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

Condition Intervention
Bradycardia Sinus Node Dysfunction Device: INGEVITY lead

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: INGEVITY(TM) Active Fixation and Passive Fixation Pace/ Sense Lead Clinical Study

Resource links provided by NLM:


Further study details as provided by Boston Scientific Corporation:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 1060
Study Start Date: October 2012
Estimated Study Completion Date: January 2019
Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: INGEVITY lead
INGEVITY lead implant
Device: INGEVITY lead

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01688843


  Show 78 Study Locations
Sponsors and Collaborators
Boston Scientific Corporation
Investigators
Principal Investigator: Charles Love, MD New York University
Principal Investigator: Jens Cosedis-Nielsen, Prof. M.D. Aarhus University Hospital, Aarhus, Denmark
  More Information

Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT01688843     History of Changes
Other Study ID Numbers: BSC-CDM00048360
First Submitted: September 17, 2012
First Posted: September 20, 2012
Last Update Posted: October 17, 2017
Last Verified: January 2017

Keywords provided by Boston Scientific Corporation:
bradycardia
sinus node dysfunction

Additional relevant MeSH terms:
Bradycardia
Sick Sinus Syndrome
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Arrhythmia, Sinus
Heart Block