Spanish Registry of Cryoballoon Ablation

NCT02785991 | Completed Results DMC

• 1 other identifier: RECABA
• Study Type: observational
• Target: 1,742
• Locations: 1 country
• Sites: 28

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.

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• The Acute Efficacy of the Procedure:

  24-48h

• Number of Adverse Events Related to the Procedure

  Up 30 days post procedure

Interventions

Balloon cryoablation PROCEDURE

pulmonary vein cryoablation for atrial fibrillation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• Subjects with a life expectancy of less than 12 months.
• 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.

Sponsors & Collaborators

• Medtronic Cardiac Ablation Solutions: lead
• Medtronic: collaborator

Study Sites (28)

Hospital Trias i Pujol

Badalona, Barcelona, Spain

Location

H. Josep Trueta

Girona, Barcelona, Spain

Location

Hospital Puerta de Hierro

Majadahonda, Madrid, 28222, Spain

Location

H. Universitario de Canarias

San Cristóbal de La Laguna, Santa Cruz De Tenerife, Spain

Location

Hospital Universitario A Coruña

A Coruña, Spain

Location

Hospital Universitario de Araba

Alava, Spain

Location

Hospital Clínico Univeristario San Juan de Alicante

Alicante, Spain

Location

Hospital General Universitario de Alicante

Alicante, Spain

Location

Hospital del Mar

Barcelona, Spain

Location

Clinica Zorrotzaurre

Bilbao, Spain

Location

Hospital de Basurto

Bilbao, Spain

Location

Hospital Universitario Reína Sofía

Córdoba, Spain

Location

Hospital Universitario Virgen De Las Nieves

Granada, Spain

Location

Hospital Juan Ramón Jiménez

Huelva, Spain

Location

H. Universitario Insular de las Palmas

Las Palmas de Gran Canaria, Spain

Location

Fundación Jiménez Díaz

Madrid, Spain

Location

Hospital La Paz

Madrid, Spain

Location

Hospital Universitario Rey Juan Carlos

Madrid, Spain

Location

H. C. U. Virgen de la Victoria

Málaga, Spain

Location

Hospital Virgen de la Arrixaca

Murcia, Spain

Location

Hospital Universitario Son Espases

Palma de Mallorca, Spain

Location

Hospital Universitario Nuestra Señora de Candelaria

Santa Cruz de Tenerife, Spain

Location

Hospital Nisa-Aljarafe

Seville, Spain

Location

Hospital Virgen Macarena

Seville, Spain

Location

H.General de Valencia

Valencia, Spain

Location

Hospital Quirón Salud Valencia

Valencia, Spain

Location

Hospital Universitario Clínico de Valencia

Valencia, Spain

Location

Hospital Universitario y Politécnico de La Fe

Valencia, Spain

Location

Related Publications (2)

• 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.

  PMID: 36908163 DERIVED

• 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.

  PMID: 34446764 DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Patricia Pascual
• Organization: Medtronic Ibérica

patricia.pascual@medtronic.com

636183869

Study Officials

• 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 Clínico de Valencia

  PRINCIPAL INVESTIGATOR

• Arcadio García Alberola, MD

  Hospital Virgen de la Arrixaca

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 25, 2016
• First Posted: May 30, 2016
• Study Start: July 1, 2016
• Primary Completion: April 1, 2020
• Study Completion: April 14, 2021
• Last Updated: March 14, 2025
• Results First Posted: March 15, 2022

Record last verified: 2025-03

Locations

ES (28)