Ventricular ArrhythmiasNCT02699255
Ventricular Arrhythmias After Pulmonary Vein Isolation
An observational study of Ventricular Arrhythmias and Atrial Fibrillation, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
Trial summary
The investigators study aimed to observe the occurrence of new premature ventricular complexes and other ventricular arrhythmias after pulmonary vein isolation. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Ventricular Arrhythmias, Atrial Fibrillation
- How many people
- 111 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2014to 27 Jan 2017
- 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 paroxysmal atrial fibrillation scheduled to undergo pulmonary vein isolation
Who may be able to join
- Age > 18 years
- Paroxysmal atrial fibrillation scheduled to undergo pulmonary vein isolation
Who cannot join
- Age < 18 years
- Persistent atrial fibrillation
- Life expectancy less than 12 months
- Acute myocardial infarction, coronary artery bypass graft surgery, open heart surgery, or percutaneous transluminal coronary angioplasty within less than 3 months prior to inclusion
- Documentation of >30 premature ventricular complexes per hour, salvos or ventricular tachycardias prior to atrial fibrillation ablation
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 Examine the Occurrence of Ventricular Arrhythmias After Pulmonary Vein Isolation
The investigators study aimed to observe the occurrence of new premature ventricular complexes and other ventricular arrhythmias after pulmonary vein isolation.
Read the detailed description
Atrial fibrillation is the most common arrhythmia with a lifetime risk for development of over 20%. Pulmonary vein isolation is now established as therapy of choice for patients with symptomatic atrial fibrillation. It is well known that this interventional therapy inevitably modulates the intracardiac autonomic nervous system. While this ablation might alter atrial electrophysiology beneficially, the impact on ventricular electrophysiology remains unclear.
- Conditions
- Ventricular Arrhythmias, Atrial Fibrillation
- Medical subject headings
- Atrial Fibrillation
What is being measured
The primary outcome is the main question the study is designed to answer.
Ventricular arrhythmias
Number of patients with premature ventricular complexes, ventricular tachycardias or ventricular fibrillation.
Measured: one year
Secondary outcomes (1)
Arrhythmia recurrence
Number of patients with premature ventricular complexes, ventricular tachycardias or ventricular fibrillation.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2016 (estimated)
- Study startOct 2014
- Primary completion27 Jan 2017
- Study completion27 Jan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventricular ArrhythmiasStudies 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
- 111 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, Department of Cardiology - Electrophysiology, University Heart Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02699255
- Sponsor's protocol ID
- WF-01/16
- Status last verified
- Oct 2018
- First submitted
- 23 Feb 2016
- Last updated
- 7 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
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 Examine the Occurrence of Ventricular Arrhythmias After Pulmonary Vein Isolation
- ClinicalTrials.gov ID
- NCT02699255
- Acronym / sponsor ID
- WF-01/16
- Conditions
- Ventricular Arrhythmias, Atrial Fibrillation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 111 participants (actual)
- Lead sponsor
- Universitätsklinikum Hamburg-EppendorfUniversity, hospital or other
- Study start
- Oct 2014 (actual)
- Primary completion
- 27 Jan 2017 (actual)
- Study completion
- 27 Jan 2017 (actual)
- First posted
- 4 Mar 2016 (estimated)
- 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 study aimed to observe the occurrence of new premature ventricular complexes and other ventricular arrhythmias after pulmonary vein isolation.
Detailed description
Atrial fibrillation is the most common arrhythmia with a lifetime risk for development of over 20%. Pulmonary vein isolation is now established as therapy of choice for patients with symptomatic atrial fibrillation. It is well known that this interventional therapy inevitably modulates the intracardiac autonomic nervous system. While this ablation might alter atrial electrophysiology beneficially, the impact on ventricular electrophysiology remains unclear.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with paroxysmal atrial fibrillation scheduled to undergo pulmonary vein isolation
Key inclusion criteria (2 listed)
- Age > 18 years
- Paroxysmal atrial fibrillation scheduled to undergo pulmonary vein isolation
Key exclusion criteria (5 listed)
- Age < 18 years
- Persistent atrial fibrillation
- Life expectancy less than 12 months
- Acute myocardial infarction, coronary artery bypass graft surgery, open heart surgery, or percutaneous transluminal coronary angioplasty within less than 3 months prior to inclusion
- Documentation of >30 premature ventricular complexes per hour, salvos or ventricular tachycardias prior to atrial fibrillation ablation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Ventricular arrhythmias
Time frame: one year
Number of patients with premature ventricular complexes, ventricular tachycardias or ventricular fibrillation.
1 secondary outcome
Arrhythmia recurrence
Time frame: one year
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.
- PubMedLink provided by the sponsor.
- full versionLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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
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 Ventricular Arrhythmias and 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 2 inclusion and 5 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?
Ventricular arrhythmias (time frame: one year). 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.