Status:
TERMINATED
Strategy of Crossing Two Ablation Techniques (Cryoballoon and Radiofrequency) After the Recurrence of Paroxysmal AF and the Need for a New Procedure
Lead Sponsor:
Galaxia Empírica
Conditions:
Atrial Fibrillation
Eligibility:
All Genders
18+ years
Phase:
NA
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 re...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 31 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2024
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT04877327
Start Date
August 31 2021
End Date
February 1 2024
Last Update
March 12 2024
Active Locations (9)
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1
Hospital Universitario Virgen de las Nieves Granada
Granada, Andalusia, Spain
2
Hospital Virgen de la Victoria
Málaga, Andalusia, Spain
3
Complejo hospitalario universitario de Albacete
Albacete, Castille-La Mancha, Spain
4
Hospital Virgen de la Salud
Toledo, Castille-La Mancha, Spain