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CompletedNCT03388333Updated Jun 7, 2019

Biomarkers in Patients Undergoing Atrial Fibrillation Ablation

An observational study in Atrial Fibrillation, sponsored by Universitätsklinikum Hamburg-Eppendorf. Completed at 1 site in Germany. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2019-06-07.

Sponsored by Universitätsklinikum Hamburg-Eppendorf · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
300
Ages
18 Years to 80 Years
Sex
All
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Study summary

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

Read the 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.

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Conditions studied

  • Atrial Fibrillation

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03

In context

Atrial Fibrillation

3,957 studies on the registry are indexed under Atrial Fibrillation; 933 are open to participants now.

This study's enrollment of 300 is close to the median of 300 across 1,390 observational studies indexed under Atrial Fibrillation.

Browse Atrial Fibrillation studies →

Lead sponsor

Universitätsklinikum Hamburg-Eppendorf is the lead sponsor of 415 studies on the registry; 85 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Patients with atrial fibrillation schedulded for pulmonary vein isolation

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
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Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
300 participants (actual)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • 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

Interventions

  • ProcedureCatheter Ablation
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What researchers measure

Primary outcomes

  1. Number of patients with short term reoccurrences of atrial fibrillation after ablation.

    Holter ECGs and ECGs after atrial fibrillation ablation

    Time frame: 3 months

Secondary outcomes

  1. Change in heart rate after pulmonary vein isolation

    Heart rates are recorded at admission and release from the hospital.

    Time frame: 3 days.

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Study locations

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

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 7, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03388333
Responsible party
Prof. Dr. Christian Meyer (Prof. Dr. Christian Meyer, Universitätsklinikum Hamburg-Eppendorf) — Principal investigator
First posted
Jan 2, 2018
Start date
Jan 2017
Primary completion
Jul 2018
Completion
Apr 2019
Last update
Jun 7, 2019

Study contacts

Christian Meyer, Prof. Dr.
principal investigator · Germany Department of Cardiology - Electrophysiology, University Heart Centre

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2018. You cannot join it, but the record below documents what was studied.

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