TRILUMINATE Pivotal Trial

NCT03904147 | Active Not Recruiting Results DMC FDA Device

• 1 other identifier: ABT-CIP-10249
• Study Type: interventional
• Target: 572
• Locations: 5 countries
• Sites: 76

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).

Conditions

Tricuspid Regurgitation

Keywords

ABT-CIP-10249; Tricuspid; Cardiovascular; Pivotal

Outcome Measures

Primary Outcomes (2)

• For Randomized Cohort: Hierarchical Composite of All-cause Death or Tricuspid Valve Surgery, Heart Failure Hospitalizations, and KCCQ Improvement

  Analysis of hierarchical composite of all-cause death or tricuspid valve surgery, heart failure hospitalizations, and KCCQ improvement of at least 15 points was performed in ITT population using Finkelstein-Schoenfeld method. A win ratio was also calculated to descriptively quantify the magnitude of treatment benefits. The win ratio is calculated as the ratio of the number of wins in Device versus Control patients. The primary analysis population consisted of 175 Device patients and 175 Control patients, resulting in 30,625 Device-Control patient pairs (i.e., 175 × 175).

  12 Months

• For Single-Arm Cohort: Rate of Survival Through 12 Months With a Quality of Life Improvement (Assessed Using KCCQ Overall Score) of at Least 10 Points Compared to Baseline.

  This outcome will be assessed as the percentage of subjects meeting the definition of the endpoint.

  12 months

Secondary Outcomes (9)

• For Randomized Cohort - Device Group Only: Rate of Kaplan-Meier Estimate (SE) of Freedom From Major Adverse Events (MAE) Occurring Within 30 Days Post-procedure

  30 Days

• For Randomized Cohort: Change in Quality of Life as Assessed by KCCQ Score

  12 months minus baseline

• For Randomized Cohort: Tricuspid Regurgitation Reduction to Moderate or Less at 30-Day Visit

  30 Days

• For Randomized Cohort: Change in 6 Minute Walk Test (6MWT) From Baseline to 12 Months

  12 Months

• For Single-Arm Cohort: The Percentage of Subjects With TR Reduction by at Least 1 Grade at 30-Day Follow-up

  30 days

Study Arms (4)

Randomized - Device Group

EXPERIMENTAL

Subjects will undergo TriClip implantation and will continue to be managed on medical therapy, per physician discretion

Device: TriClipTM Device

Randomized - Control Group

ACTIVE COMPARATOR

Subjects will continue to be managed on medical therapy, per physician discretion

Device: TriClipTM Device

Single Arm Group

EXPERIMENTAL

Subjects will receive the TriClip device and will continue to be managed on medical therapy, per physician discretion.

Device: TriClipTM Device

Continued Access Study (CAS)

EXPERIMENTAL

Subjects will undergo TriClip implantation and will continue to be managed on medical therapy, per physician discretion

Device: TriClipTM Device

Interventions

TriClipTM Device DEVICE

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

Continued Access Study (CAS); Randomized - Control Group; Randomized - Device Group; Single Arm Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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) clip.
• 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

Sponsors & Collaborators

• Abbott Medical Devices: lead

Study Sites (76)

University Hospital - University of Alabama at Birmingham

Birmingham, Alabama, 35249, United States

Location

St. Joseph's Hospital & Medical Center

Phoenix, Arizona, 85013, United States

Location

Arizona Cardiovascular Research Center

Phoenix, Arizona, 85016, United States

Location

Phoenix Cardiovascular Research Group

Phoenix, Arizona, 85018, United States

Location

Scottsdale Healthcare Shea

Scottsdale, Arizona, 85260, United States

Location

Tucson Medical Center

Tucson, Arizona, 85712, United States

Location

Scripps Green Hospital

La Jolla, California, 92037, United States

Location

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

El Camino Hospital

Mountain View, California, 94040, United States

Location

Providence Medical Foundation (St. Joseph Hospital)

