Biomarkers in Patients Undergoing Atrial Fibrillation Ablation

Completed

• Conditions: Atrial Fibrillation
• Interventions: Procedure: Catheter Ablation

• Registration Number: NCT03388333
• Lead Sponsor: Universitätsklinikum Hamburg-Eppendorf

Brief Summary

The investigators aim to find biomarkers to determine the success of pulmonary vein isolation for the treatment of atrial fibrillation.

Detailed Description

The investigators perform an observational study in patients undergoing pulmonary vein ablation to treat atrial fibrillation. Additionally, electrophysiological procedures not related to pulmonary vein isolation are also followed. The aim of the study is finding biomarkers that are able to predict short-term outcome of the procedure.The primary endpoint is defined as reoccurrences of atrial fibrillation within the first three months after pulmonary vein isolation.

Study Timeline

• Study Start: 2017-01
• Study First Submitted: 2017-12-22
• Study First Submitted QC: 2017-12-22
• Study First Posted: 2018-01-02
• Primary Completion: 2018-07
• Status Verified: 2018-10
• Study Completion: 2019-04
• Last Update Submitted: 2019-06-06
• Last Update Posted: 2019-06-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• patients with atrial fibrillation scheduled for pulmonary vein isolation with either radiofrequency of cryoballoon
• patients scheduled for an electrophysiological study without ablation
• patients with a catheter ablation at the cavotricuspid isthmus for the treatment of right atrial flutter

Exclusion Criteria

• patients with concurrent pulmonary vein isolation and ablation of the cavotricuspid isthmus
• Acute myocardial infarction, coronary artery bypass graft surgery or open heart surgery within less than 3 months prior to inclusion

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Atrial fibrillation ablation group	Catheter Ablation	Patients undergoing catheter ablation for the treatment of atrial fibrillation.
Atrial flutter ablation group	Catheter Ablation	Patients undergoing catheter ablation of right atrial flutter at the cavotricuspid isthmus.

Primary Outcome Measures

Name	Time	Method
Number of patients with short term reoccurrences of atrial fibrillation after ablation.	3 months	Holter ECGs and ECGs after atrial fibrillation ablation

Secondary Outcome Measures

Name	Time	Method
Change in heart rate after pulmonary vein isolation	3 days.	Heart rates are recorded at admission and release from the hospital.

Trial Locations

Locations (1)

Department of Cardiology - Electrophysiology, University Heart Centre, University Hospital Hamburg-Eppendorf; 🇩🇪 Hamburg, Germany