Strategy of Crossing Two Ablation Techniques (Cryoballoon and Radiofrequency) After the Recurrence of Paroxysmal AF and the Need for a New Procedure

Atrial Fibrillation Clinical Trial

— X-TRA  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04877327
• Other study ID #: X-TRA
• Status: Terminated
• Phase: N/A
• Start date: August 31, 2021
• Est. completion date: February 1, 2024

Study information

• Verified date: March 2024
• Source: Galaxia Empírica
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 16
• Est. completion date: February 1, 2024
• Est. primary completion date: February 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Recurrence

Intervention

Procedure:
• Ablation
Cryotherapy and radiofrequency

Locations

Country	Name	City	State
Spain	Complejo hospitalario universitario de Albacete	Albacete	Castilla La Mancha
Spain	Hospital General Universitario de Alicante	Alicante	Comunidad Valenciana
Spain	Hospital Universitario Virgen de las Nieves Granada	Granada	Andalucía
Spain	Hospital 12 de Octubre	Madrid
Spain	Hospital Puerta de Hierro	Madrid
Spain	Hospital Virgen de la Victoria	Málaga	Andalucía
Spain	Complejo Hospitalario Universitario de Santiago de Compostela	Santiago De Compostela	Galicia
Spain	Hospital Virgen de la Salud	Toledo	Castilla La Mancha
Spain	Hospital Clínico Valencia	Valencia	Comunidad Valenciana

Sponsors (1)

Lead Sponsor	Collaborator
Galaxia Empírica

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	42 months
Secondary	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.	42 months
Secondary	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.	42 months