150 Participants Needed

Tricuspid Valve Replacement for Tricuspid Regurgitation

Recruiting at 20 trial locations
SB
LS
JK
AF
Overseen ByAbbey Foote
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Medtronic Cardiovascular
Must be taking: Diuretics
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 1 JurisdictionThis treatment is already approved in other countries

Trial Summary

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, it mentions that participants must be symptomatic despite medical therapy, including a required diuretic, suggesting that some medications may need to be continued.

What data supports the effectiveness of the Intrepid TTVR System treatment for tricuspid regurgitation?

Research shows that transcatheter tricuspid valve replacement (TTVR) is a promising option for patients with severe tricuspid regurgitation, especially those at high risk for surgery. Studies suggest that TTVR can significantly improve the condition and survival of patients with this heart valve problem.12345

Is the Intrepid TTVR System safe for humans?

The Intrepid TTVR System, used for replacing the tricuspid valve in patients with severe tricuspid regurgitation, is considered a promising alternative to open-heart surgery. Studies suggest it is generally safe for high-risk patients, although specific safety data is still emerging.12346

How is the Intrepid TTVR System treatment different from other treatments for tricuspid regurgitation?

The Intrepid TTVR System is unique because it offers a minimally invasive alternative to open-heart surgery for treating tricuspid regurgitation, which is a condition with limited effective medical treatments and high surgical risks. This system is designed to replace the tricuspid valve without the need for traditional surgery, potentially reducing recovery time and complications.12346

What is the purpose of this trial?

The objective of this early feasibility study is to gain early clinical insight into the performance of the Intrepid transcatheter tricuspid valve replacement (TTVR) system intended for transfemoral access to deliver a self-expanding bioprosthetic valve within the tricuspid valve.

Eligibility Criteria

This trial is for people with moderate to severe heart valve disease (tricuspid regurgitation) who are still symptomatic despite medication. Candidates must be suitable for the Intrepid TTVR system and able to undergo a procedure through the thigh vein. They should commit to follow-up visits, have an acceptable risk level for valve surgery as assessed by their medical team, and not expect any non-heart related health issues to limit their life span under two years.

Inclusion Criteria

My doctors agree I need a new heart valve despite medication.
I have severe heart valve issues confirmed by heart scans.
My heart condition limits my physical activity.
See 4 more

Exclusion Criteria

I have stents or an IVC filter that might interfere with certain medical procedures.
Your heart's pumping ability, as measured by a special heart ultrasound, is less than 30%.
I have a heart valve issue due to carcinoid syndrome.
See 6 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo the transcatheter tricuspid valve replacement procedure using the Intrepid TTVR System

During Procedure

Follow-up

Participants are monitored for safety and effectiveness after the procedure, including assessment of adverse events and changes in NYHA Class and TR Grade

4 weeks

Treatment Details

Interventions

  • Intrepid TTVR System
Trial Overview The study tests the Intrepid transcatheter tricuspid valve replacement (TTVR) system's performance in replacing the heart's tricuspid valve via a leg vein without open-heart surgery. It aims to provide early clinical insights into how well this minimally invasive approach works.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Primary CohortExperimental Treatment1 Intervention
Device: Intrepid TTVR System

Intrepid TTVR System is already approved in United States for the following indications:

🇺🇸
Approved in United States as Intrepid TTVR System for:
  • Severe, symptomatic tricuspid regurgitation

Find a Clinic Near You

Who Is Running the Clinical Trial?

Medtronic Cardiovascular

Lead Sponsor

Trials
78
Recruited
37,300+

Geoff Martha

Medtronic Cardiovascular

Chief Executive Officer since 2020

Finance degree from Penn State University

Dr. Kendra J. Grubb

Medtronic Cardiovascular

Chief Medical Officer

MD from Emory University

Findings from Research

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]
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]

References

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]
Transcatheter tricuspid valve replacement in patients with severe tricuspid regurgitation. [2021]
PASCAL versus MitraClip-XTR edge-to-edge device for the treatment of tricuspid regurgitation: a propensity-matched analysis. [2021]
Orthotopic Transcatheter Tricuspid Valve Replacement. [2021]
Impact of transcatheter tricuspid valve replacement for tricuspid regurgitation on hepatic, cardiac, and venous structure. [2023]
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