PREPARE - Primary Prevention Parameters Evaluation

Medtronic Cardiac Rhythm and Heart Failure700 enrolled

Overview

The purpose of this study is to test specific device programming in patients without a previous history of a life-threatening, abnormally fast heartbeat who are implanted with a Medtronic ICD (Implantable Cardioconverter Defibrillator) or ICD with CRT (Cardiac Resynchronozation Therapy) device. The information learned from this study could be used to guide physicians in future ICD or CRT device programming.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

700

Conditions

Tachycardia, Ventricular Implantable Cardioverter Defibrillator (ICD)Fibrillation, Ventricular Syncope

Interventions

Implanted DeviceDEVICE

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: Patient is a candidate for a non-replacement Medtronic ICD device from the Marquis family or has had a non-replacement Medtronic Marquis based ICD system implanted within the previous 6 months and has not had any appropriately treated spontaneous VT/VF episodes during that time. Exclusion Criteria: Patient has history of spontaneous sustained symptomatic ventricular arrhythmias. If patient has had an electrophysiology test in the past, and has sustained inducible VT \<180 bpm.

Locations (32)

Unnamed facility

Birmingham, Alabama, United States

Outcomes

Primary Outcomes

Demonstrate that patients programmed using a prescribed set of parameters have a lower rate of cardiac syncope, symptoms of fast heart rate, VT/VF events and cardioversion or defibrillation shocks compared to patients programmed per physician discretion

Secondary Outcomes

Evaluate the percentage of inappropriate VT/VF detections

characterize the true incidence of VT/VF detections

therapy efficacy

time to first inappropriate VT/VF detection

incidence of untreated but monitored VT

programming changes

deaths and cardiovascular adverse event

Data from ClinicalTrials.gov

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