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Attain Success Clinical Trial

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Medtronic Cardiac Rhythm Disease Management
ClinicalTrials.gov Identifier:
NCT00990964
First received: October 6, 2009
Last updated: August 13, 2012
Last verified: August 2012
  Purpose

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 Intervention
Heart Failure
Device: Attain Success Lead

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Attain Success Clinical Trial

Further study details as provided by Medtronic Cardiac Rhythm Disease Management:

Primary Outcome Measures:
  • Subjects Successfully Implanted With an Attain Family Left-heart Lead Using an Attain Family Delivery Catheter [ Time Frame: Implant ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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).


Enrollment: 2014
Study Start Date: November 2009
Study Completion Date: November 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Attain Success Lead
    Attain Success Lead
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00990964

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

No publications provided

Responsible Party: Medtronic Cardiac Rhythm Disease Management
ClinicalTrials.gov Identifier: NCT00990964     History of Changes
Other Study ID Numbers: Attain Success
Study First Received: October 6, 2009
Results First Received: August 13, 2012
Last Updated: August 13, 2012
Health Authority: United States: Institutional Review Board
France: Conseil National de L'Ordre des Medecins
India: Research Review Board
Puerto Rico: Cardiovascular Center
Taiwan: The Institutional Review Board of Taichung Veterans General Hospital
Canada: The University of Western Ontario Office of Research

Additional relevant MeSH terms:
Heart Failure
Cardiovascular Diseases
Heart Diseases

ClinicalTrials.gov processed this record on November 20, 2014