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Transcatheter Mitral Valve Repair System
TMVr System for Mitral Valve Regurgitation
N/A
Recruiting
Research Sponsored by Half Moon Medical
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Anatomy suitable for transfemoral transseptal access with the Half Moon TMVr System
Age ≥ 21
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 days (+ annually through 5 years)
Awards & highlights
Study Summary
This trial is to study a new mitral valve repair system in patients who are at high risk for conventional mitral valve surgery.
Who is the study for?
This trial is for adults over 21 with severe, symptomatic mitral valve regurgitation who are at high risk for conventional surgery. Candidates must have a compatible native mitral valve geometry and size, suitable anatomy for the device access route, and be on guideline-directed medical therapy. Exclusions include recent heart attacks or strokes, certain heart failures or surgeries, renal insufficiency, bleeding disorders, pregnancy, and some other specific health conditions.Check my eligibility
What is being tested?
The Half Moon TMVr System is being tested in this early feasibility study to see if it's safe and works well for people with severe mitral regurgitation who can't have standard surgery. It's a single-arm study where all participants receive the new treatment through transfemoral transseptal access without being compared to another group.See study design
What are the potential side effects?
While not explicitly listed in the provided information, potential side effects may include complications related to heart procedures such as bleeding or infection at the access site, damage to blood vessels or cardiac structures during implantation of the device; arrhythmias; thrombosis (blood clots); stroke; kidney impairment from contrast media used during procedure.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My heart can be accessed through my leg for a valve repair procedure.
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I am 21 years old or older.
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My heart valve leak is moderate to severe.
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I have heart valve issues not improved by standard treatments.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 30 days (+ annually through 5 years)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 days (+ annually through 5 years)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Adverse Events
Secondary outcome measures
Device Durability
Device Performance
Device Placement
+1 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Half Moon TMVr SystemExperimental Treatment1 Intervention
The Half Moon Transcatheter Mitral Valve Repair (TMVr) System is designed for transfemoral access and transseptal delivery of a self-expanding implant that restores competency in a regurgitant mitral valve.
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Who is running the clinical trial?
Half Moon MedicalLead Sponsor
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have severe leakage in my heart's tricuspid valve.My heart's mitral valve has a problem like flail or prolapse.I am not pregnant, nursing, or planning to become pregnant and have a negative pregnancy test.You cannot have a transesophageal echocardiogram (TEE) for medical reasons.I need medication or machines to help my heart pump blood.I need a procedure to improve blood flow to my heart.I have severe COPD with very low lung function.I have not had endocarditis in the last 6 months.I have not had a stroke, TIA, or heart attack in the last 90 days.I have severe narrowing of my neck arteries causing symptoms.Your blood platelet count is less than 75,000 cells per cubic millimeter.I have not had any GI bleeding in the last 6 months.My creatinine level is above 2.5 mg/dL.I cannot or will not follow the blood thinner treatment plan.I have not had any surgery or endovascular procedures in the last 30 days.You have high blood pressure in the arteries of your lungs when you are at rest.My heart can be accessed through my leg for a valve repair procedure.I have stents or an IVC filter that might interfere with certain medical procedures.You have a blood clot in your heart or in certain large veins.My heart team considers me high risk for mitral valve surgery and unsuitable for other valve treatments.I have severe right-sided heart failure confirmed by an echo test.I need surgery urgently.I am 21 years old or older.I have had or need surgery for my heart's mitral valve.Your mitral valve should be the right size and shape for the Half Moon TMVr implant.I have a device implanted in my heart from a previous procedure.The size of your heart's left ventricle at the end of its resting phase is larger than 75 millimeters.I have a bleeding disorder or will not accept blood transfusions.My heart valve has severe calcification.My heart valve leak is moderate to severe.I have heart valve issues not improved by standard treatments.My heart's pumping ability is significantly reduced.I am not currently on antibiotics for an infection, or it has been 2 weeks since I finished them.
Research Study Groups:
This trial has the following groups:- Group 1: Half Moon TMVr System
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
To whom is enrollment in this clinical experiment available?
"Eligibility requirements to join this trial include having a diagnosis of mitral valve insufficiency and being between 21-95 years old. Currently, the research team is seeking 30 participants in total."
Answered by AI
What is the current enrollment size of this research trial?
"Affirmative. Clinicaltrials.gov reports that this study, which was first posted on December 8th 2020, is actively seeking participants. 30 individuals are required to be recruited from only one medical centre."
Answered by AI
Is this clinical investigation open to participants who are of legal age?
"Eligibility for this trial is determined by the patient's age, with those over 21 and less than 95 years old being able to participate."
Answered by AI
Are there any opportunities for individuals to participate in this research project?
"Information hosted on clinicaltrials.gov confirms that this healthcare trial is still allocating participants. The study was initially posted on December 8th 2020 and the data was most recently modified on March 15th 2022."
Answered by AI
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