Safety and Performance Study of the INGEVITY Lead

Boston Scientific Corporation1,060 enrolled

Overview

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

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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

1,060

Conditions

Bradycardia Sinus Node Dysfunction

Interventions

INGEVITY leadDEVICE

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (78)

Outcomes

Primary Outcomes

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%

Time frame: 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%.

Time frame: 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.

Time frame: 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

Time frame: Lead implant through 3 month follow up

Effectiveness 2(Right Atrium)

P-wave sensed amplitude at three months post-implant \> 1.5 mV

Time frame: Lead implant through 3 month follow up

Effectiveness 2(Right Ventricle)

R-wave sensed amplitude at three months post-implant \> 5 mV

Data from ClinicalTrials.gov

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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

...and 68 more locations