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Tricuspid Valve Repair Device
Tricuspid Valve Repair for Tricuspid Regurgitation
N/A
Waitlist Available
Led By Paul Sorajja, MD
Research Sponsored by Abbott Medical Devices
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Femoral vein access is determined to be feasible and can accommodate a 25 Fr catheter
New York Heart Association (NYHA) Functional Class II, III or ambulatory class IV
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights
Study Summary
This trial is testing whether the TriClip device is safe and effective in improving outcomes for people with severe tricuspid regurgitation who are at risk for mortality or morbidity with tricuspid valve surgery.
Who is the study for?
This trial is for adults over 18 with severe tricuspid regurgitation (TR), a heart valve disease, who are too high-risk for surgery. They must have stable symptoms despite treatment and be in NYHA Functional Class II-IV. Participants need suitable veins for the device and can't join if they have certain heart conditions, uncontrolled blood pressure, recent heart attacks or strokes, active infections or ulcers, allergies to the device materials or necessary medications, other serious health issues that could affect participation or life expectancy under one year.Check my eligibility
What is being tested?
The TRILUMINATE Pivotal Trial is testing the safety and effectiveness of the TriClip device compared to standard medical therapy in improving outcomes for patients with severe TR. The TriClip is an investigational device designed to repair the tricuspid valve without needing open-heart surgery.See study design
What are the potential side effects?
Potential side effects from using the TriClip may include bleeding complications due to required antiplatelet/anticoagulant therapy, risks associated with catheter insertion such as vascular injury or infection, possible damage to heart structures during placement of the clip, and potential need for additional procedures if initial repair isn't successful.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
Doctors can use a large catheter in my leg vein.
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My heart condition limits my physical activity but I can still take care of myself.
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I am 18 years old or older.
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I am at a high risk for complications if I undergo tricuspid valve surgery.
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I have severe symptoms despite treatment.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
For Randomized Cohort: Hierarchical Composite of All-cause Death or Tricuspid Valve Surgery, Heart Failure Hospitalizations, and KCCQ Improvement
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.
Secondary outcome measures
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
For Randomized Cohort: Change in 6 Minute Walk Test (6MWT) From Baseline to 12 Months
For Randomized Cohort: Change in Quality of Life as Assessed by KCCQ Score
+6 moreTrial Design
4Treatment groups
Experimental Treatment
Active Control
Group I: Single Arm GroupExperimental Treatment1 Intervention
Subjects will receive the TriClip device and will continue to be managed on medical therapy, per physician discretion.
Group II: Randomized - Device GroupExperimental Treatment1 Intervention
Subjects will undergo TriClip implantation and will continue to be managed on medical therapy, per physician discretion
Group III: Continued Access Study (CAS)Experimental Treatment1 Intervention
Subjects will undergo TriClip implantation and will continue to be managed on medical therapy, per physician discretion
Group IV: Randomized - Control GroupActive Control1 Intervention
Subjects will continue to be managed on medical therapy, per physician discretion
Find a Location
Who is running the clinical trial?
Abbott Medical DevicesLead Sponsor
638 Previous Clinical Trials
403,924 Total Patients Enrolled
Paul Sorajja, MDPrincipal InvestigatorAllina Health System
3 Previous Clinical Trials
672 Total Patients Enrolled
Erin Spinner, PhDStudy DirectorAbbott Structural Heart
1 Previous Clinical Trials
500 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your heart has high blood pressure in the arteries connected to your lungs.Your tricuspid valve cannot be properly checked using certain heart imaging tests.I need a heart or lung valve repair within the next 60 days.I am allergic or cannot take certain blood thinning medications.I have not had a stroke in the last 90 days.I am on long-term dialysis.You are allergic to the materials used in the medical device.I have not had a heart attack or unstable chest pain in the last 30 days.Doctors can use a large catheter in my leg vein.I have an active heart infection or rheumatic heart disease.I have a bleeding disorder or a condition that causes blood clots.I have been diagnosed with Ebstein Anomaly.I am currently taking antibiotics for an infection.You have a pacemaker or ICD leads that would get in the way of putting in the TriClip(TM) device.I have a narrowed tricuspid heart valve.My blood pressure and heart rate are stable.My blood pressure is not higher than 180/110 mmHg.I had a procedure to open my heart's arteries within the last 30 days.My heart condition limits my physical activity but I can still take care of myself.I am 18 years old or older.I am at a high risk for complications if I undergo tricuspid valve surgery.My heart's pumping ability is very low.You are expected to live for less than a year.My heart's tricuspid valve shape may not allow for proper treatment with a clip.I have had a heart valve procedure that may affect TriClip device placement.I currently have an active stomach ulcer or bleeding in my digestive tract.I have severe symptoms despite treatment.You have a mass or blood clot in specific veins near your heart or in your legs.I've been treated for my condition and have been stable for at least 30 days.
Research Study Groups:
This trial has the following groups:- Group 1: Single Arm Group
- Group 2: Randomized - Device Group
- Group 3: Continued Access Study (CAS)
- Group 4: Randomized - Control Group
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many facilities are managing this clinical test?
"The Novant Health Heart and Vascular Research Institute, Ohio Health Research Institute, JFK Medical Center and an additional 44 sites form the network of medical centres that are running this study."
Answered by AI
Is this research endeavor currently open to participants?
"Clinicaltrials.gov reports that this medical research is actively recruiting subjects, with initial postings on August 21st 2019 and the latest update issued October 20th 2022."
Answered by AI
What is the aggregate number of participants involved in this scientific study?
"The trial necessitates the participation of 700 qualifying patients. Such individuals can go to Novant Health Heart and Vascular Research Institute in Charlotte, North carolina or Ohio Health Research Institute in Columbus, Ohio for enrolment."
Answered by AI
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