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

Primary Purpose

Tachyarrhythmia

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
ICD
Sponsored by
Boston Scientific Corporation
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tachyarrhythmia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All Sexes

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

Sites / Locations

  • LDS Hospital

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
September 30, 2005
Last Updated
November 20, 2006
Sponsor
Boston Scientific Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT00231426
Brief Title
ASSURE Study - Arrhythmia Single Shock DFT Versus ULV: Risk Reduction Evaluation With ICD Implantations
Official Title
Arrhythmia Single Shock DFT Versus ULV: Risk Reduction Evaluation With ICDs Study
Study Type
Interventional

2. Study Status

Record Verification Date
November 2006
Overall Recruitment Status
Completed
Study Start Date
June 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
November 2005 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Boston Scientific Corporation

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tachyarrhythmia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
Single
Allocation
Randomized

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
ICD

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John D Day, M.D.
Organizational Affiliation
LDS Hospital, Salt Lake City, Utah
Official's Role
Principal Investigator
Facility Information:
Facility Name
LDS Hospital
City
Salt Lake City
State/Province
Utah
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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