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 |
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.
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
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Ohio State University The Ohio State University’s main Columbus campus is one of America’s largest...
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