TRILUMINATE Pivotal Trial

Clinical Trial to Evaluate Cardiovascular Outcomes In Patients Treated With the Tricuspid Valve Repair System Pivotal

Sponsors

Lead Sponsor: Abbott Medical Devices

Source Abbott Medical Devices
Brief Summary

The primary objective of this trial is to demonstrate the safety and effectiveness of the TriClip device in improving clinical outcomes in symptomatic patients with severe tricuspid regurgitation (TR), who are at intermediate or greater estimated risk for mortality or morbidity with tricuspid valve surgery. This randomized controlled trial will compare the investigational device (TriClip device) to Control (Medical Therapy).

Overall Status Recruiting
Start Date 2019-08-21
Completion Date 2027-03-01
Primary Completion Date 2022-08-01
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Hierarchical composite of number of participants with all-cause mortality or number of participants with tricuspid valve surgery, rate of heart failure hospitalizations, and assessment of quality of life improvement using the KCCQ 12 Months
Secondary Outcome
Measure Time Frame
Change in TR from severe to moderate or less 30 Days
Freedom from major adverse events (MAE) occurring after procedure attempt 30 Days
Change in Quality of Life as assessed by Kansas City Cardiomyopathy Questionnaire (KCCQ) Score 12 Months
Change in 6 Minute Walk Test (6MWT) 12 Months
Enrollment 700
Condition
Intervention

Intervention Type: Device

Intervention Name: Tricuspid valve repair

Description: Transcatheter TriClip placement in the tricuspid valve to repair the valve and correct regurgitation

Eligibility

Criteria:

Inclusion Criteria: - In the judgment of the site local heart team, subject has been adequately treated per applicable standards (including medical management) and stable for at least 30 days as follows: - Optimized medical therapy for treatment of TR (e.g. diuretics). - Medical and/or device therapy, for mitral regurgitation, atrial fibrillation, coronary artery disease and heart failure. - The Eligibility Committee will confirm that the subject has been adequately treated medically. - Subject is symptomatic with Severe TR despite being optimally treated as described above. TR severity is determined by the assessment of a qualifying TTE and confirmed by the ECL. The ECL will also request a TEE to confirm TR etiology. Note: If any cardiac procedure(s) occur after eligibility was determined, TR severity will need to be re-assessed 30 days after the cardiac procedure(s). - The cardiac surgeon of the site local heart team concur that the patient is at intermediate or greater estimated risk for mortality or morbidity with tricuspid valve surgery. - New York Heart Association (NYHA) Functional Class II, III or ambulatory class IV - In the judgment of the TriClip(TM) implanting Investigator, femoral vein access is determined to be feasible and can accommodate a 25 Fr catheter. - Age ≥18 years at time of consent. - Subject must provide written informed consent prior to any trial related procedure. Exclusion Criteria: - Systolic pulmonary artery pressure (sPAP) > 70 mmHg or fixed pre-capillary pulmonary hypertension as assessed by right heart catheterization (RHC) - Severe uncontrolled hypertension Systolic Blood Pressure (SBP) ≥ 180 mmHg and/or Diastolic Blood Pressure (DBP) ≥ 110 mm Hg) - Any prior tricuspid valve procedure that would interfere with placement of the TriClip(TM) device - Indication for left-sided (e.g. severe aortic stenosis, severe mitral regurgitation) or pulmonary valve correction prior 60 days). Note: Patients with concomitant Mitral and tricuspid valve disease will have the option of getting their MR treated, and wait 60 days prior to being reassessed for the trial. - Pacemaker or ICD leads that would prevent appropriate placement of the TriClip(TM) device. - Tricuspid valve stenosis - Defined as a tricuspid valve orifice of ≤ 1.0 cm2 and/or mean gradient ≥5 mmHg as measured by the ECL - Left Ventricular Ejection Fraction (LVEF) ≤20% - Tricuspid valve leaflet anatomy which may preclude clip implantation, proper clip positioning on the leaflets or sufficient reduction in TR. This may include: - Evidence of calcification in the grasping area - Presence of a severe coaptation defect (> 2cm) of the tricuspid leaflets - Severe leaflet defect(s) preventing proper device placement - Ebstein Anomaly - Identified by having a normal annulus position while the valve leaflets are attached to the walls and septum of the right ventricle. - Tricuspid valve anatomy not evaluable by TTE and TEE - Active endocarditis or active rheumatic heart disease or leaflets degenerated from rheumatic disease (i.e. noncompliant, perforated). - MI or known unstable angina within prior 30 days - Percutaneous coronary intervention within prior 30 days - Hemodynamic instability defined as systolic pressure < 90 mmHg with or without afterload reduction, cardiogenic shock or the need for inotropic support or intra-aortic balloon pump or other hemodynamic support device. - Cerebrovascular Accident (CVA) within prior 90 days - Chronic dialysis - Bleeding disorders or hypercoagulable state - Active peptic ulcer or active gastrointestinal (GI) bleeding - Contraindication, allergy or hypersensitivity to dual antiplatelet and anticoagulant therapy. - Note: Contraindication to either antiplatelet or anticoagulant therapy (individually not both therapies) is not an exclusion criterion. - Ongoing infection requiring current antibiotic therapy (if temporary illness, patients may enroll 30 days after discontinuation of antibiotics with no active infection). - Known allergy or hypersensitivity to device materials - Evidence of intracardiac, inferior vena cava (IVC), or femoral venous mass, thrombus or vegetation. - Life expectancy of less than 12 months - Subject is currently participating in another clinical trial that has not yet completed its primary endpoint. - Subject is currently participating in another clinical investigation for valvular heart disease(s). - Pregnant or nursing subjects and those who plan pregnancy during the clinical investigation follow-up period. Female subjects of child-bearing potential are required to have a negative pregnancy test done within 7 days of the baseline visit per site standard test. Female patients of childbearing potential should be instructed to use safe contraception (e.g., intrauterine devices, hormonal contraceptives: contraceptive pills, implants, transdermal patches hormonal vaginal devices, injections with prolonged release.) It is accepted, in certain cases, to include subjects having a sterilized regular partner or subjects using a double barrier contraceptive method. - Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements, or impact the scientific soundness of the clinical investigation results.

Gender:

All

Minimum Age:

18 Years

Maximum Age:

N/A

Healthy Volunteers:

No

Overall Official
Overall Contact

Last Name: Natalie Richardson

Phone: 651-756-3842

Email: [email protected]

Location
Facility: Status: Contact: Investigator:
University Hospital - University of Alabama at Birmingham | Birmingham, Alabama, 35249, United States Recruiting Katherine Phillips 205-975-9426 [email protected] Mustafa Ahmed Principal Investigator
Banner-University Medical Center Phoenix | Phoenix, Arizona, 85006, United States Withdrawn
Arizona Cardiovascular Research Center | Phoenix, Arizona, 85016, United States Recruiting Riley Dugan [email protected] Hursh Naik Principal Investigator
Phoenix Cardiovascular Research Group | Phoenix, Arizona, 85018, United States Recruiting Jessica Byrne 480-619-2754 [email protected] Timothy Byrne Principal Investigator
Scottsdale Healthcare Shea | Scottsdale, Arizona, 85260, United States Recruiting Alisha Vandriel 480-323-3390 [email protected] David Rizik Principal Investigator
Tucson Medical Center | Tucson, Arizona, 85712, United States Recruiting Natalia Calles 520-324-5512 [email protected] Tom Waggoner Principal Investigator
Scripps Green Hospital | La Jolla, California, 92037, United States Recruiting Matthew Hollen [email protected] Matthew Price Principal Investigator
USC University Hospital | Los Angeles, California, 90033, United States Withdrawn
Cedars-Sinai Medical Center | Los Angeles, California, 90048, United States Recruiting Khaled Alsabaawi 310-423-1942 [email protected] Raj Makkar Principal Investigator
El Camino Hospital | Mountain View, California, 94040, United States Recruiting Janet Lamm 650-962-4566 [email protected] Chad Rammohan Principal Investigator
Providence Medical Foundation (St. Joseph Hospital) | Orange, California, 92868, United States Recruiting Irma Rivas 714-992-3000 [email protected] Aidan Raney Principal Investigator
Sutter Medical Center, Sacramento | Sacramento, California, 95816, United States Recruiting Kimberly Marinovich 916-878-4991 [email protected] Pei-Hsiu Huang Principal Investigator
University of California - Davis Medical Center | Sacramento, California, 95817, United States Recruiting Kimberly Book 916-734-5639 [email protected] Gagan Singh Principal Investigator
California Pacific Medical Center | San Francisco, California, 94109, United States Recruiting Milena Ferreira 415-600-5707 [email protected] Christian Spies Principal Investigator
Los Robles Regional Medical Center | Thousand Oaks, California, 91360, United States Recruiting Mane Arabyan 805-796-3746 [email protected] Saibal Kar Principal Investigator
University of Colorado Hospital | Aurora, Colorado, 80045, United States Recruiting Jackson Hynes 303-724-3938 [email protected] John Carroll Principal Investigator
Yale New Haven | New Haven, Connecticut, 06510, United States Recruiting Linda Levesque 203-737-6483 [email protected] Ryan Kaple Principal Investigator
JFK Medical Center | Atlantis, Florida, 33462, United States Recruiting Zarah Agustin 561-548-1968 [email protected] Marcos Nores Principal Investigator
Manatee Memorial Hospital | Bradenton, Florida, 34208, United States Recruiting Tatiana Withers 941-708-8066 [email protected] Alessandro Golino Principal Investigator
Morton Plant Valve Clinic | Clearwater, Florida, 33756, United States Recruiting Sue Fisher 727-489-2552 [email protected] Joshua Rovin Principal Investigator
