Innovalve Artificial Mitral Valve for Mitral Valve Regurgitation
(TWIST-EFS Trial)
Recruiting in Palo Alto (17 mi)
+5 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Innovalve Bio Medical Ltd.
Disqualifiers: Unsuitable anatomy, Inoperable, EF<25%
No Placebo Group
Approved in 2 Jurisdictions
Trial Summary
What is the purpose of this trial?This trial is testing a new device called the Innovalve mitral valve replacement system. It is designed for patients who need their mitral valve replaced due to severe damage. The device works by taking over the function of the damaged valve to ensure proper blood flow in the heart.
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.
What data supports the effectiveness of the Innovalve MR system, Innostay TMVR System, and Innovalve TMVR System treatment for mitral valve regurgitation?
Transcatheter mitral valve replacement (TMVR) has shown promise as a treatment for severe mitral regurgitation, especially in patients who are not suitable for traditional surgery. Early clinical experiences with TMVR, including the use of devices like the Tendyne prosthesis, suggest it can be a safe and effective alternative for high-risk patients.
12345Is the Innovalve Artificial Mitral Valve safe for humans?
There is no specific safety data available for the Innovalve Artificial Mitral Valve or its other names. However, early experiences with similar transcatheter mitral valve replacement (TMVR) systems have shown feasibility in high-risk patients, but more studies are needed to confirm safety.
24678How is the Innovalve MR system treatment different from other treatments for mitral valve regurgitation?
The Innovalve MR system is a type of transcatheter mitral valve replacement (TMVR), which is a newer treatment option for patients with severe mitral valve regurgitation who are at high risk for traditional surgery. Unlike conventional surgery, TMVR is less invasive and can be performed through a catheter, making it suitable for patients who cannot undergo open-heart surgery.
345910Eligibility Criteria
This trial is for individuals with severe, symptomatic mitral valve regurgitation who are at high risk for open-heart surgery. Participants must meet specific anatomical criteria and have a heart's ejection fraction (EF) of more than 25%.Inclusion Criteria
I am considered high risk for open-heart surgery.
My body meets the specific physical requirements.
I have serious symptoms from mitral valve leakage.
Exclusion Criteria
Your heart is not pumping blood effectively.
My body's structure makes me ineligible for the procedure.
My condition cannot be treated with surgery.
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants undergo mitral valve replacement with the Innovalve MR system
4 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
1 visit (in-person)
Participant Groups
The study is testing the Innovalve MR system, which is a new device designed to replace the mitral valve in the heart without needing open-heart surgery. The focus is on assessing its safety and how well it works.
1Treatment groups
Experimental Treatment
Group I: TreatmentExperimental Treatment1 Intervention
MV replacement with Innovalve MR system
Innovalve MR system is already approved in United States for the following indications:
🇺🇸 Approved in United States as Innovalve TMVR System for:
- Symptomatic moderate-severe and severe mitral regurgitation
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Cedars-SinaiLos Angeles, CA
NewYork-Presbyterian / Columbia UniversityNew York, NY
OhioHealth Research InstituteColumbus, OH
NYU Langone HealthNew York, NY
More Trial Locations
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Who Is Running the Clinical Trial?
Innovalve Bio Medical Ltd.Lead Sponsor
References
Comparison of mitral annulus geometry between patients with ischemic and non-ischemic functional mitral regurgitation: implications for transcatheter mitral valve implantation. [2019]Transcatheter mitral valve replacement (TMVR) is a new therapeutic option for high surgical risk patients with mitral regurgitation (MR). Mitral valve (MV) geometry quantification is of paramount importance for success of the procedure and transthoracic 3D echocardiography represents a useful screening tool. Accordingly, we sought to asses MV geometry in patients with functional MR (FMR) that would potentially benefit of TMVR, focusing on the comparison of mitral annulus (MA) geometry between patients with ischemic (IMR) and non ischemic mitral regurgitation (nIMR).
