Does obstructive sleep apnoea treatment improve heart rhythm control in patients after having an Atrial Fibrillation ablation. A randomised controlled trial

Not Applicable

Recruiting

• Conditions: Obstructive Sleep Apnoea; Cardiovascular - Other cardiovascular diseases; Respiratory - Sleep apnoea; Atrial Fibrillation

• Registration Number: ACTRN12621001213831
• Lead Sponsor: Melbourne Health (Royal Melbourne Hospital)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-09-10
• Last Update Posted: 12 September 2022

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 220

Inclusion Criteria

1.Paroxysmal or persistent atrial fibrillation referred for AF ablation. By definition this will include highly symptomatic patients with paroxysmal or persistent AF (ablation is completed as standard of care treatment and not a research study related procedure).
2.Moderate to severe predominant OSA defined as AHI 15 or greater and a central apnoea index/total apnoea index less than 20 percent (diagnosed by either in lab Polysomnography (PSG) or at home WatchPAT device)
3.Age 18 years to less than 80 years old
4.Able and willing to provide informed consent and comply with all testing and requirements.
5.Willing to use CPAP if randomised to the treatment arm
6.Willing to defer CPAP treatment by up to 12 months if randomised to the non-treatment arm.

Exclusion Criteria

1.History of prior AF ablation procedure
2.Presence of other significant structural heart disease
a.Valvular heart disease ( moderate valvular regurgitation or stenosis)
b.Heart failure (Ejection fraction less than 45%; NYHA class 3 or 4)
c.Surgically corrected congenital heart disease (eg ASD repair)
d.Hypertrophic cardiomyopathy
e.Unstable coronary artery disease
f.Severe left atrial enlargement (LA diameter greater than 5.5cm)
3.Presence of other major comorbidities
a.Renal failure (eGFR less than 50)
b.Poorly controlled hypertension
c.COPD
4.AF due to a transient or reversible cause ie: postoperative cardiac or non-cardiac surgery, lung disease, hyperthyroidism
5.Long standing Persistent AF (long standing AF greater than 12 months with nil documentation of SR)
6.Patients in whom central apnoea index/total apnoea index make equal and greater than 20% total apnoeas
7.Patients in whom withholding CPAP is considered unethical:
a.these include patients with clinically severe symptoms of OSA defined as a history
of fall-asleep or near to fall-asleep accident.
b.patients with clinically moderate to severe daytime sleepiness
c.patients who frequent self-reported episodes of sleepiness or drowsiness while
driving
d.person has had motor vehicle crash/es caused by inattention or sleepiness
e.patients in the opinion of the treating doctor, represents a significant driving risk as
a result of a sleep disorder
8.Patient whom wish to commence CPAP treatment after diagnosis of OSA
9.Patients who have previously been diagnosed and treated for OSA
10.Vulnerable Patient
11.Use of opiates or other respiratory depressants

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Time to AF recurrence following AF ablation (single procedure without antiarrhythmic mediation) assessed as a composite outcome from an implanted loop recorder, daily Kardia Alivecor ECG recordings and 24 hour holter monitoring[Documented AF > 30 seconds, occurring 3 months (after 3 month blanking period) to 12 months after ablation. These include, implantable loop recorder assessed continuously for 12 months, daily and symptomatic ECG recordings from Kardia Alivecor device for 12 months and 24 hour holter monitoring occurring at 3, 6 and 12 months.]