Model 4196 Left Ventricular (LV) Lead Chronic Performance Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00930904
Recruitment Status : Completed
First Posted : July 2, 2009
Last Update Posted : December 27, 2017
Information provided by (Responsible Party):

June 30, 2009
July 2, 2009
December 27, 2017
June 2009
April 2017   (Final data collection date for primary outcome measure)
Lead-related complication rate [ Time Frame: 5 years ]
Evaluate lead-related complication rate [ Time Frame: 5 years ]
Complete list of historical versions of study NCT00930904 on Archive Site
  • Types of lead-related events [ Time Frame: 5 years ]
  • Percent of subjects with changes in electrode programming [ Time Frame: 5 Years ]
  • Percent of fractures with loss of function [ Time Frame: 5 years ]
  • Mean bipolar pacing threshold [ Time Frame: 1 year ]
  • Mean pacing threshold and impedance via Tip and Ring unipolar pacing configurations [ Time Frame: 1 year ]
Not Provided
Not Provided
Not Provided
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 Model: Other
Time Perspective: Prospective
Not Provided
Not Provided
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
Not Provided
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
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
Sexes Eligible for Study: All
Child, Adult, Senior
Contact information is only displayed when the study is recruiting subjects
Austria,   Belgium,   Canada,   France,   Italy,   Netherlands,   Spain,   United States
4196 Chronic Performance
Studies a U.S. FDA-regulated Device Product: No
Not Provided
Not Provided
Study Chair: 4196 LV Lead Chronic Performance Study Team Medtronic
December 2017