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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 15, 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
Results First Submitted: April 3, 2017  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Bradycardia
Sinus Node Dysfunction
Intervention: Device: INGEVITY lead

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Units Details
Units for given values
Values given as pairs: 1) number of participants and 2) number of units (Leads)

Reporting Groups
  Description
INGEVITY Study Participants Each participant was allowed to have up to 2 INGEVITY leads contribute to endpoint analyses -- one per chamber (right atrium and right ventricle). Final lead implanted or attempted during initial procedure per chamber was used for analysis.

Participant Flow:   Overall Study
    INGEVITY Study Participants
Participants Units (Leads)
STARTED   1060   1599 
COMPLETED   1060   1599 
NOT COMPLETED   0    



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
INGEVITY Lead INGEVITY lead implant

Baseline Measures
   INGEVITY Lead 
Overall Participants Analyzed 
[Units: Participants]
 1060 
Age 
[Units: Years]
Mean (Standard Deviation)
 74.3  (10.6) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      478  45.1% 
Male      582  54.9% 
Region of Enrollment 
[Units: Participants]
 
Hong Kong   11 
United States   603 
United Kingdom   39 
Malaysia   25 
Thailand   10 
Portugal   32 
Spain   88 
Canada   20 
Austria   45 
Sweden   16 
Belgium   22 
Denmark   26 
Italy   21 
Australia   8 
France   57 
Germany   37 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Safety 1 - Percentage of Leads Free From Complication (0 - 3 Months)   [ Time Frame: Lead implant through 3 month follow up ]

2.  Primary:   Safety 2 - Percentage of Leads Free From Complication (3 - 24 Months)   [ Time Frame: 3 months through 12 months post implant ]

3.  Primary:   Safety 3 - Hazard Rate of Lead-Related Complications   [ Time Frame: Implant through 12 months (including available data beyond 12 months) ]

4.  Primary:   Effectiveness 1   [ Time Frame: Lead implant through 3 month follow up ]

5.  Primary:   Effectiveness 2(Right Atrium)   [ Time Frame: Lead implant through 3 month follow up ]

6.  Primary:   Effectiveness 2(Right Ventricle)   [ Time Frame: Lead implant through 3 month follow up ]

7.  Primary:   Effectiveness 3   [ Time Frame: Lead implant through 3 month follow up ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Robert Shipley, Ph.D.
Organization: Boston Scientific
phone: 1-800-227-3422
e-mail: robert.shipley@bsci.com



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
Results First Submitted: April 3, 2017
Results First Posted: November 15, 2017
Last Update Posted: November 15, 2017