Model 4196 Left Ventricular (LV) Lead Chronic Performance Study
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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: NCT00930904 |
Recruitment Status
:
Completed
First Posted
: July 2, 2009
Last Update Posted
: December 27, 2017
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Condition or disease |
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Heart Failure |
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 |
- Lead-related complication rate [ Time Frame: 5 years ]
- 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 ]

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Ages Eligible for Study: | Child, Adult, Senior |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
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

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

Study Chair: | 4196 LV Lead Chronic Performance Study Team | Medtronic |
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 |