Status:
COMPLETED
Quadripolar CRT-D On Currently Approved Lead SystemS
Lead Sponsor:
Boston Scientific Corporation
Conditions:
Heart Failure
Eligibility:
All Genders
18+ years
Brief Summary
The purpose of the study is to evaluate different ways to program around extracardiac stimulation.
Eligibility Criteria
Inclusion
- Subject is medically indicated for implantation with a Boston Scientific (BSC) DYNAGEN or INOGEN X4 CRT-D (or any future FDA approved BSC X4 CRT-D) and already implanted with/scheduled to receive a commercially available quadripolar left ventricular lead
- Subject is willing and capable of providing informed consent and participating in all testing and study visits associated with this investigation at an approved center and at the intervals defined by this protocol
- Subject is age 18 or above, or of legal age to give informed consent specific to state and national law
Exclusion
- Subject has a known or suspected sensitivity to dexamethasone acetate (DXA)
- Subject is enrolled in any other concurrent study, without prior approval from BSC
- Women of childbearing potential who are or might be pregnant at the time of study enrollment
Key Trial Info
Start Date :
October 1 2014
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 1 2016
Estimated Enrollment :
749 Patients enrolled
Trial Details
Trial ID
NCT02232984
Start Date
October 1 2014
End Date
October 1 2016
Last Update
April 9 2019
Active Locations (60)
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1
Mercy Gilbert Medical Center
Gilbert, Arizona, United States, 85297
2
Phoenix Cardiovascular Research Group/ Heart & Vascular Center of Arizona
Phoenix, Arizona, United States, 85006
3
St. Joseph's Hospital
Phoenix, Arizona, United States, 85013
4
Yuma Regional Medical Center
Yuma, Arizona, United States, 85364