Reduction of Mitral Regurgitation With the SATURN Trans-Septal Transcatheter Mitral Valve Replace… (NCT06414265) | Clinical Trial Compass
RecruitingNot Applicable
Reduction of Mitral Regurgitation With the SATURN Trans-Septal Transcatheter Mitral Valve Replacement (TMVR) System in Patients With Severe Symptomatic Mitral Regurgitation
The goal of this clinical trial is to evaluate feasibility, safety, and performance of the SATURN TS TMVR System for the treatment of moderate-to-severe or severe, symptomatic mitral regurgitation through a transcatheter approach. The main questions it aims to answer are:
* is the use of the device feasible?
* is it safe (defined as freedom from device-related major adverse events at 30 days)?
* does it perform (defined as reduction of MR Grade to ≤ 1+ at 30 days)?
Participants will need to do the following as part of the clinical trial:
* complete 6-Minute Walking Test
* complete Quality of Life Questionnaires
* undergo blood evaluations
* CT scan
* 12 lead ECG
* Transesophageal Echocardiography
* Transthoracic Echocardiogram
* the study procedure (valve implantation, right heart catheterization, left arterial pressure, fluoroscopy/ angiogram)
Who can participate
Age range
65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Age 65 years or older.
. Symptomatic moderate to severe or severe functional mitral regurgitation (≥ Grade 3+).
. NYHA functional Class ≥ II. If Class IV, patient must be ambulatory.
. Ability to tolerate oral anticoagulation.
. Ability to qualify for bailout surgery (which may include open heart surgery).
. High risk for open-heart mitral valve surgery due to age, co-morbidities or frailty, as determined by the Heart Team.
. Willing and able to complete study-related assessments and questionnaires.
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Safety Endpoint - Freedom from Device Related Major Adverse Events
Timeframe: 30 days post-procedure
2
Technical Procedural Success Endpoint
Timeframe: Procedure
3
Efficacy Endpoint - Reduction of Mitral Regurgitation Grade to ≤ 1+