Tricuspid Valve Replacement for Tricuspid Regurgitation

(TRICURE EFS Trial)

Recruiting at 8 trial locations

Overseen By Esther Gerteis

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: TRiCares

Disqualifiers: Emergent intervention, Hemodynamic instability, Anatomical contraindications, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 31

Duration: 1 day

10 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the safety and performance of a new valve replacement system for individuals with severe tricuspid regurgitation, a condition where the heart's tricuspid valve fails to close properly, causing blood to flow backward. The treatment, Transcatheter Tricuspid Valve Replacement (TTVR), uses a special device to replace the faulty valve without open-heart surgery. Individuals diagnosed with severe tricuspid regurgitation and at high risk for traditional surgery might be suitable candidates for this trial. As an unphased trial, it offers patients access to innovative treatment options that may enhance their quality of life.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify whether you need to stop taking your current medications.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the TRiCares Topaz Tricuspid Valve Replacement System is safe?

Research has shown that transcatheter tricuspid valve replacement (TTVR) is generally safe for individuals with severe tricuspid regurgitation, a condition where the heart valve doesn't close properly. One study found a low risk of death shortly after the procedure, with a 1.37% chance of dying in the hospital and a 2.49% chance within 30 days.

Another study examined outcomes one year after the procedure and found that most patients experienced a significant reduction in the severity of their condition. However, about 14% of patients died within a year of undergoing TTVR. This indicates that while the procedure can be effective, there are risks, particularly over a longer period.

Overall, TTVR has demonstrated promising results in improving heart valve function with relatively low short-term risks, but like any medical procedure, it carries inherent risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatment for tricuspid regurgitation, which often involves open-heart surgery to repair or replace the valve, the Transcatheter Tricuspid Valve Replacement (TTVR) offers a minimally invasive alternative. Researchers are excited about this treatment because it uses the TRiCares Topaz Tricuspid Transcatheter Valve Replacement System, which can be delivered via catheter, potentially reducing recovery time and risk associated with major surgery. This method could make valve replacement more accessible to patients who are at high risk for surgical procedures.

What evidence suggests that the Transcatheter Tricuspid Valve Replacement is effective for tricuspid regurgitation?

Research has shown that Transcatheter Tricuspid Valve Replacement (TTVR), the treatment studied in this trial, holds promise for treating tricuspid regurgitation, a condition where the heart valve leaks. Studies have found that TTVR significantly reduces the severity of this leakage, with many patients improving from severe to mild symptoms. One study reported a low death rate in the hospital and within 30 days after the procedure, indicating that patients generally recover well. Another study found that a year after treatment, 86% of patients had moderate or less leakage. Overall, TTVR is associated with better heart function and higher survival rates. ^{2 3 6 7 8}

Who Is on the Research Team?

Susheel Kodali, MD

Principal Investigator

Columbia University Medical Center/ NewYork Presbyterian Hospital

Gorav Ailawadi

Principal Investigator

University of Michigan Hospital and Health Systems

Are You a Good Fit for This Trial?

This trial is for adults with severe tricuspid valve regurgitation, who are considered at high risk for surgery by a heart team. It's not suitable for those with anatomy that doesn't fit the device, involved in another study without reaching its main goal yet, needing urgent intervention or unstable.

Inclusion Criteria

I am 18 years old or older.

I have severe tricuspid regurgitation.

Institutional Heart Team evaluates patient as being at increased operative risk

Exclusion Criteria

Patient who is currently participating in another clinical investigation where the primary endpoint was not reached yet

My body cannot safely accommodate the study device due to its structure.

Patient in need of emergent intervention

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the TRiCares Topaz Tricuspid Transcatheter Valve Replacement System

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

5 years

Multiple visits at 30 days, 6 months, and annually

What Are the Treatments Tested in This Trial?

Interventions

• Transcatheter Tricuspid Valve Replacement

Trial Overview The study tests the TRiCares Topaz Tricuspid Valve Replacement System's safety and performance. It's a forward-looking study conducted across multiple centers where participants receive this new transcatheter heart valve replacement.

How Is the Trial Designed?

Group I: Transcatheter Tricuspid Valve Replacement Experimental Treatment 1 Intervention

Treatment with the TRiCares Topaz Tricuspid Transcatheter Valve Replacement System

Transcatheter Tricuspid Valve Replacement is already approved in United States, European Union for the following indications:

Approved in United States as Transcatheter Tricuspid Valve Replacement for:

• Severe tricuspid regurgitation
• Symptomatic tricuspid valve disease

Approved in European Union as Transcatheter Tricuspid Valve Replacement for:

• Severe tricuspid regurgitation
• Symptomatic tricuspid valve disease

Who Is Running the Clinical Trial?

