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Hybrid Characterization of Driver Sites During Atrial Fibrillation and Sinus Rhythm

NCT ID: NCT05077670

Last Updated: 2022-12-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-09-01

Study Completion Date

2023-09-01

Brief Summary

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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

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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

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Persistent Atrial Fibrillation

Keywords

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Atrial fibrillation Catheter ablation Rotors

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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

Pulmonary vein electrical isolation

Intervention Type PROCEDURE

Electrical isolation of the pulmonary veins from the left atrium with cryoablation therapy.

Atrial substrate mapping

Intervention Type DEVICE

Electro-anatomical maps will be performed with CARTO navigation system with multi-electrode catheters.

Interventions

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Pulmonary vein electrical isolation

Electrical isolation of the pulmonary veins from the left atrium with cryoablation therapy.

Intervention Type PROCEDURE

Atrial substrate mapping

Electro-anatomical maps will be performed with CARTO navigation system with multi-electrode catheters.

Intervention Type DEVICE

Other Intervention Names

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Pulmonary veins ablation Electro-anatomical mapping

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Biosense Webster, Inc.

INDUSTRY

Sponsor Role collaborator

Fundacion para la Innovacion en Biomedicina (FIBMED)

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ángel Arenal, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Hospital General Universitario Gregorio Marañón

Gonzalo R Ríos-Muñoz, MSc, PhD

Role: PRINCIPAL_INVESTIGATOR

Hospital General Universitario Gregorio Marañón

Locations

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Hospital General Universitario Gregorio Marañón

Madrid, , Spain

Site Status

Countries

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Spain

Other Identifiers

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Hybrid-AFMAP

Identifier Type: -

Identifier Source: org_study_id