The MODULAR ATP Clinical Study is designed to demonstrate safety, performance, and effectiveness of the Modular Cardiac Rhythm Management (mCRM) Therapy System.
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Safety Endpoint 1: Percentage of Subjects Without Major EMPOWER MPS System- or Procedure-Related Complications Through 6 Months
Timeframe: Implant through 6 Months Post-Implant
Safety Endpoint 2: Percentage of Subjects Without Major EMPOWER MPS System- or Procedure-Related Complications Through 12 Months
Timeframe: Implant through 12 Months Post-Implant
Primary Effectiveness Endpoint 1: Percentage of Body Postures With Communication Success Between the S-ICD and EMPOWER PG
Timeframe: At the 6 Month Follow-up
Primary Effectiveness Endpoint 2: Percentage of Subjects Classified as a Pacing Capture Threshold (PCT) Responder
Timeframe: At the 6 Month Follow-up