Heart FailureNCT00291564
Ensure Cardiac Resynchronization Therapy Study
An observational study of Heart Failure, run by Medtronic Cardiac Rhythm and Heart Failure at 32 sites in United States.
Trial summary
The purpose of this study is to gather information on how doctors program particular settings on cardiac resynchronization therapy implantable cardiac defibrillators (CRT-Ds), to analyze how these settings affect the amount of cardiac resynchronization therapy (CRT) patients receive and to evaluate the therapy… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Cardiac Resynchronization Therapy Device
- Type of treatment
- Medical device
- How many people
- 430 participants
- Where
- 32 sitesUnited States
- Study dates
- May 2004to Feb 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
- Patient is indicated for a Medtronic CRT-D system
- Patient is willing to sign Permission for Access to and Use of Health Information form
- Patient is willing and able to comply with follow-up visits through six months
Who cannot join
- Patient has a life expectancy of less than 6 months
- Patient is participating in any concurrent study that could confound the results for either study
Trial locations and contacts
32 sites in 1 country.
32 sites in 1 country
United States32 sites
Study site
Abington, Pennsylvania
Study site
Augusta, Georgia
Study site
Birmingham, Alabama
Study site
Bridgewater, New Jersey
Study site
Burlington, Massachusetts
Study site
Charlotte, North Carolina
Study site
Columbia, South Carolina
Study site
Dayton, Ohio
Study site
Daytona Beach, Florida
Study site
Des Moines, Iowa
Study site
Detroit, Michigan
Study site
Doylestown, Pennsylvania
Study site
Englewood, New Jersey
Study site
Fairfax, Virginia
Study site
Houston, Texas
Study site
Indianapolis, Indiana
Study site
Kankakee, Illinois
Study site
Lyndhurst, Ohio
Study site
Mexico, Missouri
Study site
Minneapolis, Minnesota
Study site
Nashville, Tennessee
Study site
New Orleans, Louisiana
Study site
Newport Beach, California
Study site
Oklahoma City, Oklahoma
Study site
Omaha, Nebraska
Study site
Owensboro, Kentucky
Study site
Portland, Oregon
Study site
Richmond, Virginia
Study site
Salisbury, Maryland
Study site
Seattle, Washington
Study site
Traverse City, Michigan
Study site
Trumbull, Connecticut
About this study
The purpose of this study is to gather information on how doctors program particular settings on cardiac resynchronization therapy implantable cardiac defibrillators (CRT-Ds), to analyze how these settings affect the amount of cardiac resynchronization therapy (CRT) patients receive and to evaluate the therapy approach for converting abnormally fast heartbeats into normal heartbeats. There are no experimental devices or procedures involved in this study.
- Conditions
- Heart Failure
- Being tested
- Cardiac Resynchronization Therapy Device
- Keywords
- Observational, Heart Failure, Continuous Cardiac Resynchronization Therapy
- Medical subject headings
- Heart Failure
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 posted14 Feb 2006 (estimated)
- Study startMay 2004
- Study completionFeb 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
- Time perspective
- Prospective
- Enrolment
- 430 participants
Sponsor and investigators
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart Failure
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Medtronic
- Investigators
- David Thompson, MD, Principal investigator, Tennessee Cardiovascular Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00291564
- Sponsor's protocol ID
- 239
- Status last verified
- Dec 2007
- First submitted
- 10 Feb 2006
- Last updated
- 21 Dec 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ensure Cardiac Resynchronization Therapy Study
- ClinicalTrials.gov ID
- NCT00291564
- Acronym / sponsor ID
- 239
- Conditions
- Heart Failure
- Keywords
- Observational, Heart Failure, Continuous Cardiac Resynchronization Therapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 430 participants
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart FailureIndustry (pharma, biotech, devices)
- Collaborators
- Medtronic
- Study start
- May 2004
- Study completion
- Feb 2006 (actual)
- First posted
- 14 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.
The purpose of this study is to gather information on how doctors program particular settings on cardiac resynchronization therapy implantable cardiac defibrillators (CRT-Ds), to analyze how these settings affect the amount of cardiac resynchronization therapy (CRT) patients receive and to evaluate the therapy approach for converting abnormally fast heartbeats into normal heartbeats. There are no experimental devices or procedures involved in this study.
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)
- Patient is indicated for a Medtronic CRT-D system
- Patient is willing to sign Permission for Access to and Use of Health Information form
- Patient is willing and able to comply with follow-up visits through six months
Key exclusion criteria (2 listed)
- Patient has a life expectancy of less than 6 months
- Patient is participating in any concurrent study that could confound the results for either study
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 21 Dec 2007.
Related trials for Heart Failure
RecruitingPhase 3
Trial Investigating the Efficacy and Safety of Weekly Lonapegsomatropin Compared to Daily Somatropin in Children and Adolescents With Short Stature or Growth Failure Due to Growth Hormone Sufficient Disorders
Turner Syndrome, Short Stature Homeobox Gene Mutation
RecruitingObservational study
Heart Failure and Aortic Stenosis Transcriptome
Heart Failure, Aortic Stenosis
Active, not recruiting
REsynchronization Comparison In LBBB and Normal or Mildly Reduced VENTricular Function With CRT (REINVENT-CRT)
Left Ventricular Ejection Fraction, Heart Failure (HF)
RecruitingObservational study
Product Performance Report: Evaluate Long-term Reliability & Performance of Medtronic Marketed Cardiac Therapy Products
Arrhythmia, Bradycardia
Recruiting
Determining Efficacy of an Artificial Intelligence-based System for Heart Failure Detection Through Interpretation of Electrocardiograms (DECISION)
Heart Failure, Cardiovascular Risk Factors
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.
David Thompson, MD principal investigator
Tennessee Cardiovascular Research Institute
32 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, run by Medtronic Cardiac Rhythm and Heart Failure at 32 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 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 21 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 32 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 21 Dec 2007.