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Attain Success Clinical Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00990964
Recruitment Status : Completed
First Posted : October 7, 2009
Results First Posted : September 12, 2012
Last Update Posted : September 12, 2012
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief 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.

Condition or disease Intervention/treatment
Heart Failure Device: Attain Success Lead

Study Design

Study Type : Observational
Actual Enrollment : 2014 participants
Time Perspective: Prospective
Official Title: Attain Success Clinical Trial
Study Start Date : November 2009
Primary Completion Date : November 2011
Study Completion Date : November 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure
U.S. FDA Resources

Groups and Cohorts

Intervention Details:
    Device: Attain Success Lead
    Attain Success Lead

Outcome Measures

Primary Outcome Measures :
  1. 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.

  2. 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).


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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.
Criteria

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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00990964


  Show 108 Study Locations
Sponsors and Collaborators
Medtronic Cardiac Rhythm and Heart Failure
Investigators
Principal Investigator: John D Hummel, MD Davis Heart & Lung Research Institute, The Ohio State University
More Information

Responsible Party: Medtronic Cardiac Rhythm and Heart Failure
ClinicalTrials.gov Identifier: NCT00990964     History of Changes
Other Study ID Numbers: Attain Success
First Posted: October 7, 2009    Key Record Dates
Results First Posted: September 12, 2012
Last Update Posted: September 12, 2012
Last Verified: August 2012

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases