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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05077670
Other study ID # Hybrid-AFMAP
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
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
Health authority
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
Accepts healthy volunteers
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

Study Design


Related Conditions & MeSH terms


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
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