Delray Medical Center | Delray Beach, Florida, 33484, United States Recruiting Christopher Minnerly 561-495-3145 [email protected] Brijeshwar Maini Principal Investigator
Baptist Hospital of Miami | Miami, Florida, 33176, United States Recruiting Maria Ines Ardid 786-596-6258 [email protected] Ramon Quesada Principal Investigator
Palm Beach Garden Medical Center | Palm Beach Gardens, Florida, 33410, United States Recruiting Lisa Wettermann 561-799-5431 [email protected] Rahul Aggarwal Principal Investigator
Tallahassee Research Institute | Tallahassee, Florida, 32308, United States Recruiting Rebecca Plasay 850-431-5024 [email protected] Thomas Noel Principal Investigator
Piedmont Heart Institute | Atlanta, Georgia, 30309, United States Recruiting Anarosa Campos 404-605-2371 [email protected] Pradeep Yadav Principal Investigator
Northwestern Memorial Hospital | Chicago, Illinois, 60611, United States Recruiting Elizabeth McCloskey 312-926-0840 [email protected] Charles Davidson Principal Investigator
Rush University Medical Center | Chicago, Illinois, 60612, United States Recruiting Samia Majid 312-942-3542 [email protected] Clifford Kavinsky Principal Investigator
Northshore University HealthSystem | Evanston, Illinois, 60201, United States Recruiting John Daseke [email protected] Mark Ricciardi Principal Investigator
Advocate Health and Hospitals Corporation | Oakbrook Terrace, Illinois, 60181, United States Withdrawn
St. Vincent Hospital | Indianapolis, Indiana, 46240, United States Recruiting Barbara Kingma 317-583-6319 [email protected] James Hermiller Principal Investigator
Kansas University Medical Center | Kansas City, Kansas, 66160, United States Recruiting Tilitha Shawgo 913-588-9720 [email protected] Peter Tadros Principal Investigator
Cardiovascular Research Institute of Kansas | Wichita, Kansas, 67226, United States Recruiting Lindsey Steele 316-219-4125 [email protected] Bassem Chehab Principal Investigator
Cardiovascular Institute of the South | Houma, Louisiana, 70361, United States Recruiting Jennifer Aucoin 985-873-5037 [email protected] Peter Fail Principal Investigator
MedStar Health Research Institute | Hyattsville, Maryland, 20782, United States Recruiting Keith Moyer 443-278-9170 [email protected] Brian Bethea Principal Investigator
Brigham and Women's Hospital | Boston, Massachusetts, 02115, United States Recruiting Sinead Coyle 617-525-7479 [email protected] Pinak Shah Principal Investigator
Beth Israel Deaconess Medical Center | Boston, Massachusetts, 02215, United States Recruiting Jenifer Kaufman 617-632-8956 [email protected] Roger Laham Principal Investigator
University of Michigan | Ann Arbor, Michigan, 48104, United States Recruiting Alexander Ivacko 734-763-6551 [email protected] Stanley Chetcuti Principal Investigator
Abbott Northwestern Hospital | Minneapolis, Minnesota, 55407, United States Recruiting Kate Jappe 612-863-7347 [email protected] Paul Sorajja Principal Investigator
Albany Medical Center | Albany, New York, 12208, United States Recruiting Rebecca Belenchia 518-262-5018 [email protected] Mohammad EL-Hajjar Principal Investigator
Montefiore Medical Center - Moses Division | Bronx, New York, 10467, United States Recruiting Kara Booth 718-920-6523 [email protected] Azeem Latib Principal Investigator
Buffalo General Hospital | Buffalo, New York, 14203, United States Recruiting Courtney Bishop 716-888-4839 [email protected] Vijay Iyer Principal Investigator
North Shore University Hospital | Manhasset, New York, 11030, United States Recruiting Kristine McGowan 516-562-2345 [email protected] Bruce Rutkin Principal Investigator
