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: June 4, 2014
Last verified: June 2014

June 30, 2009
June 4, 2014
June 2009
April 2017   (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 Post Approval 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 and is integrated within the Product Surveillance Registry (PAN Registry).

Model 4196 LV lead complication-free survivability will be summarized.

Observational
Time Perspective: Prospective
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Non-Probability Sample

Patients implanted with a 4196 LV Lead within the past 30 days. All patients 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
April 2017
April 2017   (final data collection date for primary outcome measure)

Patients who meet all of the following inclusion criteria and do not meet any of the following exclusion criteria are eligible for enrollment.

Inclusion Criteria

  • Patient or legally authorized representative provides written authorization and/or consent per institution and geographical requirements
  • Patient has or is intended to receive an Attain Ability Model 4196 LV lead
  • Patient within 30 day post implant enrollment window

Exclusion Criteria

  • Patient who is, or is expected to be inaccessible for follow-up
  • Patient with exclusion criteria required by local law
  • Patient is currently enrolled in or plans to enroll in any concurrent drug and/or device study that may confound results
Both
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No
Contact information is only displayed when the study is recruiting subjects
United States,   Austria,   Belgium,   Canada,   France,   Italy,   Netherlands,   Spain
 
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
June 2014

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