Your session is about to expire
← Back to Search
Cardiovalve System for Tricuspid Regurgitation
Study Summary
This trial is testing a new device and delivery system for replacing the tricuspid valve. The safety and performance of the device will be monitored over 30 days and then for 5 years.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
Find a Location
Who is running the clinical trial?
Media Library
- I am a heart transplant recipient or urgently need one.I am a woman who could become pregnant.I do not have a non-heart related illness limiting my life to under a year.I am unable or unwilling to sign a consent form for this study.I am receiving treatment for severe heart artery disease.I have not had a stroke or mini-stroke in the last 3 months.My heart's structure is not fit for a Cardiovalve implant.I need surgery for a heart valve problem.I can walk 60 meters or more in 6 minutes.I take chronic oral steroids or have a condition like sarcoidosis that could affect healing.My liver is not working well (MELD score over 10).Your heart's blood pressure in the lung arteries is too high when measured by an ultrasound test.I have not had heart valve infection in the past year.I do not have a major heart defect, except for a minor PFO without a significant shunt.I have severe COPD or need to use oxygen at home all the time.I have a blood clotting disorder or low platelet count (below 90,000).The heart team at the site has approved me as a candidate for the Cardiovalve system.I have had surgery or a procedure on my tricuspid valve.I have not had a heart device implant or revision within the last month.I do not have unstable heart failure or need IV medication to help my heart pump.I have severe heart valve leakage as confirmed by an ultrasound.My heart condition limits my physical activity but I can still perform light tasks.I need help with my daily activities due to my condition.I have taken antibiotics in the last 2 days.I have chronic anemia with hemoglobin levels below 9.I am allergic to certain medical device materials, vitamin K blockers, or contrast agents.I am scheduled for a surgery or procedure within the next 30 days.You have severe right ventricular failure according to specific medical guidelines.Your veins are not suitable for receiving an implant.I am between 18 and 85 years old.I cannot have an implant due to a blood clot in my veins or having a vena cava filter.I have a condition affecting my tricuspid valve.My kidney function is very low or I am on dialysis.You have had a heart attack in the past month.I need heart or carotid surgery within the next 30 days.I have been treated for heart issues according to guidelines for at least 30 days.Your heart's pumping function is not strong enough (LVEF < 35%).I have a serious heart valve problem on the left side that needs treatment.
- Group 1: Cardiovalve Transfemoral Tricuspid Valve
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
Do I satisfy the qualifications to participate in this medical experiment?
"This clinical trial is seeking 15 candidates suffering from tricuspid valve insufficiency, with an age range of 18 years to 84. To be considered a viable candidate they must have been adequately treated under medical standards for at least one calendar month prior to the procedure and receive approval by both the site's "Heart Team" as well as the Subject Screening Committee."
Are elderly individuals over 85 years partaking in this medical study?
"As stated by the study's requirements, individuals must be between 18 and 84 years old to qualify for enrolment."
What is the purpose of this investigation?
"This 30-day study will evaluate the technical success of cardiovalve delivery, unrestricted movement of cusps, tricuspid regurgitation severity (using a 0 to 4+ scale) and change in degree of cusp insufficiency."
Are there any active recruitment initiatives for this clinical trial?
"Per the data hosted on clinicaltrials.gov, this medical trial has ceased search for participants. Initially posted in October of 2022 and last edited in July 2021, there are nevertheless 40 other trials that require enrolment currently active."
Share this study with friends
Copy Link
Messenger