Status:
TERMINATED
The Efficacy of PAP Therapy on Reducing AF Recurrence in Patients With Morbidity of OSA
Lead Sponsor:
Philips (China) Investment CO., LTD
Collaborating Sponsors:
Peking University First Hospital
Beijing Tsinghua Changgeng Hospital
Conditions:
Atrial Fibrillation
Obstructive Sleep Apnea
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
This study aims to test the effectiveness of positive airway pressure therapy on reducing clinical failure after rhythm control treatment and restoring with regular heart beat in atrial fibrillation p...
Detailed Description
This study aims to test the effectiveness of positive airway pressure therapy on reducing clinical failure after rhythm control treatment and restoring with regular heart beat in atrial fibrillation p...
Eligibility Criteria
Inclusion
- Symptomatic paroxysmal or persistent atrial fibrillation:
- Paroxysmal: at least having one episode every month for the last recent 6 months. Each episode with symptoms lasting for over 30 minutes and at least one episode is documented (≥30 seconds episode length, documented by ECG).
- Persistent: lasting over 7 days to 1 year persistent AF with ECG documented.
- Implement a rhythm control strategy, including:
- Ablation and restored on sinus rhythm after the procedure.
- Underwent medical or electrical cardioversion during hospitalization and restored on sinus rhythm before enrollment.
- OSA diagnosed with PSG test showing AHI≥10;
- 18 ≤ Age ≤ 75;
- Willing to participate in the study;
- Able to provide informed consent;
- Having access to smartphones and the internet, and be capable of using them.
Exclusion
- BMI \> 30 kg/m2;
- LVEF ≤ 40% or HF with NYHA III/ IV;
- Other atrial arrhythmias, atrial flatter;
- Myocardial infarction;
- Hypertrophic Cardiomyopathy (HCM);
- Congenital heart disease;
- A clear diagnosis with heart valve diseases (including moderate-severe mitral stenosis/ insufficiency, moderate-severe aortic stenosis/ insufficiency);
- Hyperthyroidism heart disease;
- Other acute diseases leading to temporary AF;
- In surgery perioperative period;
- Accepted other cardiothoracic surgery except for ablation;
- PSG test showing mainly central apneas (Cheyne-Stokes breathing);
- Pulmonary diseases causing dyspnea at rest or on minimal exertion;
- With other active major organ system disease that is not suitable for study participation, such as cancer, severe liver diseases, severe kidney diseases, etc.;
- With significantly impaired cognitive function, having severe problems in learning, memory, perception, and problem solving, and are unable to understand or not be competent to the informed consent;
- Having already accepted treatment to the sleep apnea syndrome;
- Having received intervention in any other trial within 30 days prior to the planned recruitment.
Key Trial Info
Start Date :
September 18 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 24 2021
Estimated Enrollment :
129 Patients enrolled
Trial Details
Trial ID
NCT04519489
Start Date
September 18 2020
End Date
December 24 2021
Last Update
September 17 2025
Active Locations (2)
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1
Beijing Tsinghua Changgung Hospital
Beijing, Beijing Municipality, China
2
Peking University First Hospital
Beijing, Beijing Municipality, China