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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation
ClinicalTrials.gov Identifier:
NCT01688843
First received: September 17, 2012
Last updated: December 9, 2013
Last verified: October 2013

September 17, 2012
December 9, 2013
October 2012
September 2014   (final data collection date for primary outcome measure)
  • Safety 1 [ Time Frame: Lead implant through 3 month follow up ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.
Same as current
Complete list of historical versions of study NCT01688843 on ClinicalTrials.gov Archive Site
Safety 3 [ Time Frame: Implant through 12 months (including available data beyond 12 months) ] [ Designated as safety issue: No ]
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.
Same as current
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.

Not Provided
Interventional
Not Provided
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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
1030
September 2018
September 2014   (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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia,   Austria,   Belgium,   Canada,   Denmark,   France,   Germany,   Hong Kong,   Italy,   Malaysia,   Portugal,   Spain,   Sweden,   Thailand,   United Kingdom
 
NCT01688843
BSC-CDM00048360
No
Boston Scientific Corporation
Boston Scientific Corporation
Not Provided
Principal Investigator: Charles Love, MD The Ohio State University Wexner Medical Center, Ohio, USA
Principal Investigator: Jens Cosedis-Nielsen, Prof. M.D. Aarhus University Hospital, Aarhus, Denmark
Boston Scientific Corporation
October 2013

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