Siegel TAVR Device for Aortic Stenosis
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new device called the Siegel TAVR System to evaluate its safety and effectiveness for individuals with severe aortic stenosis, a condition where the heart valve narrows, causing symptoms like chest pain or shortness of breath. Participants will receive either the Siegel TAVR device or a standard valve replacement device for comparison. The trial seeks individuals who need aortic valve replacement due to severe symptoms and whose doctors have deemed them suitable for TAVR (Transcatheter Aortic Valve Replacement). As an unphased trial, it offers participants the chance to contribute to innovative research that could enhance future treatment options.
What prior data suggests that the Siegel TAVR System is safe for treating aortic stenosis?
Research has shown that the Siegel TAVR System is promisingly safe for treating aortic stenosis. In an earlier study, no patients died, had strokes, or needed to return to the hospital within 30 days after the procedure. Additionally, no major blood vessel problems or significant leaks around the new valve occurred. These results suggest that the Siegel TAVR System is generally well-tolerated in the short term. However, like any medical procedure, risks remain, and long-term safety is still under investigation.12345
Why do researchers think this study treatment might be promising for aortic stenosis?
The Siegel TAVR System is unique because it offers a new approach to treating aortic stenosis. It distinguishes itself from current TAVR options like Sapien and Evolute by potentially enhancing the precision and safety of the procedure. Researchers are excited about this treatment because it may provide better outcomes for patients by reducing complications associated with traditional TAVR devices, potentially leading to quicker recovery times and improved heart function. These advancements could make the Siegel TAVR System a game-changer in heart valve replacement therapy.
What evidence suggests that the Siegel TAVR System is effective for aortic stenosis?
This trial will compare the investigational Siegel TAVR System with commercially available TAVR devices, such as the Sapien TAVR or Evolute TAVR. Studies have shown that Transcatheter Aortic Valve Replacement (TAVR) effectively treats aortic stenosis, a condition where the heart's aortic valve narrows and reduces blood flow. Research indicates that the Siegel TAVR System shows promise, with a high success rate and no reports of deaths, strokes, or rehospitalizations in early studies. At 30 days post-procedure, patients did not experience major complications, such as blood vessel problems or severe leaks around the valve. TAVR treatments have proven to be safe and life-saving, with results similar to traditional surgery.23678
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive the Siegel TAVR or a commercially available TAVR device
Follow-up
Participants are monitored for safety and effectiveness after the TAVR procedure
What Are the Treatments Tested in This Trial?
Interventions
- Siegel TAVR System
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Investigational Device- Siegel TAVR
Commercially available TAVR device- Sapien TAVR or Evolute TAVR
Find a Clinic Near You
Who Is Running the Clinical Trial?
MiRus
Lead Sponsor
Citations
Innovations in TAVR: The Latest in Device Technology - PMC
Transcatheter aortic valve replacement (TAVR) has become a well-established treatment for aortic stenosis, offering outcomes comparable to surgical aortic valve ...
NCT02628899 | Feasibility of Transcatheter Aortic Valve ...
Primary Efficacy Endpoint: All-cause mortality at 30 days following transfemoral TAVR vs. bioprosthetic SAVR. Primary Safety Endpoint: Defined as the composite ...
MiRus Begins Patient Enrollment in the STAR Randomized ...
The STAR Trial (Siegel Transcatheter Aortic valve Replacement Trial), will evaluate the safety and effectiveness of the Siegel™ heart valve (THV) ...
Siegel TAVR for Aortic Stenosis · Info for Participants
The JenaValve transcatheter heart valve (THV) demonstrated a high procedural success rate of 95% in a study of 180 high-risk patients with aortic stenosis, ...
MiRus Siegel 8-F TAVR System Evaluated in Early ...
At 30 days, there were no deaths, strokes, or rehospitalizations. No patients had vascular complications or > moderate paravalvular aortic leak, ...
6.
mirusmed.com
mirusmed.com/mirus-siegel-tavr-us-early-feasibility-study-efs-30-day-results-presented-at-ny-valves-meeting/MiRus Siegel™ TAVR US Early Feasibility Study (EFS) 30 ...
At 30 days, there were no deaths, strokes or re-hospitalizations. No patients had vascular complications, PVL (> moderate) or required a ...
Siegel TAVR in Aortic Severe Stenosis
The purpose of this study is to primary objective is to assess the acute and long-term safety and feasibility of the Siegel TAVR device in adult subjects.
8.
cardiovascularbusiness.com
cardiovascularbusiness.com/topics/clinical/structural-heart-disease/tavr/new-tavr-valve-mirus-linked-positive-early-outcomesNew TAVR valve from MiRus linked to positive early ...
After 30 days, no deaths, strokes or rehospitalizations had been reported. In addition, no patients experienced vascular complications or ...
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