Persistent Atrial Fibrillation Clinical Trial
— Hybrid-AFMAPOfficial title:
Hybrid Characterization of Driver Sites During Atrial Fibrillation and Sinus Rhythm With CARTOFINDER and COHERENT Mapping
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] |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Spain | Hospital General Universitario Gregorio Marañón | Madrid |
Lead Sponsor | Collaborator |
---|---|
Fundacion para la Innovacion en Biomedicina (FIBMED) | Biosense Webster, Inc. |
Spain,
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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