Data

Randomised, Controlled Trial of Exercise Training versus Standard Medical Care on Atrial Fibrillation Recurrence After Ablation in Patients with Symptomatic Atrial Fibrillation

South Australian Health and Medical Research Institute

Dataset description

HeSANDA 1.0.0

Date Information

Collected from 2023
Click to explore relationships graph
 

Source Study

Purpose:
Treatment
Phase:
Not Applicable
Trial acronym

Not available

Trial ID

ACTRN12623000456651

Funding

University, University of Adelaide

Scientific enquiries

Dr Adrian Elliott

Brief Summary

This study will aim to assess the impact of a progressive, structured exercise program in patients with symptomatic AF in a randomised controlled trial. The study intervention will be assessed by the maintenance of sinus rhythm post-ablation, when compared with standard medical care. The primary endpoint of this study is the recurrence of any atrial arrhythmia, off anti-arrhythmic drugs (AADs) in the 18-months post-ablation. We hypothesise that exercise training will reduce arrhythmia recurrence .... Read more

Key Inclusion Criteria

Symptomatic patients with paroxysmal or persistent AF, scheduled for AF ablation, aged between 18 and 80 years (inclusive).

Key Exclusion Criteria

AF ablation within past 12 months. Cardiac surgery or myocardial infarction within the past 12 months. Left ventricular systolic dysfunction (LV Ejection Fraction less than 45%) Significant cardiac valvulopathy (except functional mitral and tricuspid regurgitation). Active malignancy, active autoimmune or systemic inflammatory disease; severe renal or hepatic failure. Unstable ventricular arrhythmias in the preceding 3 months. Inability to participate in an exercise program due to musculoskeleta .... Read more

Can healthy volunteers participate?

No

Population

Sample Size    226

Min. age    18 Years

Max. age    80 Years

Sex    Both males and females

Condition category    Atrial Fibrillation

Condition code    Cardiovascular , Physical Medicine / Rehabilitation

Intervention

Intervention code Treatment: Other

This progressive exercise interventions builds on successful interventions implemented in different settings by members of the investigator team. Specifically, the intervention includes four phases: Phase 1 (0-3 wks post-ablation, Recovery) will include a remote education component, delivered using online video consultation, that provides guidance on establishing physical activity following an ablation procedure. During these remote consultations, a clinical exercise physiologist will outline th ....
Read more

Comparison

Control group Active

Patients in the control arm (standard medical care only) will continue to receive guideline-directed, standard medical care as per current National Heart Foundation/Cardiac Society of Australia and New Zealand clinical guidelines. Principally, this focusses on three pillars of AF management (rate & rhythm control, anticoagulation). In our centre, this includes nurse and physician-led management of AF risk factors. Within this framework, participants in the control arm will attend quarterly consu ....
Read more

Outcomes

Outcome: Recurrence of any atrial fibrillation over 30s in duration, detected by implantable loop recorder, routine Holter monitoring or 12-lead electrocardiography.
Timepoint: 18-month follow-up from date of AF ablation, excluding 3-month blanking period immediately following AF ablation.

The data-sharing statement for this study is currently unavailable.

Source study information is derived from the Australian New Zealand Clinical Trials Registry (ANZCTR). For more information on the ANZCTR, please see anzctr.org.au

How is Heath Data Australia supporting health research?

To assist secondary data users in understanding the real-world impact of health and medical research data sharing, the Australian Research Data Commons (ARDC) has created an online guide that outlines a theoretical framework for four key data reuse scenarios. This practical guide was extracted from research papers, and consultation with stakeholders and the research community.

Read the guide

How to access data via Health Data Australia

With Health Data Australia, researchers can explore descriptions of data from our publishing partners, identify relevant datasets, and request access. These requests will then be forwarded to the data owner for review.

To start requesting data, simply login with your AAF account.

Learn more