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Safety and Performance Study of the INGEVITY Lead

Primary Purpose

Bradycardia, Sinus Node Dysfunction

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
INGEVITY lead
Sponsored by
Boston Scientific Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bradycardia focused on measuring bradycardia, sinus node dysfunction

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Mercy Gilbert Medical Center
  • Cardiovascular Consultants, LTD
  • Pima Heart Physicians, PC
  • Sharp Grossmont Hospital
  • Orange County Heart Institute
  • Eisenhower Medical Center
  • Sharp Memorial Hospital
  • Danbury Hospital
  • Cardiology Associates of Fairfield County
  • West Florida Cardiology Network, LLC
  • University Community Hospital
  • Wellstar Research Institute
  • St. Vincent's Hospital
  • Indiana University Health La Porte Hospital
  • University of Iowa Hospitals and Clinics
  • Southern Kentucky Heart Institute
  • Ochsner Clinic Foundation
  • Henry Ford Hospital
  • Michigan CardioVascular Institute
  • HealthEast St. Joseph's Hospital
  • Cardiovascular Associates of the Delaware Valley
  • New York Methodist Hospital
  • Rochester General Hospital
  • Staten Island University Hospital
  • Forsyth Medical Center
  • Aultman Hospital
  • Lindner Center for Research and Education at Christ Hosp
  • University Hospital, Inc.
  • Ohio State University Medical Center
  • Northwest Ohio Cardiology Consultants
  • Coastal Cardiology
  • Spartanburg Regional Medical Center
  • South Austin Hospital
  • Heart Hospital of Austin
  • North Texas Heart Center
  • Plaza Medical Center of Fort Worth
  • Trinity Mother Frances Health System
  • University of Utah Hospital and Clinics
  • Bon Secours Heart & Vascular Institute
  • PeaceHealth St. Joseph Medical Center
  • Monongalia General Hospital
  • Wheeling Hospital Inc.
  • Wheaton Franciscan Healthcare
  • St. Mary's Madison
  • St. Andrew's War Memorial Hospital
  • The Prince Charles Hospital
  • Medizinische Univ.-Kliniken Graz
  • AKH Linz
  • Klinikum Wels-Grieskirchen GmbH
  • Universitair Ziekenhuis Gent
  • AZ Groeninge Campus
  • Royal Columbian Hospital
  • Hamilton General Hospital
  • Hopital Hotel Dieu du Centre Hospitalier de l'Universite de Montreal
  • Skejby Sygehus
  • Roskilde University Hospital
  • CHU La Timone Hospital
  • NCN Nouvelles Cliniques Nantaises
  • Kardiologische Gemeinschaftspraxis Kaltofen Schubert Gerner
  • Uniklinik Köln
  • Universitätsklinikum Erlangen
  • Otto-von-Guericke-Universitaet Magdeburg
  • Prince of Wales Hospital
  • Azienda Ospedaliera Universitaria Integrata di Verona
  • Institut Jantung Negara
  • University of Malaya Medical Centre
  • Centro Hospitalar do Porto - Hospital de Santo Antonio
  • Hospital de Santarem
  • Hospital Clinico Y Provincial
  • Hospital Universitario Nuestra Senora de Candelaria
  • Hospital Doctor Peset
  • Clinico de Valladolid
  • Sahlgrenska University Hospital
  • Karolinska University Hospital
  • Chiang Mai Heart Center Medical School Hospital
  • Basildon and Thurrock University Hospitals NHS
  • Belfast City Hospital
  • Wrexham Maelor Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

INGEVITY lead

Arm Description

INGEVITY lead implant

Outcomes

Primary Outcome Measures

Safety 1 - Percentage of Leads Free From Complication (0 - 3 Months)
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%
Safety 2 - Percentage of Leads Free From Complication (3 - 24 Months)
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%.
Safety 3 - Hazard Rate of Lead-Related Complications
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.
Effectiveness 1
The bipolar pacing threshold at 0.5 ms at three months post-implant < 1.5 V
Effectiveness 2(Right Atrium)
P-wave sensed amplitude at three months post-implant > 1.5 mV
Effectiveness 2(Right Ventricle)
R-wave sensed amplitude at three months post-implant > 5 mV
Effectiveness 3
Clinically acceptable pacing impedance between 300 Ω and 1300 Ω

Secondary Outcome Measures

Full Information

First Posted
September 17, 2012
Last Updated
March 2, 2020
Sponsor
Boston Scientific Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT01688843
Brief Title
Safety and Performance Study of the INGEVITY Lead
Official Title
INGEVITY(TM) Active Fixation and Passive Fixation Pace/ Sense Lead Clinical Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
October 2012 (undefined)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
February 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boston Scientific Corporation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. 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.
Detailed Description
The objective of this study is to gather data to establish the safety, performance and effectiveness of the INGEVITY pace/ sense leads

