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Model 4195 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.
 
ClinicalTrials.gov Identifier: NCT00869921
Recruitment Status : Completed
First Posted : March 26, 2009
Last Update Posted : September 13, 2018
Sponsor:
Information provided by (Responsible Party):
Medtronic

Brief Summary:
Evaluate long-term performance of the 4195 LV Lead. This evaluation is based on the number of lead-related complications occuring 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 4195 LV Lead and is integrated within Medtronic's post-market surveillance platform.

Condition or disease
Heart Failure

Detailed Description:
Model 4195 LV lead complication-free survivability will be summarized.

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Study Type : Observational
Actual Enrollment : 1322 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Attain StarFix® Model 4195 Left Ventricular Lead Chronic Performance Post Approval Study
Study Start Date : March 2009
Actual Primary Completion Date : April 3, 2018
Actual Study Completion Date : April 3, 2018



Primary Outcome Measures :
  1. Lead-related complication rate. [ Time Frame: Implant to 5 years post-implant. ]

Secondary Outcome Measures :
  1. Types of Model 4195 lead-related events [ Time Frame: 5 years post implant ]


Information from the National Library of Medicine

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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 4195 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 StarFix Model 4195 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

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): NCT00869921


Locations
Show Show 67 study locations
Sponsors and Collaborators
Medtronic
Investigators
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Study Chair: 4195 LV Lead Chronic Performance Study Team Medtronic
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Responsible Party: Medtronic
ClinicalTrials.gov Identifier: NCT00869921    
Other Study ID Numbers: 4195 Chronic Performance
First Posted: March 26, 2009    Key Record Dates
Last Update Posted: September 13, 2018
Last Verified: September 2018
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases