CLINICAL TRIAL

Tricuspid Valve Repair System for Tricuspid Valve Insufficiency

Class II
High Risk
Waitlist Available · 18+ · All Sexes · Barcelona, Spain

This study is evaluating whether a new device can improve heart function in people with heart valve disease.

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About the trial for Tricuspid Valve Insufficiency

Treatment Groups

This trial involves 2 different treatments. Tricuspid Valve Repair System is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Tricuspid Valve Repair System
DEVICE
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.

Eligibility

This trial is for patients born any sex aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Subjects must not participate in any other clinical trial for a period of one year following the index procedure. show original
The investigator has found that the patient has been adequately treated for heart conditions, including coronary artery disease, mitral regurgitation, and heart failure show original
This individual has a New York Heart Association (NYHA) Functional Class II (conditional), III, or ambulatory IV heart condition. show original
Subjects with moderate TR are only those with NYHA Class III or IV. show original
in a heart failure clinical trial Heart failure patients who are severely limited in their activities, classified as New York Heart Association (NYHA) class II, III, or IV, may be eligible to participate in a heart failure clinical trial. show original
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.
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.
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: 3 years
Screening: ~3 weeks
Treatment: Varies
Reporting: 3 years
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 3 years.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Tricuspid Valve Repair System will improve 3 primary outcomes and 3 secondary outcomes in patients with Tricuspid Valve Insufficiency. Measurement will happen over the course of At 30 days.

Number of Participants With Echocardiographic Tricuspid Regurgitation Reduction at Least 1 Grade
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.
AT 30 DAYS
Echocardiographic Tricuspid Regurgitation Reduction at Least 1 Grade
AT 30 DAYS
Echocardiographic Tricuspid Regurgitation Reduction at Least 1 Grade
AT 30 DAYS
Prevalence of Device or Procedure-Related Adverse Events
30 DAYS
Prevalence of Device or Procedure-Related Adverse Events
30 DAYS
Number of Participants With Composite of Major Adverse Event (MAE)
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
AT 6 MONTHS
Core Lab assessment of change in Tricuspid Regurgitation (TR) Severity Grade
3 YEARS
Core Lab assessment of change in Tricuspid Regurgitation (TR) Severity Grade
3 YEARS
Composite of Major Adverse Event (MAE)
3 YEARS
Composite of Major Adverse Event (MAE)
3 YEARS

Patient Q & A Section

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

How does tricuspid valve repair system work?

TAVR is a new technique for treating severe tricuspid valve insufficiency with few complications. Although these patients are younger than is previously thought, there is still an elderly percentage of TAVR patients.

Anonymous Patient Answer

What are common treatments for tricuspid valve insufficiency?

Tricuspid valve regurgitation in adults occurs in 1.7-3.6% of the population. More than 90% of those affected require some sort of intervention for valve incompetence; surgical repair is the preferred approach. Although transcatheter interventions are growing in popularity in developed regions, their routine use remains limited. More than 50% of the patients will require subsequent concomitant surgeries.

Anonymous Patient Answer

What is tricuspid valve insufficiency?

TR is a disorder of the tricuspid valve which reduces the normal blood flow from the left ventricle of the heart into the right ventricle. At any time tricuspid stenosis (TRS) may develop. This will eventually lead to pulmonary hypertension and functional heart failure. Inappropriate tricuspid regurgitation (TRR) leads to ventricular dysfunction, and has adverse health hazards.

Anonymous Patient Answer

What causes tricuspid valve insufficiency?

Valvular lesions are an extremely common cause of tricuspid valve insufficiency. Mitral valve insufficiency can also generate this type of valvular effect, but its diagnosis remains elusive.

Anonymous Patient Answer

What are the signs of tricuspid valve insufficiency?

The signs of tricuspid regurgitation are low-grade tricuspid insufficiency, low-voltage murmurs, right mainstem bundle thrombosis and tricuspid annulus enlargement. Echocardiography should detect these signs and allow the diagnosis of tricuspid regurgitation in case of mild symptoms.

Anonymous Patient Answer

How many people get tricuspid valve insufficiency a year in the United States?

Nearly 3 million elderly people have insufficiency of the tricuspid valve. This information may be useful for future discussion of the role of echocardiography in clinical practice.

Anonymous Patient Answer

Can tricuspid valve insufficiency be cured?

Most patients with functional regurgitation of the tricuspid valve (tricuspid insufficiency) can be cured by the Ross operation, and can be spared a life-threatening operative morbidity.

Anonymous Patient Answer

What are the common side effects of tricuspid valve repair system?

Tricuspid Valve Repair System has been used since 2000 in Germany. There was no statistically significant difference in the incidence of pericardial effusion or tamponade. We can tell, that the intra-pericardial implantation of TMR systems is not associated with higher incidence and severity of pericardial effusion and tamponade.

Anonymous Patient Answer

Have there been any new discoveries for treating tricuspid valve insufficiency?

There is still much discussion and research needed to better understand and treat tricuspid stenosis. It is evident that tricuspid regurgitation does not respond as well to therapies known to treat mitral and aortic stenosis. It is also important not to forget the unique needs of patients with rheumatic pathology whose heart valves often must be compromised or valvulotomized in order to prevent further damage. As a result, it is very important to remember the patient's unique case before considering different treatment modalities. It is also important to take into account the need for a detailed transthoracic echocardiogram.

Anonymous Patient Answer

What is the primary cause of tricuspid valve insufficiency?

[Primary mitral valve regurgitation is a far more frequent cause of TR than previously believed. TR secondary to a ndisrupting annular commissure in the anterior interventricular groove is a nodal source of TR]]

Anonymous Patient Answer

Who should consider clinical trials for tricuspid valve insufficiency?

All patients with severe TAVD and severe LVSD have a large subpopulation who have no potential for treatment with a therapeutic drug and may have a poor outcome. All patients with severe TAVD should be considered for clinical trials because these patients may have an elevated risk of serious cardiac events at the time of enrollment.

Anonymous Patient Answer

Does tricuspid valve repair system improve quality of life for those with tricuspid valve insufficiency?

Although TAVI with TV repair system has an acceptable immediate operative risks and midterm survival, midterm survival has not yet been proven long-term. Although a patient can expect to be asymptomatic after operation, a deterioration in HRQoL is anticipated when a patient lives with TrS. The patients will be expected to cope with new symptoms and have improved HRQoL. TAVI with TV repair system is an effective treatment options for TrS and is still awaited to clarify its long-term survival outcomes by randomized controlled trials.

Anonymous Patient Answer
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