Atrial Fibrillation
Conditions
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.
Interventions
PROCEDUREAblation
Cryotherapy and radiofrequency
Sponsors
Galaxia Empírica
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Spain
Outcome results
None listed