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ECM Valve Replacement
ECM Valve Replacement for Tricuspid Valve Disease
N/A
Recruiting
Research Sponsored by CorMatrix Cardiovascular, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patient with a regurgitant or absent tricuspid valve requiring surgical treatment including those patients having concomitant cardiac procedures
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 days postop
Awards & highlights
Study Summary
This trial is testing a new kind of valve to treat tricuspid valve disease in children. The goal is to show that it is safe and to identify any necessary changes to the implant procedure or device.
Who is the study for?
This trial is for patients needing tricuspid valve replacement due to disease, including children with congenital issues. Participants must understand the procedure, agree to follow-ups, and not be involved in other conflicting studies. Exclusions include severe heart failure, high lung pressures, recent major heart attack or stroke, significant kidney or liver dysfunction, cancer treatment within a year (except certain skin/cervical cancers), pregnancy, emergency surgery needs, blood disorders uncorrectable by transfusion.Check my eligibility
What is being tested?
The study tests the safety and effectiveness of the CorMatrix Cor TRICUSPID ECM Valve as a surgical replacement for damaged tricuspid valves. It follows an Early Feasibility Study (EFS) and includes patients who may also undergo additional cardiac procedures during implantation.See study design
What are the potential side effects?
While specific side effects are not listed here, potential risks could include reactions related to porcine material sensitivity since the valve is made from this source. Other general risks might involve complications from surgery such as infection or bleeding.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I need surgery for a faulty or missing tricuspid valve, possibly with other heart procedures.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 30 days postop
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 days postop
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Procedural Success
Secondary outcome measures
Device Success
Technical Success
Trial Design
1Treatment groups
Experimental Treatment
Group I: CorMatrix Cor TRICUSPID ECM ValveExperimental Treatment1 Intervention
Tricuspid valve replacement in patients for the surgical management of tricuspid valve disease, including tricuspid valve disease secondary to congenital heart disease. Enrollment will include up to 60 adults subjects and up to 18 pediatric subjects.
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Who is running the clinical trial?
CorMatrix Cardiovascular, Inc.Lead Sponsor
4 Previous Clinical Trials
153 Total Patients Enrolled
1 Trials studying Tricuspid Valve Disease
92 Patients Enrolled for Tricuspid Valve Disease
Robert G Matheny, MDStudy DirectorCorMatrix Cardiovascular, Inc.
1 Previous Clinical Trials
92 Total Patients Enrolled
1 Trials studying Tricuspid Valve Disease
92 Patients Enrolled for Tricuspid Valve Disease
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My liver tests are more than 5 times the normal limit, not due to a temporary issue.I had a severe heart attack leading to shock within the last week.I do not have a major illness with a life expectancy of less than one year.I have a blood disorder or am taking medication that affects my bone marrow.I cannot take blood thinners like aspirin or Plavix.I am either male or female.I need surgery for a faulty or missing tricuspid valve, possibly with other heart procedures.I have been cancer-free for less than a year, or I am currently undergoing cancer treatment.I have had an emergency heart procedure.My kidney function is significantly impaired.I have not had a stroke in the last 30 days.
Research Study Groups:
This trial has the following groups:- Group 1: CorMatrix Cor TRICUSPID ECM Valve
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.
Are individuals above the age of twenty eligible for participation in this experiment?
"The age range for participants in this medical trial is one year old to seventy. Additionally, there are seperate clinical trials available for children under 18 and seniors over 65 that may be more suitable."
Answered by AI
May I be enrolled in this clinical investigation?
"To be eligible to partake in this clinical trial, candidates must have tricuspid valve disease and lie between 1 year old and 70 years of age. The study is recruiting a total of 15 participants."
Answered by AI
Is this study available to participants at this time?
"Per clinicaltrials.gov, this experiment is still admitting participants as of 9/10/2021 - the last time it was updated since being posted on 1/1/2019."
Answered by AI
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