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Trial registered on ANZCTR


Registration number
ACTRN12619000799156p
Ethics application status
Submitted, not yet approved
Date submitted
13/05/2019
Date registered
30/05/2019
Date last updated
30/05/2019
Date data sharing statement initially provided
30/05/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
The Role of an Implantable Loop Recorder in a Tertiary Level Atrial Fibrillation Clinic with Nurse Led Management.
Scientific title
The Role of an Implantable Loop Recorder for symptom control in patients with Paroxysmal Atrial Fibrillation: A Tertiary Level Atrial Fibrillation Clinic with Nurse Led Management.
Secondary ID [1] 298221 0
None
Universal Trial Number (UTN)
None yet
Trial acronym
None
Linked study record
None

Health condition
Health condition(s) or problem(s) studied:
Atrial Fibrillation 312820 0
Arrythmia 312845 0
Condition category
Condition code
Cardiovascular 311320 311320 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Implantable Loop Recorders utilised in the interventional group to help with the management of a patient's Paroxysmal Atrial Fibrillation.
The insertion of the Implantable Loop Recorder is inserted with the incision tool and insertion kit provided by Medtronic under aseptic technique. The Loop Recorder is inserted in one of 2 thoracic anatomic locations. These are over the fourth intercostal space on the left hemi thorax: 45° (“best”) or parallel (“good”) relative to the sternal border. During implantation, data on R waves will be collected from the value reported on-screen by the programmer. It will be inserted by an Electrophysiologist Cardiologist and takes around 30 minutes to insert. Post implantation, the patient will receive the home monitoring device with instructions about its use for nightly automated transmissions which will give the Atrial Fibrillation Nurse alerts to any arrhythmias/atrial fibrillation episodes.
The Implantable Loop Recorder will be removed at the end of its battery life which is around three years. The overall duration of the intervention will be 36 months (3 years) until the end of the Implantable Loop Recorder's battery life.
Intervention code [1] 314457 0
Treatment: Devices
Comparator / control treatment
Standard of care through an Atrial Fibrillation Clinic in a Tertiary Hospital. Standard of care involves routine cardiologist clinic appointments at 1, 3, 6 and 12 months and at patient phone contact through the Atrial Fibrillation nurse (symptoms at home or hospital presentation).
Control group
Active

Outcomes
Primary outcome [1] 320048 0
1. Burden of AF symptoms decreased by an early change in medical therapy or the application of an intervention (DCR) within 24 to 48 hours of beginning of AF episode. This primary composite outcome will be assessed by evidence of sinus rhythm on the Implantable loop recorder and the use of the European Atrial Fibrillation Symptom score questionnaire.
Timepoint [1] 320048 0
Within 48 hours from the beginning of every Atrial Fibrillation episode.
Primary outcome [2] 320077 0
2. A proportion of patients may have a change in their quality of life due to the possibility of treating AF symptoms earlier with effective rhythm and rate control strategies. This will ne assessed by Atrial Fibrillation Effect on Quality of Life (AFEQT) questionnaire.
Timepoint [2] 320077 0
The time point for this outcome will be 12 months from enrolment in the study.
Primary outcome [3] 320078 0
3. Numbers in cardiovascular hospital presentations through early identification of an AF episode and the option of an outpatient service to treat the patient. This is measured by collecting data on the number of hospital presentations and how many times a patient uses our AF clinic.
Timepoint [3] 320078 0
The time point for this outcome will be 12 months from enrolment in the study.
Secondary outcome [1] 370366 0
1. To assess the patient's experience with this model of care - looking at positive and negative aspects. This will be measured by a small 5 question survey about the study that is not yet validated, it was specifically designed for this study.
Timepoint [1] 370366 0
At 12 months post enrolment.

