N/A
N=190
Attain Model 4196 Left Ventricular (LV) Lead
Heart Failure
Bottom Line
View on ClinicalTrials.gov: NCT00271544 ↗Enrolled (actual)
190
Serious AEs
—
Results posted
Aug 2009
Primary outcome: Primary: Safety (Subjects Without a Model 4196 Lead Related Complication) — 168 participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Pacing Lead (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
- Primary completion
- Aug 2007
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Safety (Subjects Without a Model 4196 Lead Related Complication) |
168 | — |
| PRIMARY Efficacy (Pacing Voltage Thresholds of Distal Tip Electrode) |
1.1 | — |
| PRIMARY Efficacy (Pacing Voltage Threshold of Proximal Ring Electrode) |
1.9 | — |
| SECONDARY Subjects Successfully Implanted With Model 4196 Lead |
170 | — |
| SECONDARY Subjects Successfully Implanted After Cannulation |
181 | — |
| SECONDARY All Left Ventricular Leads |
181 | — |
| SECONDARY All Medtronic Left Ventricular Leads (Attain Family) |
181 | — |
| SECONDARY Cannulation Time |
10.4 | — |
| SECONDARY Fluoroscopy Time |
25.2 | — |
| SECONDARY Model 4196 Lead Placement Time |
11.9 | — |
| SECONDARY Total Implant Time |
117.1 | — |
| SECONDARY Assessment of Lead Handling Characteristics |
174 | — |
| SECONDARY Electrical Performance - Tip Electrode: Sensing |
17.0 | — |
| SECONDARY Electrical Performance - Tip Electrode: LV Voltage Threshold |
1.2 | — |
| SECONDARY Electrical Performance -Tip Electrode: Pacing Impedance |
508.7 | — |
| SECONDARY Electrical Performance -Ring Electrode: Sensing |
15.4 | — |
| SECONDARY Electrical Performance - Ring Electrode: LV Voltage Threshold |
2.0 | — |
| SECONDARY Electrical Performance -Ring Electrode: Pacing Impedance |
497.1 | — |
| SECONDARY Summarize All Adverse Events |
538 | — |
Summary
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).
Eligibility Criteria
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)
Data sourced from ClinicalTrials.gov (NCT00271544). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.