Attain Success Clinical Trial

NCT00990964 | Completed Results

• 1 other identifier: Attain Success
• Study Type: observational
• Target: 2,014
• Locations: 16 countries
• Sites: 108

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.

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Interventions

Attain Success Lead DEVICE

Attain Success Lead

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medtronic Cardiac Rhythm and Heart Failure: lead

Study Sites (108)

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Little Rock, Arkansas, United States

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Downey, California, United States

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Modesto, California, United States

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Redding, California, United States

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Riverside, California, United States

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San Diego, California, United States

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San Jose, California, United States

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Santa Rosa, California, United States

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Danbury, Connecticut, United States

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Washington D.C., District of Columbia, United States

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Delray Beach, Florida, United States

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Lake Mary, Florida, United States

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Naples, Florida, United States

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Orlando, Florida, United States

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Panama City, Florida, United States

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Saint Augustine, Florida, United States

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Tampa, Florida, United States

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Athens, Georgia, United States

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Atlanta, Georgia, United States

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Macon, Georgia, United States

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Marietta, Georgia, United States

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Chicago, Illinois, United States

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Decatur, Illinois, United States

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Indianapolis, Indiana, United States

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Newburgh, Indiana, United States

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Overland Park, Kansas, United States

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Bowling Green, Kentucky, United States

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Lexington, Kentucky, United States

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Houma, Louisiana, United States

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Baltimore, Maryland, United States

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Takoma Park, Maryland, United States

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Boston, Massachusetts, United States

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Muskegon, Michigan, United States

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Royal Oak, Michigan, United States

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Saint Clair Shore, Michigan, United States

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Ypsilanti, Michigan, United States

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Minneapolis, Minnesota, United States

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St Louis, Missouri, United States

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Washington, Missouri, United States

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Omaha, Nebraska, United States

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Concord, New Hampshire, United States

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Englewood, New Jersey, United States

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Huntington, New York, United States

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Asheville, North Carolina, United States

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Concord, North Carolina, United States

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Fargo, North Dakota, United States

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Cleveland, Ohio, United States

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Columbus, Ohio, United States

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Kettering, Ohio, United States

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Abington, Pennsylvania, United States

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Bethlehem, Pennsylvania, United States

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Erie, Pennsylvania, United States

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Harrisburg, Pennsylvania, United States

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Wormleysburg, Pennsylvania, United States

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Florence, South Carolina, United States

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Germantown, Tennessee, United States

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Knoxsville, Tennessee, United States

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Nashville, Tennessee, United States

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Amarillo, Texas, United States

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Austin, Texas, United States

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Brownsville, Texas, United States

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Dallas, Texas, United States

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Fort Worth, Texas, United States

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Houston, Texas, United States

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Longview, Texas, United States

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The Woodlands, Texas, United States

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Murray, Utah, United States

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Salt Lake City, Utah, United States

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Frederickburg, Virginia, United States

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Bellingham, Washington, United States

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Spokane, Washington, United States

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Green Bay, Wisconsin, United States

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Ontario, Canada

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Jiangsu, China

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Sichuan, China

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Xinjian, China

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Amiens, France

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Anglouleme, France

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Bayonne, France

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Bordeaux, France

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Clermont-Ferrand, France

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Créteil, France

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Metz-Tessy, France

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Montfermeil, France

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Nice, France

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Orléans, France

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Paris, France

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Poitiers, France

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Villingen, Germany

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Shatin, Hong Kong

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Haryāna, India

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New Dehli, India

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New Delhi, India

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Rajasthan, India

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Vizag, India

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Kuala Lumpur, Malaysia

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Tal-Qroqq, Malta

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Lahore, Pakistan

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Bydgoszcz, Poland

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Krakow, Poland

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Zabreze, Poland

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San Juan, Puerto Rico

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Brasov, Romania

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Bucharest, Romania

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Novena, Singapore

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Taichung, Taiwan

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Taipei, Taiwan

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Bangkok, Thailand

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MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Attain Success Clinical Trial Leader
• Organization: Medtronic, Inc.

medtronicCRMtrials@medtronic.com

800-328-2518

Study Officials

• John D Hummel, MD

  Davis Heart & Lung Research Institute, The Ohio State University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 6, 2009
• First Posted: October 7, 2009
• Study Start: November 1, 2009
• Primary Completion: November 1, 2011
• Study Completion: November 1, 2011
• Last Updated: September 12, 2012
• Results First Posted: September 12, 2012

Record last verified: 2012-08

Locations

PA (1); TH (1); US (72); PR (1); MA (1); MY (1); RO (2); CA (1); PL (3); SG (1); CN (3); FR (12); TW (2); DE (1); IN (5); HK (1)