Phase
Condition
Hyponatremia
Chest Pain
Congestive Heart Failure
Treatment
Enabling Sensor Research Holter Mode feature
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Subject has an active CromeTM or CobaltTM ICD or CRT-D MRI SureScanTM system whichhas been implanted for at least 30 days and which has not yet reached theRecommended Replacement Time (RRT)
Subject is implanted with one of the following models of a true bipolar rightventricular lead manufactured by Medtronic:
Model 6946M
Model 6947
Model 6947M
Model 6935
Model 6935M
Subject is ≥ 18 years of age
Subject (or subject's legally authorized representative) is willing and able toprovide written informed consent
Subject is willing and able to comply with study procedures
Exclusion
Exclusion Criteria:
Subject has existing condition that necessitates the use of supplemental oxygen
Subject has active acute respiratory infection or respiratory disorder that mayaffect ability to perform breathing or exercise activities, as assessed by theinvestigator
Any concomitant condition that might endanger the subject through participation inthe study or interfere with study procedures, as assessed by the investigator
Subject has an active or suspected lead integrity issue, in the opinion of theinvestigator
Subject is enrolled in another study that could confound the results of this study
Subject has NYHA Class IV heart failure
Study Design
Study Description
Connect with a study center
Hartford Hospital
Hartford, Connecticut 06102
United StatesSite Not Available
CentraCare Heart & Vascular Center
Saint Cloud, Minnesota 56303-1900
United StatesSite Not Available
South Oklahoma Heart Research
Oklahoma City, Oklahoma 73135
United StatesSite Not Available
Texas Cardiac Arrhythmia Research Foundation
Austin, Texas 78705-1852
United StatesSite Not Available
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