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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2003-06-30

Study Completion Date

2005-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Tachyarrhythmia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Interventions

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ICD

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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John D Day, M.D.

Role: PRINCIPAL_INVESTIGATOR

LDS Hospital, Salt Lake City, Utah

Locations

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LDS Hospital

Salt Lake City, Utah, United States

Site Status

Countries

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United States

Other Identifiers

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CR-CA-031203-M

Identifier Type: -

Identifier Source: org_study_id