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

NCT04606693 | Recruiting

• 1 other identifier: 20/023-E
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Atrial Fibrillation Paroxysmal; Atrial Fibrillation, Persistent; Apnea Syndrome; Hypopnea Syndrome

Keywords

Atrial Fibrillation; Apnea; Hypopnea; SAHS

Outcome Measures

Primary Outcomes (1)

• Arrhythmic load

  Rate of time in FA measured with Kardia © recorder

  Six months

Study Arms (2)

Patients with negative diagnosis of SAHS

NO INTERVENTION

Patients with low risk or negative diagnosis of SAHS will follow conventional management of their AF, according to the usual criteria of the Arrhythmia Unit

Patients with positive diagnosis of SAHS

OTHER

Patients with intermediate or high risk of SAHS and positive diagnosis

Other: Treatment of SAHS

Interventions

Treatment of SAHS OTHER

Patients diagnosed with SAHS will be treated in the Pneumology Service according to usual practice (dietary hygienic measures, CPAP, etc.).

Patients with positive diagnosis of SAHS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with paroxysmal or persistent atrial fibrillation
• Recurrent atrial fibrillation despite treatment with at least one class I or III antiarrhythmic
• No previous diagnosis of apnea-hypopnea syndrome

You may not qualify if:

• Patients \<18 years
• Pregnant women
• Doubts about the patient's ability to perform a home respiratory polygraphy
• Doubts about the patient's ability to acquire rhythm records with the Kardia system (smartphone required)
• Unavailability for follow-up at our center for at least 1 year.

Sponsors & Collaborators

• Hospital San Carlos, Madrid: lead

Study Sites (1)

Hospital Clínico San Carlos

Madrid, Madrid, 28040, Spain

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation; Sleep Apnea Syndromes; Apnea

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms

Central Study Contacts

Nicasio Pérez-Castellano, MD PhD

CONTACT

+34913303000; nicasio.perez@salud.madrid.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 16, 2020
• First Posted: October 28, 2020
• Study Start: November 5, 2020
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: September 15, 2025

Record last verified: 2025-09

Locations

ES (1)