Safety and Efficacy Study of RENEWAL 4 AVT

Sponsor

Boston Scientific Corporation (Industry)

Overall Status

Completed

CT.gov ID

NCT00180336

Collaborator

(none)

170

Enrollment

Location

Study Details

Study Description

Brief Summary

The purpose of this study is to assess the safety and effectiveness of the CONTAK RENEWAL 4 AVT device.

Condition or Disease	Intervention/Treatment	Phase
Heart Failure Tachycardia Atrial Fibrillation Atrial Flutter Ventricular Fibrillation	Device: CRT-D	Phase 2/Phase 3

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.

Study Design

Study Type:

Interventional

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

CONTAK RENEWAL 4 AVT Field Following

Study Start Date :

Jul 1, 2004

Outcome Measures

Primary Outcome Measures

System Complication-Free Rate at 6 months []
Effectiveness of LV Only/LV Offset at 6 months []

Secondary Outcome Measures

LVESD at 6 months []
Six-minute walk at 6 months []
NYHA at 6 months []
QOL at 6 months []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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