Heart Failure Clinical Trial
Official title:
Edwards EVOQUE Transcatheter Tricuspid Valve Replacement: Pivotal Clinical Investigation of Safety and Clinical Efficacy Using a Novel Device
Pivotal trial to evaluate the safety and effectiveness of the Edwards EVOQUE tricuspid valve replacement system
| Status | Recruiting |
| Enrollment | 1070 |
| Est. completion date | December 31, 2029 |
| Est. primary completion date | June 30, 2024 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| Germany | Herz- und Diabeteszentrum NRW, Bad Oeynhausen | Bad Oeynhausen | |
| Germany | Herzzentrum Universitätsklinik Bonn | Bonn | |
| Germany | Herzzentrum Dresden Universitätsklinik | Dresden | |
| Germany | Herzzentrum der Uniklinik Köln | Köln | |
| Germany | Herzzentrum Leipzig GmbH | Leipzig | |
| Germany | Johannes Gutenberg-Universität Mainz | Mainz | |
| Germany | Klinikum der Universität München - Großhadern | München | |
| United States | University of Michigan Hospital and Health Systems | Ann Arbor | Michigan |
| United States | Emory University | Atlanta | Georgia |
| United States | Piedmont Heart Institute | Atlanta | Georgia |
| United States | Florida Heart & Vascular Care - JFK | Atlantis | Florida |
| United States | Johns Hopkins Hospital | Baltimore | Maryland |
| United States | University of Maryland | Baltimore | Maryland |
| United States | Beth Israel Deaconess Medical Center | Boston | Massachusetts |
| United States | Brigham and Women's Hospital | Boston | Massachusetts |
| United States | Massachusetts General Hospital | Boston | Massachusetts |
| United States | Montefiore Medical Center | Bronx | New York |
| United States | State University of New York at Buffalo | Buffalo | New York |
| United States | University of North Carolina - Chapel Hill | Chapel Hill | North Carolina |
| United States | Carolinas Medical Center | Charlotte | North Carolina |
| United States | University of Virginia Health System | Charlottesville | Virginia |
| United States | Northwestern University | Chicago | Illinois |
| United States | The Christ Hospital | Cincinnati | Ohio |
| United States | Cleveland Clinic | Cleveland | Ohio |
| United States | Henry Ford Health System | Detroit | Michigan |
| United States | The Cardiac & Vascular Institute Research Foundation | Gainesville | Florida |
| United States | HCA Houston Healthcare | Houston | Texas |
| United States | The University of Texas Health Science Center at Houston | Houston | Texas |
| United States | St. Vincent Heart Center of Indiana | Indianapolis | Indiana |
| United States | Kansas University Medical Center | Kansas City | Kansas |
| United States | Saint Luke's Hospital of Kansas City | Kansas City | Missouri |
| United States | Scripps Memorial Hospital La Jolla | La Jolla | California |
| United States | Cedars-Sinai Medical Center | Los Angeles | California |
| United States | Medical Center of the Rockies | Loveland | Colorado |
| United States | North Shore University Hospital | Manhasset | New York |
| United States | Morristown Medical Center | Morristown | New Jersey |
| United States | Intermountain Medical Center | Murray | Utah |
| United States | NCH Heart Institute | Naples | Florida |
| United States | Saint Thomas Health | Nashville | Tennessee |
| United States | Vanderbilt University Medical Center | Nashville | Tennessee |
| United States | Rutgers Robert Wood Johnson Medical School | New Brunswick | New Jersey |
| United States | Columbia University Medical Center/NYPH | New York | New York |
| United States | Lenox Hill Hospital | New York | New York |
| United States | NYU Langone Health | New York | New York |
| United States | Weill Cornell Medicine-New York Presbyterian Hospital | New York | New York |
| United States | Sentara Norfolk General Hospital | Norfolk | Virginia |
| United States | University of Pennsylvania | Philadelphia | Pennsylvania |
| United States | SJHMC Heart and Vascular Institute | Phoenix | Arizona |
| United States | Baylor Heart Hopsital Plano | Plano | Texas |
