TricValve System for Tricuspid Regurgitation
(TRICAV-I Trial)
Recruiting in Palo Alto (17 mi)
+26 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: P+F Products + Features USA Inc.
Must be taking: Diuretics
Disqualifiers: Recent MI, Stroke, Severe renal insufficiency, others
No Placebo Group
Trial Summary
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.
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.
12345What 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.
12367How 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.
12347Eligibility 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.
+4 more
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.
+6 more
Trial 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
Participant Groups
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.
1Treatment groups
Experimental Treatment
Group I: TricValve® Device (Device) GroupExperimental Treatment1 Intervention
subjects will undergo TricValve® implantation and will continue to be managed with optimal medical therapies, per physician discretion.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Lahey Hospital & Medical CenterBurlington, MA
Columbia University Irving Medical CenterIrving, NY
Northshore Evanston HospitalEvanston, IL
Ascension Medical Group St. Vincent The Heart Center of IndianaIndianapolis, IN
More Trial Locations
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Who Is Running the Clinical Trial?
P+F Products + Features USA Inc.Lead Sponsor
Meditrial USA Inc.Collaborator
P+F Products + Features GmbHIndustry Sponsor
Meditrial USA Inc.Industry Sponsor
References
Bicaval Transcatheter Prosthesis Implantation for Treatment of Tricuspid Regurgitation: First Report of Thrombosis. [2023]The transcatheter bicaval valve system is an emerging therapeutic option for tricuspid regurgitation, consisting of 2 biological valves to prevent caval reflux. The experience with this device is still scarce, and to the best of our knowledge, this is the first case of thrombosis ever reported. (Level of Difficulty: Advanced.).
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.
First-in-man implantation of the Tricento transcatheter heart valve for the treatment of severe tricuspid regurgitation. [2019]Here we describe the first implantation of the novel bicavally anchored Tricento transcatheter heart valve via the transvenous transfemoral access in a 74-year-old woman with severe tricuspid regurgitation and holosystolic hepatic vein backflow. Following successful implantation, caval vein regurgitant volume was reduced leading to symptomatic and clinical improvement at three-month follow-up. The Tricento device represents a promising, novel therapeutic option for patients with severe tricuspid regurgitation who are not candidates for open heart surgery.
Bicaval TricValve Implantation in Patients With Severe Symptomatic Tricuspid Regurgitation: One-Year Follow-Up Outcomes. [2023]Several orthotopic transcatheter strategies have been developed to treat severe tricuspid regurgitation (TR); however, many patients are deemed unsuitable. Caval valve implantation with the TricValve system addresses this unmet need.
1-Year Outcomes of Transcatheter Tricuspid Valve Repair. [2023]Surgical management of isolated tricuspid regurgitation (TR) is associated with high morbidity and mortality, thereby creating a significant need for a lower-risk transcatheter solution.
Early Single-Site Experience With Transcatheter Tricuspid Valve Replacement. [2020]This study presents a single-site experience of 5 patients with severe tricuspid regurgitation (TR) who underwent implantation of a novel transcatheter tricuspid valve replacement device.
Transcatheter tricuspid valve implantation with the Cardiovalve system. [2022]Historically considered the 'forgotten valve', there has been increasing attention on the percutaneous transcatheter treatment of tricuspid regurgitation (TR). Prevalence of TR is high in the elderly population and prior studies have shown worse outcomes in patients with severe TR. Advances in transcatheter-based therapies have shed a new light in the treatment of TR and one such treatment option is tricuspid valve replacement with the Cardiovalve system. This device is approved as an early feasibility study in the US and also approved for clinical study in Germany, Italy and Switzerland. The Cardiovalve device is in the early stage of clinical studies and this article reviews the existing clinical data and future studies on percutaneous transcatheter treatment of severe TR.