10 Participants Needed

Tricuspid Valve Replacement for Tricuspid Regurgitation

(TRICURE EFS Trial)

Recruiting at 7 trial locations
EG
Overseen ByEsther Gerteis
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 2 JurisdictionsThis treatment is already approved in other countries

Trial Summary

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 data supports the idea that Tricuspid Valve Replacement for Tricuspid Regurgitation is an effective treatment?

The available research shows that Tricuspid Valve Replacement (TTVR) is a promising treatment for severe tricuspid regurgitation, especially in high-risk patients. It is considered safer than traditional surgery, which has high risks. TTVR is expected to improve survival rates and effectively address the heart valve issues caused by tricuspid regurgitation. While still in early development, TTVR is seen as a significant advancement compared to other treatments.12345

What data supports the effectiveness of the treatment Transcatheter Tricuspid Valve Replacement for Tricuspid Regurgitation?

Research shows that Transcatheter Tricuspid Valve Replacement (TTVR) is a promising treatment for severe tricuspid regurgitation, especially in high-risk patients who cannot undergo surgery. Early studies suggest that TTVR can significantly improve survival and address the heart valve issues effectively.12345

What safety data exists for Tricuspid Valve Replacement for Tricuspid Regurgitation?

The provided research does not contain any safety data specific to Tricuspid Valve Replacement for Tricuspid Regurgitation or its related terms such as Transcatheter Tricuspid Valve Replacement or TTVR. The studies focus on mitral valve procedures and COVID-19 vaccine safety, which are unrelated to the tricuspid valve treatment in question.678910

Is Transcatheter Tricuspid Valve Replacement a promising treatment for tricuspid regurgitation?

Yes, Transcatheter Tricuspid Valve Replacement (TTVR) is a promising treatment for tricuspid regurgitation. It is emerging as a new option for patients, especially those who are at high risk for traditional surgery. TTVR is seen as a safer and effective alternative to open-heart surgery, and it may help improve heart and liver function in patients with this condition.1231112

How is the treatment Transcatheter Tricuspid Valve Replacement (TTVR) different from other treatments for tricuspid regurgitation?

Transcatheter Tricuspid Valve Replacement (TTVR) is unique because it offers a less invasive alternative to open-heart surgery for treating tricuspid regurgitation, which is a condition with limited effective medical treatments and high surgical risks. Unlike traditional surgical methods, TTVR is performed through a catheter, reducing recovery time and potentially lowering the risk of complications.1231112

What is the purpose of this trial?

Prospective, multi-center study to assess safety and performance of the TRiCares Topaz Tricuspid Valve Replacement System

Research Team

Susheel Kumar Kodali, MD ...

Susheel Kodali, MD

Principal Investigator

Columbia University Medical Center/ NewYork Presbyterian Hospital

Gorav Ailawadi, M.B.A., M.D. - BME

Gorav Ailawadi

Principal Investigator

University of Michigan Hospital and Health Systems

Eligibility Criteria

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 have severe tricuspid regurgitation.
I am 18 years old or older.
Institutional Heart Team evaluates patient as being at increased operative risk

Exclusion Criteria

My body cannot safely accommodate the study device due to its structure.
Patient who is currently participating in another clinical investigation where the primary endpoint was not reached yet
Patient in need of emergent intervention
See 1 more

Timeline

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

Treatment Details

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.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Transcatheter Tricuspid Valve ReplacementExperimental Treatment1 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

Find a Clinic Near You

Who Is Running the Clinical Trial?

TRiCares

Lead Sponsor

Trials
3
Recruited
110+

Findings from Research

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

References

Transcatheter tricuspid valve replacement in patients with severe tricuspid regurgitation. [2021]
Initial Results after the Implementation of an Edge-To-Edge Transcatheter Tricuspid Valve Repair Program. [2021]
Outcomes of isolated tricuspid valve replacement: a systematic review and meta-analysis of 5,316 patients from 35 studies. [2023]
Orthotopic Transcatheter Tricuspid Valve Replacement. [2021]
Impact of tricuspid regurgitation with and without repair during aortic valve replacement. [2021]
Incidence and standardised definitions of mitral valve leaflet adverse events after transcatheter mitral valve repair: the EXPAND study. [2023]
Trends in reporting embolic and thrombotic events after COVID-19 vaccination: A retrospective, pharmacovigilance study. [2022]
Safety Monitoring of COVID-19 Vaccines: Perspective from the European Medicines Agency. [2023]
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. [2022]
Thrombotic events and COVID-19 vaccines. [2023]
PASCAL versus MitraClip-XTR edge-to-edge device for the treatment of tricuspid regurgitation: a propensity-matched analysis. [2021]
Impact of transcatheter tricuspid valve replacement for tricuspid regurgitation on hepatic, cardiac, and venous structure. [2023]
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