Hybrid Characterization of Driver Sites During Atrial Fibrillation and Sinus Rhythm

Active, not recruiting

• Conditions: Persistent Atrial Fibrillation
• Interventions: Procedure: Pulmonary vein electrical isolation; Device: Atrial substrate mapping

• Registration Number: NCT05077670
• Lead Sponsor: Fundacion para la Innovacion en Biomedicina (FIBMED)

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2021-09-01
• Study First Submitted: 2021-10-01
• Study First Submitted QC: 2021-10-01
• Study First Posted: 2021-10-14
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-26
• Last Update Posted: 2022-12-28
• Primary Completion: 2023-09-01
• Study Completion: 2023-09-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Study group	Pulmonary vein electrical isolation	* 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
Study group	Atrial substrate mapping	* 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

Primary Outcome Measures

Name	Time	Method
CartoFinder and COHERENT tools utility assessment	2 years	To evaluate the utility of CartoFinder and COHERENT tools in the identification of the mechanisms that maintain atrial fibrillation.

Secondary Outcome Measures

Name	Time	Method
Atrial fibrillation driver location analysis	2 years	Reentrant driver location relationship with lines of block, wavefront curvature, and slow conduction areas during SR pacing with success AF termination.

Trial Locations

Locations (1)

Hospital General Universitario Gregorio Marañón; 🇪🇸 Madrid, Spain