N/A
N=197
Model 4396 Left Ventricular (LV) Lead Study
Heart Failure
Bottom Line
View on ClinicalTrials.gov: NCT00853593 ↗Enrolled (actual)
197
Serious AEs
38.6%
Results posted
Dec 2011
Primary outcome: Primary: Safety (Subjects Without a Model 4396 Lead Related Complication) — 155 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
- Jul 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Safety (Subjects Without a Model 4396 Lead Related Complication) |
155 | — |
| PRIMARY Efficacy: Distal Tip Electrode Voltage Threshold |
1.6 | — |
| PRIMARY Efficacy: Proximal Ring Voltage Threshold |
2.3 | — |
| SECONDARY Subjects Successfully Implanted With Model 4396 Lead |
152 | — |
| SECONDARY Subjects Successfully Implanted With Any Transvenous LV Lead After Cannulation |
185 | — |
| SECONDARY Subjects Successfully Implanted With Any Transvenous LV Lead |
185 | — |
| SECONDARY Subjects Successfully Implanted With Any Medtronic Attain Family LV Lead |
183 | — |
| SECONDARY Cannulation Time |
6.1 | — |
| SECONDARY Fluoroscopy Time |
20.6 | — |
| SECONDARY Model 4396 Lead Placement Time |
13.9 | — |
| SECONDARY Total Operation Time |
97.4 | — |
| SECONDARY Assessment of Lead Handling Characteristics Reported as Acceptable |
162 | — |
| SECONDARY Efficacy: Bipolar Voltage Threshold |
2.4 | — |
| SECONDARY Characterize Model 4396 Electrical Performance- Tip Electrode: Voltage Threshold |
1.5 | — |
| SECONDARY Characterize Model 4396 Electrical Performance- Tip Electrode: Pacing Impedance |
571.2 | — |
| SECONDARY Characterize Model 4396 Electrical Performance- Tip Electrode: Sensing |
18.3 | — |
| SECONDARY Characterize Model 4396 Electrical Performance- Ring Electrode: Voltage Threshold |
2.2 | — |
| SECONDARY Characterize Model 4396 Electrical Performance- Ring Electrode: Pacing Impedance |
544.8 | — |
| SECONDARY Characterize Model 4396 Electrical Performance- Ring Electrode: Sensing |
17.6 | — |
| SECONDARY Characterize Model 4396 Electrical Performance- Bipolar Configuration: Voltage Threshold |
2.4 | — |
| SECONDARY Characterize Model 4396 Electrical Performance- Bipolar Configuration: Pacing Impedance |
967.1 | — |
| SECONDARY Characterize Model 4396 Electrical Performance- Bipolar Configuration: Sensing |
15.0 | — |
Summary
This study is designed to show that a new lead, which paces the left bottom chamber (left ventricle) of the heart, is safe and effective. Using a lead on the left side of the heart has been shown to potentially improve heart failure symptoms. The shape and size of this new lead may make it a good choice for patients or physicians.
Eligibility Criteria
Inclusion Criteria
- CRT/Cardiac Resynchronization Therapy-Defibrillator (CRT-D) indications, New York Heart Association (NYHA) III and IV, indicated for implantable cardiac defibrillator (ICD) if CRT-D is implanted, patient consent, geographically stable
Exclusion Criteria
- LV lead implant attempt in last 30 days, unstable angina or acute myocardial infarction (MI) in past 30 days, coronary artery bypass graft (CABG) or percutaneous transluminal coronary angioplasty (PTCA) in past 3 months, contraindicated for transvenous pacing, heart transplant
Data sourced from ClinicalTrials.gov (NCT00853593). 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.