Congestive Heart Failure, Atrial Arrhythmia, Atrial Tachyarrhythmia, Atrial FibrillationNCT00268320
Clinical Investigation of the Medtronic Concerto™ Device
A study testing Cardiac Resynchronization Therapy+Implantable Cardioverter Defibrillator in people with Congestive Heart Failure, Atrial Arrhythmia, Atrial Tachyarrhythmia, Atrial Fibrillation, run by Medtronic Cardiac Rhythm and Heart Failure at 51 sites in 12 countries.
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
- Congestive Heart Failure, Atrial Arrhythmia, Atrial Tachyarrhythmia, Atrial Fibrillation
- What is being tested?
- Cardiac Resynchronization Therapy+Implantable Cardioverter Defibrillator
- Type of treatment
- Medical device
- How many people
- 270 participants
- Where
- 51 sitesin 12 countries
- Study dates
- Jan 2006to Jul 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
- Subjects who require the implantation of an Implantable Cardioverter Defibrillator
- Subjects who have heart failure that severely limits daily activities (NYHA Class III) or Subjects who have severe heart failure and should always be resting (NYHA Class IV)
- Subjects with reduced heart pumping function (left ventricular ejection fraction ≤ 35%)
Who cannot join
- Subjects who have constant atrial fibrillation (top chambers of the heart beat too fast continuously)
- Subjects who are post-heart transplant
Trial locations and contacts
51 sites in 12 countries.
51 sites in 12 countries
United States30 sites
Study site
Albuquerque, New Mexico
Study site
Anchorage, Alaska
Study site
Atlanta, Georgia
Study site
Austin, Texas
Study site
Brighton, Massachusetts
Study site
Charleston, South Carolina
Study site
Cincinnati, Ohio
Study site
Cleveland, Ohio
Study site
Des Moines, Iowa
Study site
Detroit, Michigan
Study site
Evanston, Illinois
Study site
Fort Wayne, Indiana
Study site
Fort Worth, Texas
Study site
Jacksonville, Florida
Study site
Kansas City, Missouri
Study site
Morgantown, West Virginia
Study site
Nashville, Tennessee
Study site
Newark, New Jersey
Study site
Oklahoma City, Oklahoma
Study site
Orlando, Florida
Study site
Pensacola, Florida
Study site
Phoenix, Arizona
Study site
Pittsburgh, Pennsylvania
Study site
Richmond, Virginia
Study site
Saint Paul, Minnesota
Study site
Santa Monica, California
Study site
St Louis, Missouri
Study site
Syracuse, New York
Study site
Tacoma, Washington
Study site
West Reading, Pennsylvania
Germany6 sites
Study site
Aachen
Study site
Bernau
Study site
Bochum
Study site
Göttingen
Study site
Heidelberg
Study site
Münster
Japan3 sites
Study site
Shinjuku-ku, Tokyo
Study site
Suita, Osaka
Study site
Tsukuba, Ibaraki
About this study
Official title: Clinical Investigation of the Medtronic Concerto™ Cardiac Resynchronization Therapy (CRT) and Implantable Cardioverter Defibrillator (ICD) Therapies (CRT+ICD Device)
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 may be prescribed.
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
Atrial tachyarrhythmia (AT) is the name for rapid beats in the upper chambers of the heart. People with AT may experience symptoms such as heart palpitations (a racing or pounding feeling in the chest), shortness of breath, dizziness, fatigue or weakness.
The purpose of this study is to study an investigational implantable device containing Cardiac Resynchronization Therapy (CRT) and Implantable Cardioverter Defibrillator (ICD) therapies (CRT+ICD device) in subjects who are at significant risk of developing atrial tachyarrhythmias.
- Being tested
- Cardiac Resynchronization Therapy+Implantable Cardioverter Defibrillator
- Keywords
- congestive heart failure, atrial arrhythmia, cardiac resynchronization therapy, implantable cardioverter defibrillator
- Medical subject headings
- Heart Failure, Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac Resynchronization Therapy+Implantable Cardioverter DefibrillatorDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
Complication rate
Atrial defibrillation effectiveness
Secondary outcomes (3)
Change in patient health status during the study
System performance
Adverse events
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2005 (estimated)
- Study startJan 2006
- Primary completionJun 2006
- Study completionJul 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congestive Heart Failure, Atrial Arrhythmia, Atrial Tachyarrhythmia, Atrial FibrillationStudies 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
- 270 participants
Sponsor and investigators
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart Failure
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Not required for IDE studies
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00268320
- Sponsor's protocol ID
- 230
- Status last verified
- Sep 2008
- First submitted
- 21 Dec 2005
- Last updated
- 25 Sep 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Investigation of the Medtronic Concerto™ Cardiac Resynchronization Therapy (CRT) and Implantable Cardioverter Defibrillator (ICD) Therapies (CRT+ICD Device)
- ClinicalTrials.gov ID
- NCT00268320
- Acronym / sponsor ID
- 230
- Keywords
- congestive heart failure, atrial arrhythmia, cardiac resynchronization therapy, implantable cardioverter defibrillator
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 270 participants
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart FailureIndustry (pharma, biotech, devices)
- Study start
- Jan 2006
- Primary completion
- Jun 2006 (actual)
- Study completion
- Jul 2007 (actual)
- First posted
- 22 Dec 2005 (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 may be prescribed.
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).
Atrial tachyarrhythmia (AT) is the name for rapid beats in the upper chambers of the heart. People with AT may experience symptoms such as heart palpitations (a racing or pounding feeling in the chest), shortness of breath, dizziness, fatigue or weakness.
The purpose of this study is to study an investigational implantable device containing Cardiac Resynchronization Therapy (CRT) and Implantable Cardioverter Defibrillator (ICD) therapies (CRT+ICD device) in subjects who are at significant risk of developing atrial tachyarrhythmias.
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 who require the implantation of an Implantable Cardioverter Defibrillator
- Subjects who have heart failure that severely limits daily activities (NYHA Class III) or Subjects who have severe heart failure and should always be resting (NYHA Class IV)
- Subjects with reduced heart pumping function (left ventricular ejection fraction ≤ 35%)
Key exclusion criteria (2 listed)
- Subjects who have constant atrial fibrillation (top chambers of the heart beat too fast continuously)
- Subjects who are post-heart transplant
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+Implantable Cardioverter Defibrillator | Device | – |
Primary outcome
Complication rate
Atrial defibrillation effectiveness
3 secondary outcomes
Change in patient health status during the study
System performance
Adverse events
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 25 Sep 2008.
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.
Not required for IDE studies
51 sites in 12 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cardiac Resynchronization Therapy+Implantable Cardioverter Defibrillator in people with Congestive Heart Failure, Atrial Arrhythmia, Atrial Tachyarrhythmia, Atrial Fibrillation, run by Medtronic Cardiac Rhythm and Heart Failure at 51 sites in 12 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 25 Sep 2008. 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, Germany, Japan, Austria, Italy and 7 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?
Complication rate. 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 25 Sep 2008.