BIO|MASTER.CSP Study

Launched by BIOTRONIK SE & CO. KG · Sep 30, 2024

Keywords

ClinConnect Summary

The BIO|MASTER.CSP Study is a clinical trial designed to test the safety and effectiveness of new pacemaker devices called Amvia and Solia CSP S. These devices are used for patients who need help with heart rhythms, particularly those who may benefit from a special type of pacing known as left bundle branch area pacing. Participants in this study will be individuals who require a pacemaker or cardiac resynchronization therapy (CRT) and are expected to visit the study sites for several check-ups, including before and after the device is implanted and at 1, 6, and 12 months after the procedure.

To be eligible for this study, patients must have a medical reason for needing a pacemaker and be open to follow-up visits. They should also be able to understand the study and use a special monitoring device called the CardioMessenger. However, individuals with certain conditions, like those expecting other heart surgeries or who have a life expectancy of less than 12 months, cannot participate. This study is taking place in multiple locations across Europe, Australia, and New Zealand and will last until September 2027, with regular check-ups to monitor the heart's performance and the devices’ functioning.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• For patient enrollment in the study all of the following inclusion criteria have to be fulfilled at the time of enrollment:
• • Standard indication for de novo pacemaker implantation or cardiac resynchronization therapy (CRT)
• • Patient is intended for implantation of a pacemaker or CRT-P system with left bundle branch area stimulation
• • Ability to understand the nature of the study
• • Ability and willingness to perform all follow-up visits at the study site
• • Ability and willingness to use the CardioMessenger and acceptance of the BIOTRONIK Home Monitoring concept
• Exclusion Criteria:
• Enrollment of a patient is not permitted if at least one of the following criteria is fulfilled:
• • Planned cardiac surgical procedures or interventional measures other than the study procedure within the next 12 months
• • Expected to receive heart transplantation or ventricular assist device within 12 months
• • Life-expectancy less than 12 months
• • Pregnant or breast feeding
• • Age less than 18 years
• • Participation in another interventional clinical investigation (according to the definition given in the CIP)