TricValve System for Tricuspid Regurgitation

(TRICAV-I Trial)

Recruiting at 49 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

Trial Summary

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 data supports the effectiveness of the TricValve® Transcatheter Bicaval Valve System treatment for tricuspid regurgitation?

The TricValve system has shown promise in treating severe tricuspid regurgitation, with reports of reduced symptoms and improved clinical outcomes in patients who are not candidates for surgery. Early studies and case reports indicate that this treatment can effectively reduce the backward flow of blood in the veins, leading to symptom relief and better quality of life. ^{1 2 3 4 5}

What safety data exists for the TricValve System for Tricuspid Regurgitation?

The TricValve System, also known as the Tricento device, is a new treatment option for tricuspid regurgitation (a heart valve problem). While it shows promise, there is limited safety data available, and one case of thrombosis (blood clot) has been reported. ^{1 2 3 6 7}

How is the TricValve treatment different from other treatments for tricuspid regurgitation?

The TricValve treatment is unique because it uses a transcatheter bicaval valve system, which involves placing two biological valves to prevent blood from flowing backward into the veins. This approach is particularly beneficial for patients who are not suitable candidates for traditional surgery or other repair systems. ^{1 2 3 4 7}

What is the purpose of this trial?

The TricValve® Transcatheter Bicaval Valve System is a bicaval transcatheter tricuspid valve replacement system, which includes the TricValve® Transcatheter Bicaval Valve for superior vena cava (SVC) and the TricValve® Transcatheter Bicaval Valve for inferior vena cava (IVC). The TricValve® Transcatheter Bicaval Valves are pre-mounted into the TricValve® Delivery System which is used for percutaneous access and delivery of the TricValve® Transcatheter Bicaval Valve in the vena cava. The system is a single use, sterile device compatible with all the valve sizes. The prostheses are implanted percutaneously into the inferior and superior vena cava without disturbing the native tricuspid valve. The device is made of bovine pericardium leaflets sutured on a nitinol self-expanding stent system.

Research Team

Katharina Kiss, MD

Principal Investigator

Products & Features GmbH

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Bicaval Transcatheter Prosthesis Implantation for Treatment of Tricuspid Regurgitation: First Report of Thrombosis. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Early Clinical Experience With the TRICENTO Bicaval Valved Stent for Treatment of Symptomatic Severe Tricuspid Regurgitation: A Multicenter Registry. [2022]

3. France pubmed.ncbi.nlm.nih.gov

First-in-man implantation of the Tricento transcatheter heart valve for the treatment of severe tricuspid regurgitation. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Bicaval TricValve Implantation in Patients With Severe Symptomatic Tricuspid Regurgitation: One-Year Follow-Up Outcomes. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

1-Year Outcomes of Transcatheter Tricuspid Valve Repair. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Early Single-Site Experience With Transcatheter Tricuspid Valve Replacement. [2020]

7. England pubmed.ncbi.nlm.nih.gov

Transcatheter tricuspid valve implantation with the Cardiovalve system. [2022]