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Value of Screening and Treatment of SAHS in the Management of AF Ablation Candidates

Study acronym: SLEEP-AF
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary completion date: May 31, 2022 to Dec 31, 2026
    • Study completion date: Oct 31, 2022 to Dec 31, 2026
    • Site details revised
    v4
  2. Primary completion date: Jan 31, 2022 to May 31, 2022
    • Study completion date: May 31, 2022 to Oct 31, 2022
    v3
  3. Trial status: Not Yet Recruiting to Recruitingv2 Show 4 more changesShow less
    • Primary completion date: Jan 31, 2021 to Jan 31, 2022
    • Study sites: 0 to 1
    • Study completion date: May 31, 2021 to May 31, 2022
    • Start date changed from estimate of Nov 1, 2020 to Nov 5, 2020
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The present prospective cohort study (not randomized) analyses the value of screening and treatment of SAHS in the management of patients with AF refractory to antiarrhythmics drugs, potentially candidates for ablation. Patients at low risk of suffering from SAHS will follow conventional management of their AF, according to the usual criteria of the Arrhythmia Unit. Patients with high or intermediate risk of SAHS, will undergo respiratory polygraphy. If the result is positive, they will be treated as standard for this syndrome and their heart rate will be monitored for 3 months. After this, the patient's arrhythmic load will be reevaluated differentiating patients into two groups, those that must be ablated from those that have improved their condition and the clinical criteria is no longer ablation but follow-up.
Trial Details
NCT Number NCT04606693
Lead Sponsor Hospital San Carlos, Madrid
Conditions
(from sponsor)		 Atrial Fibrillation Paroxysmal, Atrial Fibrillation, Persistent, Apnea Syndrome, Hypopnea Syndrome
Related terms Apnea, Atrial Fibrillation, Sleep Apnea Syndromes
Enrollment 50 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov