Atrial FibrillationNCT06542263
Clinical Study on the Effect of CPAP on AF Recurrence After Catheter Ablation in Patients with AF and OSA
An observational study of Atrial Fibrillation and Continuous Positive Airway Pressure, run by Second Affiliated Hospital of Soochow University at 1 site in China.
Trial summary
Atrial fibrillation (AF) is the most common sustained arrhythmia in clinical practice, significantly increasing the risks of death, stroke, heart failure, cognitive impairment, and dementia, thus severely impacting patients' quality of life. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation, Continuous Positive Airway Pressure, Obstructive Sleep Apnea
- What is being tested?
- CPAP
- Type of treatment
- Medical device
- How many people
- 224 participants
- Where
- 1 siteChina
- Study dates
- 9 Aug 2024to 1 Aug 2026
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Clinical diagnosis of AF combined with moderate to severe OSA (OSA diagnostic criteria: apnea hypopnea index (AHI) greater than 15/hour, and at least 80% of all events are respiratory sleep obstructive events; AF includes persistent atrial fibrillation and paroxysmal atrial fibrillation)
Who may be able to join
- Clinical diagnosis of AF combined with moderate to severe OSA (OSA diagnostic criteria: apnea hypopnea index (AHI) greater than 15/hour, and at least 80% of all events are respiratory sleep obstructive events; AF includes persistent atrial fibrillation and paroxysmal atrial fibrillation)
- Age ≥ 18 years old
- The patient voluntarily participates in the project and signs informed consent
- All patients undergo overnight sleep pressure titration at the sleep center to determine the minimum pressure value for continuous positive airway pressure ventilation at home. All patients are required to undergo CPAP treatment at home at least 5 days a week, with each session lasting at least 4 hours
Who cannot join
- Patients with neuromuscular disorders, pulmonary hypopnea, and severe lung diseases
- Preoperative confirmation of thrombus in the left atrium
- The patient has no desire for conversion
- Secondary atrial fibrillation (hyperthyroidism, tumors, etc.)
- Individuals with contraindications to anticoagulants
- Left atrial diameter (LAD) exceeding 60mm (2D echocardiography long axis section data)
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- Pregnant women
- History of myocardial infarction, percutaneous coronary intervention, and cardiac surgery in the past three months
- Stroke or transient ischemic attack in the past six months
- After artificial valve implantation surgery
- Severe renal insufficiency (creatinine Cr>2.5mg/dl or>221umol/L, or glomerular filtration rate eGFR<30ml/min/1.73m2)
- Acute diseases or active infections that occur before surgery, recorded as pain, fever, positive blood culture, and/or leukocytosis, or have been treated with antibiotics.
- Expected survival period<1 year
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The Second Affiliated Hospital of Soochow University
Suzhou, Jinagsu, 215004
Feng Li, 17512576836, lifeng2468@suda.edu.cn
About this study
Official title: 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
Atrial fibrillation (AF) is the most common sustained arrhythmia in clinical practice, significantly increasing the risks of death, stroke, heart failure, cognitive impairment, and dementia, thus severely impacting patients' quality of life. However, for AF patients with concomitant cardiovascular risk factors, particularly those with obstructive sleep apnea (OSA), the success rate of catheter ablation is significantly reduced. Continuous positive airway pressure (CPAP) is currently an effective treatment for OSA, effectively correcting nocturnal intermittent hypoxia and fragmented sleep caused by OSA. However, the effect of CPAP therapy on AF recurrence in patients with OSA undergoing catheter ablation remains controversial. Faced with conflicting research findings, our team recently conducted a meta-analysis (registration number CRD42023398588) to assess the impact of CPAP on AF recurrence post catheter ablation in patients with AF and OSA, suggesting that CPAP significantly reduces AF recurrence post catheter ablation (RR = 0.58, P < 0.01). However, considering the limited number of included studies, potential bias risks, and confounding factors, our meta-analysis results await further confirmation through real-world studies by our team. Therefore, our team plans to conduct further research on the impact of CPAP on AF recurrence post catheter ablation in patients with moderate to severe OSA, aiming to provide clinical guidance for the treatment of AF in patients with moderate to severe OSA.
- Conditions
- Atrial Fibrillation, Continuous Positive Airway Pressure, Obstructive Sleep Apnea, Recurrence, Observational Study
- Being tested
- CPAP
- Medical subject headings
- Atrial Fibrillation, Sleep Apnea, Obstructive, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CPAPDevice
For the non-CPAP group, the intervention includes catheter ablation and conventional treatment for AF combined with OSA; For the CPAP group, the intervention includes catheter ablation and CPAP treatment for AF combined with OSA
| Study group | Role | What they receive |
|---|---|---|
| non-CPAP group | The non-CPAP group underwent catheter ablation and conventional treatment for AF combined with OSA Receives: Device: CPAP | |
| CPAP group | The CPAP group underwent catheter ablation and CPAP treatment for AF combined with OSA |
What is being measured
The primary outcome is the main question the study is designed to answer.
AF recurrence after ablation
AF recurrence after ablation via Surface electrocardiogram and 24-hour dynamic electrocardiogram examination. If there are symptoms, seek medical attention at any time for electrocardiogram examination
Measured: At 3, 6, 9, and 12 months after AF ablation
AF burden after ablation AF burden after ablation AF burden after ablation
AF burden after ablation via 24-hour dynamic electrocardiogram examination AF burden after ablation via 24-hour dynamic electrocardiogram examinatio AF burden after ablation via 24-hour dynamic electrocardiogram examinatio
Measured: At 3, 6, 9, and 12 months after AF ablation
Secondary outcomes (4)
The recurrence of AF after combination with antiarrhythmic drugs
The recurrence of AF after combination with antiarrhythmic drugs via Surface electrocardiogram and 24-hour dynamic electrocardiogram examination. If there are symptoms, seek medical attention at any time for electrocardiogram examination
Measured: At 3, 6, 9, and 12 months after AF ablation
AF burden after combination with antiarrhythmic drugs
AF burden after combination with antiarrhythmic drugs via 24-hour dynamic electrocardiogram examinatio
Measured: At 3, 6, 9, and 12 months after AF ablation
SF-36
SF-36 with standard scores ranging from 0 to 100. The higher the score, the better the health status
Measured: At 3 and 12 months after AF ablation
Euro-QoL5D Survey Scoring
Euro-QoL5D survey questionnaire is between 0 and 100, with higher scores indicating better health status
Measured: At 3 and 12 months after AF ablation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2024
- Study start9 Aug 2024
- Primary completion1 Aug 2026 (estimated)
- Study completion1 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 224 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Second Affiliated Hospital of Soochow University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06542263
- Sponsor's protocol ID
- JD-LK2024034-IR01
- Status last verified
- Aug 2024
- First submitted
- 4 Aug 2024
- Last updated
- 23 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06542263
- Acronym / sponsor ID
- JD-LK2024034-IR01
- Conditions
- Atrial Fibrillation, Continuous Positive Airway Pressure, Obstructive Sleep Apnea, Recurrence, Observational Study
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 224 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital of Soochow UniversityUniversity, hospital or other
- Study start
- 9 Aug 2024 (actual)
- Primary completion
- 1 Aug 2026 (estimated)
- Study completion
- 1 Aug 2026 (estimated)
- First posted
- 7 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Atrial fibrillation (AF) is the most common sustained arrhythmia in clinical practice, significantly increasing the risks of death, stroke, heart failure, cognitive impairment, and dementia, thus severely impacting patients' quality of life. However, for AF patients with concomitant cardiovascular risk factors, particularly those with obstructive sleep apnea (OSA), the success rate of catheter ablation is significantly reduced. Continuous positive airway pressure (CPAP) is currently an effective treatment for OSA, effectively correcting nocturnal intermittent hypoxia and fragmented sleep caused by OSA. However, the effect of CPAP therapy on AF recurrence in patients with OSA undergoing catheter ablation remains controversial. Faced with conflicting research findings, our team recently conducted a meta-analysis (registration number CRD42023398588) to assess the impact of CPAP on AF recurrence post catheter ablation in patients with AF and OSA, suggesting that CPAP significantly reduces AF recurrence post catheter ablation (RR = 0.58, P < 0.01). However, considering the limited number of included studies, potential bias risks, and confounding factors, our meta-analysis results await further confirmation through real-world studies by our team. Therefore, our team plans to conduct further research on the impact of CPAP on AF recurrence post catheter ablation in patients with moderate to severe OSA, aiming to provide clinical guidance for the treatment of AF in patients with moderate to severe OSA.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| non-CPAP group | – | Device: CPAPThe non-CPAP group underwent catheter ablation and conventional treatment for AF combined with OSA |
| CPAP group | – | –The CPAP group underwent catheter ablation and CPAP treatment for AF combined with OSA |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Clinical diagnosis of AF combined with moderate to severe OSA (OSA diagnostic criteria: apnea hypopnea index (AHI) greater than 15/hour, and at least 80% of all events are respiratory sleep obstructive events; AF includes persistent atrial fibrillation and paroxysmal atrial fibrillation)
Key inclusion criteria (4 listed)
- Clinical diagnosis of AF combined with moderate to severe OSA (OSA diagnostic criteria: apnea hypopnea index (AHI) greater than 15/hour, and at least 80% of all events are respiratory sleep obstructive events; AF includes persistent atrial fibrillation and paroxysmal atrial fibrillation)
- Age ≥ 18 years old
- The patient voluntarily participates in the project and signs informed consent
- All patients undergo overnight sleep pressure titration at the sleep center to determine the minimum pressure value for continuous positive airway pressure ventilation at home. All patients are required to undergo CPAP treatment at home at least 5 days a week, with each session lasting at least 4 hours
Key exclusion criteria (13 listed)
- Patients with neuromuscular disorders, pulmonary hypopnea, and severe lung diseases
- Preoperative confirmation of thrombus in the left atrium
- The patient has no desire for conversion
- Secondary atrial fibrillation (hyperthyroidism, tumors, etc.)
- Individuals with contraindications to anticoagulants
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CPAPFor the non-CPAP group, the intervention includes catheter ablation and conventional treatment for AF combined with OSA; For the CPAP group, the intervention includes catheter ablation and CPAP treatment for AF combined with OSA | Device | non-CPAP group |
Primary outcome
AF recurrence after ablation
Time frame: At 3, 6, 9, and 12 months after AF ablation
AF recurrence after ablation via Surface electrocardiogram and 24-hour dynamic electrocardiogram examination. If there are symptoms, seek medical attention at any time for electrocardiogram examination
AF burden after ablation AF burden after ablation AF burden after ablation
Time frame: At 3, 6, 9, and 12 months after AF ablation
AF burden after ablation via 24-hour dynamic electrocardiogram examination AF burden after ablation via 24-hour dynamic electrocardiogram examinatio AF burden after ablation via 24-hour dynamic electrocardiogram examinatio
4 secondary outcomes
The recurrence of AF after combination with antiarrhythmic drugs
Time frame: At 3, 6, 9, and 12 months after AF ablation
AF burden after combination with antiarrhythmic drugs
Time frame: At 3, 6, 9, and 12 months after AF ablation
SF-36
Time frame: At 3 and 12 months after AF ablation
Euro-QoL5D Survey Scoring
Time frame: At 3 and 12 months after AF ablation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2025.
- Individual participant dataSharing planned: Undecided
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Atrial Fibrillation (AF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation and Continuous Positive Airway Pressure, run by Second Affiliated Hospital of Soochow University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hui Li (0512-67784077, lihuifry@suda.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AF recurrence after ablation (time frame: At 3, 6, 9, and 12 months after AF ablation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2025.