Atrial FibrillationRECABANCT02785991
Spanish Registry of Cryoballoon Ablation
An observational study of Atrial Fibrillation, run by Medtronic Cardiac Ablation Solutions at 28 sites in Spain.
Trial summary
The purpose of this registry is to reflect on standard clinical practice in pulmonary vein cryoablation in Spanish hospitals, the different procedure protocols, details of intervention, complications, long-term follow-up strategy and results in these subjects. 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?
- Balloon cryoablation
- Type of treatment
- Surgery or procedure
- How many people
- 1,742 participants
- Where
- 28 sitesSpain
- Study dates
- Jul 2016to 14 Apr 2021
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Study population: The sample size will be approximately 1000 subjects who must be enrolled over the two-year period, based on the annual rate of cryoballoon ablations carried out in Spain.
Who may be able to join
- Signature of the Data Release Form
- Subjects ≥ 18 years old
- Subjects who meet the indication for the Cryoballoon Ablation procedure.
Who cannot join
- Subjects with a life expectancy of less than 12 months.
- Subjects who meet the exclusion criteria defined by local legislation (e.g., age, pregnancy, breastfeeding, etc.).
- Subjects who may currently be enrolled, or who plan to take part, in a study with a drug or device that may cause bias during the course of this study.
- Co-participation in concurrent trials is only allowed when documented pre-approval is obtained from the Medtronic study manager.
Trial locations and contacts
28 sites in 1 country.
28 sites in 1 country
Spain28 sites
Hospital Universitario A Coruña
A Coruña
Hospital Universitario de Araba
Alava
Hospital Clínico Univeristario San Juan de Alicante
Alicante
Hospital General Universitario de Alicante
Alicante
Hospital Trias i Pujol
Badalona, Barcelona
Hospital del Mar
Barcelona
Clinica Zorrotzaurre
Bilbao
Hospital de Basurto
Bilbao
Hospital Universitario Reína Sofía
Córdoba
H. Josep Trueta
Girona, Barcelona
Hospital Universitario Virgen De Las Nieves
Granada
Hospital Juan Ramón Jiménez
Huelva
H. Universitario Insular de las Palmas
Las Palmas de Gran Canaria
Fundación Jiménez Díaz
Madrid
Hospital La Paz
Madrid
Hospital Universitario Rey Juan Carlos
Madrid
Hospital Puerta de Hierro
Majadahonda, Madrid, 28222
H. C. U. Virgen de la Victoria
Málaga
Hospital Virgen de la Arrixaca
Murcia
Hospital Universitario Son Espases
Palma de Mallorca
H. Universitario de Canarias
San Cristóbal de La Laguna, Santa Cruz De Tenerife
Hospital Universitario Nuestra Señora de Candelaria
Santa Cruz de Tenerife
Hospital Nisa-Aljarafe
Seville
Hospital Virgen Macarena
Seville
H.General de Valencia
Valencia
Hospital Quirón Salud Valencia
Valencia
Hospital Universitario Clínico de Valencia
Valencia
Hospital Universitario y Politécnico de La Fe
Valencia
About this study
Official title: Prospective Observational Study of Pulmonary Vein Cryoablation in Subjects With Atrial Fibrillation (AF) in Spain
The purpose of this registry is to reflect on standard clinical practice in pulmonary vein cryoablation in Spanish hospitals, the different procedure protocols, details of intervention, complications, long-term follow-up strategy and results in these subjects.
Read the detailed description
With this study the investigators propose the performance of a prospective registry of pulmonary vein cryoablation in subjects with paroxysmal or persistent AF at Spanish sites to estimate evaluate the efficacy of the cryoablation procedure at 12 months, defined as the absence of recurrences of atrial fibrillation.
Secondary objectives are also defined as:
- Description of the profile of subjects who undergo this type of procedure (demographic factors, cardiovascular risk factors, medication, physical activity, sleep apnea, alcohol, smoking, chronic pulmonary disease, obesity, etc.).
- To evaluate the acute efficacy of the procedure: complete isolation of the pulmonary veins demonstrated by the successful electrical disconnection of the pulmonary veins in the cryoablation procedure.
- Description of the complications related to the procedure.
- To evaluate the use of healthcare resources which this cryoablation procedure entails.
- Conditions
- Atrial Fibrillation
- Being tested
- Balloon cryoablation
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Balloon cryoablationProcedure or surgery
pulmonary vein cryoablation for atrial fibrillation
What is being measured
The primary outcome is the main question the study is designed to answer.
The Efficacy of the Cryoablation Procedure at 12 Months, Defined as the Absence of Recurrences of Atrial Fibrillation.
Percentage of patients freedom from Recurrences of Atrial Fibrillation at 12 months (on ECG, Holter monitor with a duration of at least 30 seconds or implantable devices or event recording systems).
Measured: 12 months
Secondary outcomes (2)
The Acute Efficacy of the Procedure:
Complete isolation of the pulmonary veins demonstrated by the successful electrical disconnection of the pulmonary veins in the cryoablation procedure.
Measured: 24-48h
Number of Adverse Events Related to the Procedure
The outcome measure is the number of Adverse Events Related to the Procedure
Measured: Up 30 days post procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2016 (estimated)
- Study startJul 2016
- Primary completionApr 2020
- Study completion14 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Medtronic Cardiac Ablation SolutionsThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 1,742 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Cardiac Ablation Solutions
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Medtronic
- Responsible party
- Sponsor
- Investigators
- Jesús Daniel Martínez Alday, MD, Principal investigator, Hospital de BasurtoErmengol Vallés, MD, Principal investigator, Hospital del MarRocío Cozar, MD, Principal investigator, Hospital Virgen del RocíoAngel Ferrero, MD, Principal investigator, Hospital Clínico de ValenciaArcadio García Alberola, MD, Principal investigator, Hospital Virgen de la Arrixaca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02785991
- Sponsor's protocol ID
- RECABA
- Acronym
- RECABA
- Status last verified
- Mar 2025
- First submitted
- 25 May 2016
- Last updated
- 14 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided: Study Protocol
Publications
Alvarez-Ortega CA, Solorzano Guillen CR, Barrera Cordero A, Toquero Ramos JE, Martinez-Alday JD, Grande Morales CE, Rodriguez Gonzalez A, Garcia Alberola A, Perez Alvarez L, Ferrero de Loma Osorio A, Hernandez Afonso JS, Cozar Leon R, Cano Perez O, Trucco E, Peinado Peinado R. Repeat cryoablation as a redo procedure for atrial fibrillation ablation: Is it a good choice? Cardiol J. 2024;31(2):193-204. doi: 10.5603/CJ.a2023.0017. Epub 2023 Mar 13.
PubMed 36908163Ferrero-De-Loma-Osorio A, Cozar R, Garcia-Alberola A, Valles E, Barrera A, Toquero J, Ormaetxe JM, Sanchez JM, Ruiz-Granell R, Amador PB, Rubio JM, Marti-Amor J, Pascual P, Molina I, Martinez-Alday JD; RECABA Investigators. Primary results of the Spanish Cryoballoon Ablation Registry: acute and long-term outcomes of the RECABA study. Sci Rep. 2021 Aug 26;11(1):17268. doi: 10.1038/s41598-021-96655-3.
PubMed 34446764
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Observational Study of Pulmonary Vein Cryoablation in Subjects With Atrial Fibrillation (AF) in Spain
- ClinicalTrials.gov ID
- NCT02785991
- Acronym / sponsor ID
- RECABA / RECABA
- Conditions
- Atrial Fibrillation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,742 participants (actual)
- Lead sponsor
- Medtronic Cardiac Ablation SolutionsIndustry (pharma, biotech, devices)
- Collaborators
- Medtronic
- Study start
- Jul 2016
- Primary completion
- Apr 2020 (actual)
- Study completion
- 14 Apr 2021 (actual)
- First posted
- 30 May 2016 (estimated)
- Results
- Posted 15 Mar 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this registry is to reflect on standard clinical practice in pulmonary vein cryoablation in Spanish hospitals, the different procedure protocols, details of intervention, complications, long-term follow-up strategy and results in these subjects.
Detailed description
With this study the investigators propose the performance of a prospective registry of pulmonary vein cryoablation in subjects with paroxysmal or persistent AF at Spanish sites to estimate evaluate the efficacy of the cryoablation procedure at 12 months, defined as the absence of recurrences of atrial fibrillation.
