Tricuspid Valve InsufficiencyTRILUMINATENCT03227757
TRILUMINATE Study With Abbott Transcatheter Clip Repair System in Patients With Moderate or Greater TR
A study testing Tricuspid Valve Repair System in people with Tricuspid Valve Insufficiency, run by Abbott Medical Devices at 20 sites in 6 countries.
Trial summary
The primary purpose of this study is to evaluate safety and effectiveness of the Tricuspid Valve Repair System (TVRS) for treating symptomatic moderate or greater tricuspid regurgitation (TR) in patients currently on medical management and who are deemed appropriate for percutaneous transcatheter intervention. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Tricuspid Valve Insufficiency
- What is being tested?
- Tricuspid Valve Repair System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 20 sitesin 6 countries
- Study dates
- 1 Aug 2017to 30 May 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- New York Heart Association (NYHA) Functional Class II (conditional), III, or ambulatory IV
- Subjects with moderate TR: Only NYHA Class III or IV may be considered
Show all 14Show fewer
- 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 for tricuspid regurgitation per current guidelines for the management of Valvular heart disease and that the subject is at high risk for tricuspid valve surgery.
- 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:
- 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).
- Tricuspid valve anatomy determined to be suitable for implantation determined by the site heart team.
- Tricuspid valve anatomy evaluable by TTE and TEE.
Who cannot join
- 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.
- Severe uncontrolled hypertension (Systolic blood pressure [SBP] ≥ 180 mmHg and/or Diastolic blood pressure [DBP] ≥ 110 mm Hg).
- Systolic Pulmonary Artery Pressure > 60 mmHg (echo determined).
- Prior tricuspid valve leaflet surgery or any currently implanted prosthetic tricuspid valve, or any prior transcatheter tricuspid valve procedure.
- Mitral Regurgitation moderate-severe or greater severity (≥3+).
Show all 27Show fewer
- Pacemaker or implantable cardioverter-defibrillator (ICD) leads that would prevent appropriate placement of TVRS Clip.
- Active endocarditis or active rheumatic heart disease or leaflets degenerated from rheumatic disease.
- Myocardial Infarction (MI) or known unstable angina within prior 30 days prior to enrollment.
- Percutaneous coronary intervention within prior 30 days prior to enrollment.
- 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 3 months to enrollment.
- 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.
- 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.
- Life expectancy of less than 12 months due to non-cardiac conditions.
- Echocardiographic Exclusion Criteria:
- Tricuspid stenosis.
- 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
Trial locations and contacts
20 sites in 6 countries.
20 sites in 6 countries
Germany6 sites
Schuchtermann Klinik
Bad Rothenfelde, Lower Saxony, 49214
University Hospital Bonn
Bonn, North Rhine-Westphalia, 53127
Albertinen-Krankenhaus
Hamburg, 22457
Leipzig Heart Center
Leipzig, Saxony, 04289
Universitatsmedizin der Johannes Gutenberg-Universitat Mainz
Mainz, Rhineland-Palatinate, 55131
Ludwig-Maximilian University of Munich (LMU)
Munich, Bavaria, 81377
United States4 sites
Henry Ford Hospital
Detroit, Michigan, 48202
Cedars-Sinai Medical Center
Los Angeles, California, 90048
Abbott Northwestern Hospital
Minneapolis, Minnesota, 55407
Mount Sinai Hospital
New York, New York, 10029
Italy3 sites
Azienda Ospedaliero Universitaria Policlinico Vittorio Emanuele - Presidio Ferrarotto
Catania, Catania (CT), 95124
San Raffaele University Hospital
Milan, Milan, 20132
Istituto Clinico Sant'Ambrogio
Milan, Milan, 20149
Switzerland3 sites
Inselspital Bern
Bern, 3010
HerzKlinik Hirslanden - Klinik Hirslanden
Zurich, 8032
University Hospital of Zurich (USZ)
Zurich, 8091
France2 sites
Hospital Nord Laennec - Chu De Nantes
Nantes, Saint-Herblain, 44 093
Bichat-Claude Bernard Hospital
Paris, 75018
Spain2 sites
Hospital de Sant Pau
Barcelona, 08025
Clinical and Provincial Hospital of Barcelona
Barcelona, 08036
About this study
Official title: Trial to Evaluate Treatment With Abbott Transcatheter Clip Repair System in Patients With Moderate or Greater Tricuspid Regurgitation (TRILUMINATE)
The primary purpose of this study is to evaluate safety and effectiveness of the Tricuspid Valve Repair System (TVRS) for treating symptomatic moderate or greater tricuspid regurgitation (TR) in patients currently on medical management and who are deemed appropriate for percutaneous transcatheter intervention.
