Attain Model 4196 Left Ventricular (LV) Lead

Medtronic Cardiac Rhythm and Heart Failure190 enrolled

Overview

Heart failure is a progressive disease that decreases the pumping action of the heart. This may cause a backup of fluid in the heart and may result in heart beat changes. When there are changes in the heart beat sometimes an implantable heart device is used to control the rate and rhythm of the heart beat. In certain heart failure cases, when the two lower chambers of the heart no longer beat in a coordinated manner, cardiac resynchronization therapy (CRT) may be prescribed. CRT is similar to a pacemaker. It is placed (implanted) under the skin of the upper chest. CRT is delivered as tiny electrical pulses to the right and left ventricles through three or four leads (flexible insulated wires) that are inserted through the veins to the heart. The purpose of this study is to evaluate a new lead for delivering energy to the left ventricle (bottom left chamber of the heart).

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

190

Conditions

Heart Failure

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * QRS greater than or equal to 120 milliseconds (The QRS interval is a measurement of how the electrical signal involved in a heart beat travels, or is conducted, through the ventricles. A wide QRS (more than 120) suggests that there is a conduction problem, or block, in the ventricles.) * Left Ventricular Ejection Fraction (EF) less than or equal to 35 percent (Ejection Fraction is a measurement of how well the left ventricle pumps blood out to the rest of the body. The higher the EF the more blood the ventricle is pumping.) * Subject has moderate to severe heart failure despite medications Exclusion Criteria: * Subjects with a previous lead in the left ventricle or previous implant attempt within 30 days of implant or ongoing complications from a previous unsuccessful attempt * Subjects with chest pain or who have had a heart attack within the past month before enrollment in the study * Subjects that have had certain surgeries on their heart within the past three months * Subjects with chronic (permanent) fast heart beats in the upper chambers of the heart (atrial arrhythmias)

Locations (24)

Unnamed facility

Anchorage, Alaska, United States

Unnamed facility

Phoenix, Arizona, United States

Unnamed facility

Long Beach, California, United States

Unnamed facility

Palo Alto, California, United States

Unnamed facility

Davenport, Iowa, United States

Unnamed facility

Lexington, Kentucky, United States

Unnamed facility

Baton Rouge, Louisiana, United States

Unnamed facility

Detroit, Michigan, United States

Unnamed facility

Minneapolis, Minnesota, United States

Unnamed facility

Kansas City, Missouri, United States

...and 14 more locations

Outcomes

Primary Outcomes

Safety (Subjects Without a Model 4196 Lead Related Complication)

A subject who was free of a Model 4196 lead related complication by one month visit.

Time frame: One Month

Efficacy (Pacing Voltage Thresholds of Distal Tip Electrode)

Model 4196 lead distal tip electrode mean pacing voltage threshold (at 0.5 milliseconds \[ms\])

Time frame: One Month

Efficacy (Pacing Voltage Threshold of Proximal Ring Electrode)

Model 4196 lead proximal ring electrode mean pacing voltage threshold (at 0.5 milliseconds \[ms\])

Time frame: Three Months

Secondary Outcomes

Subjects Successfully Implanted With Model 4196 Lead

A successful implant occurs when the Model 4196 lead is implanted in the left ventricle of the heart and functions appropriately.

Time frame: Implant

Subjects Successfully Implanted After Cannulation

A successful implant occurs when the coronary sinus (CS) is successfully cannulated and a left ventricular lead is implanted in the left ventricle of the heart and functions appropriately.

Time frame: Implant

All Left Ventricular Leads

All left ventricular leads successfully implanted

Time frame: Implant

All Medtronic Left Ventricular Leads (Attain Family)

All Medtronic left ventricular leads (Lead Model Numbers included 4193, 4194, 4195 and 4196) successfully implanted

Time frame: Implant

Cannulation Time

Cannulation time was defined as the time from insertion of the first CS cannulation catheter to the first CS cannulation.

Time frame: Implant

Fluoroscopy Time

Fluoroscopy time was defined as the total time the fluoroscope was imaging.

Time frame: Implant

Model 4196 Lead Placement Time

Model 4196 lead placement time was defined as the time from insertion of the successfully placed lead to the time when it was placed in the first acceptable pacing location.

Time frame: Implant

Total Implant Time

Total implant time was defined as time from initial incision to final closure.

Time frame: Implant

Assessment of Lead Handling Characteristics

Lead handling characteristics assessed as "acceptable" by physicians

Time frame: Implant

Electrical Performance - Tip Electrode: Sensing

Model 4196 lead tip electrode R-wave amplitude

Time frame: 12-month

Electrical Performance - Tip Electrode: LV Voltage Threshold

Model 4196 lead tip electrode LV voltage threshold

Time frame: 12-month

Electrical Performance -Tip Electrode: Pacing Impedance

Model 4196 lead tip electrode pacing impedance

Time frame: 12-month

Electrical Performance -Ring Electrode: Sensing

Model 4196 lead ring electrode R-wave amplitude

Time frame: Implant

Electrical Performance - Ring Electrode: LV Voltage Threshold

Model 4196 lead ring electrode LV voltage threshold

Time frame: 12-month

Electrical Performance -Ring Electrode: Pacing Impedance

Model 4196 lead ring electrode pacing impedance

Time frame: 12-Month

Summarize All Adverse Events

All adverse events were collected for this trial such as, but not limited to, the following: Atrial Fibrillation, Chest Pain, Pneumonia, Cold/Flu

Time frame: Up to 18 months