Sensor Optimization of Cardiac Resynchronization Therapy Response

Sensor Optimization of CRT Response

The Sensor Optimization of Cardiac Resynchronization Therapy (CRT) Response (SOCR) Study is a multicenter, prospective, non-randomized acute feasibility study that is being conducted to determine if subcutaneous heart sounds and/or intracardiac impedance can acutely identify the optimal atrioventricular (AV) pacing intervals and optimal left ventricular (LV) electrodes in patients indicated for cardiac resynchronization therapy.

Inclusion Criteria:

• Subject must be undergoing implant of a new or replacement/upgrade Medtronic CRT-P or CRT-D device for approved indications.
• Subject is implanted or will be implanted with an right ventricular (RV) lead that supports bipolar pacing and sensing (e.g. a bipolar pace/sense lead or a true bipolar defibrillation leads)
• Subject (or subject's legally authorized representative) must be willing to give informed consent
• Subjects must be at least 18 years of age

Exclusion Criteria:

• Subject has congenital heart disease
• Subject has a tachyarrhythmia (atrial and/or ventricular) at the time of enrollment and a cardioversion will not be attempted prior to the research procedure
• Subject has unstable coronary artery disease
• Subject cannot undergo transvenous catheterization
• Subject has a mechanical tricuspid or aortic valve prosthesis or history of significant structural tricuspid or aortic valvular disease
• Subject requires dual chamber cardiac pacing or single chamber (ventricular) pacing at rest for rate control
• Subject has a recent echocardiogram (within prior 6 months) which revealed the presence of an LV thrombus
• Subject is pregnant
• Subject is enrolled in a concurrent study that may confound the results of this study without documented pre-approval from Medtronic study manager