Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000994583
Ethics application status
Approved
Date submitted
8/07/2024
Date registered
14/08/2024
Date last updated
14/08/2024
Date data sharing statement initially provided
14/08/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
The Effect of Catheter Ablation on Sexual Dysfunction
Scientific title
The Effect of Catheter Ablation on Sexual Dysfunction in patients with atrial fibrillation.
Secondary ID [1] 312476 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Atrial Fibrillation 334326 0
Erectile Dysfunction 334327 0
Premature Ejaculation 334328 0
Female Sexual Dysfunction 334329 0
Condition category
Condition code
Reproductive Health and Childbirth 330983 330983 0 0
Other reproductive health and childbirth disorders
Cardiovascular 331349 331349 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
The exposure in this prospective observational cohort study is catheter ablation for atrial fibrillation (AF) with the control group being medical therapy for AF.
Participants will receive catheter ablation regardless of their involvement in this study, and not because of enrolment into the study. Participants must have been independently referred for catheter ablation for standard of care reasons prior to enrollment.
Patients will be required to complete a number of questionnaires with a total time commitment of approximately 30 minutes at study enrollment, and at 6 months follow-up (study conclusion). The questionnaires will specifically include the Sexual quality of life (male and female) survey, the international index of erectile dysfunction, the premature ejaculation diagnostic tool, the sexual health inventory for men, and the female sexual function index. Furthermore, the Canadian cardiovascular society AF score, New York Heart Association Dyspnea scale, and the DASS-21 will also be administered.
Baseline clinical information and procedural information will also be included in the assessment. These will be entered on initial study enrollment and from the medical records.
Intervention code [1] 328995 0
Not applicable
Comparator / control treatment
The intervention group is catheter ablation for atrial fibrillation, whilst the control group is medical therapy for AF ablation.
Medical therapy will be standard of care pharmacotherapy as prescribed by the treating physician (ie, rate control, anticoagulation, heart failure therapy).
Control group
Active

Outcomes
Primary outcome [1] 338744 0
Change in Sexual Quality of Life
Timepoint [1] 338744 0
Baseline (pre-intervention), and 6 months
Secondary outcome [1] 437266 0
Change in Sexual Quality of Life
Timepoint [1] 437266 0
baseline (pre intervention), and 6 months
Secondary outcome [2] 437267 0
Change in Sexual Quality of Life
Timepoint [2] 437267 0
Baseline (pre intervention), and 6 months
Secondary outcome [3] 437268 0
Change in Sexual Quality of Life
Timepoint [3] 437268 0
baseline (pre-intervention), and 6 months.
Secondary outcome [4] 437269 0
Change in Sexual Quality of Life
Timepoint [4] 437269 0
Baseline (pre-intervention), and 6 months
Secondary outcome [5] 437270 0
Change in Sexual Quality of Life
Timepoint [5] 437270 0
Baseline (pre-intervention), and 6 months
Secondary outcome [6] 437271 0
Change in Sexual Quality of Life
Timepoint [6] 437271 0
Baseline (pre-intervention), and 6 months
Secondary outcome [7] 437731 0
Change in AF severity
Timepoint [7] 437731 0
Baseline pre ablation and at 6 months
Secondary outcome [8] 437732 0
Change in AF severity
Timepoint [8] 437732 0
Baseline pre ablation and 6 months post
Secondary outcome [9] 437733 0
Psychological Mood
Timepoint [9] 437733 0
Baseline Pre Ablation and 6 months post

Eligibility
Key inclusion criteria
All patients with persistent or paroxysmal AF referred for either catheter ablation or medical therapy.
AF documented at least once in the past 6 months.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Severe medical comorbidity the limits life expectancy to < 6 months

Unwilling or unable to consent.

Unwilling to unable to complete follow-up.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Overview. All data analysis will occur offline and be completed by a qualified statistician. Baseline patient characteristics will be presented in mean ± SD or median [IQR]. A significance level of 0.05 will be considered significant. Appropriate adjustments for multiple comparisons will be made. Differences in variables between groups will be analysed with the chi squared or fisher exact test for categorical data and the T test or Mann-Whitney U test for continuous data depending on distribution.