Read the detailed description
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.
- Conditions
- Tricuspid Valve Insufficiency
- Being tested
- Tricuspid Valve Repair System
- Keywords
- TRILUMINATE, Percutaneous transcatheter intervention, Tricuspid regurgitation, Tricuspid Valve Repair System
- Medical subject headings
- Tricuspid Valve Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tricuspid Valve Repair SystemDevice
Subjects who received TVRS will be included in this arm. The TVRS is intended for reconstruction of the insufficient tricuspid valve through tissue approximation.
| Study group | Role | What they receive |
|---|---|---|
| Tricuspid Valve Repair System | Experimental | Subjects who received TVRS will be included in this arm. Receives: Device: Tricuspid Valve Repair System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Echocardiographic Tricuspid Regurgitation Reduction at Least 1 Grade
Tricuspid regurgitation (TR) was assessed with standard 2D color doppler methods using a integrative approach. A five-class grading scheme was used: mild, moderate, severe, massive and torrential. Parameters including vena contracta area, effective regurgitant orifice area and proximal isovelocity surface area were used to quantify and grade TR.
Measured: At 30 days
Number of Participants With Composite of Major Adverse Event (MAE)
Major Adverse Event (MAE) is defined as a composite of:
- Cardiovascular Mortality
- Myocardial Infarction (MI)
- Stroke
- New onset renal failure
- Endocarditis requiring surgery, and
- Non-elective cardio-vascular (CV) surgery for TVRS device-related AE post-procedure
Measured: At 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2017
- Study start1 Aug 2017
- Primary completion14 Nov 2019
- Study completion30 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Tricuspid Valve InsufficiencyStudies of the same condition, open and under way.
- More trials run by Abbott Medical DevicesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Prof. Georg Nickenig, Principal investigator, University Hospital, Bonn
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03227757
- Sponsor's protocol ID
- 16-517
- Acronym
- TRILUMINATE
- Status last verified
- Nov 2024
- First submitted
- 20 Jun 2017
- Last updated
- 6 Nov 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Nickenig G, Lurz P, Sorajja P, von Bardeleben RS, Sitges M, Tang GHL, Hausleiter J, Trochu JN, Nabauer M, Heitkemper M, Ying SW, Weber M, Hahn RT; TRILUMINATE Investigators. Percutaneous Edge-to-Edge Repair for Tricuspid Regurgitation: 3-Year Outcomes From the TRILUMINATE Study. JACC Cardiovasc Interv. 2024 Sep 23;17(18):2113-2122. doi: 10.1016/j.jcin.2024.05.036. Epub 2024 Sep 4.
PubMed 39243264von Bardeleben RS, Lurz P, Sorajja P, Ruf T, Hausleiter J, Sitges M, Da Rocha E Silva J, Nabauer M, Weber M, Tang GHL, Heitkemper M, Ying SW, Trochu JN, Kar S, Hahn RT, Nickenig G; TRILUMINATE Trial Investigators. Two-Year Outcomes for Tricuspid Repair With a Transcatheter Edge-to-Edge Valve Repair From the Transatlantic TRILUMINATE Trial. Circ Cardiovasc Interv. 2023 Aug;16(8):e012888. doi: 10.1161/CIRCINTERVENTIONS.122.012888. Epub 2023 Aug 15.
