Study to Evaluate System Safety and Clinical Performance of the Protecta Implantable Cardioverter Defibrillator (ICD) Plus Cardiac Resynchronization Therapy Defibrillator (CRT-D)

Sponsored by Medtronic Cardiac Rhythm Disease Management

Purpose

The purpose of the study is two-fold. In Phase I (Protecta Clinical Study), system performance will be evaluated. In Phase II (PainFree SST), the inappropriate shock-free rate at one year of subjects implanted with a Medtronic Protecta implantable cardioverter defibrillator (ICD) and cardiac resynchronization therapy defibrillator (CRT-D) will be evaluated. Phase II of the study will begin when the Medtronic Protecta devices are market released in each participating geography. Subjects enrolled into Phase I of the study will continue follow up.

Eligibility

Criteria Inclusion Criteria:

• Patients meeting one of the following criteria can be included in Phase I of the study:
  • Patients indicated (per local indications) for a dual chamber implantable cardioverter defibrillator (DR-ICD)/cardiac resynchronization therapy defibrillator (CRT-D)
  • Patients undergoing a device replacement or upgrade to DR-ICD or CRT-D and with the protocol required leads (patients must be enrolled prior to implant)
• Patients meeting one of the following criteria can be included in Phase II of the study:
  • Patients indicated for a DR-ICD/VR-ICD/CRT-D device and intended to receive a Protecta device
  • Patients undergoing a DR-ICD/VR-ICD/CRT-D device replacement or an upgrade to a Protecta DR-ICD/VR-ICD or CRT-D
  • Patients indicated for a DR-ICD/VR-ICD/CRT-D already implanted with a Protecta device and the protocol required leads, who have not yet been discharged after implant

Exclusion Criteria:

• Patients with a mechanical tricuspid heart valve
• Patients enrolled or intended to participate in any concurrent drug and/or device study, which would confound the results of this trial as determined by Medtronic, during the course of this clinical study
• Patients with medical conditions that preclude the testing required for all patients by the study protocol or that otherwise limit study participation required for all patients
• Patients with exclusion criteria required by local law (e.g. age, pregnancy, breast feeding, etc)
• Patients anticipated not being able to complete the study
• Patients unwilling to provide written informed consent

Contacts and Locations

Contacts Physicians:
Ameer Kabour, MD

Coordinators:
Brenda Hoagland, RN, CCRC
Michelle Hickam, BSN
Julie Neidhardt, BSN

Please contact us at 419-251-4919 for more information about this study.