Valve trial

Contact: Regina Hollister. Philadelphia, Pennsylvania, United States, Contact: Sasha Naidu. Contact: Tracy Spirk. Contact: Kristin Konopka. Contact: Sasha Golden. Contact: Heather McKinney. Contact: Abdullah Shamsuddin. Contact: Sara Benedict. Contact: Angela Mendez. Contact: Elizabeth Justus.

Contact: Zaida Bisbal. Contact: Amber Li. Contact: Michelle Morgan. Contact: Travis Brinkerhoff. Contact: Elizabeth Purrington. Contact: Joshua Bombard. Contact: Elizabeth Grieve. Contact: Sheryll Sorenson. Contact: Libo Wu. Contact: Alana Harrignton. Contact: Sophie Robichaud. Contact: Lars Sondergaard. Contact: Mika Laine. Centre Hospitalier Universitaire de Clermont-Ferrand. Contact: Aurelie Thalamy. Principal Investigator: Geraud Souteyrand, Professor.

Contact: Zoe Pascual. Contact: Mr. Frederic Petit. Contact: Sabine Bleiziffer. Contact: Susann Tietz. Principal Investigator: Jorg Kempfert, Professor. Johannes-Hospital Dortmund. Contact: Kamila Ziegler. Principal Investigator: Prof. Helge Mollmann, MD. Contact: Elisabetha Gharib.

Contact: Petra Rothgen. Contact: Sabrina Weinschenk. Contact: Stephanie Simon. Contact: Nava Eizenberg. Principal Investigator: Amit Segev, Professor. Contact: Chiara Primerano. This allows blood to leak backward, and makes your heart work harder to pump enough blood to the rest of your body.

Typically, MR becomes more severe over time as your heart gets weaker from working harder, and if untreated can lead to heart failure or even death. New medical devices are made available to people on a regular basis. However, before they can be offered to the public, they need to be studied for how safe they are and how well they work. A clinical trial is a type of research conducted with volunteers that studies recently developed medical devices.

The ENCIRCLE clinical trial will evaluate an investigational device designed to treat severe MR by replacing your own mitral valve using a transcatheter procedure no open-heart surgery. Often patients are curious what is involved by participating in a clinical trial. While every experience is unique, you can expect the following milestones on your treatment journey.

The SAPIEN M3 system is designed to replace your mitral valve through a minimally invasive procedure called transcatheter mitral valve replacement. Ask your doctor or research coordinator for the full list of criteria.

If you choose to participate, you will be asked to complete health and imaging assessments to ensure you meet the criteria to continue in the clinical trial. We are committed to providing the highest levels of customer service to help our patients improve their quality of life. Valve Thrombosis c. Major Paravalvular leak d. Major Hemorrhage e. Endocarditis Primary Safety Endpoints: Surgical Valve Events Rate Assessment [ Time Frame: 12 months following patient enrollment completion ] The rates of other events will be compared to clinical outcomes for surgically implanted heart valves reported in the literature.

All-caused death b. Valve related death c. Valve-related reoperation d. Valve explant e. Hemorrhage f. All-cause reoperation g. Success is defined as clinically significant improvement in hemodynamic performance Effective Orifice Area EOA at one year based on literature reports for surgical aortic valve replacement. Class I - No symptoms and no limitations in ordinary physical activity, e. Class III - Marked limitation in activity due to symptoms, even during less-than-ordinary activity, e. Comfortable only at rest.

Class IV - Severe limitations. Experiences symptoms even while at rest. Mostly bedbound patients. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies. Try the modernized ClinicalTrials. Learn more about the modernization effort.