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Completed

NCT Number: NCT01688843

Safety and Performance Study of the INGEVITY Lead

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

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Key information

Conditions

Bradycardia Arrhythmia, Sinus Arrhythmias, Cardiac Cardiac Conduction System Disease Cardiovascular Diseases Heart Block Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Sick Sinus Syndrome Sinus Node Dysfunction

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

St. Andrew's War Memorial Hospital, Brisbane, Queensland, Australia

Loading trial locations.

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

INGEVITY lead

Device

Primary outcomes

  1. Safety 1 - Percentage of Leads Free From Complication (0 - 3 Months)

    Time frame: 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%

  2. Safety 2 - Percentage of Leads Free From Complication (3 - 24 Months)

    Time frame: 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%.

  3. Safety 3 - Hazard Rate of Lead-Related Complications

    Time frame: 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.

  4. Effectiveness 1

    Time frame: Lead implant through 3 month follow up

    The bipolar pacing threshold at 0.5 ms at three months post-implant < 1.5 V

  5. Effectiveness 2(Right Atrium)

    Time frame: Lead implant through 3 month follow up

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

  6. Effectiveness 2(Right Ventricle)

    Time frame: Lead implant through 3 month follow up

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

  7. Effectiveness 3

    Time frame: Lead implant through 3 month follow up

    Clinically acceptable pacing impedance between 300 Ω and 1300 Ω

Other outcomes

  1. Ancillary Safety

    Time frame: From 3 to 60 months post-implant

    Lead-related complication-free rate

Sponsors and collaborators

Lead sponsor

Boston Scientific Corporation

Industry

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2015
Study completion
2019
First posted
Sep 20, 2012
Registry last updated
Mar 10, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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