LivaNova

6500 Wedgwood Road North

Maple Grove, MN 55311

763.220.4110

IMPORTANT SAFETY INFORMATION

Disclaimer: Individual results may vary. This information is designed to help you learn more about TMVR. It is intended to provide you with helpful information but, is for information purposes only, is not medical advice and should not be used as an alternative to speaking with your doctor. Be sure to discuss questions specific to your health and treatments with a healthcare professional. For more information, please speak to your healthcare professional. Limited by federal law to investigational use in the United States, Canada and Europe. Not for sale in United States, Canada or Europe. For use by clinical investigators only. Related information on the study can be found at www.clinicaltrials.gov using identifier NCT02768402. Trademarks may be registered and are the property of their respective owners. Copyright 2017 LivaNova, Inc. All rights reserved.

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.

Review and discuss the information with your family

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
Echocardiogram
Questionnaires

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.

 

AM I ELIGIBLE?

THERE MAY BE A CLINICAL SITE ENROLLING NEAR YOU.

CALL OR E-MAIL FOR MORE INFORMATION