Attain Success Clinical Trial

August 13, 2012 updated by: Medtronic Cardiac Rhythm and Heart Failure
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

2014

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • 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
  • United States
    • Arkansas
      • Little Rock, Arkansas, 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
    • Connecticut
      • Danbury, Connecticut, United States
    • District of Columbia
      • Washington, District of Columbia, 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
    • Georgia
      • Athens, Georgia, United States
      • Atlanta, Georgia, United States
      • Macon, Georgia, United States
      • Marietta, Georgia, United States
    • Illinois
      • Chicago, Illinois, United States
      • Decatur, Illinois, United States
    • Indiana
      • Indianapolis, Indiana, United States
      • Newburgh, Indiana, United States
    • Kansas
      • Overland Park, Kansas, United States
    • Kentucky
      • Bowling Green, Kentucky, United States
      • Lexington, Kentucky, United States
    • Louisiana
      • Houma, Louisiana, United States
    • Maryland
      • Baltimore, Maryland, United States
      • Takoma Park, Maryland, United States
    • Massachusetts
      • Boston, Massachusetts, United States
    • Michigan
      • Muskegon, Michigan, United States
      • Royal Oak, Michigan, United States
      • Saint Clair Shore, Michigan, United States
      • Ypsilanti, Michigan, United States
    • Minnesota
      • Minneapolis, Minnesota, United States
    • Missouri
      • St. Louis, Missouri, United States
      • Washinton, Missouri, United States
    • Nebraska
      • Omaha, Nebraska, United States
    • New Hampshire
      • Concord, New Hampshire, United States
    • New Jersey
      • Englewood, New Jersey, United States
    • New York
      • Huntington, New York, United States
    • North Carolina
      • Asheville, North Carolina, United States
      • Concord, North Carolina, United States
    • North Dakota
      • Fargo, North Dakota, United States
    • Ohio
      • Cleveland, Ohio, United States
      • Columbus, Ohio, United States
      • Kettering, Ohio, United States
    • Pennsylvania
      • Abington, Pennsylvania, United States
      • Bethlehem, Pennsylvania, United States
      • Erie, Pennsylvania, United States
      • Harrisburg, Pennsylvania, United States
      • Wormleysburg, Pennsylvania, United States
    • South Carolina
      • Florence, South Carolina, United States
    • Tennessee
      • Germantown, Tennessee, United States
      • Knoxsville, Tennessee, United States
      • Nashville, Tennessee, 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
    • Utah
      • Murray, Utah, United States
      • Salt Lake City, Utah, United States
    • Virginia
      • Frederickburg, Virginia, United States
    • Washington
      • Bellingham, Washington, United States
      • Spokane, Washington, United States
    • Wisconsin
      • Green Bay, Wisconsin, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Subjects Successfully Implanted With an Attain Family Left-heart Lead Using an Attain Family Delivery Catheter
Time Frame: Implant
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
Time Frame: Implant to 3 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medtronic Cardiac Rhythm and Heart Failure

Investigators

  • Principal Investigator: John D Hummel, MD, Davis Heart & Lung Research Institute, The Ohio State University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2009

Primary Completion (ACTUAL)

November 1, 2011

Study Completion (ACTUAL)

November 1, 2011

Study Registration Dates

First Submitted

October 6, 2009

First Submitted That Met QC Criteria

October 6, 2009

First Posted (ESTIMATE)

October 7, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

September 12, 2012

Last Update Submitted That Met QC Criteria

August 13, 2012

Last Verified

August 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Attain Success

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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