Electrophysiology of Pulmonary VeinsNCT00530608
Electrophysiological Properties of the Pulmonary Veins
An observational study of Electrophysiology of Pulmonary Veins, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
Trial summary
The pulmonary veins are the predominant sources of AF induction and maintenance. This study aims to assess the electrophysiological properties of the pulmonary veins and their relation to AF in humans. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Electrophysiology of Pulmonary Veins
- How many people
- 35 participants
- Where
- 1 siteGermany
- Study dates
- Jun 2006to Nov 2007
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: First review of the data base with respect to study outcome was performed after 35 enrolled patients. As a result, the results were already significant and the study was stopped prematurely.
Who may be able to join
- Age > 18 years
- No antiarrhythmic drug treatment
- Indication for an electrophysiological study
Who cannot join
- Structural heart diseases
Trial locations and contacts
1 site in 1 country.
Germany1 site
University Hospital Eppendorf, Heart Center, Department of Cardiology
Hamburg, 20246
About this study
The pulmonary veins are the predominant sources of AF induction and maintenance. This study aims to assess the electrophysiological properties of the pulmonary veins and their relation to AF in humans.
- Conditions
- Electrophysiology of Pulmonary Veins
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2007 (estimated)
- Study startJun 2006
- Study completionNov 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Electrophysiology of Pulmonary VeinsStudies 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
- Prospective
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitätsklinikum Hamburg-Eppendorf
- Sponsor type
- University, hospital or other
- Investigators
- Thomas Rostock, MD, Principal investigator, University Hospital Eppendorf, Heart Center, Department of Cardiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00530608
- Sponsor's protocol ID
- UHZ/2007/1
- Status last verified
- Jun 2008
- First submitted
- 13 Sep 2007
- Last updated
- 10 Feb 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Rostock T, Steven D, Lutomsky B, Servatius H, Drewitz I, Klemm H, Mullerleile K, Ventura R, Meinertz T, Willems S. Atrial fibrillation begets atrial fibrillation in the pulmonary veins on the impact of atrial fibrillation on the electrophysiological properties of the pulmonary veins in humans. J Am Coll Cardiol. 2008 Jun 3;51(22):2153-60. doi: 10.1016/j.jacc.2008.02.059.
PubMed 18510963
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electrophysiological Properties of the Pulmonary Veins
- ClinicalTrials.gov ID
- NCT00530608
- Acronym / sponsor ID
- UHZ/2007/1
- Conditions
- Electrophysiology of Pulmonary Veins
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Universitätsklinikum Hamburg-EppendorfUniversity, hospital or other
- Study start
- Jun 2006
- Study completion
- Nov 2007 (actual)
- First posted
- 17 Sep 2007 (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 pulmonary veins are the predominant sources of AF induction and maintenance. This study aims to assess the electrophysiological properties of the pulmonary veins and their relation to AF in humans.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- First review of the data base with respect to study outcome was performed after 35 enrolled patients. As a result, the results were already significant and the study was stopped prematurely.
Key inclusion criteria (3 listed)
- Age > 18 years
- No antiarrhythmic drug treatment
- Indication for an electrophysiological study
Key exclusion criteria (1 listed)
- Structural heart diseases
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
Not reported in the source record.
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 10 Feb 2010.
- Derived from this study: PubMed 18510963Rostock T, Steven D, Lutomsky B, Servatius H, Drewitz I, Klemm H, Mullerleile K, Ventura R, Meinertz T, Willems S. Atrial fibrillation begets atrial fibrillation in the pulmonary veins on the impact of atrial fibrillation on the electrophysiological properties of the pulmonary veins in humans. J Am Coll Cardiol. 2008 Jun 3;51(22):2153-60. doi: 10.1016/j.jacc.2008.02.059.
Related trials for Electrophysiology of Pulmonary Veins
Active, not recruitingObservational study
P-wave Duration and Local Potential as Predictors of AF Recurrence Following Pulmonary Vein Isolation
Atrial Fibrillation (AF), Atrial Fibrillation Patients Treated With the FARAPULSE™ PFA System
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.
Thomas Rostock, MD principal investigator
University Hospital Eppendorf, Heart Center, Department of Cardiology
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 Electrophysiology of Pulmonary Veins, 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 1 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 10 Feb 2010. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00530608, which also lists 1 linked publication.
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 10 Feb 2010.