Atrial FibrillationNCT03388333
Biomarkers in Patients Undergoing Atrial Fibrillation Ablation
An observational study of Atrial Fibrillation, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
Trial summary
The investigators aim to find biomarkers to determine the success of pulmonary vein isolation for the treatment of atrial fibrillation. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Catheter Ablation
- Type of treatment
- Surgery or procedure
- How many people
- 300 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2017to Apr 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with atrial fibrillation schedulded for pulmonary vein isolation
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Cardiology - Electrophysiology, University Heart Centre, University Hospital Hamburg-Eppendorf
Hamburg, 20246
About this study
Official title: 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.
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.
- Conditions
- Atrial Fibrillation
- Being tested
- Catheter Ablation
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Catheter AblationProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Atrial fibrillation ablation group | Patients undergoing catheter ablation for the treatment of atrial fibrillation. Receives: 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. Receives: Procedure: Catheter Ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with short term reoccurrences of atrial fibrillation after ablation.
Holter ECGs and ECGs after atrial fibrillation ablation
Measured: 3 months
Secondary outcomes (1)
Change in heart rate after pulmonary vein isolation
Heart rates are recorded at admission and release from the hospital.
Measured: 3 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2018
- Study startJan 2017
- Primary completionJul 2018
- Study completionApr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Universitätsklinikum Hamburg-EppendorfThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitätsklinikum Hamburg-Eppendorf
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Dr. Christian Meyer, Universitätsklinikum Hamburg-Eppendorf
- Investigators
- Christian Meyer, Prof. Dr., Principal investigator, Germany Department of Cardiology - Electrophysiology, University Heart Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03388333
- Sponsor's protocol ID
- D4/17-06
- Status last verified
- Oct 2018
- First submitted
- 22 Dec 2017
- Last updated
- 7 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center Observational Study to Find Biomarkers for the Outcome of Catheter Ablation in Patients With Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT03388333
- Acronym / sponsor ID
- D4/17-06
- Conditions
- Atrial Fibrillation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Universitätsklinikum Hamburg-EppendorfUniversity, hospital or other
- Study start
- Jan 2017 (actual)
- Primary completion
- Jul 2018 (actual)
- Study completion
- Apr 2019 (actual)
- First posted
- 2 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Atrial fibrillation ablation group | – | Procedure: Catheter AblationPatients undergoing catheter ablation for the treatment of atrial fibrillation. |
| Electrophysiological study group | – | –Patients undergoing a diagnostic electrophysiological study without ablation. |
| Atrial flutter ablation group | – | Procedure: Catheter AblationPatients undergoing catheter ablation of right atrial flutter at the cavotricuspid isthmus. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with atrial fibrillation schedulded for pulmonary vein isolation
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Catheter Ablation | Procedure or surgery | Atrial fibrillation ablation group, Atrial flutter ablation group |
Primary outcome
Number of patients with short term reoccurrences of atrial fibrillation after ablation.
Time frame: 3 months
Holter ECGs and ECGs after atrial fibrillation ablation
1 secondary outcome
Change in heart rate after pulmonary vein isolation
Time frame: 3 days.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christian Meyer, Prof. Dr. principal investigator
Germany Department of Cardiology - Electrophysiology, University Heart Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with short term reoccurrences of atrial fibrillation after ablation. (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jun 2019.