Start CPAP Therapy in Obstructive Sleep Apnea Patients After Atrial Fibrillation Ablation

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorBeijing Anzhen Hospital

About this trial

Atrial fibrillation (AF) is one of the most common clinical arrhythmias. Catheter ablation is an effective therapeutic strategy; however, recurrence rates remain substantial, ranging from 20% to 45%. Previous studies have established a strong association between obstructive sleep apnea (OSA) and the risk of AF recurrence following ablation. While continuous positive airway pressure (CPAP) is the standard intervention for OSA, and some observational studies suggest it may reduce post-ablation recurrence in patients with comorbid OSA, small randomized controlled trials have failed to confirm a clear benefit, potentially due to poor adherence.

This study aims to evaluate the clinical benefit of post-ablation CPAP therapy in AF patients with comorbid OSA.

Participants will:

* Be randomly assigned to either the CPAP group or the usual care group. * If in the CPAP group, use a CPAP device for 12 months. * Wear an ambulatory ECG recorder for a 7-day period at 3, 6, 9, and 12 months after randomization. * Complete follow-up checkups either at the clinic or over the phone at 1, 3, 6, and 12 months after randomization.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 18-75 years.

Patients with persistent AF who received catheter ablation for the first time.

Diagnosed with OSA.

Able to tolerate CPAP therapy.

Disqualifiers

Secondary AF.

Left atrial anteroposterior diameter 60mm (measured via parasternal long-axis view).

Left ventricular ejection fraction < 30%.

Comorbid moderate-to-severe mitral stenosis or history of prosthetic valve replacement (mechanical or bioprosthetic).

Trial design

Design model

Parallel

Treatments tested in this trial

  • Continuous Positive Airway Pressure (CPAP)

    Device

    Participants receive CPAP therapy provided by the research team. Treatment parameters are determined following auto-titrating or manual pressure titration. Prior to treatment initiation, participants receive training on device usage, mask fitting and adjustment, equipment cleaning and maintenance, and data transmission methods. Study physicians and technicians provide support to address any CPAP-related discomfort. 'Good adherence' is defined as device usage of ≥ 4 hours per night on ≥ 70% of days.

  • Usual Care

    Other intervention

    Participants receive standardized medical therapy for atrial fibrillation in accordance with international guidelines and clinical routine. For OSA management, researchers provide standardized health education. This includes informing participants about the risks associated with OSA and advising on lifestyle modifications, including weight loss, adopting a lateral sleeping position, and avoiding alcohol and sedatives.

Treatment groups

658 Participants
are divided into 2 treatment groups
Group A: CPAP GroupExperimental treatment 2 interventions
Group B: Usual Care GroupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Incidence of freedom from atrial arrhythmia recurrence.

Recurrence is defined as a composite of: 1. Any documented atrial arrhythmia (AF / Atrial Tachycardia \[AT\] / Atrial Flutter \[AFL\]) lasting 30 seconds after a 3-month blanking period; 2. Use of Class I or III AADs after the 3-month blanking period; 3. Cardioversion performed after the 3-month blanking period; 4. Repeat catheter ablation performed at any time.

Time frame
Within 12 months

Secondary outcomes

1

Incidence of any documented atrial arrhythmia (AF/AFL/AT) lasting ≥30 seconds.

Time frame
Within 12 months (after a 3-month blanking period).
2

Incidence of documented AF lasting ≥30 seconds.

Time frame
Within 12 months (after a 3-month blanking period).
3

Incidence of documented AT lasting ≥30 seconds.

Time frame
Within 12 months (after a 3-month blanking period).
4

Incidence of documented AFL lasting ≥30 seconds.

Time frame
Within 12 months (after a 3-month blanking period).

Other outcomes

Sponsors and contacts

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