Strategy of Crossing Two Ablation Techniques (Cryoballoon and Radiofrequency) After the Recurrence of Paroxysmal AF and the Need for a New Procedure
- Conditions
- Atrial Fibrillation
- Interventions
- Procedure: Ablation
- Registration Number
- NCT04877327
- Lead Sponsor
- Galaxia Empírica
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 16
- Paroxysmal FA (one that ends, spontaneously or not, within 7 days of its onset. GUIDELINES ESC FA 2020)
- Have undergone an initial AF ablation procedure using Cryoballoon or point-to-point focal RF within the three years prior to the initial visit.
- During the initial AF ablation procedure ONLY pulmonary vein isolation / ablation will have been performed
- Documented recurrence of AF lasting more than 30 seconds after the first ablation procedure.
- With the ability and willingness to sign the informed consent of the patient.
- With a minimum follow-up capacity of 12 months.
- Patients aged <18 years.
- Previous heart surgery.
- Moderate or severe mitral valve disease.
- Severe dilation of the left atrium, defined as a volume greater than 48 ml / m2 or a left atrial diameter greater than 50 mm in the parasternal long axis.
- Contraindication for anticoagulation.
- Pregnancy or pregnancy intention during the 12-month follow-up.
- Life expectancy less than 12 months.
- Unavailability for follow-up for 12 months.
- Simultaneous participation in another clinical trial
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cross-over of ablation technique Ablation Cross-over of cardiac ablation procedures (cryotherapy and radiofrequency; radiofrequency and cryotherapy)
- Primary Outcome Measures
Name Time Method 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 42 months 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.
- Secondary Outcome Measures
Name Time Method 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. 42 months 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.
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 42 months Evaluate the anatomical location of reconnection in each patient referred for re-ablation, depending on the technique used in the first procedure.
Trial Locations
- Locations (9)
Hospital Virgen de la Victoria
🇪🇸Málaga, Andalucía, Spain
Hospital Universitario Virgen de las Nieves Granada
🇪🇸Granada, Andalucía, Spain
Complejo hospitalario universitario de Albacete
🇪🇸Albacete, Castilla La Mancha, Spain
Hospital General Universitario de Alicante
🇪🇸Alicante, Comunidad Valenciana, Spain
Hospital Virgen de la Salud
🇪🇸Toledo, Castilla La Mancha, Spain
Hospital Clínico Valencia
🇪🇸Valencia, Comunidad Valenciana, Spain
Complejo Hospitalario Universitario de Santiago de Compostela
🇪🇸Santiago De Compostela, Galicia, Spain
Hospital Puerta de Hierro
🇪🇸Madrid, Spain
Hospital 12 de Octubre
🇪🇸Madrid, Spain