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

Tachyarrhythmia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00231426
• Other study ID #: CR-CA-031203-M
• Status: Completed
• Phase: Phase 4
• First received: September 30, 2005
• Last updated: November 20, 2006
• Start date: June 2003
• Est. completion date: November 2005

Study information

• Verified date: November 2006
• Source: Boston Scientific Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: November 2005
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Tachyarrhythmia

Intervention

Device:
• ICD

Locations

Country	Name	City	State
United States	LDS Hospital	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
Boston Scientific Corporation

Country where clinical trial is conducted

United States,