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bradycardia, Sinus Node Dysfunction
Keywords
bradycardia, sinus node dysfunction

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1060 (Actual)

8. Arms, Groups, and Interventions

Arm Title
INGEVITY lead
Arm Type
Experimental
Arm Description
INGEVITY lead implant
Intervention Type
Device
Intervention Name(s)
INGEVITY lead
Primary Outcome Measure Information:
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
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
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)
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
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
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
Title
Effectiveness 3
Description
Clinically acceptable pacing impedance between 300 Ω and 1300 Ω
Time Frame
Lead implant through 3 month follow up
Other Pre-specified Outcome Measures:
Title
Ancillary Safety
Description
Lead-related complication-free rate
Time Frame
From 3 to 60 months post-implant

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Charles Love, MD
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mercy Gilbert Medical Center
City
Gilbert
State/Province
Arizona
ZIP/Postal Code
85297
Country
United States
Facility Name
Cardiovascular Consultants, LTD
City
Glendale
State/Province
Arizona
ZIP/Postal Code
85306
Country
United States
Facility Name
Pima Heart Physicians, PC
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
Facility Name
Sharp Grossmont Hospital
City
La Mesa
State/Province
California
ZIP/Postal Code
91942
Country
United States
Facility Name
Orange County Heart Institute
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Eisenhower Medical Center
City
Rancho Mirage
State/Province
California
ZIP/Postal Code
92270-3221
Country
United States
Facility Name
Sharp Memorial Hospital
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Danbury Hospital
City
Danbury
State/Province
Connecticut
ZIP/Postal Code
06810
Country
United States
Facility Name
Cardiology Associates of Fairfield County
City
Trumbull
State/Province
Connecticut
ZIP/Postal Code
06611
Country
United States
Facility Name
West Florida Cardiology Network, LLC
City
Largo
State/Province
Florida
ZIP/Postal Code
33770
Country
United States
Facility Name
University Community Hospital
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613
Country
United States
Facility Name
Wellstar Research Institute
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
St. Vincent's Hospital
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46260
Country
United States
Facility Name
Indiana University Health La Porte Hospital
City
LaPorte
State/Province
Indiana
ZIP/Postal Code
46350
Country
United States
Facility Name
University of Iowa Hospitals and Clinics
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
Southern Kentucky Heart Institute
City
Bowling Green
State/Province
Kentucky
ZIP/Postal Code
42101
Country
United States
Facility Name
Ochsner Clinic Foundation
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States
Facility Name
Henry Ford Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Michigan CardioVascular Institute
City
Saginaw
State/Province
Michigan
ZIP/Postal Code
48601
Country
United States
Facility Name
HealthEast St. Joseph's Hospital
City
Saint Paul
State/Province
Minnesota
ZIP/Postal Code
55102
Country
United States
Facility Name
Cardiovascular Associates of the Delaware Valley
City
Sewell
State/Province
New Jersey
ZIP/Postal Code
08080
Country
United States
Facility Name
New York Methodist Hospital
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11215
Country
United States
Facility Name
Rochester General Hospital
City
Rochester
State/Province
New York
ZIP/Postal Code
14621
Country
United States
Facility Name
Staten Island University Hospital
City
Staten Island
State/Province
New York
ZIP/Postal Code
10309
Country
United States
Facility Name
Forsyth Medical Center
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Aultman Hospital
City
Canton
State/Province
Ohio
ZIP/Postal Code
44710
Country
United States
Facility Name
Lindner Center for Research and Education at Christ Hosp
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
University Hospital, Inc.
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Ohio State University Medical Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Northwest Ohio Cardiology Consultants
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43615
Country
United States
Facility Name
Coastal Cardiology
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29407
Country
United States
Facility Name
Spartanburg Regional Medical Center
City
Spartanburg
State/Province
South Carolina
ZIP/Postal Code
29303
Country
United States
Facility Name
South Austin Hospital
City
Austin
State/Province
Texas
ZIP/Postal Code
78745
Country
United States
Facility Name
Heart Hospital of Austin