Transcatheter Mitral Valve Replacement: Insights From Early Clinical Experience and Future Challenges. [2020]Transcatheter mitral valve repair, particularly edge-to-edge leaflet repair, is a well-established alternative for patients with severe primary mitral regurgitation (MR) considered at high or prohibitive surgical risk. More recently, transcatheter mitral valve replacement (TMVR) has emerged as a potential therapeutic option for the treatment of severe MR. TMVR may offer some advantages over transcatheter repair by providing a more complete and reproducible MR reduction. Several devices are under preclinical and clinical evaluation, and the early experience with more than 100 patients has demonstrated the feasibility of TMVR. In this review, we describe the TMVR systems currently in development and the results obtained from early clinical experiences. We also discuss the main challenges in and future perspectives on this emerging field. Future studies with a much larger number of patients are needed to provide consistent safety and efficacy data on each of the TMVR systems.
Clinical outcomes of transcatheter mitral valve replacement: two-year results of the CHOICE-MI Registry. [2023]Transcatheter mitral valve replacement (TMVR) using dedicated devices is an alternative therapy for high-risk patients with symptomatic mitral regurgitation (MR).
Early Experience With New Transcatheter Mitral Valve Replacement. [2022]Transcatheter mitral valve replacement (TMVR) is a potential therapy for patients with symptomatic, severe mitral regurgitation (MR). The feasibility of this therapy remains to be defined.
Transcatheter Mitral Valve Replacement with Tendyne. [2020]Mitral regurgitation is the most commonly occurring valvular heart disease in developed countries. Transcatheter mitral valve replacement (TMVR) has emerged as a novel potential therapy for patients with severe mitral valve disease who are unsuitable candidates for conventional surgery or transcatheter edge-to-edge mitral repair. TMVR with the Tendyne prosthesis has shown potential at short-term follow-up to be an effective and safe treatment alternative for high-risk patients with severe mitral valve disease.
Transcatheter mitral valve replacement with Mi-thos system: First-in-human experience. [2023]Transcatheter mitral valve replacement (TMVR) has become an alternative for high-risk patients with severe mitral regurgitation (MR). The aim of this study was to evaluate the safety and feasibility of the Mi-thos TMVR system (NewMed Medical) for high-risk patients with severe MR.
Transcatheter Mitral Valve Replacement in Patients With Previous Aortic Valve Replacement. [2019]Transcatheter mitral valve replacement (TMVR) may mature to become a therapeutic option for high-risk patients with severe mitral regurgitation (MR), particularly in patients at high or prohibitive surgical risk. MR patients with preexisting aortic valve prosthesis have been excluded from most TMVR trials because of the potential risks of left ventricular outflow tract obstruction or interaction between the TMVR anchoring mechanism and the aortic prosthesis. We describe the procedural and short-term outcomes of transapical TMVR with the Tiara valve in patients experiencing severe symptomatic MR with previous aortic valve replacement (AVR).
Transcatheter Mitral Valve Replacement With the Transseptal EVOQUE System. [2021]The aim of this study was to examine the initial experience with a novel transseptal transcatheter mitral valve replacement (TMVR) system.
Transcatheter transseptal treatment of patients with severe mitral regurgitation using an atrial fixation mitral valve replacement technology. [2023]Mitral regurgitation (MR) is the most common valvular heart disease worldwide with a 5-year mortality rate of 50 % with medical therapy alone. Several transcatheter mitral valve replacement (TMVR) devices are being investigated in clinical trials. Early evidence has demonstrated clinical benefits with a reduction in heart failure symptoms, low rates of residual MR, and reverse remodeling of the left ventricle (LV) over time. However, high anatomical screen failure rates limit its applicability. The primary reasons for the anatomical screen failure are risk of LV outflow tract obstruction, large mitral valve annulus size, and the presence of mitral annular calcification. Our clinical experiences using an atrial only fixation TMVR technology delivered via a transfemoral-transseptal approach is described.
Latest Advances in Transcatheter Mitral Valve Replacement. [2022]Mitral regurgitation (MR) is the most prevalent valvular heart disease globally. Mitral valve surgery is the gold-standard treatment for MR. However, a significant portion of patients with mitral valve disease are at high or prohibitive surgical risk. Transcatheter mitral valve replacement (TMVR) has emerged as a potential treatment option for this vulnerable population. Numerous TMVR devices are currently being investigated, with early data demonstrating feasibility and efficacy of TMVR. In this article, we explore the unique challenges of designing a TMVR system and describe the TMVR systems under clinical evaluation.