Biomarkers in Patients Undergoing Atrial Fibrillation Ablation

June 6, 2019 updated by: Prof. Dr. Christian Meyer, Universitätsklinikum Hamburg-Eppendorf

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Hamburg, Germany, 20246
        • Department of Cardiology - Electrophysiology, University Heart Centre, University Hospital Hamburg-Eppendorf

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with atrial fibrillation schedulded for pulmonary vein isolation

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Atrial fibrillation ablation group
Patients undergoing catheter ablation for the treatment of atrial fibrillation.
Procedure: Catheter Ablation
Electrophysiological study group
Patients undergoing a diagnostic electrophysiological study without ablation.
Atrial flutter ablation group
Patients undergoing catheter ablation of right atrial flutter at the cavotricuspid isthmus.
Procedure: Catheter Ablation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of patients with short term reoccurrences of atrial fibrillation after ablation.
Time Frame: 3 months
Holter ECGs and ECGs after atrial fibrillation ablation
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in heart rate after pulmonary vein isolation
Time Frame: 3 days.
Heart rates are recorded at admission and release from the hospital.
3 days.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitätsklinikum Hamburg-Eppendorf

Investigators

  • Principal Investigator: Christian Meyer, Prof. Dr., Germany Department of Cardiology - Electrophysiology, University Heart Centre

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2017

Primary Completion (Actual)

July 1, 2018

Study Completion (Actual)

April 1, 2019

Study Registration Dates

First Submitted

December 22, 2017

First Submitted That Met QC Criteria

December 22, 2017

First Posted (Actual)

January 2, 2018

Study Record Updates

Last Update Posted (Actual)

June 7, 2019

Last Update Submitted That Met QC Criteria

June 6, 2019

Last Verified

October 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D4/17-06

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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