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

NCT00231426 | Completed Phase 4

• 1 other identifier: CR-CA-031203-M
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Tachyarrhythmia

Interventions

ICD DEVICE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boston Scientific Corporation: lead

Study Sites (1)

LDS Hospital

Salt Lake City, Utah, United States

Location

MeSH Terms

Conditions

Tachycardia

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• John D Day, M.D.

  LDS Hospital, Salt Lake City, Utah

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 30, 2005
• First Posted: October 4, 2005
• Study Start: June 1, 2003
• Study Completion: November 1, 2005
• Last Updated: November 22, 2006

Record last verified: 2006-11

Locations

US (1)