INGEVITY+ Active Fixation Pace/Sense Lead Clinical Study

Study Overview
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Brief Summary
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The objective of this study is it to confirm the safety and effectiveness of the INGEVITY+ Active Fixation Pace/Sense Lead.

Official Title
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INGEVITY+ Active Fixation Pace/Sense Lead Clinical Study

Conditions
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Bradycardia

Intervention / Treatment
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* Device: INGEVITY+™ Pace/Sense Lead


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject is willing and capable of providing informed consent Subject is intended to undergo initial (de novo) pacing system implant using INGEVITY+ Leads in the Right Atrium (RA) and Right Ventricle (RV) and a Boston Scientific pulse generator Subject meets an indication for a Boston Scientific Pacemaker or CRT-P device per product labeling (Physician's Technical Manual) Willing and capable of participating in all testing/visits associated with this clinical study at an approved clinical study center and at the intervals defined by this protocol Age 18 or above, or of legal age to give informed consent specific to state and national law Exclusion Criteria: Known or suspected sensitivity to dexamethasone acetate (DXA) Has a mechanical tricuspid heart valve Women of childbearing potential who are or might be pregnant at the time of study enrollment or INGEVITY+ Lead implant (method of assessment upon physician's discretion) Currently requiring hemo- or peritoneal dialysis Subject has or has had implanted any pacing or ICD system, including subcutaneous, transvenous or leadless systems Intended to receive a single chamber device Documented history of permanent or persistent AF Currently on an active organ transplant list Documented life expectancy of less than 12 months Enrolled in any other concurrent study unless prior approval is received from the Sponsor

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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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: INGEVITY+™ Pace/Sense Lead|The INGEVITY+ lead is indicated for chronic pacing and sensing in the right atrium and/or right ventricle when used with a compatible pulse generator.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary Safety: Lead-related Complication-Free Rate | This endpoint evaluated the percentage of leads free from complication from three months post-implant through twelve months post implant. The performance goal was 93%. Kaplan-Meier methodology was used to calculate the complication-free rate %. | Lead Implant through 3-Months Post-Implant | 
| Primary Efficacy: Pacing Capture Threshold Responder Rate | This endpoint evaluated the % of leads with an adequate INGEVITY+ Pacing Capture Threshold (PCT) measurement. A lead with an adequate INGEVITY+ PCT measurement was referred to as a Pacing Capture Threshold Responder. A responder was defined by a PCT at 3-month visit ≤ 2 V, measured at 0.4 ms pulse width. A performance goal of 80% was used. | At 3-Months Post-Implant | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary Efficacy: Sensed Amplitude in mV (Right Atrial Leads) | This secondary endpoint evaluated the sensed amplitudes at 3-months post-implant. Atrial and ventricular leads were evaluated separately. The performance goal for atrial leads was > 1.5 mV. | At 3-Months Post-Implant | 
| Secondary Efficacy: Sensed Amplitude in mV (Right Ventricular Leads) | This secondary endpoint evaluated the sensed amplitudes at 3-months post-implant. Atrial and ventricular leads were evaluated separately. The performance goal for ventricular leads was > 1.5 mV. | At 3-Months Post-Implant | 
| Secondary Efficacy: Pacing Impedance in Ohms | This secondary endpoint evaluated the pacing impedances at 3-months post-implant. The performance goals were > 300 ohms and < 1300 ohms. | At 3-Months Post-Implant |