Attain Success Clinical Trial

Completed

• Conditions: Heart Failure

• Registration Number: NCT00990964
• Lead Sponsor: Medtronic Cardiac Rhythm and Heart Failure

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-10-06
• Study First Submitted QC: 2009-10-06
• Study First Posted: 2009-10-07
• Study Start: 2009-11
• Primary Completion: 2011-11
• Study Completion: 2011-11
• Status Verified: 2012-08
• Results First Submitted: 2012-08-13
• Results First Submitted QC: 2012-08-13
• Last Update Submitted: 2012-08-13
• Results First Posted: 2012-09-12
• Last Update Posted: 2012-09-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2014

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Subjects Successfully Implanted With an Attain Family Left-heart Lead Using an Attain Family Delivery Catheter	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	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).