PREPARE - Primary Prevention Parameters Evaluation

Syncope Clinical Trial

Official title:

PREPARE - Primary Prevention Parameters Evaluation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00279279
• Other study ID #: 223
• Status: Completed
• Phase: N/A
• First received: January 17, 2006
• Last updated: October 25, 2006
• Start date: October 2003
• Est. completion date: May 2006

Study information

• Verified date: October 2006
• Source: Medtronic Cardiac Rhythm Disease Management
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 700
• Est. completion date: May 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

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

Intervention

Device:
• Implanted Device

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Medtronic Cardiac Rhythm Disease Management	Medtronic

Countries where clinical trial is conducted

United States,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Evaluate the percentage of inappropriate VT/VF detections
Secondary	characterize the true incidence of VT/VF detections
Secondary	therapy efficacy
Secondary	time to first inappropriate VT/VF detection
Secondary	incidence of untreated but monitored VT
Secondary	programming changes
Secondary	deaths and cardiovascular adverse event