Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000041055
Ethics application status
Approved
Date submitted
13/01/2010
Date registered
14/01/2010
Date last updated
16/12/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
Continuous ST Segment Monitoring and Incidence of Clinical Events in Implantable Cardioverter Defibrillator (ICD) Patients
Scientific title
A prospective, multicenter, anonymous registry to collect data in the population of patients implanted with a St Jude Medical (SJM) AnalyST/AnalyST Accel VR/DR device intended to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias.
Secondary ID [1] 1281 0
Nil
Universal Trial Number (UTN)
Trial acronym
AnalyST
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ventricular arrhythmias 256515 0
Paroxysmal Atrial Fibrillation 256516 0
Persistent Atrial Fibrillation 256517 0
Sinus Node Dysfunction 256518 0
Condition category
Condition code
Cardiovascular 256688 256688 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
The study is aimed at 1/ identifying the patient population selected by physicians to be implanted with a SJM ICD featuring the ST segment monitoring feature. 2/ Documenting the incidence of ST segment shifts and possible relationships with clinical events and 3/ the change in patient management related to the device diagnositic availabiltiy.
Patients will be observed for a period of 12 months with a maximum of Four Follow up visits
Intervention code [1] 255795 0
Not applicable
Comparator / control treatment
Nil
Control group
Uncontrolled

Outcomes
Primary outcome [1] 257576 0
To Identify the population of patients being selected by physicians to be implanted with a SJM ICD featuring ST segment monitoring. This will be assessed through the collection of patients medical history and demographics via the Case Report Forms (CRF's).
Timepoint [1] 257576 0
Implant date
Primary outcome [2] 257577 0
Document the Incidence of ST segment shifts, symptomatic or not, in the population and their possible relationships with clinical events. This will be achieved through Device interrogation and CRF reporting
Timepoint [2] 257577 0
12 months post implant, data will be collected at routine visits (max four follow up visits)
Secondary outcome [1] 262822 0
To document the change in patient management related to the availability of device diagnositcs. Physicians will record changes made to medication, device programming or tests/exams ordered on the CRFs.
Timepoint [1] 262822 0
12months post implant, data collected during routine visits (maximum of four follow up visits)

Eligibility
Key inclusion criteria
Any patient candidate implanted with a St Jude Medical AnalyST or AnalyST Accel DR/VR device, as per current guidelines can be enrolled in the study.
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patient not willing or able to understand and sign the 'data transfer authorization'

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
31/10/2009
Actual
3/11/2008
Date of last participant enrolment
Anticipated
Actual
31/05/2011
Date of last data collection
Anticipated
Actual
Sample size
Target
1000
Accrual to date
Final
1123
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 2384 0
2050
Recruitment postcode(s) [2] 2385 0
2076
Recruitment postcode(s) [3] 2386 0
4000
Recruitment outside Australia
Country [1] 7442 0
Austria
State/province [1] 7442 0
Country [2] 7443 0
Belgium
State/province [2] 7443 0
Country [3] 7444 0
Denmark
State/province [3] 7444 0
Country [4] 7445 0
Estonia
State/province [4] 7445 0
Country [5] 7446 0
Finland
State/province [5] 7446 0
Country [6] 7447 0
France
State/province [6] 7447 0
Country [7] 7448 0
Germany
State/province [7] 7448 0
Country [8] 7449 0
Greece
State/province [8] 7449 0
Country [9] 7450 0
Hong Kong
State/province [9] 7450 0
Country [10] 7451 0
India
State/province [10] 7451 0
Country [11] 7452 0
Ireland
State/province [11] 7452 0
Country [12] 7453 0
Israel
State/province [12] 7453 0
Country [13] 7454 0
Italy
State/province [13] 7454 0
Country [14] 7455 0
Luxembourg
State/province [14] 7455 0
Country [15] 7456 0
Netherlands
State/province [15] 7456 0
Country [16] 7457 0
Norway
State/province [16] 7457 0
Country [17] 7458 0
Saudi Arabia
State/province [17] 7458 0
Country [18] 7459 0
Spain
State/province [18] 7459 0
Country [19] 7460 0
Sweden
State/province [19] 7460 0
Country [20] 7461 0
Switzerland
State/province [20] 7461 0
Country [21] 7462 0
United Kingdom
State/province [21] 7462 0

Funding & Sponsors
Funding source category [1] 256283 0
Commercial sector/Industry
Name [1] 256283 0
St. Jude Medical
Country [1] 256283 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
St. Jude Medical
Address
St. Jude Medical World Headquarters
One Lillehei Plaza
St. Paul MN 55117
Country
United States of America
Secondary sponsor category [1] 251608 0
None
Name [1] 251608 0
Address [1] 251608 0
Country [1] 251608 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258376 0
Royal Prince Alfred Hospital Human Research Ethics Committee (HREC)
Ethics committee address [1] 258376 0
Ethics committee country [1] 258376 0
Australia
Date submitted for ethics approval [1] 258376 0
05/08/2009
Approval date [1] 258376 0
20/10/2009
Ethics approval number [1] 258376 0
X09-0211
Ethics committee name [2] 258377 0
Sydney Adventist Hospital HREC
Ethics committee address [2] 258377 0
Ethics committee country [2] 258377 0
Australia
Date submitted for ethics approval [2] 258377 0
20/07/2009
Approval date [2] 258377 0
05/08/2009
Ethics approval number [2] 258377 0
9/09/2010

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30688 0
Dr Dr Michael Kilborn
Address 30688 0
Royal Prince Alfred Hospital
Missenden Rd
Camperdown NSW 2050
AUSTRALIA
Country 30688 0
Australia
Phone 30688 0
+61 2 9515 7885
Fax 30688 0
Email 30688 0
mkilborn@med.usyd.edu.au
Contact person for public queries
Name 13935 0
Kurt Dubin
Address 13935 0
St Jude Medical BCC
Corporate Village
Leonardo Da Vincilaan, 11 Box F1
Zaventem BRUSSELS 1935
Country 13935 0
Belgium
Phone 13935 0
+322 774 6887
Fax 13935 0
Email 13935 0
kdubin@sjm.com
Contact person for scientific queries
Name 4863 0
Kurt Dubin
Address 4863 0
St. Jude Medical BCC
Corporate Village
Leonardo Da Vincilaan, 11 Box F1
Zaventem BRUSSELS 1935
Country 4863 0
Belgium
Phone 4863 0
+322 774 6887
Fax 4863 0
Email 4863 0
kdubin@sjm.com

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.