Model 4396 Left Ventricular Lead Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Heart Failure
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
- Enrollment
- 197
- Primary Endpoint
- Safety (Subjects Without a Model 4396 Lead Related Complication)
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief 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.
Detailed Description
This study is a prospective, multi-center, non-randomized design. All consented patients who meet all inclusion and no exclusion criteria may receive the investigational lead. The study design has statistical power to show safety at one-month after implant. It also has statistical power to show effectiveness at one-month and three-months after implant.
Investigators
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
Outcomes
Primary Outcomes
Safety (Subjects Without a Model 4396 Lead Related Complication)
Time Frame: One month
A subject who was free of a Model 4396 lead related complication by the one month visit. All adverse events (AE) in the time frame were recorded at the subject's center and assessed by a centralized Adverse Event Advisory Committee (AEAC). The AEAC determined whether an AE was a complication and whether the event was related to the Model 4396 lead. A complication is an AE that results in death, termination of significant device function or invasive intervention (any therapy that penetrates the skin including administration of intramuscular (IM) and parenteral (IV) fluids).
Efficacy: Distal Tip Electrode Voltage Threshold
Time Frame: One month
Subjects' distal tip electrode voltage threshold was collected at the one month visit. The Model 4396 was considered effective if the mean voltage threshold was less than 3.0 Volts. Voltage threshold was collected using LV tip to Right Ventricular (RV) coil configuration at 0.5 milliseconds \[ms\]. Voltage threshold is the minimum energy required from the device to consistently pace the ventricle.
Efficacy: Proximal Ring Voltage Threshold
Time Frame: Three months
Subject's proximal ring electrode voltage threshold was collected at the three months visit. The Model 4396 was considered effective if the mean voltage threshold was less than 3.0 Volts.
Secondary Outcomes
- Subjects Successfully Implanted With Any Medtronic Attain Family LV Lead(During implant procedure.)
- Subjects Successfully Implanted With Model 4396 Lead(During implant procedure.)
- Subjects Successfully Implanted With Any Transvenous LV Lead After Cannulation(During implant procedure.)
- Subjects Successfully Implanted With Any Transvenous LV Lead(During implant procedure.)
- Cannulation Time(During implant procedure.)
- Fluoroscopy Time(During implant procedure.)
- Model 4396 Lead Placement Time(During implant procedure.)
- Total Operation Time(During implant procedure.)
- Assessment of Lead Handling Characteristics Reported as Acceptable(During implant procedure.)
- Efficacy: Bipolar Voltage Threshold(1 month)
- Characterize Model 4396 Electrical Performance- Tip Electrode: Voltage Threshold(6 month)
- Characterize Model 4396 Electrical Performance- Tip Electrode: Pacing Impedance(6 month)
- Characterize Model 4396 Electrical Performance- Tip Electrode: Sensing(6 month)
- Characterize Model 4396 Electrical Performance- Ring Electrode: Voltage Threshold(6 month)
- Characterize Model 4396 Electrical Performance- Ring Electrode: Pacing Impedance(6 month)
- Characterize Model 4396 Electrical Performance- Ring Electrode: Sensing(During implant procedure.)
- Characterize Model 4396 Electrical Performance- Bipolar Configuration: Voltage Threshold(6 month)
- Characterize Model 4396 Electrical Performance- Bipolar Configuration: Pacing Impedance(6 month)
- Characterize Model 4396 Electrical Performance- Bipolar Configuration: Sensing(6 month)