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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 60 months
Awards & highlights
Study Summary
This trial will evaluate the safety and effectiveness of a new tricuspid valve to treat valve disease in adults and children.
Who is the study for?
This trial is for adults and children with tricuspid valve disease needing surgery, who understand the procedure and can follow up. It's not for those with recent strokes, contraindications to blood thinners, severe liver or kidney issues, very low heart function, high lung pressures, certain heart configurations (like a single ventricle as systemic AV valve), active cancers or major non-cardiac diseases.Check my eligibility
What is being tested?
The study tests the Cor TRICUSPID ECM Valve in patients requiring tricuspid valve replacement. Success and safety of implantation are evaluated along with effectiveness in treating valve dysfunction over 12 months. Follow-ups occur after surgery at set intervals up to five years.See study design
What are the potential side effects?
Potential side effects may include reactions related to the body accepting the new valve material from porcine sources (if sensitive), complications from necessary blood thinners post-surgery, and general risks associated with cardiac surgeries 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 ~ 60 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~60 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Effectiveness Outcome - Individual Patient Success
Safety Outcome - Procedural Success
Other outcome measures
Device Success
Technical Success
Trial Design
4Treatment groups
Experimental Treatment
Group I: Group D: Pediatrics treated with SIS 2.0 Cor TRICUSPID ECM ValveExperimental Treatment1 Intervention
Pediatrics (<21 years of age) treated with SIS 2.0 Cor TRICUSPID ECM Valve
Group II: Group C: Adults treated with SIS 2.0 Cor TRICUSPID ECM ValveExperimental Treatment1 Intervention
Adults (>/= 21 years of age) treated with the SIS 2.0 Cor TRICUSPID ECM Valve
Group III: Group B: Pediatrics treated with SIS 1.0 Cor TRICUSPID ECM ValveExperimental Treatment1 Intervention
Pediatrics (<21 years of age) treated with SIS 1.0 Cor TRICUSPID ECM Valve
Group IV: Group A: Adults treated with SIS 1.0 Cor TRICUSPID ECM ValveExperimental Treatment1 Intervention
Adults (>/= 21 years of age) treated with the SIS 1.0 Cor TRICUSPID ECM Valve
Find a Location
Who is running the clinical trial?
Yale UniversityOTHER
1,853 Previous Clinical Trials
2,738,469 Total Patients Enrolled
CorMatrix Cardiovascular, Inc.Lead Sponsor
4 Previous Clinical Trials
139 Total Patients Enrolled
Brad Solberg, MBAStudy DirectorVeranex
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been cancer-free for less than a year, or I am currently undergoing cancer treatment.I have a blood disorder or am taking medication that affects my bone marrow.I had a severe heart attack within the last week that caused my heart to fail.Your tricuspid annulus is too small to fit the Cor TRICUSPID ECM Valve (less than 10mm).My liver tests are more than 5 times the normal limit.I need surgery for a faulty or missing tricuspid valve, possibly with other heart procedures.My kidney function is significantly impaired.You have had a heart transplant.I have not had a stroke in the last 30 days.I cannot take blood thinners like aspirin or Plavix.I have had an emergency heart procedure.Your heart pumps out less than 25% of the blood with each beat.Your mean pulmonary pressure is higher than 50mmHg or your pulmonary vascular resistance is greater than 6 Woods Units.I have a single ventricle heart condition needing a specific valve replacement.You have a blood clotting disorder or low platelet count, unless the doctor thinks it can be fixed with a blood transfusion. For example, if you have low platelets, you might still be able to join if you get a platelet transfusion.I do not have a major illness with a life expectancy of less than one year.You are allergic to materials from pigs.The patient's right-sided atrioventricular valve will be replaced with the Cor TRICUSPID ECM Valve.
Research Study Groups:
This trial has the following groups:- Group 1: Group B: Pediatrics treated with SIS 1.0 Cor TRICUSPID ECM Valve
- Group 2: Group A: Adults treated with SIS 1.0 Cor TRICUSPID ECM Valve
- Group 3: Group C: Adults treated with SIS 2.0 Cor TRICUSPID ECM Valve
- Group 4: Group D: Pediatrics treated with SIS 2.0 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 there any vacancies available in this clinical research endeavor?
"As indicated by clinicaltrials.gov, this research study is in need of participants. It was first published on April 1st 2023 and the most recently recorded update was made on February 14th 2023."
Answered by AI
What is the participant capacity for this research endeavor?
"Affirmative. Clinicaltrials.gov data demonstrate that this medical experiment, initially posted on April 1st 2023, is currently recruiting participants. 92 patients must be enrolled from one centre of research."
Answered by AI
Who else is applying?
What site did they apply to?
St Francis Hospital
What portion of applicants met pre-screening criteria?
Met criteria
Why did patients apply to this trial?
I am only 35 have been dealing with a hole in my tricuspid valve for 3 years and do not want to have open heart surgery and have the debilitating issues for the remainder of my life.
PatientReceived no prior treatments
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