- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00279968
INSIGHTS ICD Registry
December 26, 2007 updated by: Medtronic Cardiac Rhythm and Heart Failure
Investigating Significant ICD Heart Therapies Registry Study (INSIGHTS ICD Registry)
The purpose of the Registry is to collect data on how Implantable Cardioverter Defibrillator (ICD) therapies and medications are being used by physicians to treat ventricular arrhythmias in order to better understand how to improve the clinical care of patients and effectiveness of ICD therapies.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment
1326
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
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Arkansas
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Little Rock, Arkansas, United States
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California
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Fountain Valley, California, United States
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Poway, California, United States
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Sacramento, California, United States
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Santa Ana, California, United States
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Colorado
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Boulder, Colorado, United States
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Florida
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Bradenton, Florida, United States
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Lakeland, Florida, United States
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Lauderdale Lakes, Florida, United States
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Palm Beach Gardens, Florida, United States
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Panama City, Florida, United States
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Pembroke Pines, Florida, United States
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Tampa, Florida, United States
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Georgia
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Atlanta, Georgia, United States
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Gainesville, Georgia, United States
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Illinois
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Chicago, Illinois, United States
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Indiana
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Crown Point, Indiana, United States
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Noblesville, Indiana, United States
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Louisiana
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Monroe, Louisiana, United States
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Maryland
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Annapolis, Maryland, United States
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Glen Burnie, Maryland, United States
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Massachusetts
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Boston, Massachusetts, United States
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Michigan
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Detroit, Michigan, United States
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Kalamazoo, Michigan, United States
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Missouri
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Columbia, Missouri, United States
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Nebraska
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Omaha, Nebraska, United States
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New Jersey
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Newark, New Jersey, United States
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Pomona, New Jersey, United States
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New York
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Brooklyn, New York, United States
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Mineola, New York, United States
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Williamsville, New York, United States
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North Carolina
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Charlotte, North Carolina, United States
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North Dakota
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Minot, North Dakota, United States
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Ohio
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Cincinnati, Ohio, United States
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Cleveland, Ohio, United States
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Kettering, Ohio, United States
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Pennsylvania
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Lancaster, Pennsylvania, United States
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Langhorne, Pennsylvania, United States
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Rhode Island
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Providence, Rhode Island, United States
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Texas
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Austin, Texas, United States
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Fort Worth, Texas, United States
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Houston, Texas, United States
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McAllen, Texas, United States
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Virginia
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Fredericksburg, Virginia, United States
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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:
- Patients 18 years of age or older.
- Patients or legal guardians who are willing and able to sign a Permission for Access to and Use of Health Information in a Registry Form and, if required by an Institution's IRB, an Informed Consent.
- New or replacement implants of Medtronic market released single, dual or triple chamber ICDs including: GEM VR, GEM DR, GEM III AT, Marquis VR, Marquis DR, Maximo DR, Maximo VR, InSync ICD, InSync Marquis ICD and InSync II Marquis ICD.
Exclusion Criteria:
- Patients enrolled in a device study which effects programming and or treatment.
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
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Alfred Buxton, MD, Rhode Island Hospital
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
February 1, 2004
Study Completion
January 1, 2006
Study Registration Dates
First Submitted
January 19, 2006
First Submitted That Met QC Criteria
January 19, 2006
First Posted (Estimate)
January 20, 2006
Study Record Updates
Last Update Posted (Estimate)
December 28, 2007
Last Update Submitted That Met QC Criteria
December 26, 2007
Last Verified
December 1, 2007
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 231
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Ventricular Fibrillation
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Academisch Medisch Centrum - Universiteit van Amsterdam...Enrolling by invitationShort-coupled Idiopathic Ventricular FibrillationNetherlands
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Guidant CorporationBoston Scientific CorporationCompletedHeart Failure | Ventricular Tachycardia, Ventricular FibrillationIsrael, Denmark
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Boston Scientific CorporationCompletedAtrial Fibrillation | Ventricular Fibrillation | Ventricular TachycardiaUnited States, Netherlands
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Biosense Webster, Inc.CompletedVentricular Tachycardia | Paroxysmal Atrial Fibrillation | Persistent Atrial Fibrillation | Scar-related Atrial Tachycardia | Premature Ventricular ComplexCroatia, Italy, Israel
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Biosense Webster, Inc.CompletedVentricular Tachycardia | Paroxysmal Atrial Fibrillation | Persistent Atrial Fibrillation | Scar-related Atrial Tachycardia | Premature Ventricular ComplexCroatia, Belgium, Italy
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Mayo ClinicMedtronicCompletedAtrial Fibrillation | Ventricular Fibrillation | Ventricular Tachycardia | Supraventricular TachycardiaUnited States, Israel
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Institute for Clinical and Experimental MedicineRecruitingAtrial Fibrillation | Acute Heart Failure | Left Ventricular Dysfunction | Atrial Fibrillation RapidCzechia
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University of Turin, ItalyUniversity of Padova; Centro Cardiologico Monzino; Policlinico Casilino ASL RMB; Humanitas Research Hospital IRCCS, Rozzano-MilanUnknownPersistent Atrial Fibrillation | Congestive Heart Failure Due to Left Ventricular Systolic Dysfunction
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Abbott Medical DevicesCompletedVentricular Tachycardia | Persistent Atrial FibrillationCanada, South Africa, Denmark, Australia, Italy, Austria, France, Germany, Netherlands, Portugal, Spain
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Ottawa Heart Institute Research CorporationNot yet recruitingVentricular Fibrillation | Ventricular Tachycardia | Ventricular Arrhythmias | Recurrent Ventricular Tachycardia
Clinical Trials on ICD
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Barts & The London NHS TrustCompletedHeart FailureUnited Kingdom
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Wuerzburg University HospitalUniversity of Leipzig; University of Wuerzburg; Campus Bad Neustadt; Klinikum Aschaffenburg-Alzenau and other collaboratorsCompletedDepression | Quality of Life | AnxietyGermany
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Boston Scientific CorporationCompletedTachycardia, VentricularUnited Kingdom, Denmark, Italy, New Zealand, Germany, France, Netherlands, Portugal, Czechia, Spain
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Assistance Publique - Hôpitaux de ParisMinistry of Health, FranceRecruitingHeart Failure | Implantable Cardioverter Defibrillator | Primary Prevention of Sudden Cardiac DeathFrance
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Biotronik SE & Co. KGCompletedHeart Failure | TachyarrhythmiaDenmark, France, Germany, Spain, Switzerland, Israel, Latvia, Australia, Singapore, Austria
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Biotronik, Inc.CompletedPatients Indicated for an ICDUnited States
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Medtronic Bakken Research CenterMedtronicCompletedTachycardia, VentricularGermany, Denmark
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Unity Health TorontoApplied Health Research Centre; Biotronik Canada IncActive, not recruitingCardiovascular Diseases | Implantable Cardioverter-Defibrillators | Cardiac Arrhythmias | Atrial Fibrillation and FlutterCanada
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Vanderbilt University Medical CenterThoratec CorporationCompleted
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Boston Scientific CorporationCompletedVentricular Fibrillation | Ventricular TachycardiaUnited Kingdom