Heart FailureNCT00289302
InSync Implantable Cardioverter Defibrillator Registry: Cardiac Resynchronization Therapy
An observational study of Heart Failure and Cardiomyopathy, run by Medtronic Cardiac Rhythm and Heart Failure at 51 sites in United States.
Trial summary
Heart failure is a progressive disease that decreases the pumping action of the heart. This may cause a backup of fluid in the heart and may result in heart beat changes. When there are changes in the heart beat sometimes an implantable heart device is used to control the rate and rhythm of the heart beat. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Cardiomyopathy
- What is being tested?
- Cardiac resynchronization therapy device
- Type of treatment
- Medical device
- How many people
- 600 participants
- Where
- 51 sitesUnited States
- Study dates
- Jan 2003to Dec 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 implanted with the InSync ICD or InSync Marquis cardiac resynchronization therapy (CRT) system (includes InSync ICD Model 7272 or InSync Marquis Model 7277, right atrial lead, right ventricular lead and any market released Medtronic left ventricular lead or the investigational Attain Model 4189 lead which was implanted during the MIRACLE ICD Study)
Who cannot join
- Patients with a history of a previously failed placement of a currently investigational Medtronic left ventricular lead within 30 days of enrollment in the InSync ICD Registry
Trial locations and contacts
51 sites in 1 country.
51 sites in 1 country
United States51 sites
Study site
Albany, New York
Study site
Atlanta, Georgia
Study site
Austin, Texas
Study site
Baltimore, Maryland
Study site
Baton Rouge, Louisiana
Study site
Birmingham, Alabama
Study site
Boston, Massachusetts
Study site
Burlington, Massachusetts
Study site
Chapel Hill, North Carolina
Study site
Cherry Hill, New Jersey
Study site
Chicago, Illinois
Study site
Cincinnati, Ohio
Study site
Cleveland, Ohio
Study site
Columbus, Ohio
Study site
Dallas, Texas
Study site
Davenport, Iowa
Study site
Des Moines, Iowa
Study site
Erie, Pennsylvania
Study site
Hackensack, New Jersey
Study site
Houma, Louisiana
Study site
Indianapolis, Indiana
Study site
Jacksonville, Florida
Study site
Lancaster, Pennsylvania
Study site
Las Vegas, Nevada
Study site
Lexington, Kentucky
Study site
Mayfield Heights, Ohio
Study site
Memphis, Tennessee
Study site
Miami, Florida
Study site
Milwaukee, Wisconsin
Study site
Mobile, Alabama
Study site
New Haven, Connecticut
Study site
New Orleans, Louisiana
Study site
Newark, Delaware
Study site
Oak Lawn, Illinois
Study site
Oklahoma City, Oklahoma
Study site
Orlando, Florida
Study site
Palm Beach Gardens, Florida
Study site
Phoenix, Arizona
Study site
Providence, Rhode Island
Study site
Raleigh, North Carolina
Study site
Richmond, Virginia
Study site
Rochester, Minnesota
Study site
Salt Lake City, Utah
Study site
San Diego, California
Study site
Seattle, Washington
Study site
Spartanburg, South Carolina
Study site
Spokane, Washington
Study site
St Louis, Missouri
Study site
St. Petersburg, Florida
Study site
Stanford, California
Study site
Topeka, Kansas
About this study
Heart failure is a progressive disease that decreases the pumping action of the heart. This may cause a backup of fluid in the heart and may result in heart beat changes. When there are changes in the heart beat sometimes an implantable heart device is used to control the rate and rhythm of the heart beat. In certain heart failure cases, when the two lower chambers of the heart no longer beat in a coordinated manner, cardiac resynchronization therapy (CRT) may be prescribed. CRT is similar to a pacemaker. It is placed (implanted) under the skin of the upper chest. CRT is delivered as tiny electrical pulses to the right and left ventricles through three or four leads (soft insulated wires) that are inserted through the veins to the heart.
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. If the heart is beating too slowly or at an abnormal rhythm, an ICD can also pace the heart to return the heart to its normal rhythm. The InSync ICD device can change the timing of when the left and right ventricles of the heart are paced to beat.
The purpose of this study is to monitor the long-term performance of the InSync ICD Model 7272 and the InSync Marquis 7277 systems for cardiac resynchronization therapy (CRT).
- Conditions
- Heart Failure, Cardiomyopathy
- Being tested
- Cardiac resynchronization therapy device
- Keywords
- Heart Failure, Cardiac pacing, Cardiac resynchronization therapy, Implantable Cardioverter Defibrillator
- Medical subject headings
- Heart Failure, Cardiomyopathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac resynchronization therapy deviceDevice
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2006 (estimated)
- Study startJan 2003
- Study completionDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies 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
- Observational
- Observational model
- Defined population
- Time perspective
- Prospective
- Enrolment
- 600 participants
Sponsor and investigators
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart Failure
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- InSync ICD Registry Study Leader, Study chair, Medtronic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00289302
- Sponsor's protocol ID
- 196
- Status last verified
- Sep 2006
- First submitted
- 7 Feb 2006
- Last updated
- 5 Oct 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- InSync Implantable Cardioverter Defibrillator Registry: Cardiac Resynchronization Therapy
- ClinicalTrials.gov ID
- NCT00289302
- Acronym / sponsor ID
- 196
- Conditions
- Heart Failure, Cardiomyopathy
- Keywords
- Heart Failure, Cardiac pacing, Cardiac resynchronization therapy, Implantable Cardioverter Defibrillator
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 600 participants
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart FailureIndustry (pharma, biotech, devices)
- Study start
- Jan 2003
- Study completion
- Dec 2006 (actual)
- First posted
- 9 Feb 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.
Heart failure is a progressive disease that decreases the pumping action of the heart. This may cause a backup of fluid in the heart and may result in heart beat changes. When there are changes in the heart beat sometimes an implantable heart device is used to control the rate and rhythm of the heart beat. In certain heart failure cases, when the two lower chambers of the heart no longer beat in a coordinated manner, cardiac resynchronization therapy (CRT) may be prescribed. CRT is similar to a pacemaker. It is placed (implanted) under the skin of the upper chest. CRT is delivered as tiny electrical pulses to the right and left ventricles through three or four leads (soft insulated wires) that are inserted through the veins to the heart.
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. If the heart is beating too slowly or at an abnormal rhythm, an ICD can also pace the heart to return the heart to its normal rhythm. The InSync ICD device can change the timing of when the left and right ventricles of the heart are paced to beat.
The purpose of this study is to monitor the long-term performance of the InSync ICD Model 7272 and the InSync Marquis 7277 systems for cardiac resynchronization therapy (CRT).
Study design
- Observational model
- Defined population
- 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 (1 listed)
- Patients implanted with the InSync ICD or InSync Marquis cardiac resynchronization therapy (CRT) system (includes InSync ICD Model 7272 or InSync Marquis Model 7277, right atrial lead, right ventricular lead and any market released Medtronic left ventricular lead or the investigational Attain Model 4189 lead which was implanted during the MIRACLE ICD Study)
Key exclusion criteria (1 listed)
- Patients with a history of a previously failed placement of a currently investigational Medtronic left ventricular lead within 30 days of enrollment in the InSync ICD Registry
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 |
|---|---|---|
| Cardiac resynchronization therapy device | 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 5 Oct 2007.
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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.
InSync ICD Registry Study Leader study chair
Medtronic
51 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure and Cardiomyopathy, run by Medtronic Cardiac Rhythm and Heart Failure at 51 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 1 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 5 Oct 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 51 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 5 Oct 2007.