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Trial registered on ANZCTR


Registration number
ACTRN12610000077066
Ethics application status
Approved
Date submitted
20/01/2010
Date registered
21/01/2010
Date last updated
16/12/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
Does Suppression of Atrial Fibrillation (AF) Promote Reverse Electrical Remodeling of the Atria?
Scientific title
Prospective, Randomized, Follow up Study of the St. Jude Medical identity AFx DR to determine whether or not the reduction of Atrial Fibrillation (AF) by the AF suppression algorithm halts or reverses electrical remodeling that has already begun in AF patients
Secondary ID [1] 1311 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
SAFER PACE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Atrial Fibrillation 256605 0
Condition category
Condition code
Cardiovascular 256771 256771 0 0
Coronary heart disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study aims at determining whether or not the reduction of Atrial Fibrillation (AF) by the AF suppression algorithm halts or reverses electrical remodeling that has already begun in AF patients. The algorithm provides stimulation that controls the atrial rate and rhythm minimising ectopic beats, long-short cycles and dispersion of refractoriness. It does this by monitoring the intrinsic atrial rhythm and then adapting the pacing rate slightly above the intrinsic rhythm to help ensure a high percentage of atrial pacing that is dynamically tailored to the patients rate variations. From the point of implant the device is constantly monitoring and correcting the pacing of the heart. The duration of the study is 6 months, the device will remain implanted and continue to treat the patient: Changing of the status of the AF supression algorithm being 'ON' or 'OFF' is at the discretion of the physician.
Intervention code [1] 255863 0
Treatment: Devices
Comparator / control treatment
The control group will have their device's Atrial Fibrillation Suppression Algorithm switched 'OFF' for the entire follow up period. This will be a constant feature from the point of implant. The duration of the study is 6 months, the device will remain implated at the end of the study: Changing of the status of the AF suppression algorithm being 'ON' or 'OFF' is at the discretion of the physician.
Control group
Active

Outcomes
Primary outcome [1] 257648 0
The Atrial Effectice Refractory Period (AERP) assessed using Non-invasive programmed stimulation (NIPS) via device interrogation
Timepoint [1] 257648 0
measured at implant, 3 and 6 month follow up visits
Secondary outcome [1] 262923 0
Atrial Fibrillation (AF) Burdon: Total duration of AF episodes/follow up. This will be assessed through Device Interrogation
Timepoint [1] 262923 0
All Follow up visits (3 and 6 month post implant)
Secondary outcome [2] 262924 0
AF Frequency: Number of AF episodes/time in sinus Rhythm. This will also be assessed through device interrogation
Timepoint [2] 262924 0
All Follow up Visits (3 and 6 months post implant)
Secondary outcome [3] 262925 0
Number of Auto Mode Switch (AMS) Occurances assessed through device interrogation
Timepoint [3] 262925 0
All Follow up visits (3 and 6 months post implant)
Secondary outcome [4] 262926 0
AMS duration assessed through device interrogation
Timepoint [4] 262926 0
All Follow up visits (3 and 6 months post implant)

Eligibility
Key inclusion criteria
- Patient must have standard indications for a DDD (Dual Chamber) pacemaker
- Patient must have documented paroxysmal or persistent Atrial Fibrillation (AF).
- Patient must be maintained on a stable antiarrhythmic drug regimen
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Patient has chronic Atrial Fibrillation
- Patient has Class 3 or 4 angina
- Patient has an existing Implantable Cardioverter Defibrillator (ICD) or is being considered for an ICD implant.
- Patients life expectancy is less than 6 months due to other medical conditions
- Patient has a serious comorbid condition (i.e. metastaic disease, chronic renal failure etc)

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
At implant each patient will be randomised to AF Suppression 'ON' or 'OFF', allocation concealment will be the method by which patients will be designated to their treatment group. Allocation will be through an off site contact with the randomisation procedures/schedule.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation allocation is according to age: greater or less than 75 then by simple randomisation using alternate alotment
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/07/2005
Actual
29/06/2005
Date of last participant enrolment
Anticipated
12/10/2009
Actual
12/10/2009
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
61
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 2471 0
6001
Recruitment postcode(s) [2] 2472 0
3084
Recruitment outside Australia
Country [1] 2429 0
New Zealand
State/province [1] 2429 0
Christchurch

Funding & Sponsors
Funding source category [1] 256352 0
Commercial sector/Industry
Name [1] 256352 0
St. Jude Medical
Country [1] 256352 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
St. Jude Medical
Address
St. Jude Medical Australia
17 Orion Rd
Lane Cove NSW 2066
Country
Australia
Secondary sponsor category [1] 251668 0
None
Name [1] 251668 0
Address [1] 251668 0
Country [1] 251668 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258423 0
Upper South B. Regional Ethics Committee
Ethics committee address [1] 258423 0
Ethics committee country [1] 258423 0
New Zealand
Date submitted for ethics approval [1] 258423 0
Approval date [1] 258423 0
02/05/2005
Ethics approval number [1] 258423 0
URB/05/02/013
Ethics committee name [2] 258424 0
Royal Perth Hospital Human Research Ethics Committee
Ethics committee address [2] 258424 0
Ethics committee country [2] 258424 0
Australia
Date submitted for ethics approval [2] 258424 0
Approval date [2] 258424 0
09/08/2005
Ethics approval number [2] 258424 0
20005/072
Ethics committee name [3] 258425 0
Austin Health Human Research Ethics Committee
Ethics committee address [3] 258425 0
Ethics committee country [3] 258425 0
Australia
Date submitted for ethics approval [3] 258425 0
Approval date [3] 258425 0
20/06/2005
Ethics approval number [3] 258425 0
H2005/02181

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

Contacts
Principal investigator
Name 30731 0
Dr Dr Ian Crozier
Address 30731 0
Christchurch Hosptial
Riccarton Avenue
Christchurch 8140
NEW ZEALAND
Country 30731 0
New Zealand
Phone 30731 0
+64 3 3640 640
Fax 30731 0
Email 30731 0
[email protected]
Contact person for public queries
Name 13978 0
Jessica Andrews
Address 13978 0
St. Jude Medical Australia
17 Orion Rd
Lane Cove NSW 2066
Country 13978 0
Australia
Phone 13978 0
+612 9936 1236
Fax 13978 0
+612 9936 1222
Email 13978 0
[email protected]
Contact person for scientific queries
Name 4906 0
Jessica Andrews
Address 4906 0
St. Jude Medical Australia
17 Orion Rd
Lane Cove NSW 2066
Country 4906 0
Australia
Phone 4906 0
+612 9936 1236
Fax 4906 0
+612 9936 1222
Email 4906 0
[email protected]

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
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Documents added automatically
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