Safety and Efficacy Study of RENEWAL 4 AVT

Phase 2

Completed

• Conditions: Heart Failure; Tachycardia; Atrial Fibrillation; Atrial Flutter; Ventricular Fibrillation

• Registration Number: NCT00180336
• Lead Sponsor: Boston Scientific Corporation

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.

Study Timeline

• Study Start: 2004-07
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-12
• Study First Posted: 2005-09-16
• Status Verified: 2007-06
• Last Update Submitted: 2007-06-22
• Last Update Posted: 2007-06-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 170

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
System Complication-Free Rate at 6 months
Effectiveness of LV Only/LV Offset at 6 months

Secondary Outcome Measures

Name	Time	Method
LVESD at 6 months
Six-minute walk at 6 months
NYHA at 6 months
QOL at 6 months

Trial Locations

Locations (1)

Kerckhof Klinik; 🇩🇪 Bad Nauheim, Germany