Orange, California, 92868, United States

Location

Sutter Medical Center, Sacramento

Sacramento, California, 95816, United States

Location

University of California - Davis Medical Center

Sacramento, California, 95817, United States

Location

California Pacific Medical Center

San Francisco, California, 94109, United States

Location

Los Robles Regional Medical Center

Thousand Oaks, California, 91360, United States

Location

University of Colorado Hospital

Aurora, Colorado, 80045, United States

Location

Yale New Haven

New Haven, Connecticut, 06510, United States

Location

JFK Medical Center

Atlantis, Florida, 33462, United States

Location

Manatee Memorial Hospital

Bradenton, Florida, 34208, United States

Location

Morton Plant Valve Clinic

Clearwater, Florida, 33756, United States

Location

Delray Medical Center

Delray Beach, Florida, 33484, United States

Location

Baptist Hospital of Miami

Miami, Florida, 33176, United States

Location

Palm Beach Garden Medical Center

Palm Beach Gardens, Florida, 33410, United States

Location

Tallahassee Research Institute

Tallahassee, Florida, 32308, United States

Location

Piedmont Heart Institute

Atlanta, Georgia, 30309, United States

Location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

Northshore University HealthSystem

Evanston, Illinois, 60201, United States

Location

St. Vincent Hospital

Indianapolis, Indiana, 46240, United States

Location

Kansas University Medical Center

Kansas City, Kansas, 66160, United States

Location

Cardiovascular Research Institute of Kansas

Wichita, Kansas, 67226, United States

Location

Cardiovascular Institute of the South

Houma, Louisiana, 70361, United States

Location

MedStar Health Research Institute

Hyattsville, Maryland, 20782, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

University of Michigan

Ann Arbor, Michigan, 48104, United States

Location

Abbott Northwestern Hospital

Minneapolis, Minnesota, 55407, United States

Location

Albany Medical Center

Albany, New York, 12208, United States

Location

Buffalo General Hospital

Buffalo, New York, 14203, United States

Location

North Shore University Hospital

Manhasset, New York, 11030, United States

Location

Mount Sinai Hospital

New York, New York, 10029, United States

Location

New York-Presbyterian/Columbia University Medical Center

New York, New York, 10032, United States

Location

Montefiore Medical Center - Moses Division

The Bronx, New York, 10467, United States

Location

Carolinas Medical Center

Charlotte, North Carolina, 28203, United States

Location

Novant Health Heart and Vascular Research Institute

Charlotte, North Carolina, 28204, United States

Location

Christ Hospital

Cincinnati, Ohio, 45219, United States

Location

The Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

Ohio Health Research Institute

Columbus, Ohio, 43214, United States

Location

Providence Heart and Vascular Institute

Portland, Oregon, 97225, United States

Location

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Allegheny General Hospital

Pittsburgh, Pennsylvania, 15212, United States

Location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

Centennial Heart Cardiovascular Consultants

Nashville, Tennessee, 37203, United States

Location

St. Thomas Hospital

Nashville, Tennessee, 37205, United States

Location

Austin Heart

Austin, Texas, 78756, United States

Location

Baylor Scott and White Heart and Vascular Hospital

Dallas, Texas, 75226, United States

Location

The Methodist Hospital

Houston, Texas, 77030, United States

Location

Methodist Hospital of San Antonio

San Antonio, Texas, 78229, United States

Location

Intermountain Medical Center

Murray, Utah, 84157, United States

Location

University of Virginia Medical Center

Charlottesville, Virginia, 22908, United States

Location

Inova Fairfax Hospital

Falls Church, Virginia, 22042, United States

Location

Sentara Norfolk General Hospital

Norfolk, Virginia, 23507, United States

Location

Swedish Medical Center

Seattle, Washington, 98107, United States

Location

University of Washington Medical Center

Seattle, Washington, 98195, United States

Location

Aurora Medical Group

Milwaukee, Wisconsin, 53215, United States

Location

St. Paul's Hospital

Vancouver, British Columbia, V6Z 2E8, Canada

Location

Hamilton Health Science Centre

Hamilton, Ontario, L8L 2X2, Canada

Location

Ottawa Heart Institute

Ottawa, Ontario, K1Y 4W7, Canada

Location

St. Michael's Hospital

Toronto, Ontario, M5B 1W8, Canada

Location

Sunnybrook Health Science Centre

Toronto, Ontario, M5N 3M5, Canada

Location

Institut de Cardiologie de Montreal (Montreal Heart Inst.)

