Back to resultsStrategy of Crossing Two Ablation Techniques (Cryoballoon and Radiofrequency) After the Recurrence of Paroxysmal AF and the Need for a New Procedure (X-TRA)
Primary Purpose
Atrial Fibrillation
Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Ablation
Sponsored by
About this trial
This is an interventional treatment trial for Atrial Fibrillation
Eligibility Criteria
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
Sites / Locations
- Hospital Universitario Virgen de las Nieves GranadaRecruiting
- Hospital Virgen de la VictoriaRecruiting
- Complejo hospitalario universitario de AlbaceteRecruiting
- Hospital Virgen de la SaludRecruiting
- Hospital General Universitario de AlicanteRecruiting
- Hospital Clínico ValenciaRecruiting
- Complejo Hospitalario Universitario de Santiago de CompostelaRecruiting
- Hospital 12 de Octubre
- Hospital Puerta de HierroRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Cross-over of ablation technique
Repetition of the same technique
Arm Description
Cross-over of cardiac ablation procedures (cryotherapy and radiofrequency; radiofrequency and cryotherapy)
Repeat the same procedure (cryotherapy and cryotherapy; radiofrequency and radiofrequency)
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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
Evaluate the anatomical location of reconnection in each patient referred for re-ablation, depending on the technique used in the first procedure.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04877327
Brief Title
Strategy of Crossing Two Ablation Techniques (Cryoballoon and Radiofrequency) After the Recurrence of Paroxysmal AF and the Need for a New Procedure
Acronym
X-TRA
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 31, 2021 (Actual)
Primary Completion Date
September 2024 (Anticipated)
Study Completion Date
January 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Galaxia Empírica
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
202 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Cross-over of ablation technique
Arm Type
Experimental
Arm Description
Cross-over of cardiac ablation procedures (cryotherapy and radiofrequency; radiofrequency and cryotherapy)
Arm Title
Repetition of the same technique
Arm Type
No Intervention
Arm Description
Repeat the same procedure (cryotherapy and cryotherapy; radiofrequency and radiofrequency)
Intervention Type
Procedure
Intervention Name(s)
Ablation
Intervention Description
Cryotherapy and radiofrequency
Primary Outcome Measure Information:
Title
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
Description
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.
Time Frame
42 months
Secondary Outcome Measure Information:
Title
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.
Description
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.
Time Frame
42 months
Title
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
Description
Evaluate the anatomical location of reconnection in each patient referred for re-ablation, depending on the technique used in the first procedure.
Time Frame
42 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Naiara García
Phone
+34 637213101
Email
naiara@pinvestiga.com
Facility Information:
Facility Name
Hospital Universitario Virgen de las Nieves Granada
City
Granada
State/Province
Andalucía
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Miguel Álvarez, MD
Facility Name
Hospital Virgen de la Victoria
City
Málaga
State/Province
Andalucía
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alberto Barrera, MD
Facility Name
Complejo hospitalario universitario de Albacete
City
Albacete
State/Province
Castilla La Mancha
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Víctor Hidalgo Olivares, MD
Facility Name
Hospital Virgen de la Salud
City
Toledo
State/Province
Castilla La Mancha
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Miguel Ángel Arias Palomares, MD
Facility Name
Hospital General Universitario de Alicante
City
Alicante
State/Province
Comunidad Valenciana
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alicia Ibánez Criado, MD
Facility Name
Hospital Clínico Valencia
City
Valencia
State/Province
Comunidad Valenciana
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ricardo Ruiz Granell, MD
Facility Name
Complejo Hospitalario Universitario de Santiago de Compostela
City
Santiago De Compostela
State/Province
Galicia
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Moisés Rodríguez Mañero, MD
Facility Name
Hospital 12 de Octubre
City
Madrid
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Luis Borrego, MD
Facility Name
Hospital Puerta de Hierro
City
Madrid
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jorge Toquero, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Strategy of Crossing Two Ablation Techniques (Cryoballoon and Radiofrequency) After the Recurrence of Paroxysmal AF and the Need for a New Procedure
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