Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2/PHASE3
170 participants
INTERVENTIONAL
2004-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Interventions
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CRT-D
Eligibility Criteria
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Inclusion Criteria
* Availability for follow-up at an approved Field Following center, at the protocol defined intervals
* Willing and capable of undergoing a device implant and participating in all testing associated with this clinical investigation
* Prescribed to stable optimal pharmacologic therapy for HF
* Age 18 or above, or of legal age to give informed consent specific to national law
* Able to provide documented evidence of one or more episodes of AF/AT within 12 months of implantation NOTE: Guidant recommends anticoagulation therapy per physician discretion.
Exclusion Criteria
* Life expectancy of less than six months due to other medical conditions
* Expectation of a heart transplant during the period of the study
* Patients with or who are likely to receive a mechanical tricuspid valve during the course of the study
* Have a preexisting unipolar pacemaker that will not be explanted/abandoned
* Have an atrial tachyarrhythmia that is permanent (i.e., does not terminate spontaneously and cannot be terminated with medical intervention) within 180 days prior to enrollment
* Have a known hypersensitivity to dexamethasone acetate
* Enrolled in any other study, including drug investigation
* Women that are pregnant or planning to become pregnant
* A Cerebral Vascular Event/ Transient Ischemic Attack within 12 months of implantation
* During the four weeks prior to implantation, a patient experiences an episode of AF \>= 48 hours in duration and was not anticoagulated for at an adequate therapeutic level (INR \>= 2.0) for the 4 weeks prior to enrollment
18 Years
ALL
No
Sponsors
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Boston Scientific Corporation
INDUSTRY
Principal Investigators
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Johannes Sperzel, MD
Role: PRINCIPAL_INVESTIGATOR
Kerckhoff Klinik Bad Nauheim (Germany)
Locations
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Kerckhof Klinik
Bad Nauheim, , Germany
Countries
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Other Identifiers
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Clinicals0004
Identifier Type: -
Identifier Source: org_study_id