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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-31

Study Completion Date

2024-02-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Atrial Fibrillation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Cross-over of ablation technique

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

Group Type EXPERIMENTAL

Ablation

Intervention Type PROCEDURE

Cryotherapy and radiofrequency

Repetition of the same technique

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Ablation

Cryotherapy and radiofrequency

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No