NCT02906839

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
280

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 1, 2016

Completed
19 days until next milestone

First Posted

Study publicly available on registry

September 20, 2016

Completed
7 months until next milestone

Study Start

First participant enrolled

April 27, 2017

Completed
5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 23, 2022

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 22, 2023

Completed
Last Updated

March 20, 2024

Status Verified

March 1, 2024

Enrollment Period

5.4 years

First QC Date

September 1, 2016

Last Update Submit

March 19, 2024

Conditions

Sleep Apnea SyndromeAtrial Fibrillation

Keywords

cardiovascular riskrisk of atrial fibrillation recurrencesleep apnea syndromeatrial fibrillation

Outcome Measures

Primary Outcomes (1)

  • Time to recurrence of AF after AF ablation.

    To assess the effect of SAS screening (and treatment if SAS is moderate to severe, defined by an apnea hypopnea index \> 15 / h) on recurrence of AF over a twenty-four month follow-up period, in patients on optimal medical treatment after AF ablation.

    24 month

Secondary Outcomes (8)

  • Cost utility analysis of SAS screening by reporting health resource utilization

    24 month

  • Measure of health status EQ-5D

    24 month

  • Number of cardioversions

    24 month

  • Number of radiofrequency catheter ablation

    24 month

  • AF burden

    24 month

  • +3 more secondary outcomes

Study Arms (2)

Intervention group

EXPERIMENTAL

Just after AF ablation, nocturnal polygraphy will be performed to diagnose SAS. If present and AHI \>15/h, the SAS will be treated, based on type and severity of SAS and on patient tolerance to treatment.

Other: Intervention group

Control group

NO INTERVENTION

No SAS screening will be performed in this group before the end of the 2 year follow up period.

Interventions

Intervention groupOTHER

Just after AF ablation, nocturnal polygraphy will be performed to diagnose SAS. If present and AHI \>15/h, the SAS will be treated, based on type and severity of SAS and on patient tolerance to treatment.

Also known as: SAS screening
Intervention group

Eligibility Criteria

Age18 Years - 79 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Already known SAS,
  • Severe sleepiness (Epworth sleepiness score \> 14)
  • Driving professional
  • Severe Chronic obstructive pulmonary disease (COPD)
  • Any other illness susceptible to shorten life expectancy within the study duration.
  • Previous ablation for atrial fibrillation,
  • 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
  • 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
  • Previous exam missing
  • Pregnancy and breast feeding
  • Guardianship or trusteeship patient

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Bichat-Claude Bernard

Paris, 75018, France

Location

MeSH Terms

Conditions

Sleep Apnea SyndromesAtrial Fibrillation

Condition Hierarchy (Ancestors)

ApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesArrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Marie-Pia d'ORTHO, Pr MD PhD

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 1, 2016

First Posted

September 20, 2016

Study Start

April 27, 2017

Primary Completion

September 23, 2022

Study Completion

November 22, 2023

Last Updated

March 20, 2024

Record last verified: 2024-03

Locations

FR(1)