Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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TERMINATED
NA
16 participants
INTERVENTIONAL
2014-11-30
2016-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Model 20105
Receiving the model 20105 Lead
Model 20105
implant and follow-up of study device
Interventions
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Model 20105
implant and follow-up of study device
Eligibility Criteria
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Inclusion Criteria
* Subject has signed and dated the study-specific informed consent form
* Subject is 18 years of age or older
* Subject is willing, able and committed to participate in Baseline and Follow-up and study procedures for the full length of the study
Exclusion Criteria
* Subject is pacing dependent
* Subject has a previous Pacemaker System
* Subject has known coronary venous vasculature that is inadequate for lead placement
* Subject has unstable angina pectoris or has had an acute myocardial infarction (MI) within the last month
* Subject has had a coronary artery bypass graft (CABG) or percutaneous transluminal coronary angioplasty (PTCA) within the past three months
* Subject is not in sinus rhythm at implant
* Subject has had a heart transplant (patients waiting for heart transplants are allowed in the study)
* Subject has known renal insufficiency that would prevent them from receiving an occlusive venogram during the implant procedure
* Subject is contraindicated for \<1mg dexamethasone acetate
* Subject is enrolled in any concurrent drug and/or device study that may confound the results of this study
* Subject has a terminal illness and is not expected to survive more than 6 months
* Subject is a pregnant woman or woman of childbearing potential not on adequate birth control.
* Subject is employed by Medtronic or by the department of any of the investigators or is a close relative of any of the investigators.
* Legal incapacity or evidence that a subject cannot understand the purpose and risks of the study
* Subject is unable to tolerate an urgent thoracotomy
18 Years
ALL
No
Sponsors
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Medtronic BRC
INDUSTRY
Responsible Party
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Locations
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London Teaching Hospital
London, , Canada
Reinier de Graaf Hospital
Delft, , Netherlands
NUHCS, National University Hospital
Singapore, , Singapore
Milpark hospital
Johannesburg, , South Africa
Countries
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Other Identifiers
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LV DDD
Identifier Type: -
Identifier Source: org_study_id