Boston Scientific has started the Modular ATP clinical trial to evaluate the safety, performance, and effectiveness of its cardiac rhythm management (CRM) mCRM modular therapy system.
The mCRM system has two devices intended to work together to coordinate therapy: the Emblem MRI subcutaneous implantable defibrillator (S-ICD) and the Empower modular pacing system (MPS), which is designed to be a leadless pacemaker capable of delivering both bradycardia pacing support and antitachycardia pacing (ATP).
The S-ICD system is a treatment option for the prevention of sudden cardiac death, and because it doesn't touch the heart or substernal space, it eliminates many of the complications associated with other leads, Boston Scientific said. The Empower MPS, also a leadless pacemaker and delivery catheter, is designed to complement the S-ICD system by providing a modular option for patients who need ATP.
The prospective, nonrandomized clinical trial will enroll up to 300 patients at up to 50 centers in the U.S., Canada, and Europe who need a defibrillator or who already have an Emblem or Emblem MRI S-ICD system implanted. The trial will evaluate the system- and procedure-related complication-free rate of the Empower MPS, how well the Empower MPS and S-ICD system communicate, and adequate pacing capture thresholds.
The first patients have already been enrolled.
