Randomized phase III clinical trial to compare the efficacy of the two most widely used ablation techniques (cryotherapy and radiofrequency) after recurrence of atrial fibrillation (AF) in patients requiring a new ablation procedure.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
16
Cryotherapy and radiofrequency
Hospital Universitario Virgen de las Nieves Granada
Granada, Andalusia, Spain
Hospital Virgen de la Victoria
Málaga, Andalusia, Spain
Complejo hospitalario universitario de Albacete
Albacete, Castille-La Mancha, Spain
Hospital Virgen de la Salud
Compare the effectiveness of the technique crossover strategy versus the repetition of the same technique for the isolation of the pulmonary veins during a second ablation procedure indicated by recurrence of AF
The rate of recurrent AF will be documented to check whether it is better to cross ablation techniques or not. This efficacy is defined as the absence of documented AF recurrence lasting more than 30 seconds, during a 12-month follow-up after the second ablation procedure.
Time frame: 42 months
To compare the efficacy of the AF re-ablation procedure based on the initial technique and the technique of the second procedure, during a 12-month follow-up after the second ablation procedure.
The patient's events during follow-up will be evaluated through follow-up visits and verification of his medical history and the rate of recurrent AF will be documented.
Time frame: 42 months
Analyze potential predictors of efficacy of each of the techniques based on the anatomy of the left atrium and pulmonary veins. Evaluate the number of reconnected pulmonary veins through cardiac imaging procedures
Evaluate the anatomical location of reconnection in each patient referred for re-ablation, depending on the technique used in the first procedure.
Time frame: 42 months
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Toledo, Castille-La Mancha, Spain
Complejo Hospitalario Universitario de Santiago de Compostela
Santiago de Compostela, Galicia, Spain
Hospital General Universitario de Alicante
Alicante, Valencia, Spain
Hospital Clínico Valencia
Valencia, Valencia, Spain
Hospital 12 de Octubre
Madrid, Spain
Hospital Puerta de Hierro
Madrid, Spain