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Model 4296 Left Ventricular (LV) Lead Chronic Performance Study

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01361672
First Posted: May 27, 2011
Last Update Posted: October 6, 2017
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.
Information provided by (Responsible Party):
Medtronic
  Purpose
Lead survivability will be summarized.

Condition
Heart Failure

Study Type: Observational
Study Design: Observational Model: Other
Time Perspective: Prospective
Official Title: Attain Ability® Family Left Ventricular Lead Chronic Performance Study

Further study details as provided by Medtronic:

Primary Outcome Measures:
  • Model 4296 LV Lead-related complication rate [ Time Frame: 5 years ]
    To demonstrate that the Model 4296 lead-related complication-free probability


Secondary Outcome Measures:
  • Types of lead-related adverse device effects [ Time Frame: 5 years ]
    To summarize all lead related adverse events

  • Percent of subjects with changes in electrode programming [ Time Frame: 5 years ]
    To characterize any changes in electrical programming

  • Number of fractures with and without loss of function [ Time Frame: 5 years ]
    To characterize fractures with and without loss of function

  • Bipolar electrical performance at 1 year [ Time Frame: 1 year ]
    To summarize bipolar electrical performance at one year post implant

  • Bipolar pacing impedance [ Time Frame: 1 year ]
    To characterize threshold measurements and impedance for both conductors

  • Bipolar pacing capture threshold [ Time Frame: 1 year ]
    To characterize standard bipolar pacing voltage thresholds


Enrollment: 1141
Study Start Date: May 2011
Estimated Study Completion Date: July 2019
Estimated Primary Completion Date: July 2019 (Final data collection date for primary outcome measure)
Detailed Description:
The purpose of this study is to evaluate long-term performance of the 4296 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 4296 LV Lead. This study is conducted within Medtronic's post-market surveillance platform.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients implanted with a 4296 LV Lead within 30 days. All subjects 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 4296 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
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): NCT01361672


  Show 99 Study Locations
Sponsors and Collaborators
Medtronic
  More Information

Responsible Party: Medtronic
ClinicalTrials.gov Identifier: NCT01361672     History of Changes
Other Study ID Numbers: 4296 Chronic Performance
First Submitted: May 25, 2011
First Posted: May 27, 2011
Last Update Posted: October 6, 2017
Last Verified: October 2017

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases