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

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

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 Overview

• Status: Terminated
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Procedure: Ablation

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Naiara García; Phone Number: +34 637213101; Email: naiara@pinvestiga.com

Study Locations

• Spain
  • Madrid, Spain
    • Hospital 12 de Octubre
  • Madrid, Spain
    • Hospital Puerta de Hierro
  • Andalucía
    • Granada, Andalucía, Spain
      • Hospital Universitario Virgen de las Nieves Granada
    • Málaga, Andalucía, Spain
      • Hospital Virgen de la Victoria
  • Castilla La Mancha
    • Albacete, Castilla La Mancha, Spain
      • Complejo Hospitalario Universitario de Albacete
    • Toledo, Castilla La Mancha, Spain
      • Hospital Virgen De La Salud
  • Comunidad Valenciana
    • Alicante, Comunidad Valenciana, Spain
      • Hospital General Universitario de Alicante
    • Valencia, Comunidad Valenciana, Spain
      • Hospital Clinico Valencia
  • Galicia
    • Santiago De Compostela, Galicia, Spain
      • Complejo Hospitalario Universitario De Santiago De Compostela

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cross-over of ablation technique; Cross-over of cardiac ablation procedures (cryotherapy and radiofrequency; radiofrequency and cryotherapy)	Procedure: Ablation; Cryotherapy and radiofrequency
No Intervention: Repetition of the same technique; Repeat the same procedure (cryotherapy and cryotherapy; radiofrequency and radiofrequency)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Galaxia Empírica
• Collaborators: Galaxia Empírica

Study record dates

Study Major Dates

• Study Start (Actual): August 31, 2021
• Primary Completion (Actual): February 1, 2024
• Study Completion (Actual): February 1, 2024

Study Registration Dates

• First Submitted: April 28, 2021
• First Submitted That Met QC Criteria: May 3, 2021
• First Posted (Actual): May 7, 2021

Study Record Updates

• Last Update Posted (Actual): March 12, 2024
• Last Update Submitted That Met QC Criteria: March 8, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Disease Attributes; Arrhythmias, Cardiac; Atrial Fibrillation; Recurrence
• Other Study ID Numbers: X-TRA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No