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Model 4196 Left Ventricular (LV) Lead Chronic Performance Study

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ClinicalTrials.gov Identifier: NCT00930904
Recruitment Status : Completed
First Posted : July 2, 2009
Last Update Posted : December 27, 2017
Sponsor:
Information provided by (Responsible Party):
Medtronic

Study Description
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Brief Summary:
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).

Condition or disease
Heart Failure

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

Study Design
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Study Type : Observational
Actual Enrollment : 1847 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Attain Ability® Model 4196 Left Ventricular Lead Chronic Performance Post Approval Study
Study Start Date : June 2009
Actual Primary Completion Date : April 2017
Actual Study Completion Date : April 2017
Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Lead-related complication rate [ Time Frame: 5 years ]

Secondary Outcome Measures :
  1. Types of lead-related events [ Time Frame: 5 years ]
  2. Percent of subjects with changes in electrode programming [ Time Frame: 5 Years ]
  3. Percent of fractures with loss of function [ Time Frame: 5 years ]
  4. Mean bipolar pacing threshold [ Time Frame: 1 year ]
  5. Mean pacing threshold and impedance via Tip and Ring unipolar pacing configurations [ Time Frame: 1 year ]

Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients implanted with a 4196 LV Lead within the past 30 days. All patients must meet Inclusion criteria and none of the Exclusion criteria.
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00930904


  Show 103 Study Locations
Sponsors and Collaborators
Medtronic
Investigators
Study Chair: 4196 LV Lead Chronic Performance Study Team Medtronic
More Information
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Responsible Party: Medtronic
ClinicalTrials.gov Identifier: NCT00930904     History of Changes
Other Study ID Numbers: 4196 Chronic Performance
First Posted: July 2, 2009    Key Record Dates
Last Update Posted: December 27, 2017
Last Verified: December 2017

Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases