Heart FailureNCT00990964
Attain Success Clinical Trial
An observational study of Heart Failure, run by Medtronic Cardiac Rhythm and Heart Failure at 108 sites in 16 countries.
Trial summary
The purpose of the study is to assess lead implant success and complication rate using the Medtronic Attain Family of left-heart leads and delivery catheters. 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?
- Attain Success Lead
- Type of treatment
- Medical device
- How many people
- 2,014 participants
- Where
- 108 sitesin 16 countries
- Study dates
- Nov 2009to Nov 2011
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Study population: Patient referral to a participating study center with practitioners experienced in handling and implantation of the cardiac resynchronization therapy (CRT) device, the left-heart lead, and the use of the delivery catheter.
Who may be able to join
- Subject is at least 18 years of age or older
- Subject will be implanted with Medtronic cardiac resynchronization therapy (CRT) device and Medtronic left heart lead utilizing (or attempting to utilize) Attain Family of delivery catheters. The implant procedure may include upgrades to CRT from implantable pulse generator (IPG) or implantable cardioverter-defibrillator (ICD).
Who cannot join
- Subject is enrolled in a concurrent study with the exception of a study approved by the Medtronic Clinical Trial Leader prior to enrollment
- Subject has existing CRT system implanted or was previously implanted with a CRT system.
Trial locations and contacts
108 sites in 16 countries.
108 sites in 16 countries
United States72 sites
Study site
Abington, Pennsylvania
Study site
Amarillo, Texas
Study site
Asheville, North Carolina
Study site
Athens, Georgia
Study site
Atlanta, Georgia
Study site
Austin, Texas
Study site
Baltimore, Maryland
Study site
Bellingham, Washington
Study site
Bethlehem, Pennsylvania
Study site
Boston, Massachusetts
Study site
Bowling Green, Kentucky
Study site
Brownsville, Texas
Study site
Chicago, Illinois
Study site
Cleveland, Ohio
Study site
Columbus, Ohio
Study site
Concord, New Hampshire
Study site
Concord, North Carolina
Study site
Dallas, Texas
Study site
Danbury, Connecticut
Study site
Decatur, Illinois
Study site
Delray Beach, Florida
Study site
Downey, California
Study site
Englewood, New Jersey
Study site
Erie, Pennsylvania
Study site
Fargo, North Dakota
Study site
Florence, South Carolina
Study site
Fort Worth, Texas
Study site
Frederickburg, Virginia
Study site
Germantown, Tennessee
Study site
Green Bay, Wisconsin
Study site
Harrisburg, Pennsylvania
Study site
Houma, Louisiana
Study site
Houston, Texas
Study site
Huntington, New York
Study site
Indianapolis, Indiana
Study site
Kettering, Ohio
Study site
Knoxsville, Tennessee
Study site
Lake Mary, Florida
Study site
Lexington, Kentucky
Study site
Little Rock, Arkansas
Study site
Longview, Texas
Study site
Macon, Georgia
Study site
Marietta, Georgia
Study site
Minneapolis, Minnesota
Study site
Modesto, California
Study site
Murray, Utah
Study site
Muskegon, Michigan
Study site
Naples, Florida
Study site
Nashville, Tennessee
Study site
Newburgh, Indiana
Study site
Omaha, Nebraska
Study site
Orlando, Florida
Study site
Overland Park, Kansas
Study site
Panama City, Florida
Study site
Redding, California
Study site
Riverside, California
Study site
Royal Oak, Michigan
Study site
Saint Augustine, Florida
Study site
Saint Clair Shore, Michigan
Study site
Salt Lake City, Utah
Study site
San Diego, California
Study site
San Jose, California
Study site
Santa Rosa, California
Study site
Spokane, Washington
Study site
St Louis, Missouri
Study site
Takoma Park, Maryland
Study site
Tampa, Florida
Study site
The Woodlands, Texas
Study site
Washington, Missouri
Study site
Washington D.C., District of Columbia
Study site
Wormleysburg, Pennsylvania
Study site
Ypsilanti, Michigan
France12 sites
Study site
Amiens
Study site
Anglouleme
Study site
Bayonne
Study site
Bordeaux
Study site
Clermont-Ferrand
Study site
Créteil
Study site
Metz-Tessy
Study site
Montfermeil
Study site
Nice
Study site
Orléans
Study site
Paris
Study site
Poitiers
India5 sites
Study site
Haryāna
Study site
New Dehli
Study site
New Delhi
Study site
Rajasthan
Study site
Vizag
About this study
The purpose of the study is to assess lead implant success and complication rate using the Medtronic Attain Family of left-heart leads and delivery catheters.