TRiCares

Lead Sponsor

Trials

3

Recruited

110+

Published Research Related to This Trial

In a study of 28 patients with severe tricuspid regurgitation, the edge-to-edge transcatheter tricuspid valve repair (TTVr) successfully reduced tricuspid regurgitation by at least one grade in all patients, demonstrating high efficacy.

At three months post-procedure, 83% of patients improved to NYHA class I or II, and only one patient experienced a minor complication, indicating that TTVr is a safe and effective treatment option for severe tricuspid regurgitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Initial Results after the Implementation of an Edge-To-Edge Transcatheter Tricuspid Valve Repair Program. Cepas-Guillen, PL., de la Fuente Mancera, JC., Guzman Bofarull, J., et al.[2021]

Transcatheter tricuspid valve replacement (TTVR) was performed successfully in 46 high-risk patients with severe tricuspid regurgitation, achieving a procedural success rate of 97.8% and significantly reducing the severity of TR after 6 months.

The procedure demonstrated a favorable safety profile, with a 6-month mortality rate of 17.4% and a significant reduction in symptoms like peripheral edema and ascites, indicating improved patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcatheter tricuspid valve replacement in patients with severe tricuspid regurgitation. Lu, FL., An, Z., Ma, Y., et al.[2021]

Vaccine-induced prothrombotic immune thrombocytopenia is a very rare adverse event associated with viral vector COVID-19 vaccines, primarily affecting women under 60, leading to temporary pauses in vaccination campaigns for Vaxzevria and Janssen vaccines.

Despite these rare events, mRNA vaccines have been shown to be safe in post-marketing surveillance, with no increased reports of thrombotic events in individuals over 60, who are at higher risk for severe COVID-19 outcomes, indicating that vaccination should continue in this age group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Thrombotic events and COVID-19 vaccines. Brazete, C., Aguiar, A., Furtado, I., et al.[2023]

In a study of 17,483 patients undergoing aortic valve replacement (AVR), those with more severe tricuspid regurgitation (TR) experienced higher rates of morbidity and mortality, highlighting the risks associated with TR during AVR.

While tricuspid intervention during AVR did not significantly increase operative mortality, it was linked to a higher rate of major complications (51% vs 26%), suggesting that careful consideration is needed when deciding on tricuspid correction in these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of tricuspid regurgitation with and without repair during aortic valve replacement. Chancellor, WZ., Mehaffey, JH., Beller, JP., et al.[2021]

In a study of 22 patients with severe tricuspid regurgitation (TR), transcatheter tricuspid valve replacement (TTVR) led to significant reductions in liver and heart volumes after 6 months, indicating positive remodeling effects.

The left hepatic lobe volume decreased significantly, and there was a notable reduction in right atrial volume, suggesting that TTVR can effectively reverse the adverse effects of TR on hepatic and cardiac structures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of transcatheter tricuspid valve replacement for tricuspid regurgitation on hepatic, cardiac, and venous structure. Ning, X., Cao, J., Wang, W., et al.[2023]

The meta-analysis of 35 studies involving 5,316 patients found that the operative mortality rate for isolated surgical tricuspid valve replacement (TVR) was 12%, with higher risks for patients operated on before 1995, those with prior cardiac surgeries, or liver disease.

Common complications following surgical TVR included pacemaker implantation (10%), bleeding (12%), acute kidney injury (15%), and respiratory issues (15%), highlighting the need for careful patient selection and management in future transcatheter tricuspid valve replacement trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcomes of isolated tricuspid valve replacement: a systematic review and meta-analysis of 5,316 patients from 35 studies. Scotti, A., Sturla, M., Granada, JF., et al.[2023]

In a study of 80 patients with symptomatic tricuspid regurgitation treated with either the PASCAL or MitraClip-XTR device, both systems showed similar effectiveness in reducing TR severity, with 91% of PASCAL patients and 96% of MitraClip-XTR patients achieving at least a one-grade reduction at 30 days.

Both devices were found to be safe, with no periprocedural deaths and comparable 30-day and 3-month mortality rates, indicating that TTVR is a viable option for high-surgical-risk patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

PASCAL versus MitraClip-XTR edge-to-edge device for the treatment of tricuspid regurgitation: a propensity-matched analysis. Sugiura, A., Vogelhuber, J., Öztürk, C., et al.[2021]

The European Medicines Agency (EMA) effectively monitored COVID-19 vaccine safety by implementing enhanced surveillance and independent studies, which led to the rapid identification of safety signals like thrombosis with thrombocytopenia syndrome (TTS) and myocarditis/pericarditis.

