Safety and Efficacy Study of RENEWAL 4 AVT

Heart Failure Clinical Trial

Official title:

CONTAK RENEWAL 4 AVT Field Following

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00180336
• Other study ID #: Clinicals0004
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: September 12, 2005
• Last updated: June 22, 2007
• Start date: July 2004

Study information

• Verified date: June 2007
• Source: Boston Scientific Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 170
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atrial Fibrillation
• Atrial Flutter
• Heart Failure
• Tachycardia
• Ventricular Fibrillation

Intervention

Device:
• CRT-D

Locations

Country	Name	City	State
Germany	Kerckhof Klinik	Bad Nauheim

Sponsors (1)

Lead Sponsor	Collaborator
Boston Scientific Corporation

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	System Complication-Free Rate at 6 months
Primary	Effectiveness of LV Only/LV Offset at 6 months
Secondary	LVESD at 6 months
Secondary	Six-minute walk at 6 months
Secondary	NYHA at 6 months
Secondary	QOL at 6 months