Eligibility
Key inclusion criteria
- Over the age of 18 years and under the age of 75 years.
- Documented evidence of Paroxysmal Atrial Fibrillation through any type of ECG or Holter monitoring.
- A high burden of Atrial Fibrillation symptoms reported by the patient (at least monthly).
- A normal heart structure and normal left ventricular function. Normal LVEF. Normal valves.
- Subject able and willing to give informed consent and return for all required study follow-up visits
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Under the age of 18 years and over the age of 75 years.
- Documented Persistent AF.
- Documented Atrial Flutter.
- Documented reversible cause for AF e.g. thyroid disease.
- Previous cardiac surgery.
- Structural heart disease.
- Previous left atrial ablation.
- Subject has an active systemic infection.
- A history of unstable angina, previous myocardial infarction or percutaneous intervention.
- A history of chronic obstructive pulmonary disease or evidence of other significant lung disease.
- Contraindication for oral anticoagulation.
- Previous TIA or stroke.
- Significant congenital heart defect.
- Evidence of congestive cardiac failure or left ventricular dysfunction.
- Hypertrophic cardiomyopathy.
- Abnormal long or short QT interval, signs of Brugada syndrome or Arrhythmogenic right ventricular dysplasia.
- History of sarcoidosis.
- History of myxoma.
- Pregnancy or breastfeeding.
- Life expectancy less than 2 years.
- Subject is employed by Medtronic or a close relative of investigators.

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)
Patients will randomised by using sealed opaque envelopes. There will be 15 envelopes with intervention and 15 envelopes with standard care shuffled and then labelled patient 1, patient 2, patient 3 etc. This will be witnessed by a member of the MonashHeart Research team.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using procedures like coin-tossing and dice-rolling - however this will be with shuffled opaque envelopes.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Nil
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Being a small pilot trial, it was elected by the funding company Medtronic and the PI that 30 patients (15 in each arm) would be sufficient to achieve outcomes at this time due to resources and being anew model of care with the view to increase numbers or complete a larger study in the future depending on the results.
At the end of 12 months post enrolment - the results on the outcome will be analysed using time statistics on how quickly a patient's AF episodes were managed, the amount of ED and outpatient clinic presentations and AF symptom and quality of life scores will be calculated.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/07/2019
Actual
Date of last participant enrolment
Anticipated
30/06/2020
Actual
Date of last data collection
Anticipated
30/06/2021
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 13733 0
Monash Medical Centre - Clayton campus - Clayton
Recruitment postcode(s) [1] 26480 0
3168 - Clayton

Funding & Sponsors
Funding source category [1] 302760 0
Commercial sector/Industry
Name [1] 302760 0
Medtronic Australasia
Country [1] 302760 0
Australia
Primary sponsor type
Individual
Name
Melissa Harvey
Address
MonashHeart, Monash Health
246 Clayton Road
Clayton
VICTORIA 3168
Country
Australia
Secondary sponsor category [1] 302700 0
None
Name [1] 302700 0
Address [1] 302700 0
Country [1] 302700 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 303360 0
Monash Health Human Reasearch Ethics Committee
Ethics committee address [1] 303360 0
Ethics committee country [1] 303360 0
Australia
Date submitted for ethics approval [1] 303360 0
06/05/2019
Approval date [1] 303360 0
Ethics approval number [1] 303360 0

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

Contacts
Principal investigator
Name 93398 0
Mrs Melissa Harvey
Address 93398 0
Monash Health
246 Clayton Road
Clayton VIC 3168
Country 93398 0
Australia
Phone 93398 0
+61 434753776
Fax 93398 0
Email 93398 0
melissa.harvey@monashhealth.org
Contact person for public queries
Name 93399 0
Melissa Harvey
Address 93399 0
Monash Health
246 Clayton Road
Clayton VIC 3168
Country 93399 0
Australia
Phone 93399 0
+61 434753776
Fax 93399 0
Email 93399 0
melissa.harvey@monashhealth.org
Contact person for scientific queries
Name 93400 0
Melissa Harvey
Address 93400 0
Monash Health
246 Clayton Road
Clayton VIC 3168
Country 93400 0
Australia
Phone 93400 0
+61 434753776
Fax 93400 0
Email 93400 0
melissa.harvey@monashhealth.org

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All de-identifiable data
When will data be available (start and end dates)?
Start date 1st June 2021 and will be available for 7 years post enrolment (until 30th May, 2028) as per data collection storage guidelines.
Available to whom?
Participants will be able to look at their own individual data only (not that of other participants) however, all de-identifiable data will be available to all member of the public.
Available for what types of analyses?
To achieve the aims of the research proposal.
How or where can data be obtained?
Access subject to approvals by Principal Investigator


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.