Your session is about to expire
← Back to Search
Mitral Valve Replacement System
Innovalve Artificial Mitral Valve for Mitral Valve Regurgitation (TWIST-EFS Trial)
Phase 1
Recruiting
Research Sponsored by Innovalve Bio Medical Ltd.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
High risk for open-heart surgery
Clinically significant, symptomatic mitral regurgitation
Must not have
Unsuitable anatomy
Patient is inoperable
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 days
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing a new device called the Innovalve mitral valve replacement system. It is designed for patients who need their mitral valve replaced due to severe damage. The device works by taking over the function of the damaged valve to ensure proper blood flow in the heart.
Who is the study for?
This trial is for individuals with severe, symptomatic mitral valve regurgitation who are at high risk for open-heart surgery. Participants must meet specific anatomical criteria and have a heart's ejection fraction (EF) of more than 25%.
What is being tested?
The study is testing the Innovalve MR system, which is a new device designed to replace the mitral valve in the heart without needing open-heart surgery. The focus is on assessing its safety and how well it works.
What are the potential side effects?
While not explicitly listed, side effects may include typical risks associated with heart procedures such as bleeding, infection, or issues related to device placement like blood clots or improper valve function.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am considered high risk for open-heart surgery.
Select...
I have serious symptoms from mitral valve leakage.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
My body's structure makes me ineligible for the procedure.
Select...
My condition cannot be treated with surgery.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 30 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 days
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Absence of implant or delivery related serious adverse events at 30 days
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: TreatmentExperimental Treatment1 Intervention
MV replacement with Innovalve MR system
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Mitral Valve Regurgitation (MVR) is commonly treated through medical management, surgical repair, or valve replacement. Medical management includes the use of medications such as diuretics, beta-blockers, and ACE inhibitors to reduce symptoms and manage heart failure.
Surgical repair involves techniques like annuloplasty to tighten or reinforce the valve. Valve replacement, such as with the Innovalve mitral valve replacement system, involves replacing the damaged or diseased valve with a prosthetic one to restore normal valve function.
This is crucial for MVR patients as it can significantly improve symptoms, prevent heart failure progression, and enhance overall quality of life.
Find a Location
Who is running the clinical trial?
Innovalve Bio Medical Ltd.Lead Sponsor
4 Previous Clinical Trials
30 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am considered high risk for open-heart surgery.Your heart is not pumping blood effectively.My body's structure makes me ineligible for the procedure.My body meets the specific physical requirements.My condition cannot be treated with surgery.I have serious symptoms from mitral valve leakage.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment
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.