Secondary objectives are also defined as:
- Description of the profile of subjects who undergo this type of procedure (demographic factors, cardiovascular risk factors, medication, physical activity, sleep apnea, alcohol, smoking, chronic pulmonary disease, obesity, etc.).
- To evaluate the acute efficacy of the procedure: complete isolation of the pulmonary veins demonstrated by the successful electrical disconnection of the pulmonary veins in the cryoablation procedure.
- Description of the complications related to the procedure.
- To evaluate the use of healthcare resources which this cryoablation procedure entails.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The sample size will be approximately 1000 subjects who must be enrolled over the two-year period, based on the annual rate of cryoballoon ablations carried out in Spain.
Key inclusion criteria (3 listed)
- Signature of the Data Release Form
- Subjects ≥ 18 years old
- Subjects who meet the indication for the Cryoballoon Ablation procedure.
Key exclusion criteria (4 listed)
- Subjects with a life expectancy of less than 12 months.
- Subjects who meet the exclusion criteria defined by local legislation (e.g., age, pregnancy, breastfeeding, etc.).
- Subjects who may currently be enrolled, or who plan to take part, in a study with a drug or device that may cause bias during the course of this study.
- Co-participation in concurrent trials is only allowed when documented pre-approval is obtained from the Medtronic study manager.
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 |
|---|---|---|
| Balloon cryoablationpulmonary vein cryoablation for atrial fibrillation | Procedure or surgery | – |
Primary outcome
The Efficacy of the Cryoablation Procedure at 12 Months, Defined as the Absence of Recurrences of Atrial Fibrillation.
Time frame: 12 months
Percentage of patients freedom from Recurrences of Atrial Fibrillation at 12 months (on ECG, Holter monitor with a duration of at least 30 seconds or implantable devices or event recording systems).
2 secondary outcomes
The Acute Efficacy of the Procedure:
Time frame: 24-48h
Number of Adverse Events Related to the Procedure
Time frame: Up 30 days post procedure
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36908163Alvarez-Ortega CA, Solorzano Guillen CR, Barrera Cordero A, Toquero Ramos JE, Martinez-Alday JD, Grande Morales CE, Rodriguez Gonzalez A, Garcia Alberola A, Perez Alvarez L, Ferrero de Loma Osorio A, Hernandez Afonso JS, Cozar Leon R, Cano Perez O, Trucco E, Peinado Peinado R. Repeat cryoablation as a redo procedure for atrial fibrillation ablation: Is it a good choice? Cardiol J. 2024;31(2):193-204. doi: 10.5603/CJ.a2023.0017. Epub 2023 Mar 13.
- Derived from this study: PubMed 34446764Ferrero-De-Loma-Osorio A, Cozar R, Garcia-Alberola A, Valles E, Barrera A, Toquero J, Ormaetxe JM, Sanchez JM, Ruiz-Granell R, Amador PB, Rubio JM, Marti-Amor J, Pascual P, Molina I, Martinez-Alday JD; RECABA Investigators. Primary results of the Spanish Cryoballoon Ablation Registry: acute and long-term outcomes of the RECABA study. Sci Rep. 2021 Aug 26;11(1):17268. doi: 10.1038/s41598-021-96655-3.
- Individual participant dataSharing planned: Undecided. Study Protocol
Related trials for Atrial Fibrillation
Active, not recruiting
Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
Active, not recruitingObservational study
Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
Concomitant Procedures, Atrial Fibrillation
Active, not recruiting
CONVERGE Post-Approval Study (PAS)
Chronic Atrial Fibrillation
Recruiting
Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
Ischemic Stroke, Atrial Fibrillation
RecruitingPhase 2
Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation
Atrial Fibrillation (AF)
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.
Jesús Daniel Martínez Alday, MD principal investigator
Hospital de Basurto
Ermengol Vallés, MD principal investigator
Hospital del Mar
Rocío Cozar, MD principal investigator
Hospital Virgen del Rocío
28 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation, run by Medtronic Cardiac Ablation Solutions at 28 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 3 inclusion and 4 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: finished, as of the sponsor's last update on 14 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 28 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?
Yes. Results are posted in the registry (first posted 15 Mar 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
The Efficacy of the Cryoablation Procedure at 12 Months, Defined as the Absence of Recurrences of Atrial Fibrillation. (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02785991, which also lists 2 linked publications.
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 14 Mar 2025.