Heart Failure, Tachycardia, Atrial Fibrillation, Atrial Flutter, Ventricular Fibrillation
Conditions
Keywords
Heart Failure, Tachycardia, Atrial Fibrillation, Atrial Flutter, Ventricular Fibrillation
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.
Interventions
DEVICECRT-D
Sponsors
Boston Scientific Corporation
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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 criteria
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| System Complication-Free Rate at 6 months | — |
| Effectiveness of LV Only/LV Offset at 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| LVESD at 6 months | — |
| Six-minute walk at 6 months | — |
| NYHA at 6 months | — |
| QOL at 6 months | — |
Countries
Germany
Outcome results
None listed