Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
65 participants
INTERVENTIONAL
2019-02-05
2025-05-13
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Early Feasibility Study of the Edwards FORMA Tricuspid Transcatheter Repair System
NCT02471807
Transcatheter Repair of Tricuspid Regurgitation With Edwards PASCAL Transcatheter Valve Repair System
NCT04614402
Edwards PASCAL Transcatheter Valve Repair System Pivotal Clinical Trial
NCT04097145
Early Feasibility Study (EFS) Laplace Transcatheter Tricuspid Valve Replacement (TTVR) System
NCT06183684
Edwards PASCAL CLASP IID/IIF Pivotal Clinical Trial
NCT03706833
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Treatment
Treatment with the Edwards PASCAL Transcatheter Valve Repair System
Edwards PASCAL Transcatheter Valve Repair System
Repair of the tricuspid valve through a transcatheter approach
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Edwards PASCAL Transcatheter Valve Repair System
Repair of the tricuspid valve through a transcatheter approach
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Symptomatic despite medical therapy
* The local site Heart Team determines that the patient is appropriate for transcatheter tricuspid valve repair
Exclusion Criteria
* Previous tricuspid valve repair or replacement
* Co-morbid 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Edwards Lifesciences
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Susheel K. Kodali, MD
Role: PRINCIPAL_INVESTIGATOR
Columbia University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Cedars Sinai Medical Center
Los Angeles, California, United States
Emory University Hospital
Atlanta, Georgia, United States
Northwestern University
Chicago, Illinois, United States
St. Vincent Heart Center of Indiana
Indianapolis, Indiana, United States
Henry Ford Hospital
Detroit, Michigan, United States
Mayo Clinic
Rochester, Minnesota, United States
Morristown Medical Center
Morristown, New Jersey, United States
NYU Langone Health
New York, New York, United States
Columbia University Medical Center/New York Presbyterian Hospital
New York, New York, United States
Cleveland Clinic
Cleveland, Ohio, United States
Oregon Health & Science University
Portland, Oregon, United States
Lankenau Medical Center
Wynnewood, Pennsylvania, United States
The Heart Hospital Baylor Plano
Plano, Texas, United States
Intermountain Medical Center
Murray, Utah, United States
University of Virginia Health System
Charlottesville, Virginia, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Kodali SK, Hahn RT, Davidson CJ, Narang A, Greenbaum A, Gleason P, Kapadia S, Miyasaka R, Zahr F, Chadderdon S, Smith RL, Grayburn P, Kipperman RM, Marcoff L, Whisenant B, Gonzales M, Makkar R, Makar M, O'Neill W, Wang DD, Gray WA, Abramson S, Hermiller J, Mitchel L, Lim DS, Fowler D, Williams M, Pislaru SV, Dahou A, Mack MJ, Leon MB, Eleid MF. 1-Year Outcomes of Transcatheter Tricuspid Valve Repair. J Am Coll Cardiol. 2023 May 9;81(18):1766-1776. doi: 10.1016/j.jacc.2023.02.049.
Kodali S, Hahn RT, Eleid MF, Kipperman R, Smith R, Lim DS, Gray WA, Narang A, Pislaru SV, Koulogiannis K, Grayburn P, Fowler D, Hawthorne K, Dahou A, Deo SH, Vandrangi P, Deuschl F, Mack MJ, Leon MB, Feldman T, Davidson CJ; CLASP TR EFS Investigators. Feasibility Study of the Transcatheter Valve Repair System for Severe Tricuspid Regurgitation. J Am Coll Cardiol. 2021 Feb 2;77(4):345-356. doi: 10.1016/j.jacc.2020.11.047.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2018-10
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.