NCT05077670

Hybrid Characterization of Driver Sites During Atrial Fibrillation and Sinus Rhythm

Hybrid Characterization of Driver Sites During Atrial Fibrillation and Sinus Rhythm With CARTOFINDER and COHERENT Mapping

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 50 (estimated)
• Sponsor: Fundacion para la Innovacion en Biomedicina (FIBMED) · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: —

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.

Conditions

• Persistent Atrial Fibrillation

Interventions

Type	Name	Description
PROCEDURE	Pulmonary vein electrical isolation	Electrical isolation of the pulmonary veins from the left atrium with cryoablation therapy.
DEVICE	Atrial substrate mapping	Electro-anatomical maps will be performed with CARTO navigation system with multi-electrode catheters.

Timeline

• Start date: 2021-09-01
• Primary completion: 2023-09-01
• Completion: 2023-09-01
• First posted: 2021-10-14
• Last updated: 2022-12-28

Locations

1 site across 1 country: Spain

Regulatory

• FDA-regulated device study