Model 4396 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. Identifier: NCT01361685
Recruitment Status : Active, not recruiting
First Posted : May 27, 2011
Last Update Posted : December 2, 2017
Information provided by (Responsible Party):

Brief Summary:
Lead survivability will be summarized.

Condition or disease
Heart Failure

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.

Study Type : Observational
Actual Enrollment : 367 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Attain Ability® Family Left Ventricular Lead Chronic Performance Study
Study Start Date : May 2011
Estimated Primary Completion Date : February 2021
Estimated Study Completion Date : May 2021

Primary Outcome Measures :
  1. Model 4396 LV Lead-related complication rate [ Time Frame: 5 years ]

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

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 4396 LV Lead within 30 days. All subjects must meet Inclusion criteria and none of the Exclusion 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

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 identifier (NCT number): NCT01361685

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Sponsors and Collaborators

Responsible Party: Medtronic Identifier: NCT01361685     History of Changes
Other Study ID Numbers: 4396 Chronic Performance
First Posted: May 27, 2011    Key Record Dates
Last Update Posted: December 2, 2017
Last Verified: November 2017

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases