Status:
COMPLETED
Safety and Efficacy Study of RENEWAL 4 AVT
Lead Sponsor:
Boston Scientific Corporation
Conditions:
Heart Failure
Tachycardia
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
The purpose of this study is to assess the safety and effectiveness of the CONTAK RENEWAL 4 AVT device.
Detailed Description
This is a prospective, two-arm, non-randomized, multi-center European field following, designed to demonstrate the safety and effectiveness of the CONTAK RENEWAL 4 AVT device in humans.
Eligibility Criteria
Inclusion
- Indications for the device
- 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
- Right bundle branch block morphology
- 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
Key Trial Info
Start Date :
July 1 2004
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
170 Patients enrolled
Trial Details
Trial ID
NCT00180336
Start Date
July 1 2004
Last Update
June 25 2007
Active Locations (1)
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1
Kerckhof Klinik
Bad Nauheim, Germany, 61231