CardioMech MVRS for Mitral Valve Regurgitation
Recruiting in Palo Alto (17 mi)
+10 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: CardioMech AS
Disqualifiers: Rheumatic heart disease, Prior endocarditis, Others
No Placebo Group
Trial Summary
What is the purpose of this trial?
This trial is testing a new device called the CardioMech Mitral Valve Repair System (MVRS) to help patients with a leaky heart valve who are at high risk for surgery. The device aims to fix the valve and improve heart function without needing open-heart surgery. The HARPOON Beating Heart Mitral Valve Repair System (MVRS) has shown it can safely and effectively repair the heart valve while the heart is still beating.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of the CardioMech MVRS treatment for Mitral Valve Regurgitation?
Is the CardioMech MVRS safe for humans?
The safety of transcatheter mitral valve replacement (TMVR) systems, like the CardioMech MVRS, has been evaluated in various studies. Some risks include complications such as left ventricular outflow tract obstruction, device dislocation, and bleeding, but recent studies suggest that these systems have acceptable safety profiles for high-risk patients.16789
How is the CardioMech MVRS treatment different from other treatments for mitral valve regurgitation?
The CardioMech MVRS is a minimally invasive treatment for mitral valve regurgitation that uses a catheter to repair the valve, offering a safer alternative to traditional open-heart surgery. This approach can lead to better outcomes, shorter hospital stays, and lower mortality rates, especially for patients at high surgical risk.110111213
Eligibility Criteria
This trial is for adults with moderate to severe mitral valve regurgitation due to prolapse or flail, who are at intermediate or high risk for surgical repair. It's not suitable for those with a history of heart infections, previous mitral valve surgeries, rheumatic heart disease, severely calcified leaflets that prevent device placement, or complex MR mechanisms.Inclusion Criteria
I am at a moderate to high risk for complications from mitral valve surgery.
I am 18 years old or older.
My heart valve leaks severely due to a prolapse or flail.
Exclusion Criteria
Your mitral valve has too much calcium buildup, making it difficult for the device to be positioned and placed properly.
I have had surgery on my heart's mitral valve or a device installed in my heart.
I have had rheumatic heart disease.
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Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive the CardioMech Mitral Valve Repair System (MVRS) for mitral valve repair
Not specified
Follow-up
Participants are monitored for safety and effectiveness after treatment
6 months
Treatment Details
Interventions
- CardioMech MVRS (Mitral Valve Repair System)
Trial OverviewThe CardioMech Mitral Valve Repair System (MVRS) is being tested in this trial. The MVRS aims to safely and effectively treat degenerative mitral valve regurgitation without the need for traditional surgery.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: CardioMech Mitral Valve Repair System (MVRS)Experimental Treatment1 Intervention
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
The Christ HospitalCincinnati, OH
CentraCare Heart & Vascular CenterSt. Cloud, MN
NYU LangoneNew York City, NY
Intermountain Medical CenterMurray, UT
More Trial Locations
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Who Is Running the Clinical Trial?
CardioMech ASLead Sponsor
References
PASCAL-based mitral valve repair in an all-comer population: acute and mid-term clinical results. [2021]We investigated short and mid-term safety and efficacy of the PASCAL system for percutaneous mitral valve repair (PMVr) in severe mitral regurgitation (MR) in an all-comer population.
[Mitral valve repair for mitral regurgitation--15 year results]. [2014]Mitral valve repair (MVR) for mitral regurgitation (MR) has many advantages over mitral valve replacement. However, durability and reoperations after repair still remain major problems. The aim of our study was to analyze the outcome of MVR and to determine the significant risk factors for death and reoperations.
Evaluation of mitral valve repair by intraoperative transoesophageal echocardiography. [2019]Mitral valve repair is the procedure of choice in the surgical management of mitral regurgitation. Intraoperative confirmation of successful repair is essential to the effectiveness of this procedure.
Transcatheter Mitral Valve Implantation with the Medtronic Intrepid™ Transcatheter Mitral Valve Replacement System. [2020]Mitral regurgitation is the most prevalent yet undertreated valvulopathy despite its adverse prognosis. With the emergence of transcatheter mitral interventions, the potential for this huge unmet disease burden to be addressed may finally be realized. Medtronic Intrepid™ Transcatheter Mitral Valve Replacement System represents one of several novel solutions. Based on early data from the pilot study, its efficacy and clinical utility is currently being tested against the mainstay treatment of surgical mitral valve replacement in a randomized trial. While there remain significant challenges before transcatheter mitral intervention can become part of the routine treatment algorithm, the authors are optimistic that transcatheter mitral valve repair and intervention have the potential in revolutionizing the management of severe symptomatic mitral regurgitation.
