Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000429954
Ethics application status
Approved
Date submitted
19/02/2020
Date registered
1/04/2020
Date last updated
1/04/2020
Date data sharing statement initially provided
1/04/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
Role of Gender in Long-term Outcomes of Atrial Fibrillation Ablation
Scientific title
Role of Gender in Long-term Outcomes of Atrial Fibrillation Ablation
Secondary ID [1] 297656 0
Nil
Universal Trial Number (UTN)
Trial acronym
GENDER-AF
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Atrial Fibrillation 311932 0
Condition category
Condition code
Cardiovascular 310516 310516 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
20
Target follow-up type
Years
Description of intervention(s) / exposure
Data will be from a prospectively collected registry of patients who have undergone catheter ablation and will be ongoing.
Participants will not be required to provide any additional data. All parameters and data will be collected from reviews and test that have been undertaken as part of their standard clinical follow-up.
Standard follow-up is 3monthly for the first year following ablation then yearly thereafter.
Intervention code [1] 313889 0
Diagnosis / Prognosis
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 319372 0
AF freedom off and on antiarrhythmic drugs following single ablation procedure assessed by ECG, Holter, or device interrogation.
Timepoint [1] 319372 0
3, 6, 9, 12 monthly appointments post ablation and every 12 months up to 20 years..
Secondary outcome [1] 367920 0
AF freedom off and on antiarrhythmic drugs following multiple ablation procedure assessed by ECG, Holter, or device interrogation..
Timepoint [1] 367920 0
3, 6, 9, 12 monthly appointments post ablation and every 12 months thereafter up to 20 years.
Secondary outcome [2] 367921 0
Procedural complications between sexes assessed by data-linkage to medical records, self-report, medical examination. Complications include but are not limited to stroke or thromboembolic event, tamponade, atrioeosophageal fistula, death, vascular.
Timepoint [2] 367921 0
Complication will be assessed immediately post procedure, and at clinical appointments 3, 6, 9, 12 monthly appointments post ablation and every 12 months thereafter up to 20 years..

Eligibility
Key inclusion criteria
Patients who had completed 12 months of follow-up after the inital procedure.
Minimum age
18 Years
Maximum age
90 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients who have had <12 months follow-up.
Patients <18 or >90 years of age
Patients who have not undergone ablation for AF

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Both
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
21/12/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
1000
Accrual to date
826
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 13329 0
The Royal Adelaide Hospital - Adelaide
Recruitment postcode(s) [1] 25929 0
5000 - Adelaide

Funding & Sponsors
Funding source category [1] 302187 0
University
Name [1] 302187 0
University of Adelaide
Country [1] 302187 0
Australia
Primary sponsor type
University
Name
University of Adelaide
Address
Centre for Heart Rhythm Disorders
4G751, Royal Adelaide Hospital
1 Port Rd
Adelaide
South Australia
5000
Country
Australia
Secondary sponsor category [1] 302028 0
Hospital
Name [1] 302028 0
Royal Adelaide Hospital
Address [1] 302028 0
Royal Adelaide Hospital
1 Port Rd
Adelaide
South Australia
5000
Country [1] 302028 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302867 0
Central Adelaide Local Health Network Human Research Ethics Committee
Ethics committee address [1] 302867 0
1 Port Rd,
Adelaide
SA 5000
Ethics committee country [1] 302867 0
Australia
Date submitted for ethics approval [1] 302867 0
Approval date [1] 302867 0
21/12/2018
Ethics approval number [1] 302867 0
HREC/18/CALHN/802

Summary
Brief summary
There is significant disparity in the current literature regarding outcomes of AF ablation between sexes. There is a strong male dominance in the data to date. Current literature comprises of small studies, with short follow-up and inconsistent outcomes. Based on the short term studies to date, women tend to present older and fair worse despite having less co-morbidities.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 91662 0
Prof Prashanthan Sanders
Address 91662 0
Centre for Heart Rhythm Disorders
4G751, Royal Adelaide Hospital
1 Port Rd,
Adelaide
South Australia
5000
Country 91662 0
Australia
Phone 91662 0
+610883139000
Fax 91662 0
Email 91662 0
prash.sanders@adelaide.edu.au
Contact person for public queries
Name 91663 0
Melissa Middeldorp
Address 91663 0
Centre for Heart Rhythm Disorders
4G751, Royal Adelaide Hospital
1 Port Rd,
Adelaide
South Australia
5000
Country 91663 0
Australia
Phone 91663 0
+610883139000
Fax 91663 0
Email 91663 0
melissa.middeldorp@adelaide.edu.au
Contact person for scientific queries
Name 91664 0
Prashanthan Sanders
Address 91664 0
Centre for Heart Rhythm Disorders
4G751, Royal Adelaide Hospital
1 Port Rd,
Adelaide
South Australia
5000
Country 91664 0
Australia
Phone 91664 0
+610883139000
Fax 91664 0
Email 91664 0
prash.sanders@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
IPD data will not be available


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.