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

Sponsor

Fundacion para la Innovacion en Biomedicina (FIBMED) (Other)

Overall Status

Recruiting

CT.gov ID

NCT05077670

Collaborator

Biosense Webster, Inc. (Industry)

Enrollment

Location

Anticipated Duration (Months)

2.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Persistent Atrial Fibrillation	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 Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

50 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Sep 1, 2021

Anticipated Primary Completion Date :

Sep 1, 2022

Anticipated Study Completion Date :

Sep 1, 2023

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital General Universitario Gregorio Marañón	Madrid		Spain	28007

Sponsors and Collaborators

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

Investigators

Principal Investigator: Ángel Arenal, MD, PhD, Hospital General Universitario Gregorio Marañón
Principal Investigator: Gonzalo R Ríos-Muñoz, MSc, PhD, Hospital General Universitario Gregorio Marañón

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Fundacion para la Innovacion en Biomedicina (FIBMED)

ClinicalTrials.gov Identifier:

NCT05077670

Other Study ID Numbers:

Hybrid-AFMAP

First Posted:

Oct 14, 2021

Last Update Posted:

Oct 14, 2021

Last Verified:

Oct 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Keywords provided by Fundacion para la Innovacion en Biomedicina (FIBMED)

Atrial fibrillation

Catheter ablation

Rotors

Additional relevant MeSH terms:

Atrial Fibrillation

Study Results

No Results Posted as of Oct 14, 2021