TricValve System for Tricuspid Regurgitation

(TRICAV-I Trial)

Recruiting at 51 trial locations

Overseen By Monica Tocchi, MD, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: P+F Products + Features USA Inc.

Must be taking: Diuretics

Disqualifiers: Recent MI, Stroke, Severe renal insufficiency, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1 month

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment for severe tricuspid regurgitation, a heart condition where the valve between the heart's chambers doesn't close properly, causing blood to flow backward. The treatment uses the TricValve® Transcatheter Bicaval Valve System, a device placed without surgery to improve heart function. People who have recently experienced heart failure symptoms, such as shortness of breath or swelling, may be suitable candidates if they are already managing their condition with medication. As an unphased trial, this study offers patients the chance to contribute to groundbreaking research that could enhance future treatment options.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, you must be on optimal medical therapy for heart failure, including a diuretic, for at least 30 days before the procedure.

What prior data suggests that the TricValve® Transcatheter Bicaval Valve System is safe for tricuspid regurgitation?

Research has shown that the TricValve® Transcatheter Bicaval Valve System has promising safety results from earlier studies. For example, one study found that patients experienced significant improvements in their quality of life and relatively low death rates after one year. Additionally, no reports of serious problems, such as heart damage or tears, were noted.

Another study examined short-term safety and found positive results just 30 days after the procedure. Patients did not experience major complications, suggesting that the TricValve system is well-tolerated in the short term.

These findings suggest that the TricValve system might be a safe option for people with tricuspid regurgitation. However, discussing any concerns with a healthcare provider is always important. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The TricValve® Transcatheter Bicaval Valve System is unique because it offers a minimally invasive solution for treating tricuspid regurgitation, which is often managed with medications or, in severe cases, open-heart surgery. This device is inserted using a catheter, bypassing the need for traditional surgery, and is designed to improve blood flow and reduce symptoms by targeting the specific malfunction of the tricuspid valve. Researchers are excited about the TricValve® because it promises quicker recovery times and fewer complications compared to current surgical options, potentially offering a new lease on life for patients who are poor surgical candidates.

What evidence suggests that the TricValve® System is effective for tricuspid regurgitation?

Research has shown that the TricValve® Transcatheter Bicaval Valve System holds promise for treating severe tricuspid regurgitation, a condition where a heart valve fails to close properly, causing blood to flow backward. Studies have found significant improvements in quality of life and reduced symptoms within six months of treatment. The system manages blood flow by placing special valves in the major veins leading to the heart, without affecting the existing heart valve. Additionally, it has been linked to high success rates during the procedure and relatively low risk of death. These findings suggest the TricValve system could be an effective option for patients with this condition. ^{1 2 3 5 6}

Who Is on the Research Team?

Katharina Kiss, MD

Principal Investigator

Products & Features GmbH

Are You a Good Fit for This Trial?

This trial is for adults over 18 with severe tricuspid valve disease, specifically regurgitation, who have been stable on heart failure medication for at least 30 days. They should be high risk for surgery and not candidates for other approved transcatheter devices. Exclusions include those with very weak hearts (LVEF ≤30%), recent strokes, or need other heart procedures soon.

Inclusion Criteria

I have severe heart issues but am not on strong heart medications, or I was hospitalized for heart failure in the last 6 months.

Your heart needs to be a good fit for the TricValve Device based on CT scan and right heart catheterization.

I have severe tricuspid regurgitation confirmed by an echocardiogram.

Exclusion Criteria

Your heart's pumping ability is very low, as shown on an echocardiogram.

I cannot take Coumadin or any direct oral anticoagulants.

I am scheduled for a heart procedure within 30 days before or after another procedure.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo TricValve® implantation and continue with optimal medical therapies

1 month

1 visit (in-person for procedure)

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

Regular visits (in-person and virtual)

Long-term Follow-up

Long-term safety and efficacy data collection

5 years

What Are the Treatments Tested in This Trial?

Interventions

• TricValve® Transcatheter Bicaval Valve System

Trial Overview The TricValve® Transcatheter Bicaval Valve System is being tested against standard medical therapy. This device involves placing two valves via a vein to help the heart's right side function better without disturbing the existing tricuspid valve.

How Is the Trial Designed?

Group I: TricValve® Device (Device) Group Experimental Treatment 1 Intervention

subjects will undergo TricValve® implantation and will continue to be managed with optimal medical therapies, per physician discretion.

Who Is Running the Clinical Trial?

P+F Products + Features USA Inc.

Lead Sponsor

Trials

2

Recruited

650+

Meditrial USA Inc.

Collaborator

Trials

7

Recruited

1,400+

P+F Products + Features GmbH

Industry Sponsor

Trials

6

Recruited

720+

Meditrial USA Inc.

Industry Sponsor

Trials

8

Recruited

1,900+

Published Research Related to This Trial

The Tricento transcatheter heart valve was successfully implanted in a 74-year-old woman with severe tricuspid regurgitation, marking its first use via transvenous transfemoral access.

