Do you meet the following criteria?
18 years or older with:
Severe mitral regurgitation (MR)
NYHA Class ll, lll or lVa heart failure
High risk for cardiovascular surgery
If you're interested in joining the LivaNova Caisson TMVR clinical trial, follow these simple steps to see if you qualify:
AM I ELIGIBLE?
If you answered ‘YES’ to these questions you may be eligible to participate in a clinical trial designed to evaluate non-surgical mitral valve replacement and you may consider participating the FDA-approved clinical investigation evaluating the safety and performance of the LivaNova Caisson Transcatheter Mitral Valve Replacement (TMVR) System.
A clinical study is a research study to answer specific healthcare related questions. This FDA-approved early feasibility study is a clinical research study to evaluate the safety and performance of the Caisson TMVR system in patients with severe MR who are at high risk for open-heart valve surgery. This means that the safety, performance and effectiveness of the Caisson TMVR device has not been established and therefore the study will enroll only a limited number of patients.
WHY SHOULD I VOLUNTEER?
By participating in a clinical study you can:
• Take an active role in your own healthcare
• Obtain expert medical care at leading healthcare facilities during the clinical trial
• Help others by contributing to medical research
†Before you join a clinical study you should know as much as possible about the study. It is important for you to feel very comfortable asking questions and receiving complete answers prior to deciding to participate or not in the study.You should feel comfortable not participating in the study if you so choose.
WHAT IS EXPECTED OF ME IF I PARTICIPATE?
1. SIGN THE CONSENT FORM after understanding details about the study including risks, benefits, and your responsibilities as a participant
2. THE FOLLOWING ARE REQUIRED before, during and after the study procedure:
• Medical history and physical examination
• Blood tests
• Cardiac CT
3. PARTICIPATE IN FOLLOW-UP VISITS
Return for clinical visits at 1 month, 3 months, 6 months, 1-, 2-, 3-, 4-,
and 5-years post-study procedure.
Your participation in the study ends after the 5-year visit.