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Model 4396 Left Ventricular (LV) Lead Chronic Performance Study

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by Medtronic Cardiac Rhythm Disease Management
Sponsor:
Information provided by (Responsible Party):
Medtronic Cardiac Rhythm Disease Management
ClinicalTrials.gov Identifier:
NCT01361685
First received: May 25, 2011
Last updated: October 1, 2014
Last verified: October 2014
  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 Cardiac Rhythm Disease Management:

Primary Outcome Measures:
  • Model 4396 LV Lead-related complication rate [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Types of lead-related adverse device effects [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Percent of subjects with changes in electrode programming [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Number of fractures with and without loss of function [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Bipolar electrical performance at 1 year [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Bipolar pacing impedance [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Bipolar pacing capture threshold [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 1016
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

Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01361685

Contacts
Contact: Attain Ability Family LV Lead Chronic Performance Team rs.systemlongevitystudy@medtronic.com

  Show 120 Study Locations
Sponsors and Collaborators
Medtronic Cardiac Rhythm Disease Management
  More Information

No publications provided

Responsible Party: Medtronic Cardiac Rhythm Disease Management
ClinicalTrials.gov Identifier: NCT01361685     History of Changes
Other Study ID Numbers: 4396 Chronic Performance
Study First Received: May 25, 2011
Last Updated: October 1, 2014
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board
Canada: Ethics Review Committee
Italy: Ethics Committee
Denmark: Ethics Committee
France: Conseil National de l'Ordre des Médecins
Austria: Ethikkommission

Additional relevant MeSH terms:
Heart Failure
Cardiovascular Diseases
Heart Diseases

ClinicalTrials.gov processed this record on November 27, 2014