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Trial record 22 of 133 for:    "Paroxysmal Ventricular Fibrillation"

INSIGHTS ICD Registry

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00279968
Recruitment Status : Completed
First Posted : January 20, 2006
Last Update Posted : December 28, 2007
Sponsor:
Collaborator:
Medtronic
Information provided by:
Medtronic Cardiac Rhythm and Heart Failure

Tracking Information
First Submitted Date January 19, 2006
First Posted Date January 20, 2006
Last Update Posted Date December 28, 2007
Study Start Date February 2004
Primary Completion Date Not Provided
Current Primary Outcome Measures Not Provided
Original Primary Outcome Measures Not Provided
Change History Complete list of historical versions of study NCT00279968 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title INSIGHTS ICD Registry
Official Title Investigating Significant ICD Heart Therapies Registry Study (INSIGHTS ICD Registry)
Brief Summary 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.
Detailed Description Not Provided
Study Type Observational
Study Design Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Not Provided
Study Population Not Provided
Condition
  • Ventricular Tachycardia
  • Ventricular Fibrillation
Intervention Device: ICD
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Enrollment
 (submitted: January¬†19,¬†2006)
1326
Original Enrollment Same as current
Study Completion Date January 2006
Primary Completion Date Not Provided
Eligibility Criteria

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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00279968
Other Study ID Numbers 231
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Not Provided
Study Sponsor Medtronic Cardiac Rhythm and Heart Failure
Collaborators Medtronic
Investigators
Principal Investigator: Alfred Buxton, MD Rhode Island Hospital
PRS Account Medtronic Cardiac Rhythm and Heart Failure
Verification Date December 2007