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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Persistent Atrial Fibrillation
• Intervention / Treatment: Procedure: Pulmonary vein electrical isolation; Device: Atrial substrate mapping

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 Type: Observational
• Enrollment (Anticipated): 50

Contacts and Locations

Study Locations

• Spain
  • Madrid, Spain, 28007
    • Hospital General Universitario Gregorio Marañón

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The study will include 50 patients. No statistical considerations were made to determine the sample size of this study.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Study group; 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	Procedure: Pulmonary vein electrical isolation; Electrical isolation of the pulmonary veins from the left atrium with cryoablation therapy.; Other Names: Pulmonary veins ablation; Device: Atrial substrate mapping; Electro-anatomical maps will be performed with CARTO navigation system with multi-electrode catheters.; Other Names: Electro-anatomical mapping

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Fundacion para la Innovacion en Biomedicina (FIBMED)
• Collaborators: Biosense Webster, Inc.
• Investigators: Principal Investigator: Angel Arenal, MD, PhD, Hospital General Universitario Gregorio Marañón; Principal Investigator: Gonzalo R Ríos-Muñoz, MSc, PhD, Hospital General Universitario Gregorio Marañón

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2021
• Primary Completion (Anticipated): September 1, 2023
• Study Completion (Anticipated): September 1, 2023

Study Registration Dates

• First Submitted: October 1, 2021
• First Submitted That Met QC Criteria: October 1, 2021
• First Posted (Actual): October 14, 2021

Study Record Updates

• Last Update Posted (Actual): December 28, 2022
• Last Update Submitted That Met QC Criteria: December 26, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: Atrial fibrillation; Catheter ablation; Rotors
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: Hybrid-AFMAP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes