Safety and Performance Study of the INGEVITY Lead

• Sponsor: Boston Scientific Corporation (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01688843
• Collaborator: (none)
• Enrollment: 1,060
• Locations: 78
• Arm: 1
• Duration (Months): 76
• Patients Per Site: 13.6
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Bradycardia; Sinus Node Dysfunction	Device: INGEVITY lead	N/A

Detailed Description

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

Study Design

• Study Type: Interventional
• Actual Enrollment: 1060 participants
• Allocation: N/A
• 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
• Study Start Date: Oct 1, 2012
• Actual Primary Completion Date: Jan 1, 2015
• Actual Study Completion Date: Feb 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: INGEVITY lead INGEVITY lead implant	Device: INGEVITY lead

Outcome Measures

Primary Outcome Measures

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

   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%

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

   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%.

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

   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.

4. Effectiveness 1 [Lead implant through 3 month follow up]

   The bipolar pacing threshold at 0.5 ms at three months post-implant < 1.5 V

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

   P-wave sensed amplitude at three months post-implant > 1.5 mV

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

   R-wave sensed amplitude at three months post-implant > 5 mV

7. Effectiveness 3 [Lead implant through 3 month follow up]

   Clinically acceptable pacing impedance between 300 Ω and 1300 Ω

Other Outcome Measures

1. Ancillary Safety [From 3 to 60 months post-implant]

   Lead-related complication-free rate

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Mercy Gilbert Medical Center	Gilbert	Arizona	United States	85297
2	Cardiovascular Consultants, LTD	Glendale	Arizona	United States	85306
3	Pima Heart Physicians, PC	Tucson	Arizona	United States	85712
4	Sharp Grossmont Hospital	La Mesa	California	United States	91942
5	Orange County Heart Institute	Orange	California	United States	92868
6	Eisenhower Medical Center	Rancho Mirage	California	United States	92270-3221
7	Sharp Memorial Hospital	San Diego	California	United States	92123
8	Danbury Hospital	Danbury	Connecticut	United States	06810
9	Cardiology Associates of Fairfield County	Trumbull	Connecticut	United States	06611
10	West Florida Cardiology Network, LLC	Largo	Florida	United States	33770
11	University Community Hospital	Tampa	Florida	United States	33613
12	Wellstar Research Institute	Marietta	Georgia	United States	30060
13	St. Vincent's Hospital	Indianapolis	Indiana	United States	46260
14	Indiana University Health La Porte Hospital	LaPorte	Indiana	United States	46350
15	University of Iowa Hospitals and Clinics	Iowa City	Iowa	United States	52242
16	Southern Kentucky Heart Institute	Bowling Green	Kentucky	United States	42101
17	Ochsner Clinic Foundation	New Orleans	Louisiana	United States	70121
18	Henry Ford Hospital	Detroit	Michigan	United States	48202
19	Michigan CardioVascular Institute	Saginaw	Michigan	United States	48601
20	HealthEast St. Joseph's Hospital	Saint Paul	Minnesota	United States	55102
21	Cardiovascular Associates of the Delaware Valley	Sewell	New Jersey	United States	08080
22	New York Methodist Hospital	Brooklyn	New York	United States	11215
23	Rochester General Hospital	Rochester	New York	United States	14621
24	Staten Island University Hospital	Staten Island	New York	United States	10309
25	Forsyth Medical Center	Winston-Salem	North Carolina	United States	27103
26	Aultman Hospital	Canton	Ohio	United States	44710
27	Lindner Center for Research and Education at Christ Hosp	Cincinnati	Ohio	United States	45219
28	University Hospital, Inc.	Cincinnati	Ohio	United States	45219
29	Ohio State University Medical Center	Columbus	Ohio	United States	43210
30	Northwest Ohio Cardiology Consultants	Toledo	Ohio	United States	43615
31	Coastal Cardiology	Charleston	South Carolina	United States	29407
32	Spartanburg Regional Medical Center	Spartanburg	South Carolina	United States	29303
33	South Austin Hospital	Austin	Texas	United States	78745
34	Heart Hospital of Austin	Austin	Texas	United States	78756
35	North Texas Heart Center	Dallas	Texas	United States	75231
36	Plaza Medical Center of Fort Worth	Fort Worth	Texas	United States	76104
37	Trinity Mother Frances Health System	Tyler	Texas	United States	75701
38	University of Utah Hospital and Clinics	Salt Lake City	Utah	United States	84132
39	Bon Secours Heart & Vascular Institute	Richmond	Virginia	United States	23230
40	PeaceHealth St. Joseph Medical Center	Bellingham	Washington	United States	98225
41	Monongalia General Hospital	Morgantown	West Virginia	United States	26505
42	Wheeling Hospital Inc.	Wheeling	West Virginia	United States	26003
43	Wheaton Franciscan Healthcare	Glendale	Wisconsin	United States	53212
44	St. Mary's Madison	Madison	Wisconsin	United States	53715
45	St. Andrew's War Memorial Hospital	Brisbane	Queensland	Australia	4001
46	The Prince Charles Hospital	Chermside	Queensland	Australia	4032
47	Medizinische Univ.-Kliniken Graz	Graz		Austria	8036
48	AKH Linz	Linz		Austria	4021
49	Klinikum Wels-Grieskirchen GmbH	Wels		Austria	4600
50	Universitair Ziekenhuis Gent	Gent		Belgium	9000
51	AZ Groeninge Campus	Kortrijk		Belgium	8500
52	Royal Columbian Hospital	New Westminster	British Columbia	Canada	V3L 3W7
53	Hamilton General Hospital	Hamilton	Ontario	Canada	L8L 2X2
54	Hopital Hotel Dieu du Centre Hospitalier de l'Universite de Montreal	Montreal	Quebec	Canada	H2W IT7
55	Skejby Sygehus	Aarhus		Denmark	8200
56	Roskilde University Hospital	Roskilde		Denmark	4000
57	CHU La Timone Hospital	Marseille Cedex 05		France	13005
58	NCN Nouvelles Cliniques Nantaises	Nantes Cedex 2		France	44277
59	Kardiologische Gemeinschaftspraxis Kaltofen Schubert Gerner	Chemnitz		Germany	09116
60	Uniklinik Köln	Cologne		Germany	50931
61	Universitätsklinikum Erlangen	Erlangen		Germany	91054
62	Otto-von-Guericke-Universitaet Magdeburg	Magdeburg		Germany	39120
63	Prince of Wales Hospital	Shatin		Hong Kong	999077
64	Azienda Ospedaliera Universitaria Integrata di Verona	Verona		Italy	37126
65	Institut Jantung Negara	Kuala Lumpur		Malaysia	50400
66	University of Malaya Medical Centre	Kuala Lumpur		Malaysia	50603
67	Centro Hospitalar do Porto - Hospital de Santo Antonio	Porto		Portugal	4099 - 001
68	Hospital de Santarem	Santarem		Portugal	2005-177
69	Hospital Clinico Y Provincial	Barcelona		Spain	08036
70	Hospital Universitario Nuestra Senora de Candelaria	Santa Cruz de Tenerife		Spain	38010
71	Hospital Doctor Peset	Valencia		Spain	46017
72	Clinico de Valladolid	Valladolid		Spain	47012
73	Sahlgrenska University Hospital	Göteborg		Sweden	41345
74	Karolinska University Hospital	Stockholm		Sweden
75	Chiang Mai Heart Center Medical School Hospital	Chiang Mai		Thailand	50200
76	Basildon and Thurrock University Hospitals NHS	Basildon	Essex	United Kingdom	SS16 5NL
77	Belfast City Hospital	Belfast		United Kingdom	BT9 7
78	Wrexham Maelor Hospital	Wrexham		United Kingdom	LL13 7TD

