Sensor Optimization of Cardiac Resynchronization Therapy Response



Status:Recruiting
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:July 2013
End Date:April 2016
Contact:SOCR Clinical Trial Leader
Email:medtronicCRMtrials@medtronic.com

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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
We found this trial at
4
sites
281 W. Lane Ave
Columbus, Ohio 43210
(614) 292-6446
Ohio State University The Ohio State University’s main Columbus campus is one of America’s largest...
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Des Moines, Iowa 50314
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Des Moines, IA
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Fairfield, Ohio 45014
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Victoria, British Columbia
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Victoria,
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