Model 4196 Left Ventricular (LV) Lead Chronic Performance Study

This study is ongoing, but not recruiting participants.

Sponsor:

Information provided by (Responsible Party):

Medtronic Cardiac Rhythm Disease Management

ClinicalTrials.gov Identifier:

NCT00930904

First received: June 30, 2009

Last updated: June 4, 2014

Last verified: June 2014

History of Changes

Purpose

The purpose of this study is to evaluate long-term performance of the 4196 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 4196 LV Lead and is integrated within the Product Surveillance Registry (PAN Registry).

Condition
Heart Failure


Study Type:	Observational
Study Design:	Time Perspective: Prospective
Official Title:	Attain Ability® Model 4196 Left Ventricular Lead Chronic Performance Post Approval Study

Further study details as provided by Medtronic Cardiac Rhythm Disease Management:

Primary Outcome Measures:

Lead-related complication rate [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Types of lead-related events [ 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 ]
Percent of fractures with loss of function [ Time Frame: 5 years ] [ Designated as safety issue: No ]
Mean bipolar pacing threshold [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Mean pacing threshold and impedance via Tip and Ring unipolar pacing configurations [ Time Frame: 1 year ] [ Designated as safety issue: No ]


Estimated Enrollment:	1778
Study Start Date:	June 2009
Estimated Study Completion Date:	April 2017
Estimated Primary Completion Date:	April 2017 (Final data collection date for primary outcome measure)

Detailed Description:

Model 4196 LV lead complication-free survivability will be summarized.

Eligibility


Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Patients implanted with a 4196 LV Lead within the past 30 days. All patients 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 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

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: NCT00930904

Show 103 Study Locations

Sponsors and Collaborators

Medtronic Cardiac Rhythm Disease Management

Investigators


Study Chair:	4196 LV Lead Chronic Performance Study Team	Medtronic

More Information

No publications provided


Responsible Party:	Medtronic Cardiac Rhythm Disease Management
ClinicalTrials.gov Identifier:	NCT00930904 History of Changes
Other Study ID Numbers:	4196 Chronic Performance
Study First Received:	June 30, 2009
Last Updated:	June 4, 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

ClinicalTrials.gov processed this record on March 01, 2015

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