Spanish Registry of Cryoballoon Ablation (RECABA)

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.

Study Overview

• Status: Completed
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Procedure: Balloon cryoablation

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 Type: Observational
• Enrollment (Actual): 1742

Contacts and Locations

Study Locations

• Spain
  • Alava, Spain
    • Hospital Universitario de Araba
  • Alicante, Spain
    • Hospital General Universitario de Alicante
  • Alicante, Spain
    • Hospital Clínico Univeristario San Juan de Alicante
  • Barcelona, Spain
    • Hospital Del Mar
  • Bilbao, Spain
    • Hospital De Basurto
  • Bilbao, Spain
    • Clinica Zorrotzaurre
  • Coruña, Spain
    • Hospital Universitario A Coruña
  • Córdoba, Spain
    • Hospital Universitario Reina Sofia
  • Granada, Spain
    • Hospital Universitario Virgen de las Nieves
  • Huelva, Spain
    • Hospital Juan Ramón Jimenez
  • Las Palmas de Gran Canaria, Spain
    • H. Universitario Insular de las Palmas
  • Madrid, Spain
    • Fundacion Jimenez Diaz
  • Madrid, Spain
    • Hospital La Paz
  • Madrid, Spain
    • Hospital Universitario Rey Juan carlos
  • Murcia, Spain
    • Hospital Virgen de la Arrixaca
  • Málaga, Spain
    • H. C. U. Virgen de la Victoria
  • Palma de Mallorca, Spain
    • Hospital Universitario Son Espases
  • Santa Cruz de Tenerife, Spain
    • Hospital Universitario Nuestra Señora de Candelaria
  • Sevilla, Spain
    • Hospital Nisa-Aljarafe
  • Sevilla, Spain
    • Hospital Virgen Macarena
  • Valencia, Spain
    • H.General de Valencia
  • Valencia, Spain
    • Hospital Quirón Salud Valencia
  • Valencia, Spain
    • Hospital Universitario Clínico de Valencia
  • Valencia, Spain
    • Hospital Universitario y Politécnico de La Fe
  • Barcelona
    • Badalona, Barcelona, Spain
      • Hospital Trías i Pujol
    • Gerona, Barcelona, Spain
      • H. Josep Trueta
  • Madrid
    • Majadahonda, Madrid, Spain, 28222
      • Hospital Puerta de Hierro
  • Santa Cruz De Tenerife
    • San Cristobal de la Laguna, Santa Cruz De Tenerife, Spain
      • H. Universitario de Canarias

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	24-48h
Number of Adverse Events Related to the Procedure	The outcome measure is the number of Adverse Events Related to the Procedure	Up 30 days post procedure

Collaborators and Investigators

• Sponsor: Medtronic Bakken Research Center
• Collaborators: Medtronic
• Investigators: Principal Investigator: Jesús Daniel Martínez Alday, MD, Hospital De Basurto; Principal Investigator: Ermengol Vallés, MD, Hospital Del Mar; Principal Investigator: Rocío Cozar, MD, Hospital Virgen del Rocío; Principal Investigator: Angel Ferrero, MD, Hospital Clinico de Valencia; Principal Investigator: Arcadio García Alberola, MD, Hospital Virgen de la Arrixaca

Publications and helpful links

General Publications

• Ferrero-De-Loma-Osorio Á, Cózar R, García-Alberola A, Valles E, Barrera A, Toquero J, Ormaetxe JM, Sánchez JM, Ruiz-Granell R, Amador PB, Rubio JM, Martí-Amor J, Pascual P, Molina I, Martínez-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.

Study record dates

Study Major Dates

• Study Start: July 1, 2016
• Primary Completion (Actual): April 1, 2020
• Study Completion (Actual): April 14, 2021

Study Registration Dates

• First Submitted: May 25, 2016
• First Submitted That Met QC Criteria: May 27, 2016
• First Posted (Estimate): May 30, 2016

Study Record Updates

• Last Update Posted (Actual): March 15, 2022
• Last Update Submitted That Met QC Criteria: January 14, 2022
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: RECABA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: Study Protocol

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