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Transcatheter Valve Repair

Tricuspid Valve Repair for Tricuspid Regurgitation (TRILUMINATE Trial)

N/A

Waitlist Available

Led By Prof. Georg Nickenig

Research Sponsored by Abbott Medical Devices

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Subject must be ≥18 years and ≤ 90 years at time of consent and must not be a member of a vulnerable population

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 years

Awards & highlights

TRILUMINATE Trial Summary

This trial is testing a new way to treat people who have a heart valve problem called tricuspid regurgitation. The new method is minimally invasive and done by threading a device through the person's veins.

Who is the study for?

This trial is for adults aged 18-90 with moderate or severe tricuspid regurgitation (TR), who are symptomatic and have been deemed high-risk for surgery by a heart team. They must not be pregnant, planning pregnancy within a year, or involved in another clinical trial. Candidates should have stable blood pressure without recent heart attacks, strokes, or infections.Check my eligibility

What is being tested?

The study tests the safety and effectiveness of the Tricuspid Valve Repair System (TVRS) in treating patients with moderate to severe TR who are on medical management but appropriate for transcatheter intervention—a non-surgical procedure involving catheters.See study design

What are the potential side effects?

Potential side effects may include bleeding due to antiplatelet/anticoagulant therapy required post-procedure, risks associated with catheter insertion such as vascular complications, infection risk from device implantation, and possible adverse reactions to the device materials.

TRILUMINATE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 90 years old and not considered vulnerable.

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I have received proper treatment for heart conditions over 30 days ago.

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I have moderate tricuspid regurgitation and my heart condition is severe.

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I don't need surgery for my heart's left or lung valves.

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My heart team agrees I should get treatment for my heart valve issue instead of surgery.

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My heart condition limits my physical activity but I can still take care of myself.

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I have severe heart valve issues but can still do some daily activities.

TRILUMINATE Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of Participants With Composite of Major Adverse Event (MAE)

Number of Participants With Echocardiographic Tricuspid Regurgitation Reduction at Least 1 Grade

Secondary outcome measures

Composite of Major Adverse Event (MAE)

Tricuspid Valve Insufficiency

Prevalence of Device or Procedure-Related Adverse Events

TRILUMINATE Trial Design

1Treatment groups

Experimental Treatment

Group I: Tricuspid Valve Repair SystemExperimental Treatment1 Intervention

Subjects who received TVRS will be included in this arm.

0 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

Abbott Medical DevicesLead Sponsor

638 Previous Clinical Trials

404,103 Total Patients Enrolled

Prof. Georg NickenigPrincipal InvestigatorUniversity Hospital, Bonn

Media Library

Tricuspid Valve Repair System (Transcatheter Valve Repair) Clinical Trial Eligibility Overview. Trial Name: NCT03227757 — N/A

Tricuspid Regurgitation Research Study Groups: Tricuspid Valve Repair System

Tricuspid Regurgitation Clinical Trial 2023: Tricuspid Valve Repair System Highlights & Side Effects. Trial Name: NCT03227757 — N/A

Tricuspid Valve Repair System (Transcatheter Valve Repair) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03227757 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there still vacancies available for prospective participants of this experiment?

"The clinical trial page on the website clinicaltrials.gov states that this experiment is no longer recruiting participants; it was initially posted in August 2017 and edited most recently in December 2021. However, there are 40 other ongoing studies currently seeking volunteers."

Answered by AI

Is it possible for me to sign up as a participant in this clinical experiment?

"Participants in this trial must have tricuspid valve pathology and be between 18-90 years old to qualify. 85 individuals are required for the study's completion."

Answered by AI

How many medical facilities are currently executing this experiment?

"A total of 4 medical centres are currently recruiting participants for this study, including Abbott Northwestern Hospital in Minneapolis, Henry Ford Hospital in Detroit, and Cedars-Sinai Medical Center in Los Angeles. Additionally, there are an additional four locations involved with recruitment."

Answered by AI