Three months after the implantation, the patient showed significant clinical improvement and reduced caval vein regurgitant volume, indicating the device's potential as a safe and effective treatment for patients unable to undergo open heart surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

First-in-man implantation of the Tricento transcatheter heart valve for the treatment of severe tricuspid regurgitation. Toggweiler, S., De Boeck, B., Brinkert, M., et al.[2019]

The PASCAL transcatheter valve repair system showed low complication rates and high survival rates in treating severe tricuspid regurgitation, with only 3.1% cardiovascular mortality at 30 days and 87.9% freedom from all-cause mortality at 1 year among 65 patients studied.

Significant improvements were observed in TR severity, functional status, and quality of life, with 86% of patients achieving moderate or less TR and a notable increase in walking distance and overall health scores after 1 year.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

1-Year Outcomes of Transcatheter Tricuspid Valve Repair. Kodali, SK., Hahn, RT., Davidson, CJ., et al.[2023]

The transcatheter bicaval valve system is a new treatment option for tricuspid regurgitation, designed to prevent caval reflux using two biological valves.

This report highlights the first documented case of thrombosis associated with this device, indicating potential safety concerns that need further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bicaval Transcatheter Prosthesis Implantation for Treatment of Tricuspid Regurgitation: First Report of Thrombosis. Custódio, P., Carvalho, A., Bico, P.[2023]

The TRICENTO system, a novel transfemoral bicaval valved stent, demonstrated a 100% technical success rate in 21 high-risk patients with severe tricuspid regurgitation, with no in-hospital mortality reported.

Patients showed significant symptomatic improvement, with 65% moving to a better functional class (NYHA class I/II) after a median follow-up of 61 days, alongside evidence of right ventricular reverse remodeling, although some stent fractures were noted that require further design refinement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early Clinical Experience With the TRICENTO Bicaval Valved Stent for Treatment of Symptomatic Severe Tricuspid Regurgitation: A Multicenter Registry. Wild, MG., Lubos, E., Cruz-Gonzalez, I., et al.[2022]

Tricuspid regurgitation (TR) is common in older adults and is associated with poor outcomes, highlighting the need for effective treatment options.

The Cardiovalve system for tricuspid valve replacement is currently undergoing early feasibility studies in the US and has received approval for clinical studies in Germany, Italy, and Switzerland, indicating promising advancements in the transcatheter treatment of severe TR.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcatheter tricuspid valve implantation with the Cardiovalve system. Aoi, S., Wiley, J., Ho, E., et al.[2022]

In a study involving 5 patients with severe tricuspid regurgitation (TR), the novel GATE System for transcatheter tricuspid valve replacement was successfully implanted, leading to a significant reduction in TR severity to ≤2+.

Follow-up results showed that most patients experienced right ventricular remodeling, increased cardiac output, and improved functional status, indicating the potential efficacy of this device in treating severe TR.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early Single-Site Experience With Transcatheter Tricuspid Valve Replacement. Hahn, RT., George, I., Kodali, SK., et al.[2020]

In a study of 44 patients with severe tricuspid regurgitation, the TricValve system led to significant clinical improvements in quality of life and functional status for 95.5% of participants after one year.

The procedure was associated with a low mortality rate of 6.8% and effectively reduced symptoms of congestion, with 63.8% of patients experiencing abolished hepatic vein backflow, indicating its potential as a safe treatment option for patients ineligible for open heart surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bicaval TricValve Implantation in Patients With Severe Symptomatic Tricuspid Regurgitation: One-Year Follow-Up Outcomes. Blasco-Turrión, S., Briedis, K., Estévez-Loureiro, R., et al.[2023]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38069986/

Bicaval TricValve Implantation in Patients With Severe ... Caval valve implantation with the TricValve system associated with meaningful 1-year clinical improvements in terms of QOL along with relatively low mortality ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S1936879822009487

6-Month Outcomes of the TricValve System in Patients With ... The aim of this study was to evaluate the 30-day safety and 6-month efficacy outcomes of specifically designed bioprosthetic valves for the superior and ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06137807

TRIcvalve biCAVal Valve System for Severe Tricuspid ... This is a prospective multicenter clinical investigation designed to evaluate the safety and effectiveness of the TricValve® Transcatheter Bicaval Valve System.

4. jacc.org jacc.org/doi/abs/10.1016/j.jcin.2022.05.022

6-Month Outcomes of the TricValve System in Patients With ... The dedicated bicaval system for treating severe symptomatic TR was associated with a high procedural success rate and significant improvements in both QOL and ...

5. clinicaltrials.ucsf.edu clinicaltrials.ucsf.edu/trial/NCT06137807

TRIcvalve biCAVal Valve System for Severe Tricuspid ... A prospective multicenter clinical investigation designed to evaluate the safety and effectiveness of the TricValve® Transcatheter Bicaval Valve System.

6. ahajournals.org ahajournals.org/doi/10.1161/CIRCHEARTFAILURE.122.010027

First In-Man Experience With TricValve Transcatheter ... Initial studies have demonstrated an increase in quality of life, reduction in hospitalization, and no signs of perforation or structural damage ...