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

March 8, 2024 updated by: Galaxia Empírica

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

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
16

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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
Time Frame: 42 months

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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.
Time Frame: 42 months
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
Time Frame: 42 months
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Galaxia Empírica

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Galaxia Empírica

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 31, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 28, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 3, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 7, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 12, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 8, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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