Spanish Registry of Cryoballoon Ablation

Atrial Fibrillation Clinical Trial

— RECABA  

Official title:

Prospective Observational Study of Pulmonary Vein Cryoablation in Subjects With Atrial Fibrillation (AF) in Spain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02785991
• Other study ID #: RECABA
• Status: Completed
• Start date: July 2016
• Est. completion date: April 14, 2021

Study information

• Verified date: November 2021
• Source: Medtronic Bakken Research Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1742
• Est. completion date: April 14, 2021
• Est. primary completion date: April 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Procedure:
• Balloon cryoablation
pulmonary vein cryoablation for atrial fibrillation

Locations

Country	Name	City	State
Spain	Hospital Universitario de Araba	Alava
Spain	Hospital Clínico Univeristario San Juan de Alicante	Alicante
Spain	Hospital General Universitario de Alicante	Alicante
Spain	Hospital Trias i Pujol	Badalona	Barcelona
Spain	Hospital del Mar	Barcelona
Spain	Clinica Zorrotzaurre	Bilbao
Spain	Hospital de Basurto	Bilbao
Spain	Hospital Universitario Reína Sofía	Córdoba
Spain	Hospital Universitario A Coruña	Coruña
Spain	H. Josep Trueta	Gerona	Barcelona
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	Hospital Puerta de Hierro	Majadahonda	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	H. Universitario de Canarias	San Cristobal de la Laguna	Santa Cruz De Tenerife
Spain	Hospital Universitario Nuestra Señora de Candelaria	Santa Cruz de Tenerife
Spain	Hospital Nisa-Aljarafe	Sevilla
Spain	Hospital Virgen Macarena	Sevilla
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

Sponsors (2)

Lead Sponsor	Collaborator
Medtronic Bakken Research Center	Medtronic

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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