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

Ventricular Arrhythmias Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00273195
• Other study ID #: 213
• Status: Completed
• Phase: N/A
• First received: January 4, 2006
• Last updated: October 11, 2006
• Start date: April 2004
• Est. completion date: June 2005

Study information

• Verified date: October 2006
• Source: Medtronic Cardiac Rhythm Disease Management
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: June 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.)

Study Design

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

Related Conditions & MeSH terms

• Ventricular Arrhythmias

Intervention

Device:
• Implantable Cardioverter Defibrillator

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Cardiac Rhythm Disease Management

Countries where clinical trial is conducted

United States,  Austria,  Canada,  Denmark,  Germany,  Netherlands,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and efficacy at three months.
Secondary	To evaluate how well the device distinguished between arrhythmias originating in the atrium versus those that originate in the ventricle.
Secondary	To evaluate how well the anti-tachycardia pacing function works.
Secondary	To observe the overall performance of the device system.