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Model 4396 Left Ventricular (LV) Lead Chronic Performance Study

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01361685
First Posted: May 27, 2011
Last Update Posted: June 9, 2016
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: 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 4396 LV Lead-related complication rate [ Time Frame: 5 years ]

Secondary Outcome Measures:
  • Types of lead-related adverse device effects [ Time Frame: 5 years ]
  • Percent of subjects with changes in electrode programming [ Time Frame: 5 years ]
  • Number of fractures with and without loss of function [ Time Frame: 5 years ]
  • Bipolar electrical performance at 1 year [ Time Frame: 1 year ]
  • Bipolar pacing impedance [ Time Frame: 1 year ]
  • Bipolar pacing capture threshold [ Time Frame: 1 year ]

Enrollment: 367
Study Start Date: May 2011
Estimated Study Completion Date: May 2021
Estimated Primary Completion Date: February 2021 (Final data collection date for primary outcome measure)
Detailed Description:
The purpose of this study is to evaluate long-term performance of the 4396 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 4396 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 4396 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 4396 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): NCT01361685


  Show 65 Study Locations
Sponsors and Collaborators
Medtronic
  More Information

Responsible Party: Medtronic
ClinicalTrials.gov Identifier: NCT01361685     History of Changes
Other Study ID Numbers: 4396 Chronic Performance
First Submitted: May 25, 2011
First Posted: May 27, 2011
Last Update Posted: June 9, 2016
Last Verified: March 2016

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases