Status:
WITHDRAWN
OPTIMA Bi-ventricular Capture Verification Study
Lead Sponsor:
Guidant Corporation
Conditions:
Heart Failure
Eligibility:
All Genders
18+ years
Brief Summary
The purpose of this study is to characterize the morphology (shape) of the intracardiac electrograms(EGM) from patients with a resynchronization therapy device.
Detailed Description
morphology of EGM during loss of capture in either right ventricle (RV) or left ventricle (LV) at different AV delays and LV offsets and during exercise. These EGM signals will be used to design and d...
Eligibility Criteria
Inclusion
- Signed informed consent indicating a willingness to participate, have indications for and have been implanted with a Guidant Renewal 4 CRT-D device
Exclusion
- Patients in atrial fibrillation that cannot be cardioverted for the study, sustained uncontrolled ventricular tachycardia (VT), sinus rhythm \< 40 bpm or \> 100 bpm, complete AV node block, AV node ablation, Severe aortic valve stenosis (valve area \< 1.0 cm squared), frequent ectopic beats that would preclude adequate testing, lead in the great cardiac vein, women who are pregnant or who plan to become pregnant.
Key Trial Info
Start Date :
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00887055
Last Update
June 29 2015
Active Locations (1)
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1
Hopital Laval
Ste-Foy, Quebec, Canada, G1V 4G5