Attain Success Clinical Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Heart Failure
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
- Enrollment
- 2014
- Primary Endpoint
- Subjects Successfully Implanted With an Attain Family Left-heart Lead Using an Attain Family Delivery Catheter
- Status
- Completed
- Last Updated
- 13 years ago
Overview
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.
Investigators
Eligibility 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.
Outcomes
Primary Outcomes
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).