- Conditions
- Heart Failure
- Being tested
- Attain Success Lead
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Attain Success LeadDevice
Attain Success Lead
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjects Successfully Implanted With an Attain Family Left-heart Lead Using an Attain Family Delivery Catheter
Implant success was defined as final successful placement of the Attain Family left-heart lead in the coronary vein branches utilizing the Attain Family of delivery catheters.
Measured: Implant
Subjects Without a Left-heart Lead and Delivery Catheter Related Complication
A left-heart lead and delivery related complication was defined as a complication, an adverse event that resulted in death, any termination of significant device function or invasive intervention, that resulted from the presence of or performance (intended or otherwise) of the Medtronic left-heart lead or Attain Family of delivery catheters. All adverse events were adjudicated by an Adverse Event Advisory Committee (AEAC).
Measured: Implant to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2009 (estimated)
- Study startNov 2009
- Primary completionNov 2011
- Study completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Heart FailureStudies 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
- 2,014 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart Failure
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- John D Hummel, MD, Principal investigator, Davis Heart & Lung Research Institute, The Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00990964
- Sponsor's protocol ID
- Attain Success
- Status last verified
- Aug 2012
- First submitted
- 6 Oct 2009
- Last updated
- 12 Sep 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Attain Success Clinical Trial
- ClinicalTrials.gov ID
- NCT00990964
- Acronym / sponsor ID
- Attain Success
- Conditions
- Heart Failure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,014 participants (actual)
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart FailureIndustry (pharma, biotech, devices)
- Study start
- Nov 2009
- Primary completion
- Nov 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 7 Oct 2009 (estimated)
- Results
- Posted 12 Sep 2012
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 study is to assess lead implant success and complication rate using the Medtronic Attain Family of left-heart leads and delivery catheters.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient referral to a participating study center with practitioners experienced in handling and implantation of the cardiac resynchronization therapy (CRT) device, the left-heart lead, and the use of the delivery catheter.
Key inclusion criteria (2 listed)
- Subject is at least 18 years of age or older
- Subject will be implanted with Medtronic cardiac resynchronization therapy (CRT) device and Medtronic left heart lead utilizing (or attempting to utilize) Attain Family of delivery catheters. The implant procedure may include upgrades to CRT from implantable pulse generator (IPG) or implantable cardioverter-defibrillator (ICD).
Key exclusion criteria (2 listed)
- Subject is enrolled in a concurrent study with the exception of a study approved by the Medtronic Clinical Trial Leader prior to enrollment
- Subject has existing CRT system implanted or was previously implanted with a CRT system.
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 |
|---|---|---|
| Attain Success LeadAttain Success Lead | Device | – |
Primary outcome
Subjects Successfully Implanted With an Attain Family Left-heart Lead Using an Attain Family Delivery Catheter
Time frame: Implant
Implant success was defined as final successful placement of the Attain Family left-heart lead in the coronary vein branches utilizing the Attain Family of delivery catheters.
Subjects Without a Left-heart Lead and Delivery Catheter Related Complication
Time frame: Implant to 3 months
A left-heart lead and delivery related complication was defined as a complication, an adverse event that resulted in death, any termination of significant device function or invasive intervention, that resulted from the presence of or performance (intended or otherwise) of the Medtronic left-heart lead or Attain Family of delivery catheters. All adverse events were adjudicated by an Adverse Event Advisory Committee (AEAC).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
John D Hummel, MD principal investigator
Davis Heart & Lung Research Institute, The Ohio State University
108 sites in 16 countries: 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 108 sites in 16 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 2 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 12 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 108 sites in United States, France, India, China, Poland and 11 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?
Yes. Results are posted in the registry (first posted 12 Sep 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Subjects Successfully Implanted With an Attain Family Left-heart Lead Using an Attain Family Delivery Catheter (time frame: Implant). 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 12 Sep 2012; AzTrials last refreshed its copy on 31 Oct 2026.