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

This study has been completed.
Sponsor:
Information provided by:
Boston Scientific Corporation
ClinicalTrials.gov Identifier:
NCT00231426
First received: September 30, 2005
Last updated: November 20, 2006
Last verified: November 2006

September 30, 2005
November 20, 2006
June 2003
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Complete list of historical versions of study NCT00231426 on ClinicalTrials.gov Archive Site
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ASSURE Study - Arrhythmia Single Shock DFT Versus ULV: Risk Reduction Evaluation With ICD Implantations
Arrhythmia Single Shock DFT Versus ULV: Risk Reduction Evaluation With ICDs Study

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.

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Interventional
Phase 4
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single Blind
Primary Purpose: Treatment
Tachyarrhythmia
Device: ICD
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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November 2005
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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
Both
18 Years and older
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Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00231426
CR-CA-031203-M
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Boston Scientific Corporation
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Principal Investigator: John D Day, M.D. LDS Hospital, Salt Lake City, Utah
Boston Scientific Corporation
November 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP