Hybrid Characterization of Driver Sites During Atrial Fibrillation and Sinus Rhythm (Hybrid-AFMAP)

Fundacion para la Innovacion en Biomedicina (FIBMED)

Status: Active, not recruiting

Conditions: Persistent Atrial Fibrillation

Treatments: Device: Atrial substrate mapping; Procedure: Pulmonary vein electrical isolation

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT05077670

Hybrid-AFMAP

Details and patient eligibility

About

The primary objective of this study is twofold, first we aim to identify rotors in atrial fibrillation (AF) and analyze their relationship with the left atrium-left atrial appendage (LA-LAA) connections. Secondly, we will analyze the areas harboring rotors in SR to define the characteristics that describe the presence of rotors.

Full description

The primary objective of this study is the identification of LA and LAA areas driving atrial fibrillation to study their relationship with LAA-LA connections and sinus rhythm (SR) analysis using the CartoFinder and COHERENT algorithms that CARTO V7 offers.

The CartoFinder tool will be able to determine the activation patterns of reentrant drivers (rotors) in the LA and LAA in AF. The characterization of areas harboring rotors could be performed with the COHERENT tool provided by CARTO V7 to determine the activation patterns during reentrant rhythms, and after sinus rhythm restoration it could be used to assess the conduction patterns at LA-LAA connections and driver sites identified with CartoFinder.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Persistent atrial fibrillation
• The patient has signed the informed consent form
• No LAA previous ablation procedure
• No valvular disease
• LVEF ≥ 35% prior to recruitment
• Age ≥ 18 years

Exclusion criteria

• LVEF < 35 %
• Hyperthyroidism or hypothyroidism
• Mental or physical illness incapacitation
• Planned cardiac procedure
• Non-controlled hypertension
• Terminal renal failure or dialysis
• Class IV of the NYHA
• Age ≥ 75 years
• Life expectancy < 2 years
• Atrioventricular block
• Pregnancy

Trial design

50 participants in 1 patient group

Study group

Description:

* LAA + LA Map in AF * Identify LAA connections and detect rotors with CartoFinder * Electrical cardioversion. Sinus rhythm restoration * Pacing from the coronary sinus at 300 and 600ms periods * Analyze COHERENT activation maps in sinus rhythm * Ablation as suggested by current clinical guidelines and the characteristics of the patient

Treatment:

Procedure: Pulmonary vein electrical isolation

Device: Atrial substrate mapping