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Patients recovering from mitral valve surgery may take up to several months to regain normal physical function and activity. Because PMR does not require a chest incision or the use of a heart lung machine, patients may avoid the complications and long recovery time associated with surgery. Return to top of page. Purpose / Objectives of the EVEREST II Clinical Study EVEREST II is an ongoing Phase II FDA approved clinical research study to assess the safety and efficacy (or effectiveness) of the Evalve PMR system for patients diagnosed with Grade 3 (moderate to severe) or Grade 4 (severe) MR. Study participants will be required to have a number of follow-up visits and evaluations including ultrasound studies over the course of at least a 24-month period following treatment. These follow up visits are intended to monitor the outcome of the procedure. EVEREST II consists of a randomized arm and a high risk registry arm. EVEREST II Randomized Arm This study arm compares the Evalve PMR procedure to the current standard of care, mitral valve surgery. To ensure that the results are unbiased, participants will be randomly assigned to either the Evalve PMR procedure or to surgery, in a "two-to-one" ratio. This means that two out of 3 of trial participants will undergo the Evalve PMR procedure and one out of 3 of trial participants will undergo mitral valve surgery. Initiated in late 2005, this arm will enroll approximately 300 patients. EVEREST II High Risk Registry Arm This study arm is a registry for patients who are considered to be at high risk of not surviving surgery. High risk patients enrolled in the registry will not be randomized and will undergo the Evalve PMR procedure. Initiated in February 2007, the registry will be limited to 70 patients and will be closed once enrollment is complete. To find out whether you may qualify for EVEREST II, please call toll-free: 1-877-MY-MR-FIX / (877)-696-7349. Click here to link to the EVEREST II Call Center. All information provided to the call center is kept confidential and used only for the purposes of determining eligibility to participate in this study. Alternatively, you can contact an investigational site in your area. (Click here) to view an interactive map of the investigational sites. Return to top of page. EVEREST II Trial Eligibility Guidelines If you are interested in participating in the EVEREST clinical trial, please discuss this with your doctor, contact an investigational site (link to site list) in your region or Evalve, Inc. (www.evalveinc.com). The EVEREST II investigators are seeking to enroll patients who have been diagnosed with Grade 3 (moderate to severe) or Grade 4 (severe) mitral regurgitation (MR), who are seeking treatment for their condition and who at least:
Patient Participation, Rights and Protection Patients choose to participate in clinical trials for a variety of reasons. For example, patients who enroll in clinical trials are provided with early access to investigational devices, drugs, treatments and procedures – sometimes well in advance of general market availability. In addition, participating patients may benefit from special care from the trial’s physicians during the course of the study. Further, participating in a study can help advance new therapies so that one day they may be more widely available to benefit others. However, the investigational devices, drugs and procedures being evaluated in clinical trials may involve as-yet-undiscovered risks and challenges. Therefore it is important to discuss with your physician your prospective participation in a clinical trial, so that you can make the right decision for you. In determining whether a clinical trial is right for you, you should consider the following questions:
Equally important, prospective clinical trial participants are required to sign an "informed consent" form, which provides detailed information regarding the purpose and objectives of the clinical trial, the risks involved in the trial, and potential effects and risks of the trial on patients. All trial participants have the right to leave the trial whenever they wish. A Data Safety Monitoring Board (DSMB) is set up for additional patient safety as well. A DSMB is a group of experts who meet periodically to review accumulating information (data) gathered from participants in clinical trials with the purpose of protecting
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