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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Medtronic Cardiac Rhythm and Heart Failure

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2009

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2011

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2011

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 6, 2009

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 6, 2009

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 7, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 12, 2012

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 13, 2012

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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