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NCT03388333 Clinical Trial

Biomarkers in Patients Undergoing Atrial Fibrillation Ablation

Atrial Fibrillation Clinical Trial

Official title:
A Single-center Observational Study to Find Biomarkers for the Outcome of Catheter Ablation in Patients With Atrial Fibrillation

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03388333
Other study ID # D4/17-06
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 2017
Est. completion date April 2019

Study information
Verified date October 2018
Source Universitätsklinikum Hamburg-Eppendorf
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 300
Est. completion date April 2019
Est. primary completion date July 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Procedure:
• Catheter Ablation

Locations
Country Name City State
Germany Department of Cardiology - Electrophysiology, University Heart Centre, University Hospital Hamburg-Eppendorf Hamburg

Sponsors (1)
Lead Sponsor Collaborator
Universitätsklinikum Hamburg-Eppendorf

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of patients with short term reoccurrences of atrial fibrillation after ablation. Holter ECGs and ECGs after atrial fibrillation ablation 3 months
Secondary Change in heart rate after pulmonary vein isolation Heart rates are recorded at admission and release from the hospital. 3 days.
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