| United States | Oregon Health & Science University | Portland | Oregon |
| United States | Mayo Clinic | Rochester | Minnesota |
| United States | Rochester General Hospital | Rochester | New York |
| United States | St. Francis Hospital | Roslyn | New York |
| United States | UC Davis Medical Center | Sacramento | California |
| United States | Washington University Barnes-Jewish Hospital | Saint Louis | Missouri |
| United States | Kaiser Permanente San Francisco | San Francisco | California |
| United States | University of California San Francisco | San Francisco | California |
| United States | Swedish Medical Center | Seattle | Washington |
| United States | University of Washington | Seattle | Washington |
| United States | Virginia Mason Franciscan Health | Seattle | Washington |
| United States | Stanford University | Stanford | California |
| United States | Tucson Medical Center | Tucson | Arizona |
| United States | Oklahoma Heart Institute | Tulsa | Oklahoma |
| United States | Cardiovascular Research Institute of Kansas | Wichita | Kansas |
| United States | Lankenau Heart Institute | Wynnewood | Pennsylvania |
| Lead Sponsor | Collaborator |
|---|---|
| Edwards Lifesciences |
United States, Germany,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | 6 months | |
| Primary | Rate of Major Adverse Events (MAE) | Rate of Major Adverse Events (MAE) in experimental arm | 30 days | |
| Primary | 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 | 1 year | |
| Secondary | 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 | 1 year |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT05654272 -
Development of CIRC Technologies
|
||
| Recruiting |
NCT05196659 -
Collaborative Quality Improvement (C-QIP) Study
|
N/A | |
| Recruiting |
NCT05650307 -
CV Imaging of Metabolic Interventions
|
||
| Active, not recruiting |
NCT05896904 -
Clinical Comparison of Patients With Transthyretin Cardiac Amyloidosis and Patients With Heart Failure With Reduced Ejection Fraction
|
N/A | |
| Completed |
NCT05077293 -
Building Electronic Tools To Enhance and Reinforce Cardiovascular Recommendations - Heart Failure
|
||
| Recruiting |
NCT05631275 -
The Role of Bioimpedance Analysis in Patients With Chronic Heart Failure and Systolic Ventricular Dysfunction
|
||
| Enrolling by invitation |
NCT05564572 -
Randomized Implementation of Routine Patient-Reported Health Status Assessment Among Heart Failure Patients in Stanford Cardiology
|
N/A | |
| Enrolling by invitation |
NCT05009706 -
Self-care in Older Frail Persons With Heart Failure Intervention
|
N/A | |
| Recruiting |
NCT04177199 -
What is the Workload Burden Associated With Using the Triage HF+ Care Pathway?
|
||
| Terminated |
NCT03615469 -
Building Strength Through Rehabilitation for Heart Failure Patients (BISTRO-STUDY)
|
N/A | |
| Recruiting |
NCT06340048 -
Epicardial Injection of hiPSC-CMs to Treat Severe Chronic Ischemic Heart Failure
|
Phase 1/Phase 2 | |
| Recruiting |
NCT05679713 -
Next-generation, Integrative, and Personalized Risk Assessment to Prevent Recurrent Heart Failure Events: the ORACLE Study
|
||
| Completed |
NCT04254328 -
The Effectiveness of Nintendo Wii Fit and Inspiratory Muscle Training in Older Patients With Heart Failure
|
N/A | |
| Completed |
NCT03549169 -
Decision Making for the Management the Symptoms in Adults of Heart Failure
|
N/A | |
| Recruiting |
NCT05572814 -
Transform: Teaching, Technology, and Teams
|
N/A | |
| Enrolling by invitation |
NCT05538611 -
Effect Evaluation of Chain Quality Control Management on Patients With Heart Failure
|
||
| Recruiting |
NCT04262830 -
Cancer Therapy Effects on the Heart
|
||
| Completed |
NCT06026683 -
Conduction System Stimulation to Avoid Left Ventricle Dysfunction
|
N/A | |
| Withdrawn |
NCT03091998 -
Subcu Administration of CD-NP in Heart Failure Patients With Left Ventricular Assist Device Support
|
Phase 1 | |
| Recruiting |
NCT05564689 -
Absolute Coronary Flow in Patients With Heart Failure With Reduced Ejection Fraction and Left Bundle Branch Block With Cardiac Resynchronization Therapy
|