Clinical trial NCT00273195: Clinical Investigation of the Medtronic EnTrust™ Implantable Cardioverter Defibrillator (ICD), Model D153ATG
Official title: Clinical Investigation of the Medtronic EnTrust™ Implantable Cardioverter Defibrillator (ICD), Model D153ATG
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ventricular Arrhythmias
Keywords: Implantable Cardioverter Defibrillator, Anti-tachycardia pacing (ATP)
Lead sponsor: Medtronic Cardiac Rhythm and Heart Failure
Sponsor class: INDUSTRY
First posted: 2006-01-09
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility 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.)

Primary outcomes:
measure: Safety and efficacy at three months.
Secondary outcomes:
measure: To evaluate how well the device distinguished between arrhythmias originating in the atrium versus those that originate in the ventricle.
measure: To evaluate how well the anti-tachycardia pacing function works.
measure: To observe the overall performance of the device system.
Other outcomes:
Locations:
city: Little Rock
country: United States
state: Arkansas
city: Glendale
country: United States
state: California
city: Inglewood
country: United States
state: California
city: Atlantis
country: United States
state: Florida
city: Orlando
country: United States
state: Florida
city: Macon
country: United States
state: Georgia
city: Ft. Wayne
country: United States
state: Indiana
city: Davenport
country: United States
state: Iowa
city: Des Moines
country: United States
state: Iowa
city: Salisbury
country: United States
state: Maryland
city: Boston
country: United States
state: Massachusetts
city: Kansas City
country: United States
state: Missouri
city: St. Louis
country: United States
state: Missouri
city: Winston-Salem
country: United States
state: North Carolina
city: Columbus
country: United States
state: Ohio
city: Abington
country: United States
state: Pennsylvania
city: Lancaster
country: United States
state: Pennsylvania
city: Nashville
country: United States
state: Tennessee
city: Amarillo
country: United States
state: Texas
city: Austin
country: United States
state: Texas
city: Dallas
country: United States
state: Texas
city: Richmond
country: United States
state: Virginia
city: Morgantown
country: United States
state: West Virginia
city: Milwaukee
country: United States
state: Wisconsin
city: St. Poelten
country: Austria
city: Steyr
country: Austria
city: Calgary
country: Canada
state: Alberta
city: Vancouver
country: Canada
state: British Columbia
city: Kingston
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
city: Montreal
country: Canada
state: Quebec
city: Sainte-Foy
country: Canada
state: Quebec
city: Copenhagen
country: Denmark
city: Bonn
country: Germany
city: Goettingen
country: Germany
city: Heidelberg
country: Germany
city: Kaiserslautern
country: Germany
city: Muenchen
country: Germany
city: Muenster
country: Germany
city: Eindhoven
country: Netherlands
city: Basel
country: Switzerland
Study officials:
References: