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Trial record 49 of 62 for:    "Sick Sinus Syndrome"

Safety and Performance Study of the INGEVITY Lead

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ClinicalTrials.gov Identifier: NCT01688843
Recruitment Status : Completed
First Posted : September 20, 2012
Results First Posted : November 17, 2017
Last Update Posted : April 18, 2019
Sponsor:
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
Enrollment 1060
Recruitment Details  
Pre-assignment Details  
Arm/Group Title INGEVITY Study Participants
Hide Arm/Group Description 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.
Period Title: Overall Study
Number of participants Number of units (Leads)
Started 1060 1599
Completed 1060 1599
Not Completed 0 0
Arm/Group Title INGEVITY Lead
Hide Arm/Group Description INGEVITY lead implant
Overall Number of Baseline Participants 1060
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 1060 participants
74.3  (10.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1060 participants
Female
478
  45.1%
Male
582
  54.9%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 1060 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
1.Primary Outcome
Title Safety 1 - Percentage of Leads Free From Complication (0 - 3 Months)
Hide Description Lead-related complication-free rate from lead implant through the three month follow-up, based on complications that are related to the INGEVITY Lead. The performance goal based on similar leads was set in collaboration with FDA at 91.4%
Time Frame Lead implant through 3 month follow up
Hide Outcome Measure Data
Hide Analysis Population Description
Final lead implanted or attempted during initial procedure per chamber was used for analysis. Analysis leads were from participants who met inclusion/exclusion criteria and were implanted or attempted with INGEVITY lead(s). Of the 1060 enrolled participants, 24 did not meet these criteria and were excluded from the analysis.
Arm/Group Title INGEVITY Lead
Hide Arm/Group Description:
Implanted/Attempted Leads
Overall Number of Participants Analyzed 1036
Overall Number of Units Analyzed
Type of Units Analyzed: Implant/Attempted Leads
1599
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of leads complication-free
98.4 [1] 
(97.7 to NA)
[1]
One-sided confidence interval
2.Primary Outcome
Title Safety 2 - Percentage of Leads Free From Complication (3 - 24 Months)
Hide Description Lead-related complication-free rate from three months post-implant through twelve months post implant, based on complications that are related to the INGEVITY Lead. The performance goal based on similar leads was set in collaboration with FDA at 94%.
Time Frame 3 months through 12 months post implant
Hide Outcome Measure Data
Hide Analysis Population Description
Leads still in service and implanted in actively followed participants at 92 days were included in analysis.
Arm/Group Title INGEVITY Lead
Hide Arm/Group Description:
Implanted/Attempted Leads
Overall Number of Participants Analyzed 1009
Overall Number of Units Analyzed
Type of Units Analyzed: Implant/Attempted Leads
1545
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of leads complication-free
99.7 [1] 
(99.4 to NA)
[1]
One-sided confidence interval
3.Primary Outcome
Title Safety 3 - Hazard Rate of Lead-Related Complications
Hide Description Hazard rate of lead-related complications over time. This endpoint will use the Weibull distribution to estimate the hazard over time by evaluating the Weibull shape parameter. A Weibull shape greater than one (>1), equal to one (=1) and less than one (<1) indicates accelerating, constant, and decelerating hazard of lead-related complications over time, respectively. This endpoint requires the Weibull shape estimate to be less than 1.
Time Frame Implant through 12 months (including available data beyond 12 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Final lead implanted or attempted during initial procedure per chamber was used for analysis. Analysis leads were from participants who met inclusion/exclusion criteria and were implanted or attempted with INGEVITY lead(s). Of the 1060 enrolled participants, 24 did not meet these criteria and were excluded from the analysis.
Arm/Group Title INGEVITY Lead
Hide Arm/Group Description:
Implanted/Attempted Leads
Overall Number of Participants Analyzed 1036
Overall Number of Units Analyzed
Type of Units Analyzed: Leads Implanted/Attempted
1599
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: hazard rate of lead-related complication
0.23 [1] 
(NA to 0.3)
[1]
One-sided confidence interval
4.Primary Outcome
Title Effectiveness 1
Hide Description The bipolar pacing threshold at 0.5 ms at three months post-implant < 1.5 V
Time Frame Lead implant through 3 month follow up
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title INGEVITY Lead
Hide Arm/Group Description:
INGEVITY lead implant
Overall Number of Participants Analyzed 982
Overall Number of Units Analyzed
Type of Units Analyzed: Implant/Attempted Leads
1482
Mean (95% Confidence Interval)
Unit of Measure: volts
0.67
(0.65 to 0.69)
5.Primary Outcome
Title Effectiveness 2(Right Atrium)
Hide Description P-wave sensed amplitude at three months post-implant > 1.5 mV
Time Frame Lead implant through 3 month follow up
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title INGEVITY Lead
Hide Arm/Group Description:
INGEVITY lead implant
Overall Number of Participants Analyzed 521
Overall Number of Units Analyzed
Type of Units Analyzed: Implant/Attempted Leads
521
Mean (95% Confidence Interval)
Unit of Measure: mV
4.8 [1] 
(4.6 to NA)
[1]
One-sided confidence interval
6.Primary Outcome
Title Effectiveness 2(Right Ventricle)
Hide Description R-wave sensed amplitude at three months post-implant > 5 mV
Time Frame Lead implant through 3 month follow up
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title INGEVITY Lead
Hide Arm/Group Description:
INGEVITY lead implant
Overall Number of Participants Analyzed 914
Overall Number of Units Analyzed
Type of Units Analyzed: Implant/Attempted Leads
914
Mean (95% Confidence Interval)
Unit of Measure: mV
16.5 [1] 
(16.2 to NA)
[1]
One-sided confidence interval
7.Primary Outcome
Title Effectiveness 3
Hide Description Clinically acceptable pacing impedance between 300 Ω and 1300 Ω
Time Frame Lead implant through 3 month follow up
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title INGEVITY Lead
Hide Arm/Group Description:
INGEVITY lead implant
Overall Number of Participants Analyzed 995
Overall Number of Units Analyzed
Type of Units Analyzed: Implant/Attempted Leads
1526
Mean (95% Confidence Interval)
Unit of Measure: Ω
773
(766 to 779)
Time Frame Entire follow-up (median participant follow-up = 30.9 months)
Adverse Event Reporting Description All-cause mortality evaluated in all enrolled participants (N = 1060). Adverse events evaluated in participants implanted or attempted with at least one INGEVITY lead (N = 1041). Individual adverse event categories evaluated in participants at risk for that event category (e.g., Pulse generator events evaluated in participants with a pulse generator).
 
Arm/Group Title INGEVITY Study Participants
Hide Arm/Group Description [Not Specified]
All-Cause Mortality
INGEVITY Study Participants
Affected / at Risk (%)
Total   93/1060 (8.77%)    
Show Serious Adverse Events Hide Serious Adverse Events
INGEVITY Study Participants
Affected / at Risk (%) # Events
Total   532/1041 (51.10%)    
Cardiac disorders   
Cardiovascular - Heart Failure *  101/1041 (9.70%)  163
Cardiovascular - Non-Heart Failure *  241/1041 (23.15%)  326
General disorders   
Other *  49/1041 (4.71%)  54
Non-cardiovascular *  357/1041 (34.29%)  705
Investigations   
Unclassified *  8/1041 (0.77%)  8
Product Issues   
Pulse Generator * [1]  9/1041 (0.86%)  10
Right Atrial (RA) Lead - INGEVITY Related * [2]  10/564 (1.77%)  10
RA Lead - Other (Non-INGEVITY Lead) * [3]  12/858 (1.40%)  12
Right Ventricular (RV) Lead - INGEVITY-related * [4]  15/1041 (1.44%)  20
RV Lead - Other (Non-INGEVITY Lead) * [5]  1/1041 (0.10%)  1
Left-Ventricular (LV) Lead * [6]  2/1041 (0.19%)  2
Surgical and medical procedures   
Procedure *  26/1041 (2.50%)  26
*
Indicates events were collected by non-systematic assessment
[1]
Includes: Oversensing - Defibrillation Rate response inappropriate Inappropriate AV delay Pacemaker-mediated tachycardia (PMT) Erosion Infection (> 30 days post-implant) Migration
[2]
564 patients were attempted/implanted with a INGEVITY RA lead, therefore that is the number at risk for an adverse event
[3]
858 patients were attempted/implanted with an OTHER (non-INGEVITY) RA lead, therefore that is the number at risk for an adverse event
[4]
Includes: Unable to capture - RV - INGEVITY-related Elevated threshold - RV - INGEVITY-related Extracardiac stimulation - RV - INGEVITY-related Conductor coil fracture - RV - INGEVITY-related Dislodgment - RV - INGEVITY-related
[5]
Includes: Other - RV Lead - Other
[6]
Includes: Elevated threshold - LV Extracardiac stimulation - LV Dislodgment - LV
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
INGEVITY Study Participants
Affected / at Risk (%) # Events
Total   621/1041 (59.65%)    
Cardiac disorders   
Cardiovascular - HF *  61/1041 (5.86%)  74
Cardiovascular - Non-HF *  412/1041 (39.58%)  720
General disorders   
Other *  89/1041 (8.55%)  103
Unclassified *  9/1041 (0.86%)  10
Product Issues   
Pulse Generator *  32/1041 (3.07%)  37
RA Lead - INGEVITY-related * [1]  16/564 (2.84%)  17
RA Lead - Other * [2]  4/858 (0.47%)  4
RV Lead - INGEVITY-related *  11/1041 (1.06%)  11
LV Lead * [3]  6/47 (12.77%)  7
Surgical and medical procedures   
Procedure *  58/1041 (5.57%)  66
*
Indicates events were collected by non-systematic assessment
[1]
564 patients were attempted/implanted with an INGEVITY RA lead, therefore that is the number at risk for an adverse event
[2]
858 patients were attempted/implanted with an OTHER (non-INGEVITY) RA lead, therefore that is the number at risk for an adverse event
[3]
47 patients were attempted/implanted with any LV lead, therefore that is the number at risk for an adverse event
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: Gena Kantor, MPH
Organization: Boston Scientific
Phone: 1-800-227-3422
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 17, 2017
Last Update Posted: April 18, 2019