Safety and Performance Study of the INGEVITY Lead

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01688843

Enrollment

1060

Registered

2012-09-20

Start date

2012-10-31

Completion date

2019-02-28

Last updated

2020-03-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bradycardia, Sinus Node Dysfunction

Keywords

bradycardia, sinus node dysfunction

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

Interventions

DEVICEINGEVITY lead

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Effectiveness 3	Lead implant through 3 month follow up	Clinically acceptable pacing impedance between 300 Ω and 1300 Ω
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 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%.
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.
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
Effectiveness 2(Right Ventricle)	Lead implant through 3 month follow up	R-wave sensed amplitude at three months post-implant \> 5 mV

Other

Measure	Time frame	Description
Ancillary Safety	From 3 to 60 months post-implant	Lead-related complication-free rate

Countries

Australia, Austria, Belgium, Canada, Denmark, France, Germany, Hong Kong, Italy, Malaysia, Portugal, Spain, Sweden, Thailand, United Kingdom, United States

Participant flow

Participants by arm

Arm	Count
INGEVITY Lead INGEVITY lead implant	1,060
Total	1,060

Baseline characteristics

Characteristic	INGEVITY Lead
Age, Continuous	74.3 years STANDARD_DEVIATION 10.6
Region of Enrollment Australia	8 participants
Region of Enrollment Austria	45 participants
Region of Enrollment Belgium	22 participants
Region of Enrollment Canada	20 participants
Region of Enrollment Denmark	26 participants
Region of Enrollment France	57 participants
Region of Enrollment Germany	37 participants
Region of Enrollment Hong Kong	11 participants
Region of Enrollment Italy	21 participants
Region of Enrollment Malaysia	25 participants
Region of Enrollment Portugal	32 participants
Region of Enrollment Spain	88 participants
Region of Enrollment Sweden	16 participants
Region of Enrollment Thailand	10 participants
Region of Enrollment United Kingdom	39 participants
Region of Enrollment United States	603 participants
Sex: Female, Male Female	478 Participants
Sex: Female, Male Male	582 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	93 / 1,060
other Total, other adverse events	621 / 1,041
serious Total, serious adverse events	532 / 1,041