City
Austin
State/Province
Texas
ZIP/Postal Code
78756
Country
United States
Facility Name
North Texas Heart Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Plaza Medical Center of Fort Worth
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Facility Name
Trinity Mother Frances Health System
City
Tyler
State/Province
Texas
ZIP/Postal Code
75701
Country
United States
Facility Name
University of Utah Hospital and Clinics
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States
Facility Name
Bon Secours Heart & Vascular Institute
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23230
Country
United States
Facility Name
PeaceHealth St. Joseph Medical Center
City
Bellingham
State/Province
Washington
ZIP/Postal Code
98225
Country
United States
Facility Name
Monongalia General Hospital
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26505
Country
United States
Facility Name
Wheeling Hospital Inc.
City
Wheeling
State/Province
West Virginia
ZIP/Postal Code
26003
Country
United States
Facility Name
Wheaton Franciscan Healthcare
City
Glendale
State/Province
Wisconsin
ZIP/Postal Code
53212
Country
United States
Facility Name
St. Mary's Madison
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53715
Country
United States
Facility Name
St. Andrew's War Memorial Hospital
City
Brisbane
State/Province
Queensland
ZIP/Postal Code
4001
Country
Australia
Facility Name
The Prince Charles Hospital
City
Chermside
State/Province
Queensland
ZIP/Postal Code
4032
Country
Australia
Facility Name
Medizinische Univ.-Kliniken Graz
City
Graz
ZIP/Postal Code
8036
Country
Austria
Facility Name
AKH Linz
City
Linz
ZIP/Postal Code
4021
Country
Austria
Facility Name
Klinikum Wels-Grieskirchen GmbH
City
Wels
ZIP/Postal Code
4600
Country
Austria
Facility Name
Universitair Ziekenhuis Gent
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
AZ Groeninge Campus
City
Kortrijk
ZIP/Postal Code
8500
Country
Belgium
Facility Name
Royal Columbian Hospital
City
New Westminster
State/Province
British Columbia
ZIP/Postal Code
V3L 3W7
Country
Canada
Facility Name
Hamilton General Hospital
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8L 2X2
Country
Canada
Facility Name
Hopital Hotel Dieu du Centre Hospitalier de l'Universite de Montreal
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2W IT7
Country
Canada
Facility Name
Skejby Sygehus
City
Aarhus
ZIP/Postal Code
8200
Country
Denmark
Facility Name
Roskilde University Hospital
City
Roskilde
ZIP/Postal Code
4000
Country
Denmark
Facility Name
CHU La Timone Hospital
City
Marseille Cedex 05
ZIP/Postal Code
13005
Country
France
Facility Name
NCN Nouvelles Cliniques Nantaises
City
Nantes Cedex 2
ZIP/Postal Code
44277
Country
France
Facility Name
Kardiologische Gemeinschaftspraxis Kaltofen Schubert Gerner
City
Chemnitz
ZIP/Postal Code
09116
Country
Germany
Facility Name
Uniklinik Köln
City
Cologne
ZIP/Postal Code
50931
Country
Germany
Facility Name
Universitätsklinikum Erlangen
City
Erlangen
ZIP/Postal Code
91054
Country
Germany
Facility Name
Otto-von-Guericke-Universitaet Magdeburg
City
Magdeburg
ZIP/Postal Code
39120
Country
Germany
Facility Name
Prince of Wales Hospital
City
Shatin
ZIP/Postal Code
999077
Country
Hong Kong
Facility Name
Azienda Ospedaliera Universitaria Integrata di Verona
City
Verona
ZIP/Postal Code
37126
Country
Italy
Facility Name
Institut Jantung Negara
City
Kuala Lumpur
ZIP/Postal Code
50400
Country
Malaysia
Facility Name
University of Malaya Medical Centre
City
Kuala Lumpur
ZIP/Postal Code
50603
Country
Malaysia
Facility Name
Centro Hospitalar do Porto - Hospital de Santo Antonio
City
Porto
ZIP/Postal Code
4099 - 001
Country
Portugal
Facility Name
Hospital de Santarem
City
Santarem
ZIP/Postal Code
2005-177
Country
Portugal
Facility Name
Hospital Clinico Y Provincial
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Hospital Universitario Nuestra Senora de Candelaria
City
Santa Cruz de Tenerife
ZIP/Postal Code
38010
Country
Spain
Facility Name
Hospital Doctor Peset
City
Valencia
ZIP/Postal Code
46017
Country
Spain
Facility Name
Clinico de Valladolid
City
Valladolid
ZIP/Postal Code
47012
Country
Spain
Facility Name
Sahlgrenska University Hospital
City
Göteborg
ZIP/Postal Code
41345
Country
Sweden
Facility Name
Karolinska University Hospital
City
Stockholm
Country
Sweden
Facility Name
Chiang Mai Heart Center Medical School Hospital
City
Chiang Mai
ZIP/Postal Code
50200
Country
Thailand
Facility Name
Basildon and Thurrock University Hospitals NHS
City
Basildon
State/Province
Essex
ZIP/Postal Code
SS16 5NL
Country
United Kingdom
Facility Name
Belfast City Hospital
City
Belfast
ZIP/Postal Code
BT9 7
Country
United Kingdom
Facility Name
Wrexham Maelor Hospital
City
Wrexham
ZIP/Postal Code
LL13 7TD
Country
United Kingdom

12. IPD Sharing Statement

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Safety and Performance Study of the INGEVITY Lead

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