Hybrid Characterization of Driver Sites During Atrial Fibrillation and Sinus Rhythm

Persistent Atrial Fibrillation Clinical Trial

— Hybrid-AFMAP  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05077670
• Other study ID #: Hybrid-AFMAP
• Status: Active, not recruiting
• Start date: September 1, 2021
• Est. completion date: September 1, 2023

Study information

• Verified date: December 2022
• Source: Fundacion para la Innovacion en Biomedicina (FIBMED)
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 50
• Est. completion date: September 1, 2023
• Est. primary completion date: September 1, 2023
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Persistent Atrial Fibrillation

Intervention

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.

Locations

Country	Name	City	State
Spain	Hospital General Universitario Gregorio Marañón	Madrid

Sponsors (2)

Lead Sponsor	Collaborator
Fundacion para la Innovacion en Biomedicina (FIBMED)	Biosense Webster, Inc.

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CartoFinder and COHERENT tools utility assessment	To evaluate the utility of CartoFinder and COHERENT tools in the identification of the mechanisms that maintain atrial fibrillation.	2 years
Secondary	Atrial fibrillation driver location analysis	Reentrant driver location relationship with lines of block, wavefront curvature, and slow conduction areas during SR pacing with success AF termination.	2 years