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
  Purpose

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 Intervention Phase
Tachyarrhythmia
Device: ICD
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single Blind
Primary Purpose: Treatment
Official Title: Arrhythmia Single Shock DFT Versus ULV: Risk Reduction Evaluation With ICDs Study

Resource links provided by NLM:


Further study details as provided by Boston Scientific Corporation:

Study Start Date: June 2003
Estimated Study Completion Date: November 2005
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00231426

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

No publications provided

ClinicalTrials.gov Identifier: NCT00231426     History of Changes
Other Study ID Numbers: CR-CA-031203-M
Study First Received: September 30, 2005
Last Updated: November 20, 2006
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Arrhythmias, Cardiac
Tachycardia
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on April 15, 2014