Trillium™ Stent Graft for Tricuspid Regurgitation
Recruiting in Palo Alto (17 mi)
+11 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Innoventric LTD
Disqualifiers: Severe RV dysfunction, Kidney dysfunction, Liver cirrhosis, others
No Placebo Group
Approved in 1 Jurisdiction
Trial Summary
What is the purpose of this trial?Early Feasibility Study to evaluate the safety and performance of the Innoventric Trillium™ Stent Graft in the treatment of severe or greater tricuspid regurgitation (TR).
Do I need to stop my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.
What data supports the effectiveness of the Trillium™ Stent Graft treatment for tricuspid regurgitation?
While there is no direct data on the Trillium™ Stent Graft, similar treatments like the TRICENTO bicaval valved stent and the LuX-Valve have shown promising results in treating severe tricuspid regurgitation, improving patient symptoms and heart function. These treatments suggest that using stent grafts for tricuspid regurgitation can be effective and safe.
12345How is the Trillium™ Stent Graft treatment for tricuspid regurgitation different from other treatments?
The Trillium™ Stent Graft is unique because it offers a minimally invasive option for treating tricuspid regurgitation by using a stent graft to substitute the tricuspid valve function, unlike traditional open-heart surgery. This approach is similar to other emerging transcatheter interventions, but it specifically targets the tricuspid valve with a novel stent graft design.
14567Eligibility Criteria
This trial is for patients with severe tricuspid regurgitation (TR), a heart valve disease, who are in NYHA functional class III or IV, indicating advanced symptoms. Participants must have high central venous pressure and be ineligible for or have refused standard treatments, or remain symptomatic after such treatments.Inclusion Criteria
I am not eligible for or have refused standard surgery and remain symptomatic despite treatment.
Peak central venous pressure of ≥ 15mmHg
My heart condition severely limits my physical activity.
+1 more
Exclusion Criteria
I have moderate issues with my heart valves.
Thrombocytopenia (Platelet count< 100,000/mm3) or thrombocytosis (Platelet count > 750,000/mm3) within 14 days of the index procedure
In the opinion of the Investigator or the study eligibility committee, the patient's life expectancy < 12 months
+7 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Procedure
Transcatheter cross-caval tricuspid valve replacement with the Innoventric Trillium™ Stent Graft
1 day
1 visit (in-person)
Post-procedure Monitoring
Participants are monitored for immediate safety and device performance post-procedure
1 week
1 visit (in-person)
Follow-up
Participants are monitored for safety and effectiveness after treatment
5 years
Multiple visits at 1 month, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, and 5 years
Participant Groups
The Innoventric Trillium™ Stent Graft is being tested to see if it's safe and effective for treating severe TR. This early study will gather initial data on how well the device works when implanted in patients with this condition.
1Treatment groups
Experimental Treatment
Group I: Innoventric Trillium™ Stent GraftExperimental Treatment1 Intervention
Transcatheter cross-caval tricuspid valve replacement with the Innoventric Trillium™ Stent Graft
Trillium™ is already approved in European Union for the following indications:
🇪🇺 Approved in European Union as Trillium Stent Graft for:
- Severe or greater tricuspid regurgitation (TR)
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Ascension St. JohnDetroit, MI
Cardiovascular Institute of Los Robles Health SystemThousand Oaks, CA
Mayo Clinic Hospital (Rochester)Rochester, MN
Weill Cornell MedicineNew York, NY
More Trial Locations
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Who Is Running the Clinical Trial?
Innoventric LTDLead Sponsor
Innoventric Inc.Collaborator
References
4-Year Follow-Up after Transatrial Transcatheter Tricuspid Valve Replacement with the LuX-Valve. [2022]Tricuspid regurgitation (TR) has become one of the most common valve diseases. Patients with severe TR are often at high surgical mortality risk. Transcatheter tricuspid valve interventions have emerged as a promising alternative to open-heart surgery. The LuX-Valve is a novel radial force-independent transcatheter tricuspid valve replacement system. We presented here the first patient treated for symptomatic TR using the LuX-Valve replacement system in September 2018. Four-year follow-up outcomes suggested that the bioprosthesis was in normal function, with stable hemodynamics (mean transtricuspid gradient 2.55 mmHg) and the patient's clinical symptoms were significantly improved; thus indicating that it is a safe, effective, and satisfactory case of the LuX-Valve application in treating a patient with severe TR.
