TMVR for Mitral Valve Regurgitation
(APOLLO Trial)
Recruiting in Palo Alto (17 mi)
+90 other locations
Overseen byDavid Adams, MD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Medtronic Cardiovascular
Disqualifiers: Prior mitral procedure, others
No Placebo Group
Trial Summary
What is the purpose of this trial?Multi-center, global, prospective, non-randomized, interventional, pre-market trial. All subjects enrolled with receive the study device.
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 treatment Medtronic Intrepid Transcatheter Mitral Valve Replacement System (TMVR) for Mitral Valve Regurgitation?
Early studies suggest that the Medtronic Intrepid TMVR System may be effective for patients with severe mitral regurgitation (a condition where the heart's mitral valve doesn't close tightly, allowing blood to flow backward in the heart) who are not good candidates for surgery. The system is being tested against traditional surgical methods, and there is optimism about its potential to improve treatment for this condition.
12345Is the Intrepid TMVR system safe for humans?
The Intrepid TMVR system has been used in patients who are at high risk for traditional surgery, and early trials have been conducted to assess its safety. However, more studies are needed to fully understand the risks, including potential procedural invasiveness and long-term valve issues.
23678How is the Medtronic Intrepid TMVR System treatment different from other treatments for mitral valve regurgitation?
The Medtronic Intrepid TMVR System is unique because it offers a minimally invasive option for high-risk patients with mitral valve regurgitation who are not suitable for traditional surgery, using a transcatheter approach that can be delivered through transfemoral transseptal access.
12359Eligibility Criteria
This trial is for patients with severe symptoms of mitral valve regurgitation, who are considered unsuitable for standard treatments by a heart team. Candidates should not have had previous transcatheter mitral procedures, significant heart valve calcification, very weak heart pumping function (ejection fraction <30%), or be in need of urgent surgery.Inclusion Criteria
A team of heart specialists agrees I can't have standard heart valve treatments.
I have moderate to severe symptoms from a leaky heart valve.
Exclusion Criteria
My heart's pumping ability is very low.
I need surgery as soon as possible.
I have severe calcium buildup on my heart's mitral valve.
+3 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive the Medtronic Transcatheter Mitral Valve Replacement System (TMVR) for treatment of mitral regurgitation
Hospital stay (up to 30 days or until discharge)
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessments of mortality, heart failure hospitalization, and echocardiographic evaluations
1 year
Quality of Life Assessment
Participants' quality of life is assessed using SF-12 and KCCQ
3 months
Participant Groups
The trial is testing the Medtronic Intrepid Transcatheter Mitral Valve Replacement System (TMVR) on all enrolled subjects. It's a global study that's prospective and non-randomized, meaning everyone gets the new device without being compared to another group.
2Treatment groups
Experimental Treatment
Group I: Primary Cohort- TMVRExperimental Treatment1 Intervention
Treatment of mitral regurgitation with the Medtronic Transcatheter Mitral Valve Replacement System (TMVR)
Group II: Mitral Annular Calcification -TMVRExperimental Treatment1 Intervention
Treatment of mitral regurgitation with the Medtronic Transcatheter Mitral Valve Replacement System (TMVR)
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Morton PlantClearwater, FL
NYU Langone Medical CenterNew York, NY
Saint Francis HospitalRoslyn, NY
Massachusetts General HospitalBoston, MA
More Trial Locations
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Who Is Running the Clinical Trial?
Medtronic CardiovascularLead Sponsor
References
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.
2-Year Outcomes of Transcatheter Mitral Valve Replacement in Patients With Severe Symptomatic Mitral Regurgitation. [2022]Transcatheter mitral valve replacement (TMVR) is feasible for selected patients with severe mitral regurgitation (MR) who are poor candidates for valve surgery. Intermediate-term to long-term TMVR outcomes have not been reported.
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.
1-Year Outcomes Following Transfemoral Transseptal Transcatheter Mitral Valve Replacement: Intrepid TMVR Early Feasibility Study Results. [2023]High surgical risk may preclude mitral valve replacement in many patients. Transcatheter mitral valve replacement (TMVR) using transfemoral transseptal access is a novel technology for the treatment of mitral regurgitation (MR) in high-risk surgical patients.
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 with Intrepid. [2020]Transcatheter mitral valve replacement with the Intrepid device is intended for patients who need mitral valve replacement and who are at an increased risk for conventional surgery. The early published results of the early feasibility trial are reviewed as well as device design and the implant procedure. The Apollo trial is reviewed: a randomized trial of the Intrepid device versus conventional surgery including a single arm study for inoperable patients. The mitral valve structure, pathophysiology, and postimplant physiology pose unique hurdles for any transcatheter implant.
Randomized Trials Are Needed for Transcatheter Mitral Valve Replacement. [2021]Transcatheter mitral valve replacement (TMVR) is a new therapy for treating symptomatic mitral regurgitation (MR) and stenosis. The proposed benefit of TMVR is the predictable, complete elimination of MR, which is less certain with transcatheter repair technologies such as TEER (transcatheter edge-to-edge repair). The potential benefit of MR elimination with TMVR needs to be rigorously evaluated against its risks which include relative procedural invasiveness, need for anticoagulation, and chronic structural valve deterioration. Randomized controlled trials (RCTs) are a powerful method for evaluating the safety and effectiveness of TMVR against current standard of care transcatheter therapies, such as TEER. RCTs not only help with the assessment of benefits and risks, but also with policies for determining operator or institutional requirements, resource utilization, and reimbursement. In this paper, the authors provide recommendations and considerations for designing pivotal RCTs for first-in-class TMVR devices.
Transcatheter Mitral Valve Replacement for Native and Failed Bioprosthetic Mitral Valves. [2019]Transcatheter mitral valve replacement (TMVR) is a novel approach for treatment of severe mitral regurgitation. A number of TMVR devices are currently undergoing feasibility trials using both transseptal and transapical routes for device delivery. Overall experience worldwide is limited to fewer than 200 cases. At present, the 30-day mortality exceeds 30% and is attributable to both patient- and device-related factors. TMVR has been successfully used to treat patients with degenerative mitral stenosis (DMS) as well as failed mitral bioprosthesis and mitral repair using transcatheter mitral valve-in-valve (TMViV)/valve-in-ring (ViR) repair. These patients are currently treated with devices designed for transcatheter aortic valve replacement. Multicenter registries have been initiated to collect outcomes data on patients currently undergoing TMViV/ViR and TMVR for DMS and have confirmed the feasibility of TMVR in these patients. However, the high periprocedural and 30-day event rates underscore the need for further improvements in device design and multicenter randomized studies to delineate the role of these technologies in patients with mitral valve disease.