Montreal, Quebec, H1T 1C8, Canada

Location

The Royal Victoria

Montreal, Quebec, H4A 3J1, Canada

Location

München Grosshadern

München, Bavaria, 81377, Germany

Location

Universitätsklinikum Bonn AdöR

Bonn, North Rhine-Westphalia, 53105, Germany

Location

UNIVERSITATSMEDIZIN der Johannes Gutenberg-Universität Mainz

Mainz, Rhineland-Palatinate, 55131, Germany

Location

Herzzentrum Leipzig GmbH

Leipzig, Saxony, 04289, Germany

Location

Ospedale San Raffaele - Cardiac

Milan, Lombard, 20132, Italy

Location

Hospital Clinic I Provincial de Barcelona

Barcelona, Catalonia, 08036, Spain

Location

Related Publications (5)

• Kar S, Makkar RR, Whisenant BK, Hamid N, Naik H, Tadros P, Price MJ, Singh G, Schwartz JG, Kapadia S, Alli O, Horr S, Seshiah P, Batchelor W, Jones BM, Ahmed MI, Benza R, Jorde U, Thourani VH, Ghobrial AA, Tang GHL, Trusty PM, Huang D, Hahn RT, Adams DH, Sorajja P; TRILUMINATE Pivotal Investigators. Two-Year Outcomes of Transcatheter Edge-to-Edge Repair for Severe Tricuspid Regurgitation: The TRILUMINATE Pivotal Randomized Controlled Trial. Circulation. 2025 Jun 10;151(23):1630-1638. doi: 10.1161/CIRCULATIONAHA.125.074536. Epub 2025 Mar 30.

  PMID: 40159089 DERIVED

• Naik H, Price MJ, Kapadia S, Whisenant BK, Tadros P, Makkar R, Asgar AW, Fam N, Tang GHL, Mehta SR, Byrne T, Singh G, Panaich SS, Peterman K, Trusty PM, Hamid N, Hahn RT, Adams DH, Sorajja P. Tricuspid Transcatheter Edge-to-Edge Repair in Patients With Transvalvular CIED Leads: The TRILUMINATE Pivotal Trial. JACC Clin Electrophysiol. 2025 May;11(5):1012-1020. doi: 10.1016/j.jacep.2025.01.001. Epub 2025 Jan 20.

  PMID: 39903153 DERIVED

• Cavalcante JL, Scherer M, Fukui M, Lerakis S, Harb S, Pursnani A, Schwartz JG, Kapadia S, Ricciardi MJ, Khalique O, Kodali S, Shah D, Little SH, Sekaran N, Whisenant B, Flueckiger P, Yadav P, Emaminia A, Batchelor W, Kellman P, Lin Z, Trusty PM, Hahn RT, Adams D, Sorajja P. Advanced Imaging Assessment of the Impact of Tricuspid Regurgitation on Cardiac Remodeling: The TRILUMINATE Pivotal Imaging Substudy. J Am Coll Cardiol. 2025 Jan 28;85(3):250-261. doi: 10.1016/j.jacc.2024.09.009. Epub 2024 Nov 20.

  PMID: 39570246 DERIVED

• Jorde UP, Benza R, McCarthy PM, Ailawadi G, Whisenant B, Makkar R, Tadros P, Naik H, Fam N, Sauer AJ, Murthy S, Kar S, von Bardeleben RS, Hahn RT, Hamid N, Zbinden J, Sorajja P, Adams D. Impact of Renal and Liver Function on Clinical Outcomes Following Tricuspid Valve Transcatheter Edge-to-Edge Repair. J Am Coll Cardiol. 2024 Dec 17;84(25):2446-2456. doi: 10.1016/j.jacc.2024.08.044. Epub 2024 Aug 31.

  PMID: 39222896 DERIVED

• Sorajja P, Whisenant B, Hamid N, Naik H, Makkar R, Tadros P, Price MJ, Singh G, Fam N, Kar S, Schwartz JG, Mehta S, Bae R, Sekaran N, Warner T, Makar M, Zorn G, Spinner EM, Trusty PM, Benza R, Jorde U, McCarthy P, Thourani V, Tang GHL, Hahn RT, Adams DH; TRILUMINATE Pivotal Investigators. Transcatheter Repair for Patients with Tricuspid Regurgitation. N Engl J Med. 2023 May 18;388(20):1833-1842. doi: 10.1056/NEJMoa2300525. Epub 2023 Mar 4.

  PMID: 36876753 DERIVED

MeSH Terms

Conditions

Tricuspid Valve Insufficiency

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Natalie Richardson, Senior Clinical Project Manager
• Organization: Abbott

natalie.richardson@abbott.com

651-756-3842

Study Officials

• Meghan Griffin, PhD

  Abbott Structural Heart

  STUDY DIRECTOR

• David Adams, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

• Paul Sorajja, MD

  Allina Health System

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 3, 2019
• First Posted: April 5, 2019
• Study Start: August 21, 2019
• Primary Completion: November 18, 2022
• Study Completion (Estimated): April 1, 2029
• Last Updated: December 19, 2024
• Results First Posted: March 27, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (63); CA (7); IT (1); DE (4); ES (1)