The combination of spontaneous reporting and real-world data allowed for quick risk assessment and communication, highlighting the need for improved data collection methods across EU Member States to better evaluate vaccine safety in diverse populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety Monitoring of COVID-19 Vaccines: Perspective from the European Medicines Agency. Durand, J., Dogné, JM., Cohet, C., et al.[2023]

A total of 604,157 adverse events (AEs) were reported for COVID-19 vaccines, with the Pfizer-BioNTech and Moderna vaccines accounting for the majority of reports, indicating a need for ongoing safety monitoring.

While most reported AEs were mild, serious outcomes like hospitalization and life-threatening events were noted, particularly among older adults with pre-existing conditions, highlighting the importance of careful surveillance of vaccine safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Characteristics and Comparison of Adverse Events of Coronavirus Disease 2019 Vaccines Reported to the United States Vaccine Adverse Event Reporting System Between 14 December 2020 and 8 October 2021. Zou, C., Xue, X., Qian, J.[2022]

Transcatheter tricuspid valve replacement (TTVR) is a promising treatment for patients with severe tricuspid regurgitation, particularly those with significant annular dilation and large coaptation gaps, which are difficult to address with traditional surgery.

Most TTVR devices are still in early clinical development, but one device is currently in a pivotal trial, suggesting that TTVR could greatly improve outcomes and survival rates for these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Orthotopic Transcatheter Tricuspid Valve Replacement. Greenbaum, AB., Babaliaros, VC., Eng, MH.[2021]

A retrospective analysis of Vaccine Adverse Event Reporting System (VAERS) data revealed that embolic and thrombotic events (ETEs) were reported following COVID-19 vaccination, with a median onset time of 6 days for mRNA vaccines and 11 days for viral vector vaccines.

The study indicates that the type of COVID-19 vaccine influences the likelihood and timing of ETEs, suggesting that healthcare providers should monitor patients for these events based on the specific vaccine administered.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Trends in reporting embolic and thrombotic events after COVID-19 vaccination: A retrospective, pharmacovigilance study. Kan, Y., Asada, M., Uesawa, Y.[2022]

The expert panel confirmed a low incidence of mitral valve leaflet adverse events (LAE) at 2.0% in the EXPAND study, indicating that the MitraClip NTR/XTR device is safe for mitral valve repair.

Among the confirmed cases, most were single leaflet device attachments (SLDA), which were often resolved with additional clips, suggesting effective management of these events compared to older-generation devices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Incidence and standardised definitions of mitral valve leaflet adverse events after transcatheter mitral valve repair: the EXPAND study. Asch, FM., Little, SH., Mackensen, GB., et al.[2023]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40560107/

Early Outcomes of Real-World Transcatheter Tricuspid ... Conclusions: TR elimination following TTVR in a real-world setting was associated with significant symptom and end-organ functional improvement.

2. sciencedirect.com sciencedirect.com/science/article/pii/S2474870625003136

Clinical Outcomes Following Transcatheter Tricuspid Valve ... TTVR was associated with low in-hospital (1.37%) and 30-day (2.49%) mortality rates, with significant reduction in tricuspid regurgitation and improvement in ...

3. jacc.org jacc.org/doi/10.1016/j.jacc.2023.02.049

1-Year Outcomes of Transcatheter Tricuspid Valve Repair One-year postprocedure, TR severity significantly reduced (P < 0.001), with 31 of 36 (86.0%) patients achieving moderate or less TR; 100% had at ...

4. nejm.org nejm.org/doi/full/10.1056/NEJMe2413200

Early-Stage Results with Transcatheter Tricuspid-Valve ... The severity of regurgitation was reduced from severe (or greater) to mild or less in 95.3% of the patients, according to the assessment of the ...

5. eurjmedres.biomedcentral.com eurjmedres.biomedcentral.com/articles/10.1186/s40001-024-01947-9

Comparing outcomes of transcatheter tricuspid valve ... The TTVR group had better 2-years survival (75.8% and 48.4%, P = 0.019) and freedom from 2-years combined endpoint (61.5% vs 45.9%, P = 0.007) ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36531713/

Safety, efficacy, and clinical outcomes of transcatheter ... Using the LuX-Valve for TTVR to treat patients with severe TR is a feasible and relatively safe method with reliable clinical results.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12183386/

Efficacy and Safety of Transcatheter Tricuspid Valve ... [63], the 1‐year mortality rate was 14% among patients undergoing transcatheter tricuspid valve repair and replacement. Similarly, Buğan et al.

8. eurointervention.pcronline.com eurointervention.pcronline.com/article/transcatheter-valve-repair-of-tricuspid-regurgitation-1-year-outcomes-from-the-triclasp-study

Transcatheter valve repair of tricuspid regurgitation: 1-year ... Conclusions: The 1-year results of the TriCLASP study confirm the safety and effectiveness of T-TEER with the PASCAL system in patients with ≥severe TR.