Emerging trends in heart valve engineering: Part III. Novel technologies for mitral valve repair and replacement. [2015]In this portion of an extensive review of heart valve engineering, we focus on the current and emerging technologies and techniques to repair or replace the mitral valve. We begin with a discussion of the currently available mechanical and bioprosthetic mitral valves followed by the rationale and limitations of current surgical mitral annuloplasty methods; a discussion of the technique of neo-chordae fabrication and implantation; a review the procedures and clinical results for catheter-based mitral leaflet repair; a highlight of the motivation for and limitations of catheter-based annular reduction therapies; and introduce the early generation devices for catheter-based mitral valve replacement.
[Initial experience of treating patients with severe mitral regurgitation with transcatheter mitral valve edge-to-edge repair in China]. [2013]To evaluate the safety and efficacy and summarize the initial experience of transcatheter mitral valve repair (TMVR) for treating Chinese patients with severe mitral regurgitation.
Balloon assisted translocation of the mitral anterior leaflet to prevent left ventricular outflow obstruction (BATMAN): A novel technique for patients undergoing transcatheter mitral valve replacement. [2020]Transcatheter mitral valve replacement (TMVR) is an option for patients at high risk for mitral valve replacement or repair via sternotomy or left thoracotomy approach. TMVR carries up to 22% risk of left ventricular outflow tract (LVOT) obstruction. Severe LVOT obstruction can have devastating hemodynamic and clinical consequences.
Predictors of adverse outcomes after transcatheter mitral valve replacement. [2019]Introduction: Transcatheter mitral valve replacement (TMVR) is still a recent technology with numerous unknowns but also great promises. The risk of complications reported in observational studies have limited its adoption by interventional cardiology and surgical communities. Areas covered: Some of the major setbacks of TMVR are complications related to the devices and those related to the pathway. Device-related complications include left ventricle outflow tract (LVOT) obstruction, transcatheter heart valve (THV) dislocation or embolization, thrombosis, and stroke. The transapical approach currently remains the main pathway for TMVR but is associated with high risk of major bleeding and residual apical myocardial scarring. Complication prediction and prevention seem possible. Device-related complication prediction is based on pre-operative imaging including multi-slice computed tomography with 3-dimensional reconstructions and echocardiography which allow LVOT obstruction prediction and appropriate sizing aiming at avoiding dislocation. Industry should aim at the development of transfemoral delivery systems. Nevertheless, several recent feasibility observational studies suggested acceptable safety and efficacy of transcatheter mitral valve replacement. Expert opinion: TMVR complications and transapical delivery are some of the main setbacks which need to be addressed for TMVR to be adopted for broad clinical use.
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: An Alternate Treatment Methodology for Patients at High Surgical Risk. [2020]Mitral valve regurgitation (MVR) is the reverse passage of blood through the mitral valve when the valve fails to close during ventricle contraction. Transcatheter mitral valve repair and replacement (TMVR) is a recent technology that can benefit MVR patients as an alternative, minimally invasive, and safer solution than conventional open-heart surgical approaches. TMVR uses a catheter guided by ultrasonography to replace or repair the defective valve and has provided better clinical outcomes, decreased hospital stay, and reduced mortality rates. Therefore, TVMR should be made possible worldwide, especially in South-Asian regions where heart conditions such as atrial fibrillation and stroke are major contributing factors in a high postoperative mortality rate.
Transcatheter mitral repair according to the cause of mitral regurgitation: real-life data from the Spanish MitraClip registry. [2021]Transcatheter mitral valve repair (TMVR) with MitraClip is a therapeutic option for high surgical risk patients with severe mitral regurgitation (MR). The main objective of this study was to analyze differences in outcomes in patients with severe MR according to the cause of MR.
Impact of MitraClip™ therapy on secondary mitral valve surgery in patients at high surgical risk. [2022]Conventional or minimally invasive surgical mitral valve repair (MVR) is the gold-standard treatment for severe mitral regurgitation (MR) of any etiology. Given its good safety profile, trans-catheter MVR with the MitraClip™ device is used increasingly for high-risk or inoperable patients. We report our experience with failed MitraClip™ therapy and its impact on subsequent surgical strategies, such as the feasibility of MVR in high-risk patients.
Functional and hemodynamic results after transcatheter mitral valve leaflet repair with the PASCAL device depending on etiology in a real-world cohort. [2022]The PASCAL system (Edwards Lifescience, Irvine, CA, USA) is a novel device for edge-to-edge treatment of mitral regurgitation (MR). The aim of our study was to examine the functional and hemodynamic outcome after repair of functional (FMR) and degenerative mitral regurgitation (DMR) using the PASCAL system in a real-world setting.