Sensor Optimization of Cardiac Resynchronization Therapy Response

Completed · Not applicable

Conditions studied: Heart Failure

In brief

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.

Key facts

Study ID

NCT01832493

Run by

Medtronic Cardiac Rhythm and Heart Failure

People needed

50

Starts

2013-07-01

Expected to finish

2016-06-01

Last updated by the study team

2016-08-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Iowa Heart Center — Des Moines, Iowa, United States
• The Ohio State University — Columbus, Ohio, United States
• Mercy Hospital Fairfield — Fairfield, Ohio, United States
• Victoria Cardiac Arrhythmia Trials — Victoria, British Columbia, Canada
• Ottawa Heart Institute — Ottawa, Ontario, Canada
• Institut Universitaire de Cardiologie et de Pneumologie de Québec — Québec, Quebec, Canada
• Grantham Hospital — Hong Kong, Hong Kong
• Queen Mary Hospital — Hong Kong, Hong Kong
• Kings College Hospital — London, United Kingdom

Full record on ClinicalTrials.gov

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