Actively Recruiting

Age: 18Years +
All Genders
ID06542263

Clinical Study on the Effect of Continuous Positive Airway Pressure Ventilation on Atrial Fibrillation Recurrence After Catheter Ablation in Patients with Atrial Fibrillation and Obstructive Sleep Apnea

Led by Second Affiliated Hospital of Soochow University · Updated on 2025-01-23

224

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Atrial fibrillation (AF) is a common heart rhythm problem that greatly raises the risk of serious health issues like stroke, heart failure, and dementia, affecting quality of life. This research focuses on patients with AF who also have moderate to severe obstructive sleep apnea (OSA), a condition that can lower the success of catheter ablation, a treatment for AF. The study aims to clarify whether using continuous positive airway pressure (CPAP) therapy can reduce the chance of AF returning after ablation, as previous studies have shown mixed results and further real-world data is needed. Participants are divided into two groups: one receives catheter ablation combined with CPAP therapy for OSA, while the other receives catheter ablation and conventional treatment without CPAP. All patients undergo overnight testing to determine the appropriate CPAP pressure, and those in the CPAP group are asked to use the device at home for at least five days a week, with a minimum of four hours per session. The study monitors participants for up to 12 months after ablation to compare outcomes between these two groups. During the study, researchers track the recurrence and burden of AF at 3, 6, 9, and 12 months after ablation. They also assess the impact of combining antiarrhythmic drugs with treatment. Quality of life is measured using surveys at 3 and 12 months. The study includes regular follow-up visits and evaluations to monitor heart rhythm, treatment adherence, and overall health, aiming to provide guidance on managing AF in patients with OSA.

CONDITIONS

Brief Title

Clinical Study on the Effect of CPAP on AF Recurrence After Catheter Ablation in Patients with AF and OSA

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Clinical diagnosis of atrial fibrillation combined with moderate to severe obstructive sleep apnea (apnea hypopnea index greater than 15/hour with at least 80% obstructive events; includes persistent and paroxysmal atrial fibrillation)
  • Age 18 years or older
  • Voluntary participation with signed informed consent
  • Ability to undergo overnight sleep pressure titration and use CPAP therapy at home at least 5 days a week for 4 hours each session
Not Eligible

You will not qualify if you...

  • Neuromuscular disorders, pulmonary hypopnea, or severe lung diseases
  • Presence of thrombus in the left atrium before surgery
  • Lack of desire for conversion
  • Secondary atrial fibrillation due to conditions like hyperthyroidism or tumors
  • Contraindications to anticoagulants
  • Left atrial diameter exceeding 60mm
  • Pregnancy
  • History of myocardial infarction, coronary intervention, or cardiac surgery within 3 months
  • Stroke or transient ischemic attack within 6 months
  • Artificial valve implantation surgery
  • Severe kidney failure (creatinine above 2.5mg/dl or eGFR below 30 ml/min/1.73m2)
  • Acute illness or active infection before surgery
  • Expected survival less than 1 year

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Implementation

Duration - Single procedure with immediate post-procedure period

Participants undergo catheter ablation and either receive CPAP treatment or conventional treatment for atrial fibrillation combined with obstructive sleep apnea.

1 procedure visit

Long-term Monitoring

Duration - 12 months

Participants are monitored for atrial fibrillation recurrence and burden, and quality of life is assessed after ablation.

Visits at 3, 6, 9, and 12 months after ablation

Trial Site Locations

Total: 1 location

1

The Second Affiliated Hospital of Soochow University

Suzhou, Jinagsu, China, 215004

Actively Recruiting

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Research Team

H

Hui Li

W

WenYan Hua

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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