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Transcatheter Mitral Valve Replacement System
Transcatheter Mitral Valve Replacement for Mitral Valve Regurgitation
N/A
Waitlist Available
Research Sponsored by Medtronic Cardiovascular
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Severe mitral regurgitation (MR Grade 3-4+)
Symptomatic mitral regurgitation (NYHA Class II-IV)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through 5 years
Awards & highlights
Study Summary
This trial is to test the safety and effectiveness of a new mitral valve replacement system in people with severe, symptomatic mitral regurgitation.
Who is the study for?
This trial is for very high-risk patients with severe, symptomatic mitral valve regurgitation (MR Grade 3-4+), specifically those who can undergo a transcatheter procedure. Participants must have a heart structure that fits the TMVR system and not have had recent strokes, heart attacks, or other valve surgeries.Check my eligibility
What is being tested?
The study tests two versions of the Medtronic Intrepid™ Transcatheter Mitral Valve Replacement System: one via trans-apical access (PILOT) and another through transfemoral transseptal access (EFS). It aims to assess their safety and performance in treating severe mitral regurgitation.See study design
What are the potential side effects?
Potential side effects may include complications related to heart procedures such as bleeding, blood vessel damage, irregular heartbeats, infection risk at the incision site, stroke risks due to clots or device malfunction.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have severe leakage in my heart's mitral valve.
Select...
I have symptoms of heart valve issues causing shortness of breath or fatigue.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~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
Procedural Success (Number of patients with successful TMVR placement)
Reduction of MR (Number of patients with a reduction of MR Grade)
Trial Design
1Treatment groups
Experimental Treatment
Group I: Transcatheter Mitral Valve Replacement (TMVR) ImplantExperimental Treatment2 Interventions
Twelve TMVR Implant
Find a Location
Who is running the clinical trial?
Medtronic CardiovascularLead Sponsor
75 Previous Clinical Trials
36,299 Total Patients Enrolled
MedtronicIndustry Sponsor
605 Previous Clinical Trials
828,162 Total Patients Enrolled
Lynnett StahlStudy DirectorMedtronic
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My kidney function is impaired with high creatinine levels.Your doctor thinks it's possible to access your heart through the chest (for PILOT study only).There is something abnormal in your heart that could cause a blockage.I have had or need surgery for a heart valve problem.I need a procedure to improve blood flow to my heart.I have severe leakage in my heart's mitral valve.Your mitral valve is the right shape and size for the Twelve TMVR/Intrepid device.You are physically suitable for the Intrepid TMVR delivery system, which includes access through the leg artery or a puncture in the heart wall.I have not had a heart attack in the last 6 months.Your heart's pumping ability, measured as LVEF, is below a certain level.I had a stroke within the last 4 weeks (PILOT) or 90 days (EFS).I have had or currently have endocarditis.I have symptoms of heart valve issues causing shortness of breath or fatigue.
Research Study Groups:
This trial has the following groups:- Group 1: Transcatheter Mitral Valve Replacement (TMVR) Implant
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.
Is this clinical research currently open to enrollees?
"Affirmative. Information from clinicaltrials.gov demonstrates that this medical trial has been ongoing since April 1st of 2015 and is currently recruiting participants for enrollment, with 110 individuals required between 8 different sites. The study was last updated on November 21st 2022."
Answered by AI
How many people have signed up to be included in this clinical trial?
"To execute this study, a total of 110 candidates who meet the necessary qualifications are needed. Medtronic Cardiovascular is managing this trial from medical facilities in Grand Rapids, Michigan and Portland, Oregon such as Spectrum Health Hospitals and Oregon Health Sciences University Hospital respectively."
Answered by AI
To what extent is this experiment being conducted in the healthcare sector?
"This trial is taking place at Spectrum Health Hospitals in Grand Rapids, Michigan, Oregon Health Sciences University Hospital in Portland, Oregon, and Columbia in New york City as well as 8 other research centres."
Answered by AI
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