TRILUMINATE Study With Abbott Transcatheter Clip Repair System in Patients With Moderate or Greater TR (TRILUMINATE)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03227757 |
Recruitment Status :
Active, not recruiting
First Posted : July 24, 2017
Last Update Posted : July 28, 2020
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Condition or disease | Intervention/treatment | Phase |
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Tricuspid Valve Insufficiency | Device: Tricuspid Valve Repair System | Not Applicable |
This is a prospective, single arm, multi-center study.
A minimum of 85 subjects will be prospectively enrolled into this single arm study in approximately 25 sites, in Europe, Canada and the United States. Patients will be seen for follow-up visits at discharge (≤ 7 days post index procedure), 30 days, 6 months, 1,2,3 years. Whereas, in United States patients will be followed-up till 5 years.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 98 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Trial to Evaluate Treatment With Abbott Transcatheter Clip Repair System in Patients With Moderate or Greater Tricuspid Regurgitation (TRILUMINATE) |
Actual Study Start Date : | August 1, 2017 |
Estimated Primary Completion Date : | November 30, 2024 |
Estimated Study Completion Date : | March 30, 2025 |
Arm | Intervention/treatment |
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Experimental: Tricuspid Valve Repair System
Subjects who received TVRS will be included in this arm.
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Device: Tricuspid Valve Repair System
Subjects who received TVRS will be included in this arm. The TVRS is intended for reconstruction of the insufficient tricuspid valve through tissue approximation. |
- Echocardiographic Tricuspid Regurgitation Reduction at Least 1 Grade [ Time Frame: At 30 days ]Echocardiographic Tricuspid Regurgitation Reduction at Least 1 Grade
- Composite of Major Adverse Event (MAE) [ Time Frame: At 6 months ]Composite of Major Adverse Event (MAE)
- Composite of Major Adverse Event (MAE) [ Time Frame: At Discharge (≤ 7 days post index procedure) ]Composite of Major Adverse Event (MAE)
- Composite of Major Adverse Event (MAE) [ Time Frame: 30 days ]Composite of Major Adverse Event (MAE)
- Composite of Major Adverse Event (MAE) [ Time Frame: 1 year ]Composite of Major Adverse Event (MAE)
- Composite of Major Adverse Event (MAE) [ Time Frame: 2 years ]Composite of Major Adverse Event (MAE)
- Composite of Major Adverse Event (MAE) [ Time Frame: 3 years ]Composite of Major Adverse Event (MAE)
- Prevalence of Device or Procedure-Related Adverse Events [ Time Frame: 30 days ]Prevalence of Device or Procedure-Related Adverse Events
- Core Lab assessment of change in Tricuspid Regurgitation (TR) Severity Grade [ Time Frame: 30 days ]Core Lab assessment of change in Tricuspid Regurgitation (TR) Severity Grade
- Core Lab assessment of change in Tricuspid Regurgitation (TR) Severity Grade [ Time Frame: 6 months ]Core Lab assessment of change in Tricuspid Regurgitation (TR) Severity Grade
- Core Lab assessment of change in Tricuspid Regurgitation (TR) Severity Grade [ Time Frame: 1 year ]Core Lab assessment of change in Tricuspid Regurgitation (TR) Severity Grade
- Core Lab assessment of change in Tricuspid Regurgitation (TR) Severity Grade [ Time Frame: 2 years ]Core Lab assessment of change in Tricuspid Regurgitation (TR) Severity Grade
- Core Lab assessment of change in Tricuspid Regurgitation (TR) Severity Grade [ Time Frame: 3 years ]Core Lab assessment of change in Tricuspid Regurgitation (TR) Severity Grade

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 90 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Subject must be 18 years and ≤ 90 years at time of consent and must not be a member of a vulnerable population.
- Subject or a legally authorized representative (where allowed per local regulations) must provide written informed consent prior to any trial related procedure.
- Subject must agree not to participate in any other clinical trial for a period of one year following the index procedure.
- In the judgment of the investigator at the site, the subject has been adequately treated per applicable standards, including for coronary artery disease, mitral regurgitation and heart failure at least 30-days prior to index procedure. The Eligibility Committee must concur that the subject has been adequately treated.
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New York Heart Association (NYHA) Functional Class II (conditional), III, or ambulatory IV
- Subjects with moderate TR: Only NYHA Class III or IV maybe considered for inclusion.
- Subjects with severe or greater TR: NYHA II, III, or IV may be considered for inclusion.
- No indication for left-sided or pulmonary valve correction.
- The Site Heart Team concur the benefit-risk analysis supports intervention of Valvular heart disease and that the subject is at high risk for tricuspid valve surgery.
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In the judgement of the TVRS implanting investigator, femoral vein access is determined to be feasible and can accommodate a 25 Fr catheter.
Echocardiographic Inclusion Criteria:
- Subjects with moderate or greater (≥2+) Tricuspid Regurgitation determined by the assessment of a qualifying transthoracic echocardiogram (TTE) and transesophageal echocardiogram (TEE) confirmed by the Echocardiography Core Lab (ECL). Subjects with moderate TR will only be included in the trial if moderate TR is accompanied by a tricuspid annular diameter of ≥ 40mm as measured by the site heart team echocardiographer. Note: Additional NYHA criteria for moderate TR patients(see Inclusion Criteria #5). Additional note: If any cardiac procedure(s) that may occur within 90-days of procedure, then TTE and TEE must be repeated prior to the index procedure.
- Subjects with tricuspid valve anatomy determined to be suitable for implantation determined by the site heart team
- Subjects with tricuspid valve anatomy evaluable by TTE and TEE
Exclusion Criteria:
- Subject is currently participating in another clinical trial that has not yet completed its primary endpoint.
- Pregnant or nursing subjects and those who plan pregnancy in the period up to 1 year following index procedure. Female subjects of child-bearing potential must have a negative pregnancy test done within 7 days prior to the index procedure per site standard test.
- Subjects with severe uncontrolled hypertension (Systolic blood pressure [SBP] ≥ 180 mmHg and/or Diastolic blood pressure [DBP] ≥ 110 mm Hg)
- Subjects with Systolic Pulmonary Artery Pressure > 60 mmHg (echo determined)
- Subjects with prior tricuspid valve leaflet surgery or any currently implanted prosthetic tricuspid valve, or any prior transcatheter tricuspid valve procedure.
- Subjects with Mitral Regurgitation moderate-severe or greater severity (≥3+)
- Subjects with Pacemaker or ICD leads that would prevent appropriate placement of TVRS Clip
- Subjects with active endocarditis or active rheumatic heart disease or leaflets degenerated from rheumatic disease.
- Subjects with MI or known unstable angina within prior 30 days prior to enrollment
- Subjects with percutaneous coronary intervention within prior 30 days prior to enrollment
- Subjects with 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.
- Subjects with Cerebrovascular Accident (CVA) within prior 3 months to enrollment
- Subjects with chronic dialysis
- Subjects with bleeding disorders or hypercoagulable state
- Subjects with active peptic ulcer or active gastrointestinal (GI) bleeding
- Subjects with contraindication, allergy or hypersensitivity to dual antiplatelet and anticoagulant therapy.
- Active infections requiring current antibiotic therapy (if temporary illness, patients may enroll 4 weeks after discontinuation of antibiotics with no active infection).
- Known allergy or hypersensitivity to device materials
- In the judgement of the investigator, a condition that could limit a patient's ability or unwillingness to participate in the study, comply with study required testing and/or follow-up visits or that could impact scientific integrity of the study
- Evidence of intracardiac, inferior vena cava (IVC), or femoral venous mass, thrombus or vegetation.
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Subjects with life expectancy of less than 12 months due to non-cardiac conditions
Echocardiographic Exclusion Criteria:
- Subjects with tricuspid stenosis
- Left Ventricular Ejection Fraction (LVEF)≤20%
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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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03227757

Principal Investigator: | Prof. Georg Nickenig | University Hospital, Bonn |
Responsible Party: | Abbott Medical Devices |
ClinicalTrials.gov Identifier: | NCT03227757 |
Other Study ID Numbers: |
16-517 |
First Posted: | July 24, 2017 Key Record Dates |
Last Update Posted: | July 28, 2020 |
Last Verified: | July 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 |
TRILUMINATE Percutaneous transcatheter intervention Tricuspid regurgitation Tricuspid Valve Repair System |
Tricuspid Valve Insufficiency Heart Valve Diseases Heart Diseases Cardiovascular Diseases |