Model 4296 Left Ventricular (LV) Lead Chronic Performance Study

Attain Ability® Family Left Ventricular Lead Chronic Performance Study

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01361672

Enrollment

1140

Registered

2011-05-27

Start date

2011-05-31

Completion date

2019-07-31

Last updated

2019-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure

Brief summary

Lead survivability will be summarized.

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.

Interventions

None listed

Study design

Observational model

OTHER

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion 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

Design outcomes

Primary

Measure	Time frame	Description
Model 4296 LV Lead-related complication rate	5 years	To demonstrate that the Model 4296 lead-related complication-free probability

Secondary

Measure	Time frame	Description
Percent of subjects with changes in electrode programming	5 years	To characterize any changes in electrical programming
Number of fractures with and without loss of function	5 years	To characterize fractures with and without loss of function
Types of lead-related adverse device effects	5 years	To summarize all lead related adverse events
Bipolar pacing impedance	1 year	To characterize threshold measurements and impedance for both conductors
Bipolar pacing capture threshold	1 year	To characterize standard bipolar pacing voltage thresholds
Bipolar electrical performance at 1 year	1 year	To summarize bipolar electrical performance at one year post implant

Countries

Canada, Germany, United States

Outcome results