Safety and Performance Study of the INGEVITY Lead

Not Applicable

Completed

Conditions: Bradycardia
Sinus Node Dysfunction

Registration Number: NCT01688843

Lead Sponsor: Boston Scientific Corporation

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

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 1060

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Effectiveness 1	Lead implant through 3 month follow up	The bipolar pacing threshold at 0.5 ms at three months post-implant \< 1.5 V
Effectiveness 2(Right Atrium)	Lead implant through 3 month follow up	P-wave sensed amplitude at three months post-implant \> 1.5 mV
Safety 1 - Percentage of Leads Free From Complication (0 - 3 Months)	Lead implant through 3 month follow up	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%
Safety 3 - Hazard Rate of Lead-Related Complications	Implant through 12 months (including available data beyond 12 months)	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.
Safety 2 - Percentage of Leads Free From Complication (3 - 24 Months)	3 months through 12 months post implant	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%.
Effectiveness 2(Right Ventricle)	Lead implant through 3 month follow up	R-wave sensed amplitude at three months post-implant \> 5 mV
Effectiveness 3	Lead implant through 3 month follow up	Clinically acceptable pacing impedance between 300 Ω and 1300 Ω

Secondary Outcome Measures

Name	Time	Method

Trial Locations

Locations (78): Mercy Gilbert Medical Center
🇺🇸
Gilbert, Arizona, United States
Cardiovascular Consultants, LTD
🇺🇸
Glendale, Arizona, United States
Pima Heart Physicians, PC
🇺🇸
Tucson, Arizona, United States
Sharp Grossmont Hospital
🇺🇸
La Mesa, California, United States
Orange County Heart Institute
🇺🇸
Orange, California, United States
Eisenhower Medical Center
🇺🇸
Rancho Mirage, California, United States
Sharp Memorial Hospital
🇺🇸
San Diego, California, United States
Danbury Hospital
🇺🇸
Danbury, Connecticut, United States
Cardiology Associates of Fairfield County
🇺🇸
Trumbull, Connecticut, United States
West Florida Cardiology Network, LLC
🇺🇸
Largo, Florida, United States
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Mercy Gilbert Medical Center
🇺🇸Gilbert, Arizona, United States