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

NCT04877327 | Terminated

• 1 other identifier: X-TRA
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 9

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.

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

• 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

Study Arms (2)

Cross-over of ablation technique

EXPERIMENTAL

Cross-over of cardiac ablation procedures (cryotherapy and radiofrequency; radiofrequency and cryotherapy)

Procedure: Ablation

Repetition of the same technique

NO INTERVENTION

Repeat the same procedure (cryotherapy and cryotherapy; radiofrequency and radiofrequency)

Interventions

Ablation PROCEDURE

Cryotherapy and radiofrequency

Cross-over of ablation technique

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Galaxia Empírica: lead

Study Sites (9)

Hospital Universitario Virgen de las Nieves Granada

Granada, Andalusia, Spain

Location

Hospital Virgen de la Victoria

Málaga, Andalusia, Spain

Location

Complejo hospitalario universitario de Albacete

Albacete, Castille-La Mancha, Spain

Location

Hospital Virgen de la Salud

Toledo, Castille-La Mancha, Spain

Location

Complejo Hospitalario Universitario de Santiago de Compostela

Santiago de Compostela, Galicia, Spain

Location

Hospital General Universitario de Alicante

Alicante, Valencia, Spain

Location

Hospital Clínico Valencia

Valencia, Valencia, Spain

Location

Hospital 12 de Octubre

Madrid, Spain

Location

Hospital Puerta de Hierro

Madrid, Spain

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2021
• First Posted: May 7, 2021
• Study Start: August 31, 2021
• Primary Completion: February 1, 2024
• Study Completion: February 1, 2024
• Last Updated: March 12, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (9)