The Incraft stent graft for the treatment of abdominal aortic aneurysms: an iliac-friendly device with an effective conventional proximal sealing mechanism. [2022]The Incraft aortic stent graft (Cordis, Bridgewater, NJ, USA) is a trimodular endovascular stent graft with a conventional suprarenal active fixation specifically designed to overcome the anatomic limitation of small, stenotic, and tortuous iliac vessels.
Transcatheter Leaflet Strategies for Tricuspid Regurgitation TriClip and CLASP. [2021]Since the recognition of the impact of significant tricuspid regurgitation on the clinical course and mortality, intensive efforts have been made in identifying and developing individually suitable and catheter-based therapy strategies to offer those often older and multimorbid patients at high surgical risk safe, feasible, and efficacious treatment options with justifiable risk. Up to now, transcatheter edge-to-edge repair with leaflet approximation devices such as TriClip (Abbott, Santa Clara, CA, USA) and PASCAL Implant System (Edwards Lifesciences, Irvine, CA, USA) have been evaluated best and several clinical trials could prove safety, feasibility, and efficacy of said devices leading to their recent CE mark. However, further randomized controlled trial are pending and necessary to evaluate their impact on clinical course and outcome in comparison to established treatment recommendations.
Percutaneous caval stent valve implantation: investigation of an interventional approach for treatment of tricuspid regurgitation. [2010]Severe tricuspid regurgitation (TR) reduces cardiac output (CO) and increases central venous pressure leading to secondary organ dysfunction. To date, the open surgical approach is the only option to treat TR. Herein, we report our experience of treatment by percutaneous implantation of valved stents in the inferior vena cava (IVC) and superior vena cava (SVC) to substitute tricuspid valve function in a model of acute insufficiency.
Early Clinical Experience With the TRICENTO Bicaval Valved Stent for Treatment of Symptomatic Severe Tricuspid Regurgitation: A Multicenter Registry. [2022]Patients with severe tricuspid regurgitation present late and are often ineligible for surgery or transcatheter repair systems. Transfemoral venous implantation of a bicaval valved stent has been proposed as therapeutic option in selected patients. The aim of this study was to summarize the early procedural and clinical outcomes of the novel TRICENTO system for the treatment of patients with symptomatic severe tricuspid regurgitation.
A new approach to the interventional therapy of tricuspid regurgitation. [2022]Currently, there are no fully developed interventional approaches for the treatment of tricuspid regurgitation (TR). The aim of this study was to evaluate the feasibility of orthotopic interventional placement of a biological prosthetic valve in the tricuspid position by inserting, with a transvenous approach, a self-expandable valve-bearing stent into the right atrium. Based on findings of computerized tomography (CT), a model of the porcine right heart was obtained. A self-expanding vascular endoprosthesis, carrying a prosthetic heart valve, was reshaped to fit the superior vena cava and the tricuspid annulus. Fenestrations were created to allow blood flow from the inferior vena cava and coronary sinus. This new device ("tricuspid endoprosthesis": TE) was implanted operatively into the superior vena cava, right atrium, and tricuspid annulus in six pigs. CT demonstrated proper fitting of the device, and echocardiography demonstrated correct positioning and function of the TE. Five animals were successfully weaned from cardiopulmonary bypass. Autopsy confirmed correct positioning of the TE without major trauma to surrounding tissues. These findings demonstrate a complete interventional approach for treating TR.
Transcatheter Tricuspid Valve-in-Valve Implantation With a Novel Balloon Expandable Myval THV. [2021]The transcatheter tricuspid valve-in-valve implantation has not yet been clarified, and several case series have documented results in patients with tricuspid bioprosthetic valve degeneration who underwent transcatheter implantation of Edwards SAPIEN XT and SAPIEN 3 (Edwards Lifesciences, Irvine, CA) and Medtronic (Minneapolis, MN) valves. Here, we present the case of a patient with severe bioprosthetic tricuspid valve stenosis who was successfully treated with the transfemoral route through the 29-mm novel balloon expandable Myval transcatheter heart valve (Meril Life Sciences Pvt Ltd, Vapi, Gujarat, India) system.