Attain Success Clinical Trial - Full Text View

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 Clinical 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:

Subjects Successfully Implanted With an Attain Family Left-heart Lead Using an Attain Family Delivery Catheter [ Time Frame: Implant ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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).

Enrollment:	2014
Study Start Date:	November 2009
Study Completion Date:	November 2011
Primary Completion Date:	November 2011 (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

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Locations

United States, Arkansas

Little Rock, Arkansas, United States
United States, California

Downey, California, United States

Modesto, California, United States

Redding, California, United States

Riverside, California, United States

San Diego, California, United States

San Jose, California, United States

Santa Rosa, California, United States
United States, Connecticut

Danbury, Connecticut, United States
United States, District of Columbia

Washington, District of Columbia, United States
United States, Florida

Delray Beach, Florida, United States

Lake Mary, Florida, United States

Naples, Florida, United States

Orlando, Florida, United States

Panama City, Florida, United States

St. Augustine, Florida, United States

Tampa, Florida, United States
United States, Georgia

Athens, Georgia, United States

Atlanta, Georgia, United States

Macon, Georgia, United States

Marietta, Georgia, United States
United States, Illinois

Chicago, Illinois, United States

Decatur, Illinois, United States
United States, Indiana

Indianapolis, Indiana, United States

Newburgh, Indiana, United States
United States, Kansas

Overland Park, Kansas, United States
United States, Kentucky

Bowling Green, Kentucky, United States

Lexington, Kentucky, United States
United States, Louisiana

Houma, Louisiana, United States
United States, Maryland

Baltimore, Maryland, United States

Takoma Park, Maryland, United States
United States, Massachusetts

Boston, Massachusetts, United States
United States, Michigan

Muskegon, Michigan, United States

Royal Oak, Michigan, United States

Saint Clair Shore, Michigan, United States

Ypsilanti, Michigan, United States
United States, Minnesota

Minneapolis, Minnesota, United States
United States, Missouri

St. Louis, Missouri, United States

Washinton, Missouri, United States
United States, Nebraska

Omaha, Nebraska, United States
United States, New Hampshire

Concord, New Hampshire, United States
United States, New Jersey

Englewood, New Jersey, United States
United States, New York

Huntington, New York, United States
United States, North Carolina

Asheville, North Carolina, United States

Concord, North Carolina, United States
United States, North Dakota

Fargo, North Dakota, United States
United States, Ohio

Cleveland, Ohio, United States

Columbus, Ohio, United States

Kettering, Ohio, United States
United States, Pennsylvania

Abington, Pennsylvania, United States

Bethlehem, Pennsylvania, United States

Erie, Pennsylvania, United States

Harrisburg, Pennsylvania, United States

Wormleysburg, Pennsylvania, United States
United States, South Carolina

Florence, South Carolina, United States
United States, Tennessee

Germantown, Tennessee, United States

Knoxsville, Tennessee, United States

Nashville, Tennessee, United States
United States, Texas

Amarillo, Texas, United States

Austin, Texas, United States

Brownsville, Texas, United States

Dallas, Texas, United States

Fort Worth, Texas, United States

Houston, Texas, United States

Longview, Texas, United States

The Woodlands, Texas, United States
United States, Utah

Murray, Utah, United States

Salt Lake City, Utah, United States
United States, Virginia

Frederickburg, Virginia, United States
United States, Washington

Bellingham, Washington, United States

Spokane, Washington, United States
United States, Wisconsin

Green Bay, Wisconsin, United States
Canada

Ontario, Canada
China

Jiangsu, China

Sichuan, China

Xinjian, China
France

Amiens, France

Anglouleme, France

Bayonne, France

Bordeaux, France

Clermont-Ferrand, France

Creteil, France

Metz-Tessy, France

Montfermeil, France

Nice, France

Orleans, France

Paris, France

Poitiers, France
Germany

Villingen, Germany
Hong Kong

Sha Tin, Hong Kong
India

Haryana, India

New Dehli, India

New Delhi, India

Rajasthan, India

Vizag, India
Malaysia

Kuala Lumpur, Malaysia
Malta

Tal-Qroqq, Malta
Pakistan

Lahore, Pakistan
Poland

Bydgoszcz, Poland

Krakow, Poland

Zabreze, Poland
Puerto Rico

San Juan, Puerto Rico
Romania

Brasov, Romania

Bucharest, Romania
Singapore

Novena, Singapore
Taiwan

Taichung, Taiwan

Taipei, Taiwan
Thailand

Bangkok, Thailand

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:	Medtronic Cardiac Rhythm Disease Management
ClinicalTrials.gov Identifier:	NCT00990964 History of Changes
Other Study ID Numbers:	Attain Success
Study First Received:	October 6, 2009
Results First Received:	August 13, 2012
Last Updated:	August 13, 2012
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 June 17, 2013