MiCLASP Post Market Clinical Follow-Up (PMCF) Study

Launched by EDWARDS LIFESCIENCES · Jun 11, 2020

Keywords

ClinConnect Summary

The MiCLASP Post Market Clinical Follow-Up Study is looking at the safety and effectiveness of two specific devices, the Edwards PASCAL and the Edwards PASCAL Precision, used to repair the mitral valve in the heart. This study is important because it helps ensure that these treatments continue to work well for patients who have problems like mitral regurgitation, which is when the heart's mitral valve doesn't close properly, allowing blood to flow backward.

To participate in this study, you need to be between 65 and 74 years old and have been approved for the valve repair procedure by a medical team. You also need to be willing to attend follow-up visits and complete any necessary tests after the procedure. Participants will be monitored to see how well the devices work and if there are any safety concerns. It’s essential to know that this study is currently recruiting participants, and your involvement could help improve heart treatments for others in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Mitral TEER patients eligible per the current approved indication after Heart Team discussion and agreement
• • 2. Patient is willing and able to attend all follow-up visits and to perform all tests
• • 3. Provision of written informed consent
• Exclusion Criteria:
• • 1. Patients are not eligible per the current Instructions for Use
• • 2. Non-elective or emergency TEER procedure for mitral regurgitation
• • 3. Patients in ICU prior to the index procedure