PubMed 37582170Lurz P, Stephan von Bardeleben R, Weber M, Sitges M, Sorajja P, Hausleiter J, Denti P, Trochu JN, Nabauer M, Tang GHL, Biaggi P, Ying SW, Trusty PM, Dahou A, Hahn RT, Nickenig G; TRILUMINATE Investigators. Transcatheter Edge-to-Edge Repair for Treatment of Tricuspid Regurgitation. J Am Coll Cardiol. 2021 Jan 26;77(3):229-239. doi: 10.1016/j.jacc.2020.11.038.
PubMed 33478646Nickenig G, Weber M, Lurz P, von Bardeleben RS, Sitges M, Sorajja P, Hausleiter J, Denti P, Trochu JN, Nabauer M, Dahou A, Hahn RT. Transcatheter edge-to-edge repair for reduction of tricuspid regurgitation: 6-month outcomes of the TRILUMINATE single-arm study. Lancet. 2019 Nov 30;394(10213):2002-2011. doi: 10.1016/S0140-6736(19)32600-5. Epub 2019 Nov 7.
PubMed 31708188
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trial to Evaluate Treatment With Abbott Transcatheter Clip Repair System in Patients With Moderate or Greater Tricuspid Regurgitation (TRILUMINATE)
- ClinicalTrials.gov ID
- NCT03227757
- Acronym / sponsor ID
- TRILUMINATE / 16-517
- Conditions
- Tricuspid Valve Insufficiency
- Keywords
- TRILUMINATE, Percutaneous transcatheter intervention, Tricuspid regurgitation, Tricuspid Valve Repair System
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- 14 Nov 2019 (actual)
- Study completion
- 30 May 2024 (actual)
- First posted
- 24 Jul 2017 (actual)
- Results
- Posted 26 Oct 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary purpose of this study is to evaluate safety and effectiveness of the Tricuspid Valve Repair System (TVRS) for treating symptomatic moderate or greater tricuspid regurgitation (TR) in patients currently on medical management and who are deemed appropriate for percutaneous transcatheter intervention.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tricuspid Valve Repair System | Experimental | Device: Tricuspid Valve Repair SystemSubjects who received TVRS will be included in this arm. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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.
- New York Heart Association (NYHA) Functional Class II (conditional), III, or ambulatory IV
Key exclusion criteria (27 listed)
- 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.
- Severe uncontrolled hypertension (Systolic blood pressure [SBP] ≥ 180 mmHg and/or Diastolic blood pressure [DBP] ≥ 110 mm Hg).
- Systolic Pulmonary Artery Pressure > 60 mmHg (echo determined).
- Prior tricuspid valve leaflet surgery or any currently implanted prosthetic tricuspid valve, or any prior transcatheter tricuspid valve procedure.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tricuspid Valve Repair SystemSubjects who received TVRS will be included in this arm. The TVRS is intended for reconstruction of the insufficient tricuspid valve through tissue approximation. | Device | Tricuspid Valve Repair System |
Primary outcome
Number of Participants With Echocardiographic Tricuspid Regurgitation Reduction at Least 1 Grade
Time frame: At 30 days
Tricuspid regurgitation (TR) was assessed with standard 2D color doppler methods using a integrative approach. A five-class grading scheme was used: mild, moderate, severe, massive and torrential. Parameters including vena contracta area, effective regurgitant orifice area and proximal isovelocity surface area were used to quantify and grade TR.
