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OpenTrials
Completed

NCT Number: NCT00279279

PREPARE - Primary Prevention Parameters Evaluation

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.

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Key information

Conditions

Tachycardia, Ventricular Arrhythmias, Cardiac Cardiac Conduction System Disease Cardiovascular Diseases Consciousness Disorders Death Death, Sudden Death, Sudden, Cardiac Fibrillation, Ventricular Heart Arrest Heart Diseases Implantable Cardioverter Defibrillator (ICD) Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms Syncope Tachycardia Unconsciousness Ventricular Fibrillation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

San Juan, Puerto Rico

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Implanted Device

Device

Primary outcomes

  1. 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

  1. Evaluate the percentage of inappropriate VT/VF detections

  2. characterize the true incidence of VT/VF detections

  3. therapy efficacy

  4. time to first inappropriate VT/VF detection

  5. incidence of untreated but monitored VT

  6. programming changes

  7. deaths and cardiovascular adverse event

Sponsors and collaborators

Lead sponsor

Medtronic Cardiac Rhythm and Heart Failure

Industry

Collaborators

  • Medtronic

Registry information

Important dates

Study start
2003
Study completion
2006
First posted
Jan 19, 2006
Registry last updated
Oct 26, 2006

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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