New York University Hospital | New York, New York, 10016, United States Withdrawn
Mount Sinai Hospital | New York, New York, 10029, United States Recruiting Michael Fusilero 212-241-8905 [email protected] David Adams Principal Investigator
New York-Presbyterian/Columbia University Medical Center | New York, New York, 10032, United States Recruiting Nikolas Bletnitsky 917-826-4376 [email protected] Susheel Kodali Principal Investigator
Carolinas Medical Center | Charlotte, North Carolina, 28203, United States Recruiting Susan Mcclain 704-355-4794 [email protected] Jonathan Schwartz Principal Investigator
Novant Health Heart and Vascular Research Institute | Charlotte, North Carolina, 28204, United States Recruiting Darren Crawford 704-264-1400 [email protected] Oluseun Alli Principal Investigator
Christ Hospital | Cincinnati, Ohio, 45219, United States Recruiting Susie Frakes [email protected] Joseph Choo Principal Investigator
The Cleveland Clinic Foundation | Cleveland, Ohio, 44195, United States Recruiting Lydia Sweeney 216-445-7754 [email protected] Samir Kapadia Principal Investigator
Ohio Health Research Institute | Columbus, Ohio, 43214, United States Recruiting Martha Slyman 614-566-1274 [email protected] Carlos Sanchez Principal Investigator
Providence Heart and Vascular Institute | Portland, Oregon, 97225, United States Recruiting Angela Redd 503-216-2170 [email protected] Brandon Jones, MD Principal Investigator
Hospital of the University of Pennsylvania | Philadelphia, Pennsylvania, 19104, United States Recruiting Suveeksha Naidu 215-662-6590 [email protected] Howard Herrmann Principal Investigator
Allegheny General Hospital | Pittsburgh, Pennsylvania, 15212, United States Recruiting Tracy Spirk 412-359-4025 [email protected] David Lasorda Principal Investigator
University of Pittsburgh Medical Center | Pittsburgh, Pennsylvania, 15213, United States Recruiting Sarah Tomer 412-647-2931 [email protected] Conrad Smith Principal Investigator
Centennial Heart Cardiovascular Consultants | Nashville, Tennessee, 37203, United States Recruiting Marisa Gunthert [email protected] Samuel Horr Principal Investigator
St. Thomas Hospital | Nashville, Tennessee, 37205, United States Recruiting Erin Beller 615-222-6997 [email protected] Andrew Morse Principal Investigator
Austin Heart | Austin, Texas, 78756, United States Recruiting Renila Abraham [email protected] Frank Zidar Principal Investigator
Baylor Scott and White Heart and Vascular Hospital | Dallas, Texas, 75226, United States Recruiting Susan Aston 214-820-7358 [email protected] James Choi Principal Investigator
Park Plaza Hospital | Houston, Texas, 77004, United States Withdrawn
The Methodist Hospital | Houston, Texas, 77030, United States Recruiting Carol Underwood 713-441-4536 [email protected] Stephen Little Principal Investigator
Methodist Hospital of San Antonio | San Antonio, Texas, 78229, United States Recruiting Maurene Cantu [email protected] Dan Donovan Principal Investigator
Intermountain Medical Center | Murray, Utah, 84157, United States Recruiting Riley Hodgson 801-507-4764 [email protected] Brian Whisenant Principal Investigator
University of Virginia Medical Center | Charlottesville, Virginia, 22908, United States Recruiting Christin Henderson 434-982-1058 [email protected] Scott Lim Principal Investigator
Inova Fairfax Hospital | Falls Church, Virginia, 22042, United States Recruiting Brian Moore 703-776-4713 [email protected] Wayne Batchelor Principal Investigator
