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Safety and Efficacy Study of RENEWAL 4 AVT

Primary Purpose

Heart Failure, Tachycardia, Atrial Fibrillation

Status
Completed
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
CRT-D
Sponsored by
Boston Scientific Corporation
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure focused on measuring Heart Failure, Tachycardia, Atrial Fibrillation, Atrial Flutter, Ventricular Fibrillation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Kerckhof Klinik

Outcomes

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

Full Information

First Posted
September 12, 2005
Last Updated
June 22, 2007
Sponsor
Boston Scientific Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT00180336
Brief Title
Safety and Efficacy Study of RENEWAL 4 AVT
Official Title
CONTAK RENEWAL 4 AVT Field Following
Study Type
Interventional

2. Study Status

Record Verification Date
June 2007
Overall Recruitment Status
Completed
Study Start Date
July 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Boston Scientific Corporation

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Tachycardia, Atrial Fibrillation, Atrial Flutter, Ventricular Fibrillation
Keywords
Heart Failure, Tachycardia, Atrial Fibrillation, Atrial Flutter, Ventricular Fibrillation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
170 (false)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
CRT-D
Primary Outcome Measure Information:
Title
System Complication-Free Rate at 6 months
Title
Effectiveness of LV Only/LV Offset at 6 months
Secondary Outcome Measure Information:
Title
LVESD at 6 months
Title
Six-minute walk at 6 months
Title
NYHA at 6 months
Title
QOL at 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Johannes Sperzel, MD
Organizational Affiliation
Kerckhoff Klinik Bad Nauheim (Germany)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kerckhof Klinik
City
Bad Nauheim
ZIP/Postal Code
61231
Country
Germany

12. IPD Sharing Statement

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Safety and Efficacy Study of RENEWAL 4 AVT

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