Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000166279
Ethics application status
Approved
Date submitted
22/01/2018
Date registered
2/02/2018
Date last updated
2/02/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Electroanatomical Remodeling of the Atria in Obesity:
Impact of the Adjacent Epicardial Fat
Scientific title
Electroanatomical Remodeling of the Atria in Obesity patients undergoing AF ablation:
Impact of the Adjacent Epicardial Fat
Secondary ID [1] 293839 0
N/A
Universal Trial Number (UTN)
N/A
Trial acronym
N/A
Linked study record
N/A

Health condition
Health condition(s) or problem(s) studied:
Obesity 306285 0
Atrial fibrillation 306286 0
Epicardial fat 306287 0
Condition category
Condition code
Cardiovascular 305372 305372 0 0
Other cardiovascular diseases
Diet and Nutrition 305374 305374 0 0
Obesity

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This is an observational study where data is collected from investigations and electrophysiology study prior to ablation for atrial fibrillation. There is no follow up for the patients. The data collected will with 1) electrical atrial remodelling: a) voltage, b) fractionation, c) conduction velocity. The cardiac MRI will be analysed for 1) cardiac structure and function and 2) epicardial fat.
Intervention code [1] 300099 0
Not applicable
Comparator / control treatment
The patients were allocated into the following two groups on the basis on body mass index (BMI): (1) Obese group with a BMI greater than and equal to 27 kg/m2; and (2) Reference group with a BMI<27 kg/m2
Control group
Active

Outcomes
Primary outcome [1] 304519 0
Characterise electrophysiological and electroanatomical remodeling of the atria due to obesity in humans assessed by bipolar voltage, fractionation and conduction velocity.
Timepoint [1] 304519 0
single assessment prior to ablation
Primary outcome [2] 304568 0
Epicardial fat assessment- total, total atrial, left atrial as assessed by cardiac MRI
Timepoint [2] 304568 0
single assessment prior to electrophysiology study and ablation
Primary outcome [3] 304569 0
Correlation between epicardial fat (MRI) and electrical properties (voltage, fractionation, conduction velocity assessed on electrophysiology study)
Timepoint [3] 304569 0
based on measure obtained in single timepoint
Secondary outcome [1] 342220 0
N/A
Timepoint [1] 342220 0
N/A

Eligibility
Key inclusion criteria
The inclusion criterion was (1) Symptomatic AF refractory to at least one anti-arrhythmic medication.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
The exclusion criteria were (1) long standing persistent AF; (2) previous left atrial ablation; (3) contraindication for cardiac magnetic resonance imaging (CMR); (4) restrictive or hypertrophic cardiomyopathy; (5) valvular heart disease; (6) left ventricular dysfunction with LVEF<45%; (7) uncontrolled hypertension with left ventricular hypertrophy (LV wall thickness 12mm or more); (8) uncontrolled diabetes mellitus with HBA1C >7%; (9) amiodarone use in previous 6 months; (10) left atrial thrombus; (11) atrial arrhythmia > 30 seconds in the 7 days prior to the procedure by continuous ambulatory monitoring; (11) pregnancy and (12) inability to provide informed consent.

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Case control
Timing
Retrospective
Statistical methods / analysis
Normally distributed data will be expressed as mean ± standard deviation. A mixed effects model will be used for all analyses that contained multiple regional measures within each patient (e.g. CV, Voltage). Generalized estimating equations will be utilised for nested categorical variables (e.g. % fractionation, % low voltage). To investigate left atrial regional patterns in both approaches, region (posterior LA, anterior LA, septal LA, inferior LA, lateral LA, and LA roof) and group (obese and control) will be modeled as fixed effects with an interaction term (region*group). If a significant interaction is seen present, mixed effects post-hoc test p-values will be reported.
For data without multiple measures or levels of data within an individual (e.g. fat mass, LA size, LVEF) a conventional unpaired t test will be used. Linear regressions between predictor variables of 1) total pericardial fat, 2) atrial epicardial fat 3) left atrial epicardial fat and 4) BMI will be correlated with mean posterior LA conduction velocity, mean posterior LA voltage and percent fractionation of posterior LA. Statistical significance will be set as p<0.05 and a trend at p<0.10.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/12/2011
Date of last participant enrolment
Anticipated
Actual
1/12/2012
Date of last data collection
Anticipated
Actual
1/06/2013
Sample size
Target
33
Accrual to date
Final
33
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 9839 0
The Royal Adelaide Hospital - Adelaide
Recruitment postcode(s) [1] 18618 0
5000 - Adelaide

Funding & Sponsors
Funding source category [1] 298458 0
University
Name [1] 298458 0
The University of Adelaide
Country [1] 298458 0
Australia
Primary sponsor type
University
Name
The University of Adelaide
Address
Cardiology - 4G751
Royal Adelaide Hospital
Port Road,
Adelaide, SA 5000,
Australia
Country
Australia
Secondary sponsor category [1] 297599 0
None
Name [1] 297599 0
N/A
Address [1] 297599 0
N/A
Country [1] 297599 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299449 0
Royal Adelaide Hospital Ethic Committee
Ethics committee address [1] 299449 0
Ethics committee country [1] 299449 0
Australia
Date submitted for ethics approval [1] 299449 0
11/11/2011
Approval date [1] 299449 0
22/11/2011
Ethics approval number [1] 299449 0
111116

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

Contacts
Principal investigator
Name 80438 0
Dr Rajiv Mahajan
Address 80438 0
Centre of Heart Rhythm Disorders,
Cardiology - 4G751
Royal Adelaide Hospital
Port Road,
Adelaide, SA 5000
Country 80438 0
Australia
Phone 80438 0
+61870741785
Fax 80438 0
+61870746182
Email 80438 0
[email protected]
Contact person for public queries
Name 80439 0
Rajiv Mahajan
Address 80439 0
Centre of Heart Rhythm Disorders,
Cardiology - 4G751
Royal Adelaide Hospital
Port Road,
Adelaide SA 5000
Country 80439 0
Australia
Phone 80439 0
+61870741785
Fax 80439 0
+61870746182
Email 80439 0
[email protected]
Contact person for scientific queries
Name 80440 0
Rajiv Mahajan
Address 80440 0
Centre of Heart Rhythm Disorders,
Cardiology - 4G751
Royal Adelaide Hospital
Port Road,
Adelaide SA 5000
Country 80440 0
Australia
Phone 80440 0
+61870741785
Fax 80440 0
+61870746182
Email 80440 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
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.