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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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05077670
Acronym
Hybrid-AFMAP
Enrollment
50
Registered
2021-10-14
Start date
2021-09-01
Completion date
2023-09-01
Last updated
2022-12-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Persistent Atrial Fibrillation

Keywords

Atrial fibrillation, Catheter ablation, Rotors

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.

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.

Interventions

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

DEVICEAtrial substrate mapping

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

Sponsors

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

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years

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

Design outcomes

Primary

MeasureTime frameDescription
CartoFinder and COHERENT tools utility assessment2 yearsTo evaluate the utility of CartoFinder and COHERENT tools in the identification of the mechanisms that maintain atrial fibrillation.

Secondary

MeasureTime frameDescription
Atrial fibrillation driver location analysis2 yearsReentrant driver location relationship with lines of block, wavefront curvature, and slow conduction areas during SR pacing with success AF termination.

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026