Clinical trial NCT04877327: Strategy of Crossing Two Ablation Techniques (Cryoballoon and Radiofrequency) After the Recurrence of Paroxysmal AF and the Need for a New Procedure
Official title: X-TRA CLINICAL TRIAL (X-therapy for Redo AF Ablation). Strategy of Crossing Two Ablation Techniques (Cryoballoon and Radiofrequency) After the Recurrence of Paroxysmal AF and the Need for a New Procedure
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Atrial Fibrillation
Lead sponsor: Galaxia Empírica
Sponsor class: NETWORK
First posted: 2021-05-07
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: 42 months
Secondary outcomes:
measure: 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.
timeFrame: 42 months
measure: 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
timeFrame: 42 months
Other outcomes:
Locations:
city: Granada
country: Spain
facility: Hospital Universitario Virgen de las Nieves Granada
state: Andalucía
city: Málaga
country: Spain
facility: Hospital Virgen de la Victoria
state: Andalucía
city: Albacete
country: Spain
facility: Complejo hospitalario universitario de Albacete
state: Castilla La Mancha
city: Toledo
country: Spain
facility: Hospital Virgen de la Salud
state: Castilla La Mancha
city: Alicante
country: Spain
facility: Hospital General Universitario de Alicante
state: Comunidad Valenciana
city: Valencia
country: Spain
facility: Hospital Clínico Valencia
state: Comunidad Valenciana
city: Santiago De Compostela
country: Spain
facility: Complejo Hospitalario Universitario de Santiago de Compostela
state: Galicia
city: Madrid
country: Spain
facility: Hospital 12 de Octubre
city: Madrid
country: Spain
facility: Hospital Puerta de Hierro
Study officials:
References: