Transcatheter Valve Intervention for Tricuspid Regurgitation
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Jenscare Innovation Inc.
Must be taking: Diuretics
Must not be taking: Antiplatelets, Anticoagulants
Disqualifiers: Low LVEF, Pulmonary hypertension, others
No Placebo Group
Approved in 3 Jurisdictions
Trial Summary
What is the purpose of this trial?The LuX-Valve Plus System is intended for the treatment of patients with at least severe TR who are symptomatic and determined by a Heart Team not to be suitable for surgical treatment. This study aims to assess the safety and effectiveness of the LuX-Valve Plus System in high-surgical risk patients with at least severe tricuspid regurgitation (TR).
Do I need to stop my current medications for the trial?
The trial protocol does not specify if you need to stop taking your current medications. However, you must be on an optimal dosage of diuretics as determined by the investigator.
What data supports the effectiveness of the treatment LuX-Valve Plus System for tricuspid regurgitation?
Research shows that the LuX-Valve treatment significantly improved symptoms in patients with severe tricuspid regurgitation, with most patients experiencing reduced valve leakage and better heart function. In a study, 11 out of 12 patients had successful outcomes, and their quality of life improved without major complications.
12345Is the LuX-Valve system safe for treating tricuspid regurgitation?
The LuX-Valve system has been shown to be generally safe for treating severe tricuspid regurgitation, with studies reporting successful procedures and significant improvement in patients' symptoms. In a study of 12 patients, there were no device-related complications, and most patients experienced improved quality of life.
12367How is the LuX-Valve Plus treatment different from other treatments for tricuspid regurgitation?
The LuX-Valve Plus is unique because it is a transcatheter valve replacement system that does not rely on radial force, making it a promising alternative for patients who are at high risk for open-heart surgery. It is implanted through a minimally invasive approach, which can significantly improve symptoms and quality of life for patients with severe tricuspid regurgitation.
12358Eligibility Criteria
This trial is for adults over 18 with severe heart murmur or tricuspid valve regurgitation, who are symptomatic but considered unsuitable for surgery by a Heart Team. They must understand the study and consent to participate, be on stable diuretic medication, and have their condition confirmed by specialized labs.Inclusion Criteria
I am 18 years old or older.
My heart valve leak is severe or worse, confirmed by an echo.
My heart condition limits my physical activity.
+4 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive the LuX-Valve Plus System for the treatment of severe tricuspid regurgitation
1 day
1 visit (in-person)
Follow-up
Participants are monitored for safety and effectiveness after treatment
30 days
1 visit (in-person) at 30 days post-procedure
Extended Follow-up
Participants are monitored for long-term safety and effectiveness
1 year
1 visit (in-person) at 1 year post-procedure
Participant Groups
The LuX-Valve Plus System is being tested in this trial. It's a non-surgical procedure designed to replace the tricuspid valve through a vein (transcatheter intervention) in patients at high risk from traditional surgery.
1Treatment groups
Experimental Treatment
Group I: : LuX-Valve Plus transvenous tricuspid valve and delivery system(LuX-Valve Plus System)Experimental Treatment1 Intervention
The LuX-Valve Plus System is intended for the treatment of patients with severe TR who are determined by a Heart Team to be at high risk of traditional open-heart surgery.
LuX-Valve Plus System is already approved in China, United States, European Union for the following indications:
🇨🇳 Approved in China as LuX-Valve Plus for:
- Severe tricuspid regurgitation (TR)
🇺🇸 Approved in United States as LuX-Valve Plus for:
- Severe tricuspid regurgitation (TR)
🇪🇺 Approved in European Union as LuX-Valve Plus for:
- Severe tricuspid regurgitation (TR)
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Montefiore Medical CenterNew York, NY
Loading ...
Who Is Running the Clinical Trial?
Jenscare Innovation Inc.Lead Sponsor
Cardiovascular Research Foundation, New YorkCollaborator
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.
[Safety and efficacy of transcatheter tricuspid valve replacement with LuX-Valve in patients with severe tricuspid regurgitation]. [2021]Objectives: To evaluate the safety and efficacy of LuX-Valve on the treatment of severe tricuspid regurgitation (TR). Methods: This is a prospective observational study. From September 2018 to March 2019, 12 patients with severe TR, who were not suitable for surgery, received LuX-Valve implantation in Changhai Hospital. LuX-Valve was implanted under general anesthesia and the guidance of transesophageal echocardiography and X-ray fluoroscopy. Access to the tricuspid valve was achieved via a minimally invasive thoracotomy and transatrial approach. Main endpoints were surgery success and device success. Surgery success was defined as successful implanting the device and withdrawing the delivery system, positioning the valve correctly and stably without severe or life-threatening adverse events. Device success was defined as satisfied valve function (TR severity reduction ≥ 2 grades, tricuspid gradient ≤ 6 mmHg (1 mmHg=0.133 kPa)), absence of malposition, valve failure and reintervention, major adverse events including device related mortality, embolization, conduction system disturbances and new onset shunt across ventricular septum at day 30 post implantation. Results: A total of 12 patients with severe to torrential TR were included in this study. The age was (68.5±6.9) years and 7 were female. All patients had typical right heart failure symptoms. Procedural success was achieved in all cases, there was no intraprocedural mortality or transfer to open surgery. TR significantly improved after LuX-Valve implantation (none/trivial in 8 patients, mild in 3 patients and moderate in 1 patient). The average device time was (9.2±4.2) minutes. Intensive care unit duration was 3.0 (2.0, 4.8) days. One patient died at postoperative day 18 due to non-surgery and device reasons. Transthoracic echocardiography at 30 days after operation showed that TR was significantly reduced (none/trivial in 8 patients, mild in 2 patients and moderate in 1 patient) and device success was achieved in 11 cases. All survived patients experienced a significant improvement in life quality with significantly improvement in New York Heart Association (NYHA) classification (Ⅰ and Ⅱ: 6/11 post operation vs. 0/11 before operation, P=0.012) and there were no device related complications in this patient cohort. Conclusions: LuX-Valve implantation is feasible, safe and effective for the treatment of patients with severe TR.
Hemodynamics of transcatheter tricuspid valve replacement with Lux-Valve. [2022]Transcatheter tricuspid valve intervention (TTVI) has emerged as an alternative treatment option for high-risk and inoperable patients with symptomatic tricuspid regurgitation (TR). However, scarce data in hemodynamic profiles were available on TTVI. In this paper, we attempt to report the hemodynamic profiles of LuX-Valve.
[Transcatheter Treatment of Severe Tricuspid Regurgitation]. [2020]Transcatheter Treatment of Severe Tricuspid Regurgitation Abstract. Severe tricuspid regurgitation can lead to increased morbidity and mortality due to clinical symptoms and impairment of organ function. With the emergence of new interventional treatment options, the once neglected tricuspid valve is receiving increased attention. The following article intends to provide an overview of the causes, diagnostic modalities, and therapeutic options of severe tricuspid regurgitation.
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.
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.
Compassionate Use of the PASCAL Transcatheter Valve Repair System for Severe Tricuspid Regurgitation: A Multicenter, Observational, First-in-Human Experience. [2020]The purpose of this observational first-in-human experience was to investigate the feasibility and safety of the PASCAL transcatheter valve repair system and its impact on short-term clinical outcomes in patients with severe tricuspid regurgitation (TR).
[Current technologies in interventional treatment of tricuspid valve regurgitation]. [2021]For a long time, severe tricuspid valve regurgitation (TR) was an underestimated disease, especially in the older population and was associated with high morbidity and mortality. Due to the high perioperative mortality of tricuspid valve surgery, historically only pharmaceutical treatment was a practical treatment option. In the first studies interventional approaches could achieve promising results with an effective reduction of TR with simultaneous proof of a convincing safety profile. Conceptually, the currently available interventional treatment options can be divided into three concepts: coaptation systems (edge-to-edge repair), annuloplasty and interventional valve replacement. The largest clinical experience and best scientific body of evidence could so far be generated in the field of coaptation systems. Very promising preliminary results with effective reduction of TR and improvement of the clinical symptoms are, however, also available for interventional valve replacement. Meticulous preprocedural diagnostics with selection of the most suitable treatment option for each individual patient is paramount for successful treatment in this critically ill patient cohort. Future prospective randomized studies will investigate the net benefit of an interventional treatment of TR in comparison to a purely conservative treatment concept.