Attain Success Clinical Trial

NCT ID: NCT00990964

Last Updated: 2012-09-12

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

2014 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-11-30

Study Completion Date

2011-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Heart Failure

Study Design

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Study Time Perspective

PROSPECTIVE

Interventions

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Attain Success Lead

Attain Success Lead

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medtronic Cardiac Rhythm and Heart Failure

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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John D Hummel, MD

Role: PRINCIPAL_INVESTIGATOR

Davis Heart & Lung Research Institute, The Ohio State University

Locations

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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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Countries

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

Other Identifiers

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Attain Success

Identifier Type: -

Identifier Source: org_study_id