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Transcatheter Mitral Valve Replacement
Transcatheter Mitral Valve Replacement for Mitral Valve Regurgitation
N/A
Recruiting
Research Sponsored by HighLife SAS
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age ≥ 18 years
Patient has New York Heart Association (NYHA) Functional Class II, III or ambulatory IV
Timeline
Screening 3 weeks
Treatment Varies
Follow Up immediately after procedure
Awards & highlights
Study Summary
This triallooks at the safety and performance of a transcatheter mitral valve for high-risk patients with moderate-severe and severe mitral regurgitation.
Who is the study for?
This trial is for adults over 18 with moderate to severe mitral valve regurgitation who are at high risk for surgery. Candidates must have been on medical therapy for a month, be in NYHA Functional Class II-IV, and meet specific anatomical criteria. Exclusions include recent stroke/TIA, severe carotid stenosis, pregnancy, inability to follow up or take blood thinners, recent pacemaker implantation, active infections or ulcers.Check my eligibility
What is being tested?
The study tests the HighLife Transcatheter Mitral Valve Replacement System's safety and performance in patients with significant heart valve leakage who can't undergo standard surgery. It involves placing a new valve via catheter without open-heart surgery.See study design
What are the potential side effects?
While not explicitly listed here, potential side effects may include bleeding due to anticoagulation therapy required after the procedure; risks associated with catheter-based interventions such as vascular complications; infection risks; and possible device-related complications.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
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I have some limitations on physical activity due to heart problems.
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I have severe leakage in my heart's mitral valve.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at 30 days post procedure
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 30 days post procedure
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Continued intended performance of the HighLife™ bioprosthesis
Freedom of major adverse events
Secondary outcome measures
Technical success
Trial Design
1Treatment groups
Experimental Treatment
Group I: Transcatheter Mitral Valve ReplacementExperimental Treatment1 Intervention
HighLife TMVR System is a novel and innovative approach developed as an alternative treatment for severe MR when medical treatment is maximal and surgical interventions not possible or at high risk. The HighLife TMVR system is composed of a Transcatheter Mitral Valve (TMV), a sub-annular implant (SAI), and their delivery systems and loading tools.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Transcatheter Mitral Valve Replacement
2015
N/A
~100
Find a Location
Who is running the clinical trial?
HighLife SASLead Sponsor
3 Previous Clinical Trials
155 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not had an active ulcer or GI bleeding in the last 3 months.My doctor expects I have less than 12 months to live due to a non-heart related condition.I cannot tolerate blood thinners or medications that prevent blood clots.I am willing to join the study and have signed the consent form.You are at a high risk for open-heart surgery based on evaluations from a team of heart doctors, considering other health problems, weakness, and difficulty performing daily activities.I am 18 years old or older.I am currently on antibiotics for an infection.You have a history of problems with bleeding or blood clotting, or you don't want to receive a blood transfusion in the future.I have some limitations on physical activity due to heart problems.If you have a specific type of heart problem, the amount of blood leaking back into your heart is too high.The patient's anatomy fits the requirements for the HighLife valve.I have severe leakage in my heart's mitral valve.You are unable to have a transesophageal echocardiogram.I have severe narrowing in my neck arteries.I have not had a stroke or mini-stroke in the last 30 days.If you have a specific measurement of the size of the leaky valve in your heart that shows it is severely leaking.I have been following a heart treatment plan for at least one month.
Research Study Groups:
This trial has the following groups:- Group 1: Transcatheter Mitral Valve Replacement
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.
What is the population size of this experiment?
"A total of 15 patients that meet the eligibility criteria are required for this trial and can be recruited from two separate medical institutions: Chippenham Hospital Richmond in Virginia, and University of Pennsylvania in Philadelphia."
Answered by AI
In what number of healthcare facilities is this trial currently taking place?
"At the present moment, 8 different clinical trial sites are operational. These locations span from Richmond to Philadelphia and Charleston with other centres scattered in between. To minimize travel time, those interested should select a facility closest to them if they choose to enroll."
Answered by AI
Is this experiment recruiting participants currently?
"Affirmative. According to clinicaltrials.gov, this healthcare experiment is currently in need of participants and was first posted on July 14th 2020. This study has been updated as recently as October 21st 2022 and requires 15 people between 8 sites."
Answered by AI
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