Clinical Investigation of the Medtronic EnTrust™ Implantable Cardioverter Defibrillator (ICD), Model D153ATG - Full Text View

Sponsored by:	Medtronic Cardiac Rhythm Disease Management
Information provided by:	Medtronic Cardiac Rhythm Disease Management
ClinicalTrials.gov Identifier:	NCT00273195

Purpose

People who have a dangerously fast heart beat, or whose heart is at risk of stopping beating, may be in need of an electronic device called an implantable cardioverter defibrillator (ICD). An ICD is implanted surgically just under the skin in the upper chest area and it sends a strong electrical impulse, or shock, to the heart to return it to a normal rhythm.

The purpose of this study was to evaluate the safety and efficacy of the EnTrust ICD device. A feature of this device allows it to send small, painless electrical impulses (Anti-tachycardia pacing or ATP) to the heart instead of shocking it out of a rhythm that is too fast. Stopping a dangerous heart rhythm this way does not cause any pain whereas a shock to the heart can feel like a punch in the chest. This device also allows the heart to beat on its own when it can and helping it (by pacing, or sending it electrical signals) when it needs help. This feature is important because previously studies have shown that pacing the heart too often can increase the risk for heart failure or for atrial fibrillation (having too rapid of heart beats in the atrium).

This study is now complete and the device has since been approved by the FDA.

Condition	Intervention
Ventricular Arrhythmias	Device: Implantable Cardioverter Defibrillator

Genetics Home Reference related topics: Brugada syndrome short QT syndrome

MedlinePlus related topics: Arrhythmia Pacemakers and Implantable Defibrillators

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	Clinical Investigation of the Medtronic EnTrust™ Implantable Cardioverter Defibrillator (ICD), Model D153ATG

Further study details as provided by Medtronic Cardiac Rhythm Disease Management:

Primary Outcome Measures:

Safety and efficacy at three months.

Secondary Outcome Measures:

To evaluate how well the device distinguished between arrhythmias originating in the atrium versus those that originate in the ventricle.
To evaluate how well the anti-tachycardia pacing function works.
To observe the overall performance of the device system.

Estimated Enrollment:	500
Study Start Date:	April 2004
Estimated Study Completion Date:	June 2005

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Subjects with failure but no symptoms (NYHA Class I) or subjects with mild heart failure that only sometimes interferes with daily activities (NYHA Class II)

Subjects who have, or are risk of having, a heart beat that is too fast and his/her doctor has determined he/she needs an implantable cardioverter defibrillator (ICD)

Subjects who have, or are at risk of developing, rapid beats in the upper chambers of the heart (atrial tachyarrhythmias)

Exclusion Criteria:

Subjects with rapid heart beats in their ventricles (lower chambers of the heart) associated only with reversible causes

Subjects with mechanical tricuspid heart valves (A structure in the heart, located between the right atrium and right ventricle, which allows blood to flow down from the atrium into the ventricle.)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00273195

Show 41 Study Locations

Sponsors and Collaborators

Medtronic Cardiac Rhythm Disease Management

More Information

Study ID Numbers:	213
Study First Received:	January 4, 2006
Last Updated:	October 11, 2006
ClinicalTrials.gov Identifier:	NCT00273195
Health Authority:	United States: Food and Drug Administration

Keywords provided by Medtronic Cardiac Rhythm Disease Management:

Implantable Cardioverter Defibrillator, Anti-tachycardia pacing (ATP)

Study placed in the following topic categories:

Heart Diseases
Tachycardia
Arrhythmias, Cardiac

Additional relevant MeSH terms:

Pathologic Processes
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009