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

Galaxia Empírica

Status

Terminated

Conditions

Atrial Fibrillation

Treatments

Procedure: Ablation

Study type

Interventional

Funder types

NETWORK

Identifiers

NCT04877327

X-TRA

Details and patient eligibility

About

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.

Enrollment

16 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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