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NOT YET RECRUITING
NCT07444372
NA

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

Sponsor: Beijing Anzhen Hospital

View on ClinicalTrials.gov

Summary

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 at least once a week to monitor their heart rhythm. * Complete follow-up checkups either at the clinic or over the phone at 1, 3, 6, and 12 months after their procedure.

Official title: Start CPAP Therapy in Obstructive Sleep Apnea Patients After Atrial Fibrillation Ablation: A Multicenter, Open-label, Randomized Clinical Trial

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

658

Start Date

2026-04-15

Completion Date

2029-01-31

Last Updated

2026-03-02

Healthy Volunteers

No

Interventions

DEVICE

Continuous Positive Airway Pressure (CPAP)

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.

OTHER

Usual Care

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.

Locations (13)

Beijing Anzhen Hospital

Beijing, Beijing Municipality, China

Beijing Jishuitan Hospital

Beijing, Beijing Municipality, China

Beijing Hospital

Beijing, Beijing Municipality, China

Peking University International Hospital

Beijing, Beijing Municipality, China

First Affiliated Hospital of Fujian Medical University

Fuzhou, Fujian, China

Langfang People's Hospital

Langfang, Hebei, China

Second Affiliated Hospital of Harbin Medical University

Harbin, Heilongjiang, China

Wuhan No. 1 Hospital

Wuhan, Hubei, China

The First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, China

First Affiliated Hospital of Dalian Medical University

Dalian, Liaoning, China

First Affiliated Hospital of China Medical University

Shenyang, Liaoning, China

Second Hospital of Shanxi Medical University

Taiyuan, Shanxi, China

First Affiliated Hospital of Ningbo University

Ningbo, Zhejiang, China