Ventricular TachycardiaNCT00279968
INSIGHTS ICD Registry
An observational study of Ventricular Tachycardia and Ventricular Fibrillation, run by Medtronic Cardiac Rhythm and Heart Failure at 44 sites in United States.
Trial summary
The purpose of the Registry is to collect data on how Implantable Cardioverter Defibrillator (ICD) therapies and medications are being used by physicians to treat ventricular arrhythmias in order to better understand how to improve the clinical care of patients and effectiveness of ICD therapies. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventricular Tachycardia, Ventricular Fibrillation
- What is being tested?
- ICD
- Type of treatment
- Medical device
- How many people
- 1,326 participants
- Where
- 44 sitesUnited States
- Study dates
- Feb 2004to Jan 2006
- Phase
- Observational
- 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 18 years of age or older.
- Patients or legal guardians who are willing and able to sign a Permission for Access to and Use of Health Information in a Registry Form and, if required by an Institution's IRB, an Informed Consent.
- New or replacement implants of Medtronic market released single, dual or triple chamber ICDs including: GEM VR, GEM DR, GEM III AT, Marquis VR, Marquis DR, Maximo DR, Maximo VR, InSync ICD, InSync Marquis ICD and InSync II Marquis ICD.
Who cannot join
- Patients enrolled in a device study which effects programming and or treatment.
Trial locations and contacts
44 sites in 1 country.
44 sites in 1 country
United States44 sites
Study site
Annapolis, Maryland
Study site
Atlanta, Georgia
Study site
Austin, Texas
Study site
Boston, Massachusetts
Study site
Boulder, Colorado
Study site
Bradenton, Florida
Study site
Brooklyn, New York
Study site
Charlotte, North Carolina
Study site
Chicago, Illinois
Study site
Cincinnati, Ohio
Study site
Cleveland, Ohio
Study site
Columbia, Missouri
Study site
Crown Point, Indiana
Study site
Detroit, Michigan
Study site
Fort Worth, Texas
Study site
Fountain Valley, California
Study site
Fredericksburg, Virginia
Study site
Gainesville, Georgia
Study site
Glen Burnie, Maryland
Study site
Houston, Texas
Study site
Kalamazoo, Michigan
Study site
Kettering, Ohio
Study site
Lakeland, Florida
Study site
Lancaster, Pennsylvania
Study site
Langhorne, Pennsylvania
Study site
Lauderdale Lakes, Florida
Study site
Little Rock, Arkansas
Study site
McAllen, Texas
Study site
Mineola, New York
Study site
Minot, North Dakota
Study site
Monroe, Louisiana
Study site
Newark, New Jersey
Study site
Noblesville, Indiana
Study site
Omaha, Nebraska
Study site
Palm Beach Gardens, Florida
Study site
Panama City, Florida
Study site
Pembroke Pines, Florida
Study site
Pomona, New Jersey
Study site
Poway, California
Study site
Providence, Rhode Island
Study site
Sacramento, California
Study site
Santa Ana, California
Study site
Tampa, Florida
Study site
Williamsville, New York
About this study
Official title: Investigating Significant ICD Heart Therapies Registry Study (INSIGHTS ICD Registry)
The purpose of the Registry is to collect data on how Implantable Cardioverter Defibrillator (ICD) therapies and medications are being used by physicians to treat ventricular arrhythmias in order to better understand how to improve the clinical care of patients and effectiveness of ICD therapies.
- Conditions
- Ventricular Tachycardia, Ventricular Fibrillation
- Being tested
- ICD
- Keywords
- ICD, Registry, Ventricular tachycardia, Ventricular Fibrillation
- Medical subject headings
- Tachycardia, Ventricular, Ventricular Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ICDDevice
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2006 (estimated)
- Study startFeb 2004
- Study completionJan 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventricular TachycardiaStudies of the same condition, open and under way.
- 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
- Observational
- Time perspective
- Prospective
- Enrolment
- 1,326 participants
Sponsor and investigators
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart Failure
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Medtronic
- Investigators
- Alfred Buxton, MD, Principal investigator, Rhode Island Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00279968
- Sponsor's protocol ID
- 231
- Status last verified
- Dec 2007
- First submitted
- 19 Jan 2006
- Last updated
- 28 Dec 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating Significant ICD Heart Therapies Registry Study (INSIGHTS ICD Registry)
- ClinicalTrials.gov ID
- NCT00279968
- Acronym / sponsor ID
- 231
- Conditions
- Ventricular Tachycardia, Ventricular Fibrillation
- Keywords
- ICD, Registry, Ventricular tachycardia, Ventricular Fibrillation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,326 participants
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart FailureIndustry (pharma, biotech, devices)
- Collaborators
- Medtronic
- Study start
- Feb 2004
- Study completion
- Jan 2006
- First posted
- 20 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.
The purpose of the Registry is to collect data on how Implantable Cardioverter Defibrillator (ICD) therapies and medications are being used by physicians to treat ventricular arrhythmias in order to better understand how to improve the clinical care of patients and effectiveness of ICD therapies.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients 18 years of age or older.
- Patients or legal guardians who are willing and able to sign a Permission for Access to and Use of Health Information in a Registry Form and, if required by an Institution's IRB, an Informed Consent.
- New or replacement implants of Medtronic market released single, dual or triple chamber ICDs including: GEM VR, GEM DR, GEM III AT, Marquis VR, Marquis DR, Maximo DR, Maximo VR, InSync ICD, InSync Marquis ICD and InSync II Marquis ICD.
Key exclusion criteria (1 listed)
- Patients enrolled in a device study which effects programming and or treatment.
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 |
|---|---|---|
| ICD | Device | – |
Primary outcome
Not reported in the source record.
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 28 Dec 2007.
Related trials for Ventricular Tachycardia
Not yet recruiting
MRI-guided Ventricular Tachycardia Ablation in Patients With Structural Heart Disease
Ventricular Tachycardia (VT), Ischemic Cardiomyopathy
Enrolling by invitation
VINTAGE (Ventricular Intramyocardial Navigation for Tachycardia Ablation Guided by Electrograms) Using Commercial Off-The-Shelf (COTS) Catheters
Ventricular Arrhythmia
Recruiting
Safety and Effectiveness of the Sphere-9™ Catheter and Affera™ Ablation System for the Treatment of Ventricular Tachycardia (Sphere VT)
Ventricular Tachycardia
RecruitingPhase 1
A Study of SGT-501 Gene Therapy in Catecholaminergic Polymorphic Ventricular Tachycardia (CPVT)
Catecholaminergic Polymorphic Ventricular Tachycardia
Recruiting
SPIKE FLOW Endocardial Lead Safety and Performance Study
Acute Myocardial Infarction (AMI), Asystole
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.
Alfred Buxton, MD principal investigator
Rhode Island Hospital
44 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ventricular Tachycardia and Ventricular Fibrillation, run by Medtronic Cardiac Rhythm and Heart Failure at 44 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 3 inclusion and 1 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 28 Dec 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 44 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.
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 28 Dec 2007.