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OpenTrials
Completed

NCT Number: NCT00231426

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

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

LDS Hospital

Salt Lake City, Utah, United States

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ICD

Device

Sponsors and collaborators

Lead sponsor

Boston Scientific Corporation

Industry

Registry information

Official study title

Arrhythmia Single Shock DFT Versus ULV: Risk Reduction Evaluation With ICDs Study

Important dates

Study start
2003
Study completion
2005
First posted
Oct 4, 2005
Registry last updated
Nov 22, 2006

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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