Number of Participants With Composite of Major Adverse Event (MAE)
Time frame: At 6 months
Major Adverse Event (MAE) is defined as a composite of: * Cardiovascular Mortality * Myocardial Infarction (MI) * Stroke * New onset renal failure * Endocarditis requiring surgery, and * Non-elective cardio-vascular (CV) surgery for TVRS device-related AE post-procedure
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39243264Nickenig G, Lurz P, Sorajja P, von Bardeleben RS, Sitges M, Tang GHL, Hausleiter J, Trochu JN, Nabauer M, Heitkemper M, Ying SW, Weber M, Hahn RT; TRILUMINATE Investigators. Percutaneous Edge-to-Edge Repair for Tricuspid Regurgitation: 3-Year Outcomes From the TRILUMINATE Study. JACC Cardiovasc Interv. 2024 Sep 23;17(18):2113-2122. doi: 10.1016/j.jcin.2024.05.036. Epub 2024 Sep 4.
- Derived from this study: PubMed 37582170von Bardeleben RS, Lurz P, Sorajja P, Ruf T, Hausleiter J, Sitges M, Da Rocha E Silva J, Nabauer M, Weber M, Tang GHL, Heitkemper M, Ying SW, Trochu JN, Kar S, Hahn RT, Nickenig G; TRILUMINATE Trial Investigators. Two-Year Outcomes for Tricuspid Repair With a Transcatheter Edge-to-Edge Valve Repair From the Transatlantic TRILUMINATE Trial. Circ Cardiovasc Interv. 2023 Aug;16(8):e012888. doi: 10.1161/CIRCINTERVENTIONS.122.012888. Epub 2023 Aug 15.
- Derived from this study: PubMed 33478646Lurz P, Stephan von Bardeleben R, Weber M, Sitges M, Sorajja P, Hausleiter J, Denti P, Trochu JN, Nabauer M, Tang GHL, Biaggi P, Ying SW, Trusty PM, Dahou A, Hahn RT, Nickenig G; TRILUMINATE Investigators. Transcatheter Edge-to-Edge Repair for Treatment of Tricuspid Regurgitation. J Am Coll Cardiol. 2021 Jan 26;77(3):229-239. doi: 10.1016/j.jacc.2020.11.038.
- Derived from this study: PubMed 31708188Nickenig G, Weber M, Lurz P, von Bardeleben RS, Sitges M, Sorajja P, Hausleiter J, Denti P, Trochu JN, Nabauer M, Dahou A, Hahn RT. Transcatheter edge-to-edge repair for reduction of tricuspid regurgitation: 6-month outcomes of the TRILUMINATE single-arm study. Lancet. 2019 Nov 30;394(10213):2002-2011. doi: 10.1016/S0140-6736(19)32600-5. Epub 2019 Nov 7.
- Individual participant dataSharing planned: No
Related trials for Tricuspid Valve Insufficiency
Recruiting
First-in-man Trial to Assess the Safety, Performance and Clinical Benefit of the TRICENTO G2 Transcatheter Valve System for Tricuspid Regurgitation
Symptomatic Tricuspid Regurgitation (TR) Graded as Severe or Greater
Recruiting
The TRICURE US IDE Pivotal Study
Tricuspid Regurgitation (TR)
Recruiting
EFS of the DUO System for Tricuspid Regurgitation
Tricuspid Regurgitation, Tricuspid Valve Insufficiency
Recruiting
Safety and Feasibility Study: Transcatheter Valve Repair in Severe Symptomatic Functional Tricuspid Regurgitation
Tricuspid Regurgitation Functional, Tricuspid Regurgitation (TR)
Not yet recruiting
A Prospective, Randomized Multicenter Clinical Trial of the TricValve® Transcatheter Bicaval Valve System in Subjects With Severe Tricuspid Regurgitation.
Tricuspid Valve Disease, Heart Valve Diseases
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Prof. Georg Nickenig principal investigator
University Hospital, Bonn
20 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tricuspid Valve Repair System in people with Tricuspid Valve Insufficiency, run by Abbott Medical Devices at 20 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in Germany, United States, Italy, Switzerland, France and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Oct 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Echocardiographic Tricuspid Regurgitation Reduction at Least 1 Grade (time frame: At 30 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03227757, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2024.