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ASSURE Study - Arrhythmia Single Shock DFT Versus ULV: Risk Reduction Evaluation With ICD Implantations

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. Identifier: NCT00231426
Recruitment Status : Completed
First Posted : October 4, 2005
Last Update Posted : November 22, 2006
Information provided by:
Boston Scientific Corporation

Brief Summary:
The ASSURE Study will evaluate shock conversion performance when programming the first shock of an implantable cardioverter-defibrillation (ICD) is based on an implant test consisting of either 1) a single induction of ventricular fibrillation (VF) and subsequent demonstration conversion success at 14 J or 2) an upper limit of vulnerability (ULV) test at 14 J.

Condition or disease Intervention/treatment Phase
Tachyarrhythmia Device: ICD Phase 4

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Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single
Primary Purpose: Treatment
Official Title: Arrhythmia Single Shock DFT Versus ULV: Risk Reduction Evaluation With ICDs Study
Study Start Date : June 2003
Study Completion Date : November 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Shock

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All

Inclusion Criteria:

  • Patients who meet current indications for an ICD including cardiac resynchronization therapy (CRT) devices
  • Patients who sign and date a Patient Informed Consent form prior to the implant visit
  • Patients who remain in the clinical care of the enrolling physician in approved centers
  • Patients who receive only left-sided pectoral implantations with the ICD lead placed in the right ventricular apex
  • Patients who have a minimum R wave of at least 7 mV; or for ICD replacement, patients who have a minimum chronic R wave of at least 5 mV

Exclusion Criteria:

  • Patients who are involved in Non-Invasive Programming Stimulation (NIPS) studies
  • Patients who undergo lead repositioning
  • Patients who are expected to receive a heart transplant during the duration of the study
  • Patients who have or who are likely to receive a tricuspid valve prosthesis
  • Patients who are currently enrolled in another investigational study or registry that would directly impact the treatment or outcome of the current study
  • Patients who are younger than 18 years of age
  • Patients who are pregnant or plan to become pregnant during the study
  • Patients whose life expectancy is less than 12 months
  • Patients who are mentally incompetent and cannot sign a Patient Informed Consent form or comply with the study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00231426

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United States, Utah
LDS Hospital
Salt Lake City, Utah, United States
Sponsors and Collaborators
Boston Scientific Corporation
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Principal Investigator: John D Day, M.D. LDS Hospital, Salt Lake City, Utah

Layout table for additonal information Identifier: NCT00231426     History of Changes
Other Study ID Numbers: CR-CA-031203-M
First Posted: October 4, 2005    Key Record Dates
Last Update Posted: November 22, 2006
Last Verified: November 2006

Additional relevant MeSH terms:
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Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Cardiac Conduction System Disease
Pathologic Processes