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Trial record 1 of 3 for:    INGEVITY
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Safety and Performance Study of the INGEVITY Lead

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01688843
First Posted: September 20, 2012
Last Update Posted: November 17, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Boston Scientific Corporation
September 17, 2012
September 20, 2012
April 3, 2017
November 17, 2017
November 17, 2017
October 2012
January 2015   (Final data collection date for primary outcome measure)
  • 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%
  • 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%.
  • 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.
  • 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
  • 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
  • Effectiveness 2(Right Ventricle) [ Time Frame: Lead implant through 3 month follow up ]
    R-wave sensed amplitude at three months post-implant > 5 mV
  • Effectiveness 3 [ Time Frame: Lead implant through 3 month follow up ]
    Clinically acceptable pacing impedance between 300 Ω and 1300 Ω
  • Safety 1 [ Time Frame: Lead implant through 3 month follow up ]
    Safety of the INGEVITY Leads will be evaluated by the lead-related complication-free rate (CFR) from lead implant through the three month follow-up, based on complications that are related to the INGEVITY Lead
  • Safety 2 [ Time Frame: 3 months through 12 months post implant ]
    To satisfy the safety assessment requirements of FDA, safety of the INGEVITY Leads will also be evaluated by the lead-related complication-free rate (CFR) from three months post-implant through twelve months post implant based on complications that are related to the INGEVITY Lead during that period.
  • Effectiveness 1 [ Time Frame: Lead implant through 3 month follow up ]
    The first aspect of effectiveness of the INGEVITY Leads will be established by demonstrating that the leads provide clinically acceptable bipolar pacing thresholds at a 0.5 ms pulse width at three months post implant.
  • Effectiveness 2 [ Time Frame: Lead implant through 3 month follow up ]
    The second aspect of effectiveness of the INGEVITY Leads will be established by demonstrating that the leads provide clinically acceptable sensing amplitudes at three months post implant.
  • Effectiveness 3 [ Time Frame: Lead implant through 3 month follow up ]
    The third aspect of effectiveness of the INGEVITY Leads will be established by demonstrating that the leads provide clinically acceptable pacing impedance at three months post implant.
Complete list of historical versions of study NCT01688843 on ClinicalTrials.gov Archive Site
Not Provided
Safety 3 [ Time Frame: Implant through 12 months (including available data beyond 12 months) ]
Safety Endpoint 3 will characterize the hazard of lead-related complications over time. This endpoint will use the Weibull distribution to estimate the hazard over time.
Not Provided
Not Provided
 
Safety and Performance Study of the INGEVITY Lead
INGEVITY(TM) Active Fixation and Passive Fixation Pace/ Sense Lead Clinical Study
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
Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Bradycardia
  • Sinus Node Dysfunction
Device: INGEVITY lead
Experimental: INGEVITY lead
INGEVITY lead implant
Intervention: Device: INGEVITY lead
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
1060
January 2019
January 2015   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Australia,   Austria,   Belgium,   Canada,   Denmark,   France,   Germany,   Hong Kong,   Italy,   Malaysia,   Portugal,   Spain,   Sweden,   Thailand,   United Kingdom,   United States
 
 
NCT01688843
BSC-CDM00048360
No
Not Provided
Not Provided
Boston Scientific Corporation
Boston Scientific Corporation
Not Provided
Principal Investigator: Charles Love, MD New York University
Principal Investigator: Jens Cosedis-Nielsen, Prof. M.D. Aarhus University Hospital, Aarhus, Denmark
Boston Scientific Corporation
January 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP