Spanish Registry of Cryoballoon Ablation

NCT ID: NCT02785991

Last Updated: 2025-03-14

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1742 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-07-31
• Study Completion Date: 2021-04-14

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.

Conditions

Atrial Fibrillation

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Interventions

Balloon cryoablation

pulmonary vein cryoablation for atrial fibrillation

Intervention Type: PROCEDURE

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 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medtronic

INDUSTRY

Sponsor Role: collaborator

Medtronic Cardiac Ablation Solutions

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jesús Daniel Martínez Alday, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital de Basurto

Ermengol Vallés, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital del Mar

Rocío Cozar, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Virgen del Rocío

Angel Ferrero, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Clínico de Valencia

Arcadio García Alberola, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Virgen de la Arrixaca

Locations

Hospital Trias i Pujol

Badalona, Barcelona, Spain

H. Josep Trueta

Girona, Barcelona, Spain

Hospital Puerta de Hierro

Majadahonda, Madrid, Spain

H. Universitario de Canarias

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

Hospital Universitario A Coruña

A Coruña, , Spain

Hospital Universitario de Araba

Alava, , Spain

Hospital Clínico Univeristario San Juan de Alicante

Alicante, , Spain

Hospital General Universitario de Alicante

Alicante, , Spain

Hospital del Mar

Barcelona, , Spain

Clinica Zorrotzaurre

Bilbao, , Spain

Hospital de Basurto

Bilbao, , Spain

Hospital Universitario Reína Sofía

Córdoba, , Spain

Hospital Universitario Virgen De Las Nieves

Granada, , Spain

Hospital Juan Ramón Jiménez

Huelva, , Spain

H. Universitario Insular de las Palmas

Las Palmas de Gran Canaria, , Spain

Fundación Jiménez Díaz

Madrid, , Spain

Hospital La Paz

Madrid, , Spain

Hospital Universitario Rey Juan Carlos

Madrid, , Spain

H. C. U. Virgen de la Victoria

Málaga, , Spain

Hospital Virgen de la Arrixaca

Murcia, , Spain

Hospital Universitario Son Espases

Palma de Mallorca, , Spain

Hospital Universitario Nuestra Señora de Candelaria

Santa Cruz de Tenerife, , Spain

Hospital Nisa-Aljarafe

Seville, , Spain

Hospital Virgen Macarena

Seville, , 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

Valencia, , Spain

Countries

Spain

References

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.

Reference Type: DERIVED

PMID: 36908163 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 34446764 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

RECABA

Identifier Type: -

Identifier Source: org_study_id