Detect Fluid Early From Intra-thoracic Impedance Monitoring

NCT ID: NCT00916929

Last Updated: 2019-02-19

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

162 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-05-31

Study Completion Date

2012-03-31

Brief Summary

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To demonstrate the safety and effectiveness of the Impedance Monitoring Feature in St Jude Medical cardiac devices.

Detailed Description

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Conditions

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Heart Failure

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Implantable Cardioverter Defibrillator (ICD)

Impedance Monitoring Feature in an Implantable Cardioverter Defibrillator (ICD).

Group Type OTHER

Impedance Monitoring Feature

Intervention Type DEVICE

Algorithm in cardiac device that measures intra-thoracic impedance from the implanted leads

Cardiac Resynchronization Therapy (CRT-D)

Impedance Monitoring Feature in a Cardiac Resynchronization Therapy (CRT-D) device.

Group Type OTHER

Impedance Monitoring Feature

Intervention Type DEVICE

Algorithm in cardiac device that measures intra-thoracic impedance from the implanted leads

Interventions

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Impedance Monitoring Feature

Algorithm in cardiac device that measures intra-thoracic impedance from the implanted leads

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Must have a St. Jude Medical (SJM) ICD or CRT-D for at least 31 days
* Must have had an episode of acute decompensated heart failure (ADHF) within the past 6 months

Exclusion Criteria

* History of kidney disease requiring hemodialysis
* Refractory end stage heart failure
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Abbott Medical Devices

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Edwin K Heist, MD, PhD

Role: STUDY_CHAIR

Massachusetts General Hospital

Locations

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University of Alabama at Birmingham

Birmingham, Alabama, United States

Site Status

Arizona Arrhythmia Research Center

Phoenix, Arizona, United States

Site Status

Arkansas Cardiology, PA

Little Rock, Arkansas, United States

Site Status

Little Rock Cardiology Clinic, PA

Little Rock, Arkansas, United States

Site Status

Glendale Memorial Hospital and MC

Glendale, California, United States

Site Status

Cardiac Rhythm Specialists, Inc

Northridge, California, United States

Site Status

Colorado Cardiac Alliance, LLC

Colorado Springs, Colorado, United States

Site Status

Shands Jacksonville

Jacksonville, Florida, United States

Site Status

Watson Clinic Center

Lakeland, Florida, United States

Site Status

Orlando Heart Center

Orlando, Florida, United States

Site Status

Tallahassee Research Institute

Tallahassee, Florida, United States

Site Status

Iowa Heart Center

West Des Moines, Iowa, United States

Site Status

Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status

Cardiology Consultants of East Michigan

Flint, Michigan, United States

Site Status

Thoracic Cardiovascular HC Found. (Sparrow Research)

Lansing, Michigan, United States

Site Status

Hattiesburg Clinic

Hattiesburg, Mississippi, United States

Site Status

North Mississippi Medical Center

Tupelo, Mississippi, United States

Site Status

Deborah Heart and Lung Center

Browns Mills, New Jersey, United States

Site Status

Associated Cardiovascular Consultants

Cherry Hill, New Jersey, United States

Site Status

New York Presbyterian Hospital / Cornell University

New York, New York, United States

Site Status

Mid Carolina Cardiology

Charlotte, North Carolina, United States

Site Status

The Cleveland Clinic Foundation

Cleveland, Ohio, United States

Site Status

Ohio State University

Columbus, Ohio, United States

Site Status

Mercy Hospital Fairfield

Fairfield, Ohio, United States

Site Status

Saint Vincent Consultants in Cardiovascular Diseases

Erie, Pennsylvania, United States

Site Status

Hospital of the University of PA

Philadelphia, Pennsylvania, United States

Site Status

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, United States

Site Status

York Hospital

York, Pennsylvania, United States

Site Status

Medical University of South Carolina

Charleston, South Carolina, United States

Site Status

Methodist University Hospital

Memphis, Tennessee, United States

Site Status

St Thomas Hospital

Nashville, Tennessee, United States

Site Status

South Texas Cardiovascular Consultants

San Antonio, Texas, United States

Site Status

Sentara Norfolk General Hospital

Norfolk, Virginia, United States

Site Status

The Hope Heart Institute

Bellevue, Washington, United States

Site Status

Countries

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United States

Other Identifiers

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40006062/D

Identifier Type: -

Identifier Source: org_study_id

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