CArdioSurgEry Atrial Fibrillation Register

Atrial Fibrillation Clinical Trial

— CASE-AF  

Official title:

CArdioSurgEry Atrial Fibrillation Register - CASE-AF Register

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03091452
• Other study ID #: CASE-AF
• Status: Recruiting
• Start date: January 2017
• Est. completion date: December 2025

Study information

• Verified date: April 2024
• Source: Stiftung Institut fuer Herzinfarktforschung
• Contact: Belgin Özdemir
• Phone: 00496215032888
• Email: oezdemir[@]stiftung-ihf.de
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

CASE AF aims to describe the reality of medical care of patients in whom atrial fibrillation is treated by cardiac surgical ablation.

Description:

CASE AF aims to describe the reality of medical care of patients in whom atrial fibrillation is treated by cardiac surgical ablation. In particular, the following questions should be answered:

• Indication: Which are the different indications for cardiac surgical ablation in patients with atrial fibrillation?

• How often and in which patients the different concepts of surgery and ablation procedures are used? At the same time, how often an intervention at the left atrial appendage is carried out?

• Safety: How secure is the cardiac surgical ablation of atrial fibrillation (periprocedural, during hospital stay and during the long-term follow up)?

• Effectiveness: How effectively is the cardiac surgical ablation of atrial fibrillation (procedural success)? How often are AF recurrences in the long-term follow up?

• What is the concommitant medical treatment after surgical ablation?

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: December 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

• Atrial fibrilation

• Treated by cardiac surgical ablation

Exclusion Criteria:

• Patient denies participation

Related Conditions & MeSH terms

• Atrial Fibrillation

Locations

Country	Name	City	State
Germany	Schüchtermann Kliniken	Bad Rothenfelde	NRW
Germany	Asklepios Harburg	Hamburg
Germany	Klinikum Bogenhausen	Munchen	Bayern

Sponsors (1)

Lead Sponsor	Collaborator
Stiftung Institut fuer Herzinfarktforschung

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of major bleeding events	Documentation of procedural results and clinical short-and long-term results of the documented therapies	12 months
Secondary	Number of major adverse cardiac events	Documentation of procedural results and clinical short-and long-term results of the documented therapies	12 months
Secondary	Complications during hospital stay	Documentation of hospital mortality, nonfatal major complications	12 months