Safety and Performance Study of the INGEVITY Lead

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to gather data to establish the safety, performance and effectiveness of the INGEVITY pace/ sense leads.

Detailed Description
-----------------
The objective of this study is to gather data to establish the safety, performance and effectiveness of the INGEVITY pace/ sense leads

Official Title
-----------------
INGEVITY(TM) Active Fixation and Passive Fixation Pace/ Sense Lead Clinical Study

Conditions
-----------------
Bradycardia, Sinus Node Dysfunction

Intervention / Treatment
-----------------
* Device: INGEVITY lead


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject is willing and capable of providing informed consent Subject has a Class I or II indication for implantation of a single(VVI (R) only) or dual chamber pacemaker or a CRT-P system according to the ACC/AHA/HRS, or ESC guidelines Subject is 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 Subject is age 18 or above, or of legal age to give informed consent specific to state and national law Exclusion Criteria: Subject has or has had any pacing or ICD system implants Subject has a sensitivity to dexamethasone acetate (DXA) Subject has a mechanical tricuspid heart valve Subject is enrolled in any other concurrent study, with the exception of local mandatory governmental registries and observational studies/registries Subjects with documented permanent or persistent AF where the physician intends to implant dual chamber pulse generator (single chamber VVIR pulse generators in these subjects is acceptable) Subject is currently on the active heart transplant list Subject has documented life expectancy of less than 12 months Women of childbearing potential who are or might be pregnant at the time of study enrollment or INGEVITY Lead implant Subjects currently requiring dialysis

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: INGEVITY lead<br>INGEVITY lead implant | Device: INGEVITY lead<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety 1 - Percentage of Leads Free From Complication (0 - 3 Months) | Lead-related complication-free rate from lead implant through the three month follow-up, based on complications that are related to the INGEVITY Lead. The performance goal based on similar leads was set in collaboration with FDA at 91.4% | Lead implant through 3 month follow up | 
| Safety 2 - Percentage of Leads Free From Complication (3 - 24 Months) | Lead-related complication-free rate from three months post-implant through twelve months post implant, based on complications that are related to the INGEVITY Lead. The performance goal based on similar leads was set in collaboration with FDA at 94%. | 3 months through 12 months post implant | 
| Safety 3 - Hazard Rate of Lead-Related Complications | Hazard rate of lead-related complications over time. This endpoint will use the Weibull distribution to estimate the hazard over time by evaluating the Weibull shape parameter. A Weibull shape greater than one (>1), equal to one (=1) and less than one (<1) indicates accelerating, constant, and decelerating hazard of lead-related complications over time, respectively. This endpoint requires the Weibull shape estimate to be less than 1. | Implant through 12 months (including available data beyond 12 months) | 
| Effectiveness 1 | The bipolar pacing threshold at 0.5 ms at three months post-implant < 1.5 V | Lead implant through 3 month follow up | 
| Effectiveness 2(Right Atrium) | P-wave sensed amplitude at three months post-implant > 1.5 mV | Lead implant through 3 month follow up | 
| Effectiveness 2(Right Ventricle) | R-wave sensed amplitude at three months post-implant > 5 mV | Lead implant through 3 month follow up | 
| Effectiveness 3 | Clinically acceptable pacing impedance between 300 Ω and 1300 Ω | Lead implant through 3 month follow up | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
bradycardia, sinus node dysfunction