Safety and Performance Study of the INGEVITY Lead

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. Identifier: NCT01688843
Recruitment Status : Active, not recruiting
First Posted : September 20, 2012
Results First Posted : November 17, 2017
Last Update Posted : November 17, 2017
Information provided by (Responsible Party):
Boston Scientific Corporation

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

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Units Details
Units for given values
Values given as pairs: 1) number of participants and 2) number of units (Leads)

Reporting Groups
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 

  Baseline Characteristics

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.
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Reporting Groups
INGEVITY Lead INGEVITY lead implant

Baseline Measures
Overall Participants Analyzed 
[Units: Participants]
[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

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

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

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

Responsible Party: Boston Scientific Corporation 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 17, 2017
Last Update Posted: November 17, 2017