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Transcatheter Mitral Valve Replacement System
TMVR System for Mitral Valve Regurgitation (PRELUDE Trial)
N/A
Waitlist Available
Research Sponsored by Caisson Interventional LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 days
Awards & highlights
PRELUDE Trial Summary
This trial is testing a new device to treat people with a certain kind of heart valve disease.
Eligible Conditions
- Mitral Valve Regurgitation
PRELUDE Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 30 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of patients without Major Adverse Events (MAEs)
Secondary outcome measures
Number of living, stroke-free patients with prosthetic valve in place (device success)
Number of patients with successful delivery and implantation of the prosthetic valve (technical success)
PRELUDE Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment ArmExperimental Treatment1 Intervention
All eligible patients will be in the treatment arm for the 'Caisson TMVR System' (transcatheter mitral valve replacement) procedure. No control or comparator in this study.
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Who is running the clinical trial?
Caisson Interventional LLCLead Sponsor
1 Previous Clinical Trials
75 Total Patients Enrolled
Mathew Williams, MDStudy DirectorNYU Langone Medical Center
4 Previous Clinical Trials
412 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- Your heart's left ventricle is larger than 7 centimeters when it's full of blood.You have moderate to severe heart failure, as classified by the New York Heart Association.You have a high chance of needing heart surgery.Your mitral valve is severely damaged or has abnormal growth.You have a blockage in the pathway that carries blood out of the heart's main pumping chamber.You have a serious problem with the right side of your heart.You had a stroke within the last 90 days, or a mini-stroke or heart attack within the last 30 days.You have a serious problem with the valve in your heart called the mitral valve.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment Arm
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.
How many health care centers are conducting this experiment across the state?
"Presently, 13 clinical sites are running this medical trial. These locations span from Washington to Nashville and Charlottesville as well as other cities across the United States. To reduce travel demands on participants, it is wise to select a clinic that is close by your own residence."
Answered by AI
Are participants able to join this trial at present?
"Unfortunately, the information on clinicaltrials.gov suggests that this particular trial is no longer recruiting participants; it was initially posted in June 2016 and last updated in late January 2020. However, there are currently 98 additional studies actively looking for volunteers."
Answered by AI
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