Status:
COMPLETED
Sensor Optimization of Cardiac Resynchronization Therapy Response
Lead Sponsor:
Medtronic Cardiac Rhythm and Heart Failure
Conditions:
Heart Failure
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 s...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2016
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT01832493
Start Date
July 1 2013
End Date
June 1 2016
Last Update
August 29 2016
Active Locations (9)
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1
Iowa Heart Center
Des Moines, Iowa, United States, 50314-3017
2
The Ohio State University
Columbus, Ohio, United States, 43210
3
Mercy Hospital Fairfield
Fairfield, Ohio, United States, 45014
4
Victoria Cardiac Arrhythmia Trials
Victoria, British Columbia, Canada, V8R 4R2