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
  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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 1030
Study Start Date: October 2012
Estimated Study Completion Date: September 2018
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: INGEVITY lead
INGEVITY lead implant
Device: INGEVITY lead

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01688843

  Show 84 Study Locations
Sponsors and Collaborators
Boston Scientific Corporation
Investigators
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
  More Information

No publications provided

Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT01688843     History of Changes
Other Study ID Numbers: BSC-CDM00048360
Study First Received: September 17, 2012
Last Updated: December 9, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Boston Scientific Corporation:
bradycardia
sinus node dysfunction

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

ClinicalTrials.gov processed this record on April 15, 2014