Model 4196 Left Ventricular (LV) Lead Chronic Performance Study

Heart Failure Clinical Trial

Official title:

Attain Ability® Model 4196 Left Ventricular Lead Chronic Performance Post Approval Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00930904
• Other study ID #: 4196 Chronic Performance
• Status: Completed
• Phase: N/A
• First received: June 30, 2009
• Last updated: December 22, 2017
• Start date: June 2009
• Est. completion date: April 2017

Study information

• Verified date: December 2017
• Source: Medtronic
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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).

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1847
• Est. completion date: April 2017
• Est. primary completion date: April 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic

Countries where clinical trial is conducted

United States,  Austria,  Belgium,  Canada,  France,  Italy,  Netherlands,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lead-related complication rate		5 years
Secondary	Types of lead-related events		5 years
Secondary	Percent of subjects with changes in electrode programming		5 Years
Secondary	Percent of fractures with loss of function		5 years
Secondary	Mean bipolar pacing threshold		1 year
Secondary	Mean pacing threshold and impedance via Tip and Ring unipolar pacing configurations		1 year