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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
NameTimeMethod
Effectiveness 1Lead 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 ComplicationsImplant 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 3Lead implant through 3 month follow up

Clinically acceptable pacing impedance between 300 Ω and 1300 Ω

Secondary Outcome Measures
NameTimeMethod

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

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