Attain Success Clinical Trial

Heart Failure Clinical Trial

Official title:

Attain Success Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00990964
• Other study ID #: Attain Success
• Status: Completed
• Phase: N/A
• First received: October 6, 2009
• Last updated: August 13, 2012
• Start date: November 2009
• Est. completion date: November 2011

Study information

• Verified date: August 2012
• Source: Medtronic Cardiac Rhythm Disease Management
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardFrance: Conseil National de L'Ordre des MedecinsIndia: Research Review BoardPuerto Rico: Cardiovascular CenterTaiwan: The Institutional Review Board of Taichung Veterans General HospitalCanada: The University of Western Ontario Office of Research
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2014
• Est. completion date: November 2011
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Time Perspective: Prospective

Related Conditions & MeSH terms

• Heart Failure

Intervention

Device:
• Attain Success Lead
Attain Success Lead

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Cardiac Rhythm Disease Management

Countries where clinical trial is conducted

United States,  Canada,  China,  France,  Germany,  Hong Kong,  India,  Malaysia,  Malta,  Pakistan,  Poland,  Puerto Rico,  Romania,  Singapore,  Taiwan,  Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Subjects Successfully Implanted With an Attain Family Left-heart Lead Using an Attain Family Delivery Catheter	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.	Implant	No
Primary	Subjects Without a Left-heart Lead and Delivery Catheter Related Complication	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).	Implant to 3 months	No