Clinical Evaluation of Mediguide System in Cardiac Resynchronization Therapy (CRT) Implants

Clinical Evaluation of Mediguide System in CRT Implants

The purpose of this study is to evaluate the safety and performance of the MediGuide™ system during CRT implants.

Inclusion Criteria:

• Meet clinical indication for implantation of an SJM CRT system according to the current European Society of Cardiology (ESC) Guidelines for cardiac and resynchronization therapy
• Receiving a new implant or undergoing an upgrade from an existing ICD or pacemaker implant with no prior LV lead placement
• Ability to provide informed consent for study participation and are willing and able to comply with the prescribed follow-up tests and schedule of evaluations

Exclusion Criteria:

• Currently participating in any other clinical study
• Have prosthetic valves
• Are pregnant or planning pregnancy in the next 1 month
• Are less than 18 years of age
• Have ventricular tachyarrhythmias resulting from transient or correctable factors such as drug toxicity, electrolyte imbalance, or acute myocardial infarction