NCT02906839Completed
Sleep Apnea and Atrial Fibrillation Recurrence
Effect of Sleep Apnea Screening and Treatment on Atrial Fibrillation Recurrence : a Randomized Controlled Trial
Source: ClinicalTrials.gov · Last updated 20 Mar 2024
Brief summary (registry, in English)
The main aim of this project is to assess the effect of Sleep apnea syndrome (SAS) screening (and treatment if SAS is moderate to severe, defined by an apnea hypopnea index \>15 / h) on recurrence of atrial fibrillation (AF) over a twenty-four month follow-up period, in patients on optimal medical treatment after AF ablation.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 280 (actual)
- First submitted
- 1 Sept 2016
- Start date
- 27 Apr 2017
- Primary completion date
- 23 Sept 2022
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Diseases
- Atrial fibrillation
- NCT number
- NCT02906839
What you commit to
- Study type: Interventional
- Participants enrolled: 280
- From 27 Apr 2017 to the primary completion date, 23 Sept 2022
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous ablation for atrial fibrillation,
- Previous exam missing
Other illness
- Severe Chronic obstructive pulmonary disease (COPD)
- Any other illness susceptible to shorten life expectancy within the study duration.
- Secondary atrial fibrillation (due to cardiac surgery, infection, or hyperthyroidism).
- Severe heart failure (NYHA functional class III to IV),
- Expected surgery for structural heart disease
Other
- Already known SAS,
- Severe sleepiness (Epworth sleepiness score \> 14)
- Driving professional
- Unable to understand and to comply to clinical research procedures,
- Not covered by the national health insurance system
- No consenting for a randomised controlled trial
- Pregnancy and breast feeding
- Guardianship or trusteeship patient
Who the study is looking for
- Patients experiencing at least a second episode of symptomatic and documented atrial fibrillation (paroxysmal or persistent) within the preceding 12 months, unrelated to an acute cause, considered to be appropriate candidates for rhythm-control therapy (catheter ablation therapy)
- Age \>18 y and \< 80y
- Expected hospitalization for atrial fibrillation ablation
Age in the registry: 18 years to 79 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hôpital Bichat - Claude-Bernard Coordinator of this site? Confirm its status | Paris | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.