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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01688843




Registration number
NCT01688843
Ethics application status
Date submitted
17/09/2012
Date registered
20/09/2012
Date last updated
10/03/2020

Titles & IDs
Public title
Safety and Performance Study of the INGEVITY Lead
Scientific title
INGEVITY(TM) Active Fixation and Passive Fixation Pace/ Sense Lead Clinical Study
Secondary ID [1] 0 0
BSC-CDM00048360
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Bradycardia 0 0
Sinus Node Dysfunction 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Other cardiovascular diseases
Cardiovascular 0 0 0 0
Normal development and function of the cardiovascular system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - INGEVITY lead

Experimental: INGEVITY lead - INGEVITY lead implant


Treatment: Devices: INGEVITY lead
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Safety 1 - Percentage of Leads Free From Complication (0 - 3 Months)
Timepoint [1] 0 0
Lead implant through 3 month follow up
Primary outcome [2] 0 0
Safety 2 - Percentage of Leads Free From Complication (3 - 24 Months)
Timepoint [2] 0 0
3 months through 12 months post implant
Primary outcome [3] 0 0
Safety 3 - Hazard Rate of Lead-Related Complications
Timepoint [3] 0 0
Implant through 12 months (including available data beyond 12 months)
Primary outcome [4] 0 0
Effectiveness 1
Timepoint [4] 0 0
Lead implant through 3 month follow up
Primary outcome [5] 0 0
Effectiveness 2(Right Atrium)
Timepoint [5] 0 0
Lead implant through 3 month follow up
Primary outcome [6] 0 0
Effectiveness 2(Right Ventricle)
Timepoint [6] 0 0
Lead implant through 3 month follow up
Primary outcome [7] 0 0
Effectiveness 3
Timepoint [7] 0 0
Lead implant through 3 month follow up

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/10/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/02/2019
Sample size
Target
Accrual to date
Final
1060
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
St. Andrew's War Memorial Hospital - Brisbane
Recruitment hospital [2] 0 0
The Prince Charles Hospital - Chermside
Recruitment postcode(s) [1] 0 0
4001 - Brisbane
Recruitment postcode(s) [2] 0 0
4032 - Chermside
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Connecticut
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Georgia
Country [6] 0 0
United States of America
State/province [6] 0 0
Indiana
Country [7] 0 0
United States of America
State/province [7] 0 0
Iowa
Country [8] 0 0
United States of America
State/province [8] 0 0
Kentucky
Country [9] 0 0
United States of America
State/province [9] 0 0
Louisiana
Country [10] 0 0
United States of America
State/province [10] 0 0
Michigan
Country [11] 0 0
United States of America
State/province [11] 0 0
Minnesota
Country [12] 0 0
United States of America
State/province [12] 0 0
New Jersey
Country [13] 0 0
United States of America
State/province [13] 0 0
New York
Country [14] 0 0
United States of America
State/province [14] 0 0
North Carolina
Country [15] 0 0
United States of America
State/province [15] 0 0
Ohio
Country [16] 0 0
United States of America
State/province [16] 0 0
South Carolina
Country [17] 0 0
United States of America
State/province [17] 0 0
Texas
Country [18] 0 0
United States of America
State/province [18] 0 0
Utah
Country [19] 0 0
United States of America
State/province [19] 0 0
Virginia
Country [20] 0 0
United States of America
State/province [20] 0 0
Washington
Country [21] 0 0
United States of America
State/province [21] 0 0
West Virginia
Country [22] 0 0
United States of America
State/province [22] 0 0
Wisconsin
Country [23] 0 0
Austria
State/province [23] 0 0
Graz
Country [24] 0 0
Austria
State/province [24] 0 0
Linz
Country [25] 0 0
Austria
State/province [25] 0 0
Wels
Country [26] 0 0
Belgium
State/province [26] 0 0
Gent
Country [27] 0 0
Belgium
State/province [27] 0 0
Kortrijk
Country [28] 0 0
Canada
State/province [28] 0 0
British Columbia
Country [29] 0 0
Canada
State/province [29] 0 0
Ontario
Country [30] 0 0
Canada
State/province [30] 0 0
Quebec
Country [31] 0 0
Denmark
State/province [31] 0 0
Aarhus
Country [32] 0 0
Denmark
State/province [32] 0 0
Roskilde
Country [33] 0 0
France
State/province [33] 0 0
Marseille Cedex 05
Country [34] 0 0
France
State/province [34] 0 0
Nantes Cedex 2
Country [35] 0 0
Germany
State/province [35] 0 0
Chemnitz
Country [36] 0 0
Germany
State/province [36] 0 0
Cologne
Country [37] 0 0
Germany
State/province [37] 0 0
Erlangen
Country [38] 0 0
Germany
State/province [38] 0 0
Magdeburg
Country [39] 0 0
Hong Kong
State/province [39] 0 0
Shatin
Country [40] 0 0
Italy
State/province [40] 0 0
Verona
Country [41] 0 0
Malaysia
State/province [41] 0 0
Kuala Lumpur
Country [42] 0 0
Portugal
State/province [42] 0 0
Porto
Country [43] 0 0
Portugal
State/province [43] 0 0
Santarem
Country [44] 0 0
Spain
State/province [44] 0 0
Barcelona
Country [45] 0 0
Spain
State/province [45] 0 0
Santa Cruz de Tenerife
Country [46] 0 0
Spain
State/province [46] 0 0
Valencia
Country [47] 0 0
Spain
State/province [47] 0 0
Valladolid
Country [48] 0 0
Sweden
State/province [48] 0 0
Göteborg
Country [49] 0 0
Sweden
State/province [49] 0 0
Stockholm
Country [50] 0 0
Thailand
State/province [50] 0 0
Chiang Mai
Country [51] 0 0
United Kingdom
State/province [51] 0 0
Essex
Country [52] 0 0
United Kingdom
State/province [52] 0 0
Belfast
Country [53] 0 0
United Kingdom
State/province [53] 0 0
Wrexham

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Boston Scientific Corporation
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The objective of this study is to gather data to establish the safety, performance and
effectiveness of the INGEVITY pace/ sense leads.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01688843
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Charles Love, MD
Address 0 0
Johns Hopkins University
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries