Atrial FibrillationX-TRANCT04877327
Strategy of Crossing Two Ablation Techniques (Cryoballoon and Radiofrequency) After the Recurrence of Paroxysmal AF and the Need for a New Procedure
A study testing Ablation in people with Atrial Fibrillation, run by Galaxia Empírica at 9 sites in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Ablation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 9 sitesSpain
- Study dates
- 31 Aug 2021to 1 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- Life expectancy less than 12 months.
- Unavailability for follow-up for 12 months.
- Simultaneous participation in another clinical trial
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
Spain9 sites
Complejo hospitalario universitario de Albacete
Albacete, Castille-La Mancha
Hospital General Universitario de Alicante
Alicante, Valencia
Hospital Universitario Virgen de las Nieves Granada
Granada, Andalusia
Hospital 12 de Octubre
Madrid
Hospital Puerta de Hierro
Madrid
Hospital Virgen de la Victoria
Málaga, Andalusia
Complejo Hospitalario Universitario de Santiago de Compostela
Santiago de Compostela, Galicia
Hospital Virgen de la Salud
Toledo, Castille-La Mancha
Hospital Clínico Valencia
Valencia, Valencia
About this study
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
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.
- Conditions
- Atrial Fibrillation
- Being tested
- Ablation
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AblationProcedure or surgery
Cryotherapy and radiofrequency
| Study group | Role | What they receive |
|---|---|---|
| Cross-over of ablation technique | Experimental | Cross-over of cardiac ablation procedures (cryotherapy and radiofrequency; radiofrequency and cryotherapy) Receives: Procedure: Ablation |
| Repetition of the same technique | No intervention | Repeat the same procedure (cryotherapy and cryotherapy; radiofrequency and radiofrequency) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 42 months
Secondary outcomes (2)
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.
Measured: 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
Evaluate the anatomical location of reconnection in each patient referred for re-ablation, depending on the technique used in the first procedure.
Measured: 42 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2021
- Study start31 Aug 2021
- Primary completion1 Feb 2024
- Study completion1 Feb 2024
Why it stopped: Low recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Galaxia Empírica
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04877327
- Sponsor's protocol ID
- X-TRA
- Acronym
- X-TRA
- Status last verified
- Mar 2024
- First submitted
- 28 Apr 2021
- Last updated
- 12 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04877327
- Acronym / sponsor ID
- X-TRA / X-TRA
- Conditions
- Atrial Fibrillation
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low recruitment
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Galaxia EmpíricaResearch network
- Study start
- 31 Aug 2021 (actual)
- Primary completion
- 1 Feb 2024 (actual)
- Study completion
- 1 Feb 2024 (actual)
- First posted
- 7 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cross-over of ablation technique | Experimental | Procedure: AblationCross-over of cardiac ablation procedures (cryotherapy and radiofrequency; radiofrequency and cryotherapy) |
| Repetition of the same technique | No intervention | –Repeat the same procedure (cryotherapy and cryotherapy; radiofrequency and radiofrequency) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AblationCryotherapy and radiofrequency | Procedure or surgery | Cross-over of ablation technique |
Primary outcome
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.
2 secondary outcomes
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
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
Results and safety
The study was stopped early (reason given: Low recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ablation in people with Atrial Fibrillation, run by Galaxia Empírica at 9 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 12 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Low recruitment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2024.