Ventricular ArrhythmiasNCT00273195
Clinical Investigation of the Medtronic EnTrust™ Implantable Cardioverter Defibrillator (ICD), Model D153ATG
A study testing Implantable Cardioverter Defibrillator in people with Ventricular Arrhythmias, run by Medtronic Cardiac Rhythm and Heart Failure at 41 sites in 7 countries.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventricular Arrhythmias
- What is being tested?
- Implantable Cardioverter Defibrillator
- Type of treatment
- Medical device
- How many people
- 500 participants
- Where
- 41 sitesin 7 countries
- Study dates
- Apr 2004to Jun 2005
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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.)
Trial locations and contacts
41 sites in 7 countries.
41 sites in 7 countries
United States24 sites
Study site
Abington, Pennsylvania
Study site
Amarillo, Texas
Study site
Atlantis, Florida
Study site
Austin, Texas
Study site
Boston, Massachusetts
Study site
Columbus, Ohio
Study site
Dallas, Texas
Study site
Davenport, Iowa
Study site
Des Moines, Iowa
Study site
Fort Wayne, Indiana
Study site
Glendale, California
Study site
Inglewood, California
Study site
Kansas City, Missouri
Study site
Lancaster, Pennsylvania
Study site
Little Rock, Arkansas
Study site
Macon, Georgia
Study site
Milwaukee, Wisconsin
Study site
Morgantown, West Virginia
Study site
Nashville, Tennessee
Study site
Orlando, Florida
Study site
Richmond, Virginia
Study site
Salisbury, Maryland
Study site
St Louis, Missouri
Study site
Winston-Salem, North Carolina
Canada6 sites
Study site
Calgary, Alberta
Study site
Kingston, Ontario
Study site
Montreal, Quebec
Study site
Sainte-Foy, Quebec
Study site
Toronto, Ontario
Study site
Vancouver, British Columbia
Germany6 sites
Study site
Bonn
Study site
Göttingen
Study site
Heidelberg
Study site
Kaiserslautern
Study site
München
Study site
Münster
About this study
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.
- Conditions
- Ventricular Arrhythmias
- Being tested
- Implantable Cardioverter Defibrillator
- Keywords
- Implantable Cardioverter Defibrillator, Anti-tachycardia pacing (ATP)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implantable Cardioverter DefibrillatorDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and efficacy at three months.
Secondary outcomes (3)
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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2006 (estimated)
- Study startApr 2004
- Study completionJun 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventricular ArrhythmiasStudies of the same condition, open and under way.
- More trials run by Medtronic Cardiac Rhythm and Heart FailureThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 500 participants
Sponsor and investigators
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart Failure
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00273195
- Sponsor's protocol ID
- 213
- Status last verified
- Oct 2006
- First submitted
- 4 Jan 2006
- Last updated
- 13 Oct 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Investigation of the Medtronic EnTrust™ Implantable Cardioverter Defibrillator (ICD), Model D153ATG
- ClinicalTrials.gov ID
- NCT00273195
- Acronym / sponsor ID
- 213
- Conditions
- Ventricular Arrhythmias
- Keywords
- Implantable Cardioverter Defibrillator, Anti-tachycardia pacing (ATP)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 500 participants
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart FailureIndustry (pharma, biotech, devices)
- Study start
- Apr 2004
- Study completion
- Jun 2005
- First posted
- 9 Jan 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (2 listed)
- 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.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Implantable Cardioverter Defibrillator | Device | – |
Primary outcome
Safety and efficacy at three months.
3 secondary outcomes
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2006.
Related trials for Ventricular Arrhythmias
Enrolling by invitation
VINTAGE (Ventricular Intramyocardial Navigation for Tachycardia Ablation Guided by Electrograms) Using Commercial Off-The-Shelf (COTS) Catheters
Ventricular Arrhythmia
Enrolling by invitation
EDEN Intracardiac Electrogram Recording and Classifying System
Ventricular Arrhythmia
Active, not recruiting
Assessment of Combined CCM and ICD Device in HFrEF
Heart Failure, Heart Failure With Reduced Ejection Fraction
RecruitingObservational study
Physical Impairments in Premature Ventricular Complex
Premature Ventricular Complexes
Recruiting
A Study of Dual Energy THERMOCOOL SMARTTOUCH™ SF Catheter With the TRUPULSE™ Generator for Treatment of Ventricular Arrhythmias
Arrhythmias, Cardiac
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
41 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Implantable Cardioverter Defibrillator in people with Ventricular Arrhythmias, run by Medtronic Cardiac Rhythm and Heart Failure at 41 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Oct 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 41 sites in United States, Canada, Germany, Austria, Denmark and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and efficacy at three months.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2006.