Model 4196 Left Ventricular (LV) Lead Chronic Performance Study

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Medtronic Cardiac Rhythm Disease Management
ClinicalTrials.gov Identifier:
NCT00930904
First received: June 30, 2009
Last updated: February 1, 2013
Last verified: February 2013

June 30, 2009
February 1, 2013
June 2009
May 2016   (final data collection date for primary outcome measure)
Lead-related complication rate [ Time Frame: 5 years ] [ Designated as safety issue: No ]
Evaluate lead-related complication rate [ Time Frame: 5 years ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00930904 on ClinicalTrials.gov Archive Site
  • Types of lead-related events [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Percent of subjects with changes in electrode programming [ Time Frame: 5 Years ] [ Designated as safety issue: No ]
  • Percent of fractures with loss of function [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Mean bipolar pacing threshold [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Mean pacing threshold and impedance via Tip and Ring unipolar pacing configurations [ Time Frame: 1 year ] [ Designated as safety issue: No ]
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Model 4196 Left Ventricular (LV) Lead Chronic Performance Study
Attain Ability® Model 4196 Left Ventricular Lead Chronic Performance Study

The purpose of this study is to evaluate long-term performance of the 4196 LV Lead. This evaluation is based on the number of lead-related complications occurring during the study compared to the number of leads enrolled in the study. The leads will be followed for 5 years after implant. This study is required by FDA as a condition of approval of the Model 4196 LV Lead. This study is part of the Product Performance Platform (PPP).

Lead survivability will be summarized.

Observational
Time Perspective: Prospective
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Non-Probability Sample

Patients implanted with a 4196 LV Lead within the last 6 months. All subjects must meet Inclusion criteria and none of the Exclusion criteria.

Heart Failure
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
1778
May 2016
May 2016   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Subject or appropriate legal guardian provides written informed consent and authorization for access to and use of health information (if applicable).
  • Complete implant and follow-up data, including Model 4196 lead-related events are available.

AND one of the following must apply:

  • Subject is within six months post-implant of a 4196 Model lead connected to a market released Cardiac Resynchronization Therapy (Cardiac Resynchronization Therapy-Pacemaker or Cardiac Resynchronization Therapy-Defibrillator) device. The Medtronic lead must be used for a pacing or sensing application.
  • Subject who participated in the Medtronic Attain Ability Model 4196 Left Ventricular Lead Pre-Market Study.

Exclusion Criteria:

  • Subject implanted at a non-participating site, and implant, follow-up data, including Model 4196 lead-related events are not available within 30 days from implant.
  • Subject who is, or will be inaccessible for follow-up at a study site.
  • Subject with exclusion criteria required by local law (Europe, Middle East or Africa only).
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
United States,   Austria,   Belgium,   Canada,   France,   Italy,   Netherlands
 
NCT00930904
4196 Chronic Performance
No
Medtronic Cardiac Rhythm Disease Management
Medtronic Cardiac Rhythm Disease Management
Not Provided
Study Chair: 4196 LV Lead Chronic Performance Study Team Medtronic
Medtronic Cardiac Rhythm Disease Management
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP