The MODULAR ATP Clinical Study is designed to demonstrate safety, performance, and effectiveness of the Modular Cardiac Rhythm Management (mCRM) Therapy System.
The MODULAR ATP Clinical Study will enroll subjects with a standard Implantable Cardioverter Defibrillator (ICD) indication applying international practice guidelines, as well as those who already have an implanted S-ICD System and satisfy the inclusion criteria for this study, while not meeting any exclusion criteria. Subjects will be followed for at least 6 months following mCRM Therapy System implantation.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
297
Communication testing between S-ICD and LCP in 4 body postures as well as required electrical testing.
Safety Endpoint 1: Percentage of Subjects Without Major EMPOWER MPS System- or Procedure-Related Complications Through 6 Months
Major EMPOWER MPS System- and Procedure-related Complication-Free Rate Subjects will be assessed for safety issues related to the procedure or system through 6 months post implant
Time frame: Implant through 6 Months Post-Implant
Safety Endpoint 2: Percentage of Subjects Without Major EMPOWER MPS System- or Procedure-Related Complications Through 12 Months
Major EMPOWER MPS System- and Procedure-related Complication-free Rate Subjects will be assessed for safety issues related to the procedure or system through 12 months post implant
Time frame: Implant through 12 Months Post-Implant
Primary Effectiveness Endpoint 1: Percentage of Body Postures With Communication Success Between the S-ICD and EMPOWER PG
Communication Success between the S-ICD and EMPOWER PG Data from subjects will be assessed for effectiveness of communication between S-ICD and the EMPOWER PG by evaluating if a paced beat is present during communication testing in four postures: upright, supine, and right and left side.
Time frame: At the 6 Month Follow-up
Primary Effectiveness Endpoint 2: Percentage of Subjects Classified as a Pacing Capture Threshold (PCT) Responder
Proportion of Subjects with Adequate Pacing Capture Threshold Effectiveness will be confirmed by evaluating the percentage of subjects considered to be a PCT Responder, defined as a subject with a PCT measurement of ≤ 2.0 V @ 0.4 ms pulse width
Time frame: At the 6 Month Follow-up
Secondary Effectiveness Endpoint: Subject-specific Slope of EMPOWER PG Sensor-Indicated Rate to the Subject's Workload on Treadmill Test
Metabolic-Chronotropic Relation Slope (MCR Slope) from the Kay-Wilkoff Model Using the Kay-Wilkoff model, data will be assessed to evaluate the proportionality of the EMPOWER PG's sensor-indicated rate to the subject's workload during the treadmill test
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Banner University Medical Center Phoenix
Phoenix, Arizona, United States
Scottsdale Healthcare - Shea
Scottsdale, Arizona, United States
Arrhythmia Research Group
Jonesboro, Arkansas, United States
AdventHealth Orlando
Orlando, Florida, United States
Emory University Hospital
Atlanta, Georgia, United States
Baptist Health Lexington
Lexington, Kentucky, United States
Mayo Clinic
Rochester, Minnesota, United States
Cooper Hospital - University Medical Center
Camden, New Jersey, United States
Northwell University Hospital
Manhasset, New York, United States
Mount Sinai Medical Center
New York, New York, United States
...and 28 more locations
Time frame: At the 3 Month Visit
Secondary Safety Endpoint
All-Cause Survival; data not reported as it is still being collected
Time frame: Implant through 2 years post-implant