Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001159145
Ethics application status
Approved
Date submitted
12/07/2019
Date registered
19/08/2019
Date last updated
9/12/2020
Date data sharing statement initially provided
19/08/2019
Date results information initially provided
9/12/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
Long term cardiac monitoring in mitral valve prolapse
Scientific title
Mitral valve prolapse and ventricular arrhythmias: outcomes of continuous cardiac rhythm monitoring
Secondary ID [1] 298723 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mitral valve prolapse 313643 0
Arrhythmias 313644 0
Condition category
Condition code
Cardiovascular 312066 312066 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients with mitral valve prolapse will be recruited for insertion of a continuous cardiac rhythm monitor (implantable loop recorder - ILR). Outcomes over a 2 year period will be compared to patients with ILR for other reasons.

An ILR is a USB sized device designed to provide continuous heart rhythm monitoring. insertion of an ILR is performed under local anaesthesia. A 2cm incision is made at the 4th intercostal space at the left sternal edge. The device is inserted into the subcutaneous tissue through this incision.

The ILR will be inserted by a cardiologist (Dr. Hui-Chen Han and Dr. Han S. Lim will be responsible for ILR insertion in the study participants). After ILR insertion, patients will be reviewed at 3 monthly intervals over a 2 year period
Intervention code [1] 314985 0
Diagnosis / Prognosis
Comparator / control treatment
The control group will be patients who have an ILR implanted for clinical reasons (e.g. syncope or palpitations).
Historical data is being used as a comparator. This data will be sourced from the Austin Hospital cardiology database (Cardiobase) system. Data from January 1 2010 to December 31 2018 will be used.
Control group
Historical

Outcomes
Primary outcome [1] 320695 0
Ventricular arrhythmias as assessed during interrogation of the ILR.
Interrogation of ILR is performed using a wireless programmer (in a similar fashion to how pacemakers are checked) placed over the skin of the patient.
Timepoint [1] 320695 0
3 monthly intervals up to 2 years post ILR insertion.
Secondary outcome [1] 372545 0
Significant bradyarrhythmias detected on ILR. This information will be obtained at the same time as the primary outcome using through interrogation of the ILR whereby a wireless programmer is placed over the skin of the patient.
Timepoint [1] 372545 0
3 monthly intervals up to 2 years post ILR insertion.
Secondary outcome [2] 373547 0
Significant ventricular pauses detected on ILR. This information will be obtained at the same time as the primary outcome using through interrogation of the ILR whereby a wireless programmer is placed over the skin of the patient.
Timepoint [2] 373547 0
3 monthly intervals up to 2 years post ILR insertion.
Secondary outcome [3] 373549 0
Presence of atrial fibrillation detected on ILR. This information will be obtained at the same time as the primary outcome using through interrogation of the ILR whereby a wireless programmer is placed over the skin of the patient.
Timepoint [3] 373549 0
3 monthly intervals up to 2 years post ILR insertion.
Secondary outcome [4] 373552 0
Potential exploratory outcomes such as requirement of cardiac device insertion (pacemaker or defibrillator) may also be assessed. Assessment for need of cardiac device insertion will be determined based on significant findings noted above (e.g. defibrillator for ventricular arrhythmias, or pacemaker for significant bradycardia or significant ventricular pauses). For the MVP group, this determination will be made during their 3 monthly visits. For the comparator group, this will be through historical data available on Cardiobase (see Step 3).
Timepoint [4] 373552 0
3 monthly intervals up to 2 years post ILR insertion.

Eligibility
Key inclusion criteria
Mitral valve prolapse diagnosed by echocardiography.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Nil

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
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
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Kaplan Meier curve to determine cumulative incidence of ventricular arrhythmias in patients with mitral valve prolapse compared with control group. Log rank test to determine significance.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
15/05/2017
Date of last participant enrolment
Anticipated
30/09/2019
Actual
26/08/2019
Date of last data collection
Anticipated
30/09/2021
Actual
3/07/2020
Sample size
Target
21
Accrual to date
Final
21
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 14216 0
Austin Health - Austin Hospital - Heidelberg
Recruitment postcode(s) [1] 27203 0
3084 - Heidelberg

Funding & Sponsors
Funding source category [1] 303276 0
Charities/Societies/Foundations
Name [1] 303276 0
Austin Medical Research Foundation
Country [1] 303276 0
Australia
Funding source category [2] 303278 0
Commercial sector/Industry
Name [2] 303278 0
Abbott
Country [2] 303278 0
Australia
Primary sponsor type
Individual
Name
Han S. Lim
Address
Department of Cardiology
Level 5N, Austin Hospital
145 Studley Road
Heidelberg, VIC, 3084
Country
Australia
Secondary sponsor category [1] 303294 0
None
Name [1] 303294 0
Address [1] 303294 0
Country [1] 303294 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303814 0
Austin Human Research Ethics Committee
Ethics committee address [1] 303814 0
Office for Research
Level 8, Harold Stokes Building
Austin Hospital
145 Studley Road
Heidelberg, VIC, 3084
Ethics committee country [1] 303814 0
Australia
Date submitted for ethics approval [1] 303814 0
Approval date [1] 303814 0
08/06/2016
Ethics approval number [1] 303814 0

Summary
Brief summary
MVP is a common clinical diagnosis. Whilst the majority of patients with MVP have a benign prognosis, increased rates of arrhythmias and sudden cardiac death have been reported in some patients with MVP. This observational study will attempt to assess whether patients with MVP are at higher risk of ventricular arrhythmias or sudden death compared to a control cohort.
Patients (study group and control group 1) will be recruited after initial echocardiography has identified the presence of mitral valve prolapse and will undergo continuous cardiac rhythm monitoring with an implantable loop recorder. They be followed up for a minimum of 3 months. The patients for control group will be patients who have an ILR inserted for clinical reasons.
The primary outcome will be identification of ILR detected ventricular arrhythmias.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 94902 0
Dr Han S. Lim
Address 94902 0
Department of Cardiology
Level 5N, Austin Hospital
145 Studley Road
Heidelberg, VIC, 3084
Country 94902 0
Australia
Phone 94902 0
+61 411035988
Fax 94902 0
Email 94902 0
[email protected]
Contact person for public queries
Name 94903 0
Dr Hui-Chen Han
Address 94903 0
Department of Cardiology
Level 5N, Austin Hospital
145 Studley Road
Heidelberg, VIC, 3084
Country 94903 0
Australia
Phone 94903 0
+61 401682286
Fax 94903 0
Email 94903 0
[email protected]
Contact person for scientific queries
Name 94904 0
Dr Hui-Chen Han
Address 94904 0
Department of Cardiology
Level 5N, Austin Hospital
145 Studley Road
Heidelberg, VIC, 3084
Country 94904 0
Australia
Phone 94904 0
+61 401682286
Fax 94904 0
Email 94904 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
IPD for published results only.
When will data be available (start and end dates)?
Beginning 6 months and up to 5 years after publication of main results.
Available to whom?
Researchers who provide a methodologically sound proposal.
Available for what types of analyses?
To achieve the aims in the approved proposal.
How or where can data be obtained?
They will made available upon reasonable request to be the Principal Investigator, via email - [email protected]


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.