Trial Evaluates Outcomes from Left–Heart Leads, Delivery Catheters
November 12, 2009 – The first enrollments were made this week in the global Attain Success trial that will evaluate implant success, complication rates and procedure times in the market-released Attain Family of left-heart leads and delivery systems portfolio from Medtronic.
Fifteen new Attain Family therapy delivery products were commercially released in the last two years, including 13 catheters and two Medtronic-exclusive left-heart leads – Attain StarFix and Attain Ability. Safwat Gassis, M.D. with Associated Cardiologists at Pinnacle Health Harrisburg Hospital, in Harrisburg, Pa., completed the first enrollment.
“This broad portfolio of left-heart lead and catheter delivery tools help physicians address the needs of a range of patients, especially those with difficult-to-navigate anatomies,” said John Hummel, M.D., electrophysiologist with The Ohio State University in Columbus, Ohio, and global principal investigator for Attain Success. “This trial will explore how well these easy-to-use tools work to simplify and reduce the procedure time for physicians.”
“The Attain family is a comprehensive portfolio of left-heart technologies supported by clinical evidence demonstrating low dislodgment and high implant success rates,” said Marshall Stanton, M.D., vice president of clinical research for the Cardiac Rhythm Disease Management business at Medtronic. “As part of Medtronic’s ongoing dedication to post-market analysis of our products, we are excited to do the first large global analysis to confirm our previous clinical results and gather procedure and handling information from physicians on this innovative portfolio.”
The prospective, post-market, global trial will enroll approximately 2,000 subjects at 150 medical centers in 18 countries around the world. Data will be analyzed at baseline, implant and three months post-implant. Implant success and complication rates (up to three months), procedure times, handling feedback and physician survey data also will be captured in the Attain Success trial. A sub-study will assess final left-heart lead placement site. Results are expected in two and a half years.
Study enrollees will have a Medtronic cardiac resynchronization therapy-defibrillator (CRT) device and use one of the following from the Attain family: Attain StarFix or attain ability left-heart leads; Attain Command, Attain Select II, Attain Select, Attain Deflectable, or Attain Prevail catheters; or any other market released Attain model of delivery catheters, left-heart leads or guidewires.
For more information: www.medtronic.com