Heart DiseasesNCT00328705
D2-EPG Study: Evaluation of New Sensing Circuitry and Capture Management
A study testing Implantable Cardioverter Defibrillator in people with Heart Diseases, run by Medtronic Cardiac Rhythm and Heart Failure at 5 sites in United States.
Trial summary
This is an acute, prospective, multi-center, non-randomized, investigational device exemption (IDE) clinical study. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Diseases
- What is being tested?
- Implantable Cardioverter Defibrillator
- Type of treatment
- Medical device
- How many people
- 65 participants
- Where
- 5 sitesUnited States
- Study dates
- May 2006to Jan 2007
- 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
- Patients who are scheduled for implantation or replacement of an implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy (CRT) device
- Patients must have or receive Medtronic transvenous atrial and ventricular leads in association with the scheduled device implant or replacement.
Who cannot join
- Patients who have 3rd degree heart block, as assessed by the investigator
- Patients who have a mechanical tricuspid heart valve
- Patients who have received an investigational new drug or device, or are currently enrolled in a clinical study for a new indication of an approved drug or device
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Study site
Charlotte, North Carolina
Study site
Coon Rapids, Minnesota
Study site
Rochester, Minnesota
Study site
Saint Paul, Minnesota
Study site
Tampa, Florida
About this study
This is an acute, prospective, multi-center, non-randomized, investigational device exemption (IDE) clinical study.
Read the detailed description
The purpose of this study is to confirm the performance of new sensing circuitry, and to confirm the performance of a Ventricular Capture Management feature in subjects with implantable cardioverter defibrillator (ICD) leads connected to an external pacemaker/defibrillator.
- Conditions
- Heart Diseases
- Being tested
- Implantable Cardioverter Defibrillator
- Keywords
- Sensing, Capture Management, Heart Failure, ICD Indication
- Medical subject headings
- Heart Diseases, Heart Failure
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.
Ventricular fibrillation (VF) detection time
Ventricular Capture Management accuracy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2006 (estimated)
- Study startMay 2006
- Primary completionJan 2007
- Study completionJan 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart DiseasesStudies 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
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart Failure
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Medtronic
- Investigators
- Cole Hannon, Study director, Medtronic CRDM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00328705
- Sponsor's protocol ID
- 209
- Status last verified
- Feb 2008
- First submitted
- 19 May 2006
- Last updated
- 13 Feb 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- D2-EPG Study: Evaluation of New Sensing Circuitry and Capture Management
- ClinicalTrials.gov ID
- NCT00328705
- Acronym / sponsor ID
- 209
- Conditions
- Heart Diseases
- Keywords
- Sensing, Capture Management, Heart Failure, ICD Indication
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart FailureIndustry (pharma, biotech, devices)
- Collaborators
- Medtronic
- Study start
- May 2006
- Primary completion
- Jan 2007 (actual)
- Study completion
- Jan 2007 (actual)
- First posted
- 22 May 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.
This is an acute, prospective, multi-center, non-randomized, investigational device exemption (IDE) clinical study.
Detailed description
The purpose of this study is to confirm the performance of new sensing circuitry, and to confirm the performance of a Ventricular Capture Management feature in subjects with implantable cardioverter defibrillator (ICD) leads connected to an external pacemaker/defibrillator.
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 (2 listed)
- Patients who are scheduled for implantation or replacement of an implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy (CRT) device
- Patients must have or receive Medtronic transvenous atrial and ventricular leads in association with the scheduled device implant or replacement.
Key exclusion criteria (3 listed)
- Patients who have 3rd degree heart block, as assessed by the investigator
- Patients who have a mechanical tricuspid heart valve
- Patients who have received an investigational new drug or device, or are currently enrolled in a clinical study for a new indication of an approved drug or device
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
Ventricular fibrillation (VF) detection time
Ventricular Capture Management accuracy
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 Feb 2008.
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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.
Cole Hannon study director
Medtronic CRDM
5 sites in 1 country: 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 Heart Diseases, run by Medtronic Cardiac Rhythm and Heart Failure at 5 sites in United States.
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 2 inclusion and 3 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 Feb 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. 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?
Ventricular fibrillation (VF) detection time. The study lists 2 primary outcomes in all. 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 Feb 2008.