irving Medical Center / NYPH; Recruiting

New York, New York, United States, 10032

Contact: Parisha Masud 213-304-6362 pm3075@cumc.columbia.edu

Contact: Deniz Akkoc 212-342-3479 da2454@cumc.columbia.edu

Principal Investigator: Susheel Kodali, MD

Sub-Investigator: Isaac George, MD

Sub-Investigator: Omar Khalique, MD

Sub-Investigator: Amirali Masoumi, MD

Sub-Investigator: Nadira Hamid, MD

Sub-Investigator: Torsten Vahl, MD

Sub-Investigator: Rebecca Hahn, MD

United States, Oregon

Oregon Health & Science University; Recruiting

Portland, Oregon, United States, 97239

Contact: Zoe Kilmer 503-494-3491 kilmer@ohsu.edu

Contact: Kelsey Cameron 503-418-9677 cameronk@ohsu.edu

Principal Investigator: Firas Zahr, MD

Sub-Investigator: Scott Chadderdon, MD

Sub-Investigator: Howard Song, MD

Sub-Investigator: Johannes Steiner, MD

United States, Pennsylvania

Hospital of the University of Pennsylvania; Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contact: Eva Laverty-Wilson 215-300-7456 eva.laverty-wilson@pennmedicine.upenn.edu

Contact: Naidu Suveeksha 215-662-6590 Suveeksha.Naidu@pennmedicine.upenn.edu

Principal Investigator: Howard Herrmann, MD

United States, Texas

Baylor Heart Hopsital Plano; Recruiting

Plano, Texas, United States, 75093

Contact: Gabriella Velder 469-814-4732 Gabriella.Velder@BSWHealth.org

Principal Investigator: Robert Smith, MD

Sub-Investigator: Molly Szerlip, MD

Sub-Investigator: Paul Grayburn, MD

Sub-Investigator: Zuyue Wang, MD

Sub-Investigator: Ambarish Gopal, MD

Sub-Investigator: Aasim Afzal, MD

United States, Virginia

University of Virginia Health System; Recruiting

Charlottesville, Virginia, United States, 22908

Contact: Linda Bryceland 434-982-1058 lgs2m@hscmail.mcc.virginia.edu

Contact: Isabelle Giordano 434-982-1058 IHM7DC@hscmail.mcc.virginia.edu

Principal Investigator: Scott Lim, MD

Canada, Ontario

St. Michael's Hospital; Recruiting

Toronto, Ontario, Canada, M5B 1W8

Contact: Ivana Kandic 416-360-4000 ext 43003 ivana.kandic@unityhealh.to

Contact: Alana Harrington 416-360-4000 ext 49003 alana.harrington@unityhealth.to

Principal Investigator: Neil Fam, MD

Sub-Investigator: Mark Peterson, MD

Sub-Investigator: Geraldine Ong, MD

Canada

Institut universitaire de cardiologie et de pneumologie de Québec - Université Laval (IUCPQ-ULaval); Recruiting

Québec, Canada, G1V 4G5

Contact: Dominique Lachance 418-656-8711 ext 3055 dominique.lachance@criucpq.ulaval.ca

Contact: Shirley Baril 418-656-8711 ext 4129 shirley.baril@criucpq.ulaval.ca

Principal Investigator: Josep Rodés-Cabau, MD

Sub-Investigator: Elisabeth Bédard, MD

Sub-Investigator: Fraçois Dagenais, MD

Sub-Investigator: Kim O'Connor, MD

Sub-Investigator: Mathieu Bernier, MD

Sub-Investigator: Jonathan Beaudoin, MD

Sub-Investigator: Erwan Salaun, MD

Sub-Investigator: Marie-Hélène Lévesque, MD

Sub-Investigator: Guillem Mutan Carol, MD

Sponsors and Collaborators

Edwards Lifesciences

Investigators

• Principal Investigator: Susheel Kodali, MD; Columbia University

More Information

• Responsible Party: Edwards Lifesciences
• ClinicalTrials.gov Identifier: NCT04221490
• Other Study ID Numbers: 2019-06
• First Posted: January 9, 2020
• Last Update Posted: December 3, 2020
• Last Verified: December 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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

Keywords provided by Edwards Lifesciences:

Tricuspid Regurgitation; Transcatheter; Replacement; Functional; Degenerative; Regurgitation; Valve Replacement; Cardiovascular Disease

Additional relevant MeSH terms:

Cardiovascular Diseases; Heart Valve Diseases; Tricuspid Valve Insufficiency; Heart Diseases