CRT-D in Heart Failure and Atrial Fibrillation and Ventricular Fibrillation - Clinical Trials Registry

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Device: CRT-D

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 Type

Interventional

Enrollment

170

Phase

Phase 2
Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Germany
- - Bad Nauheim, Germany, 61231
    - Kerckhof Klinik

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: TREATMENT
Allocation: NON_RANDOMIZED
Interventional Model: PARALLEL
Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
System Complication-Free Rate at 6 months
Effectiveness of LV Only/LV Offset at 6 months

Secondary Outcome Measures

Outcome Measure
LVESD at 6 months
Six-minute walk at 6 months
NYHA at 6 months
QOL at 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boston Scientific Corporation

Investigators

Principal Investigator: Johannes Sperzel, MD, Kerckhoff Klinik Bad Nauheim (Germany)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2004

Study Registration Dates

First Submitted

September 12, 2005

First Submitted That Met QC Criteria