Sentara Norfolk General Hospital | Norfolk, Virginia, 23507, United States Recruiting Christina Calayo 757-388-3876 [email protected] Paul Mahoney Principal Investigator
Swedish Medical Center | Seattle, Washington, 98107, United States Recruiting Janet Zaltsman 206-215-2455 [email protected] Sameer Gafoor Principal Investigator
University of Washington Medical Center | Seattle, Washington, 98195, United States Recruiting John Tushinski 206-685-4346 [email protected] G. Burkhard Mackensen Principal Investigator
Aurora Medical Group | Milwaukee, Wisconsin, 53215, United States Recruiting Jodi Kresa 414-649-3546 [email protected] Suhail Allaqaband Principal Investigator
St. Paul's Hospital | Vancouver, British Columbia, V6Z 2E8, Canada Recruiting Cynthia Vanhoof 604-682-2344 [email protected] Robert Boone Principal Investigator
Hamilton Health Science Centre | Hamilton, Ontario, L8L 2X2, Canada Recruiting Chris Beck [email protected] Shamir Mehta Principal Investigator
Ottawa Heart Institute | Ottawa, Ontario, K1Y 4W7, Canada Recruiting Hannah Feagan [email protected] Benjamin Hibbert Principal Investigator
St. Michael's Hospital | Toronto, Ontario, M5B 1W8, Canada Recruiting Ivana Kandic (416) 312-4117 [email protected] Neil Fam Principal Investigator
Sunnybrook Health Science Centre | Toronto, Ontario, M5N 3M5, Canada Recruiting Sulagna Sarker 416-480-6100 [email protected] Andrew Czarnecki Principal Investigator
Institut de Cardiologie de Montreal (Montreal Heart Inst.) | Montréal, Quebec, H1T 1C8, Canada Recruiting Natasha Moisan (514) 376-3330 [email protected] Anita Asgar Principal Investigator
The Royal Victoria | Montréal, Quebec, H4A 3J1, Canada Recruiting Thi Mong Ngoc Phan (514) 934-1934 [email protected] Nicolo Piazza Principal Investigator
München Grosshadern | München, Bavaria, 81377, Germany Recruiting Diana Roesler +498944076084 [email protected] Jörg Hausleiter Principal Investigator
Universitätsklinikum Bonn AdöR | Bonn, North Rhine-Westphalia, 53105, Germany Recruiting Yvonne Hermes [email protected] Georg Nickenig Principal Investigator
UNIVERSITATSMEDIZIN der Johannes Gutenberg-Universität Mainz | Mainz, Rhineland-Palatinate, 55131, Germany Recruiting Therese Pauli [email protected] Ralph Stephan von Bardeleben Principal Investigator
Herzzentrum Leipzig GmbH | Leipzig, Saxony, 04289, Germany Recruiting Josephin Kister [email protected] Philipp Lurz Principal Investigator
Ospedale San Raffaele - Cardiac | Milano, Lombard, 20132, Italy Recruiting Davide Schiavi [email protected] Paolo Denti Principal Investigator
Hospital Clinic I Provincial de Barcelona | Barcelona, Catalonia, 08036, Spain Recruiting Anna Campos [email protected] Marta Sitges Principal Investigator
Location Countries

Canada

Germany

Italy

Spain

United States

Verification Date

2022-04-01

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 3
Arm Group

Label: Roll-In

Type: Experimental

Description: TriClip Device treatment for physicians requiring additional training prior to beginning randomized cohort enrollment.

Label: Randomized Cohort

Type: Active Comparator

Description: TriClip (Device) Group vs. Medical Therapy (Control) Group

Label: Single Arm

Type: Experimental

Description: Subjects in which it is believed TR is not going to be reduced to moderate or less severity will receive the TriClip device.

Patient Data No
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Single (Outcomes Assessor)

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