Sample Size. Most outcomes described in this study are qualitative in nature and hence amalgamated data and themes will be presented and are expected to be the main theme seen in the results. There is limited data to guide sample size calculations. One study reports a rate of approximately 10% for erectile dysfunction in new AF, whereas a recent meta analysis demonstrates that the prevalence of erectile dysfunction in AF is as high as 57%. Furthermore, a large observational study of patients with cardiovascular disease in general reports a prevalence of sexual dysfunction in men of 55% and 29% of women. There is limited to no data describing rates of sexual dysfunction post AF ablation. If we hypothesize that an AF ablation will cause a 15% decrease in major sexual dysfunction that would yield a total of 173 patients in each comparison group.

Assessment of bias. Reducing bias in observational studies remains difficult but is crucial to ensure the reliability and validity of results. Described below is out plan of how this will be addressed:

Design Phase

By strictly adhering to well-defined inclusion and exclusion criteria, selection bias can be minimized. This ensures that the study population accurately reflects the target demographic and that any external factors influencing sexual function are appropriately accounted for

To balance the characteristics of the intervention and control groups, propensity score matching may be employed depending on baseline assessment of the demographics in each group.

Data Collection Phase

All researchers and staff involved in data collection will be trained to follow standardized procedures. This includes the use of uniform scripts when administering surveys and consistent methods for recording and storing data to prevent measurement bias.

Employing validated questionnaires and instruments for assessing sexual function ensures that the data collected are reliable and comparable across participants. This approach helps in reducing information bias.

Analysis Phase

Statistical analyses will include adjustments for known confounders that might affect the relationship between catheter ablation and sexual function. Multivariable regression models can be used to account for these variables, thereby reducing the risk of confounding bias.

Conducting sensitivity analyses to explore the effects of potential unmeasured confounders on the study outcomes can provide insights into the robustness of the findings. This helps in assessing the impact of bias that may not have been fully eliminated.

An intention-to-treat approach, where participants are analyzed in the groups to which they were originally assigned regardless of whether they completed the intervention as planned, helps to mitigate the effects of attrition bias.

Reporting Phase

All methods, including those employed to reduce bias, will be transparently reported in accordance with the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) guidelines. Additionally, any limitations of the study related to potential biases will be openly discussed.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/09/2024
Actual
Date of last participant enrolment
Anticipated
5/07/2025
Actual
Date of last data collection
Anticipated
5/01/2026
Actual
Sample size
Target
346
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 26768 0
The Alfred - Melbourne
Recruitment hospital [2] 26769 0
Cabrini Hospital - Malvern - Malvern
Recruitment postcode(s) [1] 42818 0
3004 - Melbourne
Recruitment postcode(s) [2] 42819 0
3144 - Malvern

Funding & Sponsors
Funding source category [1] 316894 0
Hospital
Name [1] 316894 0
Cabrini Hospital General Research Grant
Country [1] 316894 0
Australia
Primary sponsor type
Hospital
Name
Alfred Hospital
Address
Country
Australia
Secondary sponsor category [1] 319144 0
None
Name [1] 319144 0
Address [1] 319144 0
Country [1] 319144 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315656 0
Alfred Hospital Ethics Committee
Ethics committee address [1] 315656 0
Ethics committee country [1] 315656 0
Australia
Date submitted for ethics approval [1] 315656 0
30/05/2024
Approval date [1] 315656 0
18/06/2024
Ethics approval number [1] 315656 0

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

Contacts
Principal investigator
Name 135394 0
A/Prof Aleksandr Voskoboinik
Address 135394 0
55 commercial road, Alfred Heart centre, Alfred Hospital, Victoria, Australia, 3004
Country 135394 0
Australia
Phone 135394 0
+613 9076 3263
Fax 135394 0
Email 135394 0
[email protected]
Contact person for public queries
Name 135395 0
Nicholas D'Elia
Address 135395 0
55 Commercial Road, Alfred Heart Centre, Alfred Hospital, Victoria, Australia, 3004
Country 135395 0
Australia
Phone 135395 0
+613 90762000
Fax 135395 0
Email 135395 0
[email protected]
Contact person for scientific queries
Name 135396 0
Nicholas D'Elia
Address 135396 0
55 commercial road, Alfred Heart Centre, Alfred Hospital, Victoria, Australia, 3004
Country 135396 0
Australia
Phone 135396 0
+61 3 90762000
Fax 135396 0
Email 135396 0
[email protected]

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


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.