Attain Success Trial

This study is currently recruiting participants.

Verified March 2011 by Medtronic Cardiac Rhythm Disease Management

First Received on October 6, 2009. Last Updated on March 11, 2011 History of Changes

Sponsor:	Medtronic Cardiac Rhythm Disease Management
Information provided by:	Medtronic Cardiac Rhythm Disease Management
ClinicalTrials.gov Identifier:	NCT00990964

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 Trial

Resource links provided by NLM:

MedlinePlus related topics: Heart Failure

U.S. FDA Resources

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

Primary Outcome Measures:

Implant success rate for the Attain Family of left-heart leads using the Attain Family of delivery catheters [ Time Frame: Implant to 3 months ] [ Designated as safety issue: No ]
Left-heart lead and delivery catheter related complication rate [ Time Frame: Implant to 3 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	2000
Study Start Date:	November 2009
Estimated Study Completion Date:	April 2012
Estimated Primary Completion Date:	April 2012 (Final data collection date for primary outcome measure)

Intervention Details:

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

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

Contacts

Contact: Attain Success Trial Leader

medtronicCRMtrials@medtronic.com

Show 84 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:	Attain Success Trial Leader, Medtronic, Inc.
ClinicalTrials.gov Identifier:	NCT00990964 History of Changes
Other Study ID Numbers:	Attain Success
Study First Received:	October 6, 2009
Last Updated:	March 11, 2011
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
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 23, 2012