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Trial registered on ANZCTR


Registration number
ACTRN12616001353482
Ethics application status
Approved
Date submitted
26/09/2016
Date registered
29/09/2016
Date last updated
3/12/2018
Date data sharing statement initially provided
3/12/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Clinical Effectiveness of Atrial Anti-tachycardia Pacing Therapy in Sick Sinus Syndrome with Previous Atrial Fibrillation Ablation (CEASE-AF)
Scientific title
Clinical Effectiveness of Atrial Anti-tachycardia Pacing Therapy in Sick Sinus Syndrome with Previous Atrial Fibrillation Ablation
Secondary ID [1] 290128 0
Nil
Universal Trial Number (UTN)
Trial acronym
CEASE-AF
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sick sinus syndrome 300232 0
Atrial Fibrillation 300233 0
Condition category
Condition code
Cardiovascular 300108 300108 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Dual chamber pacemaker device - MVP+APP+aATP algorithm group
Intervention period: 12 months

1. Managed ventricular pacing
MVP is an atrial-based pacing mode that is designed to switch to a dual-chamber pacing mode in the presence of AV block. Specifically, MVP provides the following functions:
*AAI(R) mode pacing when AV conduction is intact
*The ability to switch to DDD(R) pacing during AV block
*Periodic conduction checks while operating in DDD(R) mode, with the ability to switch back to AAI(R) mode when AV conduction resumes
*Back-up ventricular support for transient loss of AV conduction

2. Atrial Preference Pacing (APP)
The device includes three atrial preventive pacing algorithms designed to eliminate some of the onset mechanisms of atrial tachyarrhythmias and to reduce the incidence of atrial tachyarrhythmias. These atrial pacing features comprise the atrial pacing preference algorithm, for maintenance of a pacing rate just above the intrinsic rate, the atrial rate stabilization algorithm, designed to avoid short-long intervals following a premature atrial contraction, and the post-mode switching overdrive pacing algorithm designed to inhibit early re-initiation of atrial tachyarrhythmia following a mode switching episode.

3. Reactive atrial Anti-tachycardia pacing
If the device detects an atrial tachyarrhythmia episode, aATP therapy will be delivered. Treatments for such episodes are intended to interrupt the atrial tachycardia and restore patient’s normal sinus rhythm.
The device can deliver up to 3 aATP therapies to treat an AT/AF or a Fast AT/AF episode. aATP therapies become available when the duration of sustained atrial tachyarrhythmias exceeds the programmed value of episode duration before aATP delivery - which in this study will be set at 0 minute.
When an AT/AF or Fast AT/AF episode is detected, the device delivers the first sequence of the ATP therapy. After the first ATP sequence, it continues to monitor for the presence of the atrial tachycardia episode. If it redetects the atrial tachycardia episode, the device and repeats this cycle until the episode is terminated or all sequences in the therapy are exhausted.
Intervention code [1] 295877 0
Treatment: Other
Intervention code [2] 296000 0
Treatment: Devices
Comparator / control treatment
MVP algorithm only group
Control group
Active

Outcomes
Primary outcome [1] 299584 0
AT/AF burden
will be assessed by interrogating pacemaker device with device programmer.
AT/AF burden will be measured as percentage and minutes per day
Timepoint [1] 299584 0
3 months, 6 months, 9 months, and 12 months post commencement of intervention
Secondary outcome [1] 327612 0
ATP efficacy
will be assessed by interrogating pacemaker device with device programmer.
ATP efficacy will be measured as percentage.
Timepoint [1] 327612 0
6 months and 12 months post commencement of intervention
Secondary outcome [2] 327613 0
Number of subject who develop AF (Paroxysmal, persistent, and permanent)
AF will be evaluated from pacemaker storage that is manually adjudicated by an electrophysiology consultant.
Timepoint [2] 327613 0
12 months post commencement of intervention
Secondary outcome [3] 327614 0
Quality of life
Will be evaluated by AFSS questionnaire
Timepoint [3] 327614 0
6 months and 12 months post commencement of intervention
Secondary outcome [4] 327615 0
Fibrotic changes that will be assessed from blood sample.
Serum biomarkers that will be used are TGF-alpha, TIMP, and MMP9
Timepoint [4] 327615 0
6 months and 12 months post commencement of intervention
Secondary outcome [5] 327616 0
Electrical changes (SNRT, cSNRT, Wenkebach block point)
Will be assessed by interrogating pacemaker with device programmer
Timepoint [5] 327616 0
6 months, 12 months post commencement of intervention
Secondary outcome [6] 327617 0
Structural changes measured by echocardiogram
Parameter that will be assessed: LV ejection fraction, cardiac chamber dimension, and diastolic function
Timepoint [6] 327617 0
6 months and 12 months post commencement of intervention
Secondary outcome [7] 328000 0
Inflamatory changesthat will be assessed from blood sample.
Serum biomarkers that will be used is hs-CRP
Timepoint [7] 328000 0
6 and 12 months post commencement of intervention

Eligibility
Key inclusion criteria
a. The patient has a dual chamber pacemaker capable of atrial anti-tachycardia based therapy,
b. Had AF ablation at least 3 months prior to recruitment,
c. AF/atrial arrhythmia burden >0.1% and <30%,
d. greater than or equal to 18 years of age
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
a. Atrioventricular block with ventricular pacing >40 percent,
b. Atrial fibrillation episode >90 days. However, presence of prolonged episodes of atrial flutter will not be an exclusion corner,
c. Absence of indication for cardiac resynchronization or defibrillator,
d. Had < 12 months of life expectancy,
e. Cardiac surgery in the last six months, or expected during 12 months of study period,
f. A recent history of (< 1 year) or current malignancy, advanced heart failure (NYHA class IV), end-stage chronic obstructive pulmonary disease or other severe life-threatening comorbidities within 3 months of diagnosis, or
g. Unable to provide consent.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computerised sequence generation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The sample size was calculated based on the study that showed a recurrence rate of 48.6% after AF ablation in patients with paroxysmal AF and prolonged sinus pauses and a 49% relative reduction in the DDDR with all algorithm ON (MVP+APP+aATP) versus DDDR+MVP group, with a power of 80%, a confidence interval of 95%, and an assumed rate of loss to follow-up of 10%. Based on the calculation, it is planned to recruit 68 patients in each arm.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/10/2016
Actual
29/03/2017
Date of last participant enrolment
Anticipated
31/12/2019
Actual
Date of last data collection
Anticipated
31/12/2020
Actual
Sample size
Target
136
Accrual to date
55
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 6647 0
The Royal Adelaide Hospital - Adelaide
Recruitment postcode(s) [1] 14271 0
5000 - Adelaide

Funding & Sponsors
Funding source category [1] 294500 0
University
Name [1] 294500 0
Centre for Heart Rhythm Disorders, University of Adelaide, Royal Adelaide Hospital
Country [1] 294500 0
Australia
Primary sponsor type
University
Name
Centre for Heart Rhythm Disorders, University of Adelaide, Royal Adelaide Hospital
Address
Level 5
McEwin Building
Royal Adelaide Hospital
THE UNIVERSITY OF ADELAIDE
SA 5000
AUSTRALIA
Country
Australia
Secondary sponsor category [1] 293364 0
None
Name [1] 293364 0
None
Address [1] 293364 0
None
Country [1] 293364 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295934 0
CALHN HUMAN RESEARCH ETHICS RAH
Ethics committee address [1] 295934 0
Ethics committee country [1] 295934 0
Australia
Date submitted for ethics approval [1] 295934 0
18/07/2016
Approval date [1] 295934 0
23/09/2016
Ethics approval number [1] 295934 0
HREC/16/RAH/286

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 1108 1108 0 0
/AnzctrAttachments/371474-CEASE-AF Protocol - update26Augl2016.docx
Attachments [2] 1109 1109 0 0
/AnzctrAttachments/371474-participant information and inform consent-update_26Aug2016.docx

Contacts
Principal investigator
Name 68954 0
Prof Prashanthan Sanders
Address 68954 0
CVIU, Level 6, Theatre Block
Royal Adelaide Hospital
North terrace, Adelaide, South Australia, 5000
Country 68954 0
Australia
Phone 68954 0
+61882222723
Fax 68954 0
Email 68954 0
prash.sanders@adelaide.edu.au
Contact person for public queries
Name 68955 0
Dian Munawar
Address 68955 0
CVIU, Level 6, Theatre Block
Royal Adelaide Hospital
North terrace, Adelaide, South Australia, 5000
Country 68955 0
Australia
Phone 68955 0
+61406400335
Fax 68955 0
Email 68955 0
dian.munawar@adelaide.edu.au
Contact person for scientific queries
Name 68956 0
Dian Munawar
Address 68956 0
CVIU, Level 6, Theatre Block
Royal Adelaide Hospital
North terrace, Adelaide, South Australia, 5000
Country 68956 0
Australia
Phone 68956 0
+61406400335
Fax 68956 0
Email 68956 0
dian.munawar@adelaide.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Data will be unidentified


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.