Sponsors and Collaborators

• Boston Scientific Corporation

Investigators

• Principal Investigator: Charles Love, MD, Johns Hopkins University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Boston Scientific Corporation
• ClinicalTrials.gov Identifier: NCT01688843
• Other Study ID Numbers: BSC-CDM00048360
• First Posted: Sep 20, 2012
• Last Update Posted: Mar 10, 2020
• Last Verified: Mar 1, 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Keywords provided by Boston Scientific Corporation: bradycardia; sinus node dysfunction
• Additional relevant MeSH terms: Bradycardia; Sick Sinus Syndrome

Study Results

Participant Flow

Arm/Group Title	INGEVITY Study Participants
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
STARTED	1060
COMPLETED	1060
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	INGEVITY Lead
Arm/Group Description	INGEVITY lead implant
Overall Participants	1060
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	74.3 (10.6)
Sex: Female, Male (Count of Participants)
Female	478 45.1%
Male	582 54.9%
Region of Enrollment (participants) [Number]
Hong Kong	11 1%
United States	603 56.9%
United Kingdom	39 3.7%
Malaysia	25 2.4%
Thailand	10 0.9%
Portugal	32 3%
Spain	88 8.3%
Canada	20 1.9%
Austria	45 4.2%
Sweden	16 1.5%
Belgium	22 2.1%
Denmark	26 2.5%
Italy	21 2%
Australia	8 0.8%
France	57 5.4%
Germany	37 3.5%

Outcome Measures

1. Primary Outcome

Title	Safety 1 - Percentage of Leads Free From Complication (0 - 3 Months)
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

Outcome Measure Data

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
Arm/Group Description	Implanted/Attempted Leads
Measure Participants	1036
Measure Implant/Attempted Leads	1599
Number (95% Confidence Interval) [percentage of leads complication-free]	98.4

2. Primary Outcome

Title	Safety 2 - Percentage of Leads Free From Complication (3 - 24 Months)
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

Outcome Measure Data

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
Arm/Group Description	Implanted/Attempted Leads
Measure Participants	1009
Measure Implant/Attempted Leads	1545
Number (95% Confidence Interval) [percentage of leads complication-free]	99.7

3. Primary Outcome

Title	Safety 3 - Hazard Rate of Lead-Related Complications
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)

Outcome Measure Data

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
Arm/Group Description	Implanted/Attempted Leads
Measure Participants	1036
Measure Leads Implanted/Attempted	1599
Number (95% Confidence Interval) [hazard rate of lead-related complication]	0.23

4. Primary Outcome

Title	Effectiveness 1
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	INGEVITY Lead
Arm/Group Description	INGEVITY lead implant
Measure Participants	982
Measure Implant/Attempted Leads	1482
Mean (95% Confidence Interval) [volts]	0.67

5. Primary Outcome

Title	Effectiveness 2(Right Atrium)
Description	P-wave sensed amplitude at three months post-implant > 1.5 mV
Time Frame	Lead implant through 3 month follow up

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	INGEVITY Lead
Arm/Group Description	INGEVITY lead implant
Measure Participants	521
Measure Implant/Attempted Leads	521
Mean (95% Confidence Interval) [mV]	4.8

6. Primary Outcome

Title	Effectiveness 2(Right Ventricle)
Description	R-wave sensed amplitude at three months post-implant > 5 mV
Time Frame	Lead implant through 3 month follow up

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	INGEVITY Lead
Arm/Group Description	INGEVITY lead implant
Measure Participants	914
Measure Implant/Attempted Leads	914
Mean (95% Confidence Interval) [mV]	16.5

7. Primary Outcome

Title	Effectiveness 3
Description	Clinically acceptable pacing impedance between 300 Ω and 1300 Ω
Time Frame	Lead implant through 3 month follow up

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	INGEVITY Lead
Arm/Group Description	INGEVITY lead implant
Measure Participants	995
Measure Implant/Attempted Leads	1526
Mean (95% Confidence Interval) [Ω]	773

8. Other Pre-specified Outcome

Title	Ancillary Safety
Description	Lead-related complication-free rate
Time Frame	From 3 to 60 months post-implant

Outcome Measure Data

Analysis Population Description

Leads eligible for endpoint analyses

Arm/Group Title	INGEVITY Lead
Arm/Group Description	INGEVITY lead implant INGEVITY lead
Measure Participants	1038
Measure Leads	1599
Number (95% Confidence Interval) [percentage of leads complication-free]	99.1

Adverse Events

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
Arm/Group Description
All Cause Mortality
	INGEVITY Study Participants
	Affected / at Risk (%)	# Events
Total	93/1060 (8.8%)
Serious Adverse Events
	INGEVITY Study Participants
	Affected / at Risk (%)	# Events
Total	532/1041 (51.1%)
Cardiac disorders
Cardiovascular - Heart Failure	101/1041 (9.7%)	163
Cardiovascular - Non-Heart Failure	241/1041 (23.2%)	326
General disorders
Other	49/1041 (4.7%)	54
Non-cardiovascular	357/1041 (34.3%)	705
Investigations
Unclassified	8/1041 (0.8%)	8
Product Issues
Pulse Generator	9/1041 (0.9%)	10
Right Atrial (RA) Lead - INGEVITY Related	10/564 (1.8%)	10
RA Lead - Other (Non-INGEVITY Lead)	12/858 (1.4%)	12
Right Ventricular (RV) Lead - INGEVITY-related	15/1041 (1.4%)	20
RV Lead - Other (Non-INGEVITY Lead)	1/1041 (0.1%)	1
Left-Ventricular (LV) Lead	2/1041 (0.2%)	2
Surgical and medical procedures
Procedure	26/1041 (2.5%)	26
Other (Not Including Serious) Adverse Events
	INGEVITY Study Participants
	Affected / at Risk (%)	# Events
Total	621/1041 (59.7%)
Cardiac disorders
Cardiovascular - HF	61/1041 (5.9%)	74
Cardiovascular - Non-HF	412/1041 (39.6%)	720
General disorders
Other	89/1041 (8.5%)	103
Unclassified	9/1041 (0.9%)	10
Product Issues
Pulse Generator	32/1041 (3.1%)	37
RA Lead - INGEVITY-related	16/564 (2.8%)	17
RA Lead - Other	4/858 (0.5%)	4
RV Lead - INGEVITY-related	11/1041 (1.1%)	11
LV Lead	6/47 (12.8%)	7
Surgical and medical procedures
Procedure	58/1041 (5.6%)	66

Limitations/Caveats

[Not Specified]

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.