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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 October 2017 |
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Main ID: |
NCT00990964 |
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Date of registration:
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06/10/2009 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Attain Success Clinical Trial
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Scientific title:
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Attain Success Clinical Trial |
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Date of first enrolment:
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November 2009 |
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Target sample size:
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2014 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT00990964 |
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Study type:
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Observational |
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Study design:
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Phase:
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N/A
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Countries of recruitment
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Canada
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China
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France
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Germany
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Hong Kong
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India
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Malaysia
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Malta
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Pakistan
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Poland
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Puerto Rico
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Romania
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Singapore
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Taiwan
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Thailand
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United States
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Contacts
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Name:
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John D Hummel, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Davis Heart & Lung Research Institute, The Ohio State University |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- 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).
Exclusion Criteria:
- 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.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Heart Failure
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Intervention(s)
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Device: Attain Success Lead
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Primary Outcome(s)
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Subjects Successfully Implanted With an Attain Family Left-heart Lead Using an Attain Family Delivery Catheter
[Time Frame: Implant]
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Subjects Without a Left-heart Lead and Delivery Catheter Related Complication
[Time Frame: Implant to 3 months]
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Secondary ID(s)
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Attain Success
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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