Clinical trial NCT02785991: Spanish Registry of Cryoballoon Ablation
Official title: Prospective Observational Study of Pulmonary Vein Cryoablation in Subjects With Atrial Fibrillation (AF) in Spain
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrillation
Lead sponsor: Medtronic Cardiac Ablation Solutions
Sponsor class: INDUSTRY
Collaborators: name: Medtronic
First posted: 2016-05-30
Enrollment: 1742
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
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.

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* Signature of the Data Release Form
* Subjects ≥ 18 years old
* Subjects who meet the indication for the Cryoballoon Ablation procedure.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: The Efficacy of the Cryoablation Procedure at 12 Months, Defined as the Absence of Recurrences of Atrial Fibrillation.
timeFrame: 12 months
Secondary outcomes:
measure: The Acute Efficacy of the Procedure:
timeFrame: 24-48h
measure: Number of Adverse Events Related to the Procedure
timeFrame: Up 30 days post procedure
Other outcomes:
Locations:
city: Badalona
country: Spain
facility: Hospital Trias i Pujol
state: Barcelona
city: Gerona
country: Spain
facility: H. Josep Trueta
state: Barcelona
city: Majadahonda
country: Spain
facility: Hospital Puerta de Hierro
state: Madrid
city: San Cristobal de la Laguna
country: Spain
facility: H. Universitario de Canarias
state: Santa Cruz De Tenerife
city: Alava
country: Spain
facility: Hospital Universitario de Araba
city: Alicante
country: Spain
facility: Hospital Clínico Univeristario San Juan de Alicante
city: Alicante
country: Spain
facility: Hospital General Universitario de Alicante
city: Barcelona
country: Spain
facility: Hospital del Mar
city: Bilbao
country: Spain
facility: Clinica Zorrotzaurre
city: Bilbao
country: Spain
facility: Hospital de Basurto
city: Coruña
country: Spain
facility: Hospital Universitario A Coruña
city: Córdoba
country: Spain
facility: Hospital Universitario Reína Sofía
city: Granada
country: Spain
facility: Hospital Universitario Virgen De Las Nieves
city: Huelva
country: Spain
facility: Hospital Juan Ramón Jiménez
city: Las Palmas de Gran Canaria
country: Spain
facility: H. Universitario Insular de las Palmas
city: Madrid
country: Spain
facility: Fundación Jiménez Díaz
city: Madrid
country: Spain
facility: Hospital La Paz
city: Madrid
country: Spain
facility: Hospital Universitario Rey Juan Carlos
city: Murcia
country: Spain
facility: Hospital Virgen de la Arrixaca
city: Málaga
country: Spain
facility: H. C. U. Virgen de la Victoria
city: Palma de Mallorca
country: Spain
facility: Hospital Universitario Son Espases
city: Santa Cruz de Tenerife
country: Spain
facility: Hospital Universitario Nuestra Señora de Candelaria
city: Sevilla
country: Spain
facility: Hospital Nisa-Aljarafe
city: Sevilla
country: Spain
facility: Hospital Virgen Macarena
city: Valencia
country: Spain
facility: H.General de Valencia
city: Valencia
country: Spain
facility: Hospital Quirón Salud Valencia
city: Valencia
country: Spain
facility: Hospital Universitario Clínico de Valencia
city: Valencia
country: Spain
facility: Hospital Universitario y Politécnico de La Fe
Study officials:
affiliation: Hospital de Basurto
name: Jesús Daniel Martínez Alday, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital del Mar
name: Ermengol Vallés, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Virgen del Rocío
name: Rocío Cozar, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Clínico de Valencia
name: Angel Ferrero, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Virgen de la Arrixaca
name: Arcadio García Alberola, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ferrero-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.