DSMB
ADVERSE EVENTS
The DSMB, comprising general and interventional cardiologists, will function in accordance with the applicable regulatory guidelines. Board members are independent and will not participate in the trial. The DSMB committee will review the safety data from this study and make recommendations based on the safety analyses of the unanticipated device effects, serious adverse events, protocol deviation, device failures, and 30-day follow-up reports. The frequency of DSMB meetings will be determined prior to the commencement of the study. Additionally, the DSMB can call meetings at times when it suspects that safety is an issue.All cumulative safety data will be reported to the DSMB and reviewed as an ongoing process throughout the enrollment and follow-up periods to ensure patient safety. Every effort will be made to allow the DSMB to conduct an unbiased review of patient safety information. All DSMB reports will be made available to the appropriate agencies upon request; otherwise, they will remain strictly confidential.