Model 20066 Left Ventricular (LV) Lead Study

Study Overview
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Brief Summary
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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 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).

Official Title
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Model 20066 Left Ventricular (LV) Lead Study

Conditions
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Heart Failure

Intervention / Treatment
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* Device: Pacing Lead


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient meets CRT inclusion criteria as determined by local regulatory and/or hospital policy Patient has signed and dated the study-specific informed consent form Patient is 18 years of age or older Patient is expected to remain available for follow-ups at the investigational center Patient is willing and able to comply with protocol Exclusion Criteria: Patient has a previous complete atrial based biventricular CRT system Patient has a previous LV lead implanted or previous implant attempt within 30 days of implant or ongoing Adverse Events from previous unsuccessful attempt Patient has known coronary venous vasculature that is inadequate for lead placement Patient has unstable angina pectoris or has had an acute myocardial infarction (MI) within the past month Patient has had a coronary artery bypass graft (CABG) or percutaneous transluminal coronary angioplasty (PTCA) within the past three months Patient has chronic (permanent) atrial arrhythmias Patient has contraindications for standard transvenous cardiac pacing (e.g., mechanical right heart valve) Patient has had a heart transplant (patients waiting for heart transplants are allowed in the study) Patient is enrolled in any concurrent drug and/or device study that may confound the results of this study Patient has a terminal illness and is not expected to survive more than three months Patient meets exclusion criteria required by local law (e.g. age, incompetence, pregnancy, breast feeding, etc). Patient is unable to tolerate an urgent thoracotomy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 20066 Lead<br>Non-randomized study. Intervention: Device: Pacing Lead | Device: Pacing Lead<br>* Implant and follow up of Model 20066 lead<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of implant procedure related and lead-related complications in the first month post-implant |  | One Month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Success rate of the Model 20066 lead |  | Within 24 hours of procedure initiation | 
| Cannulation time |  | Within 24 hours of procedure initiation | 
| Fluoroscopy Time |  | Within 24 hours of procedure initiation | 
| Model 20066 Lead Placement Time |  | Within 24 hours of procedure initiation | 
| Total Implant Time |  | Within 24 hours of procedure initiation | 
| Assessment of Lead Handling Characteristics |  | Within 24 hours of procedure initiation | 
| Electrical Performance-Tip Electrode: LV Voltage Threshold |  | 12-month | 
| Electrical Performance -Tip Electrode: Sensing |  | 12-month | 
| Electrical Performance -Tip Electrode: Pacing Impedance |  | 12-month | 
| Electrical Performance -Ring Electrode: LV Voltage Threshold |  | 12-month | 
| Electrical Performance -Ring Electrode: Sensing |  | Within 24 hours of procedure initiation | 
| Electrical Performance -Ring Electrode: Pacing Impedance |  | 12-month | 
| Summarize All Adverse Events |  | 12-month | 
| Summarize Final 20066 Lead Position |  | Within 24 hours of procedure initiation |