Atrial FibrillationNCT00209911
Study of the Effect of Cardioversion on Cardiac Volume in Patients With Persistent Atrial Fibrillation
An observational study of Atrial Fibrillation, run by Hvidovre University Hospital at 1 site in Denmark.
Trial summary
The main objectives in this study were to examine the cardiac structural and functional changes in patients with persistent and permanent AF, with the aim of improving our understanding of the underlying pathophysiological mechanisms. In addition we aimed to identify variables predictive of recurrent AF. Read more about this study
- Who is it for?
- Ages 0 years and olderHealthy volunteers can take part
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- cardioversion
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- 1 siteDenmark
- Study dates
- Jan 2001to Jan 2003
- 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 0 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- -
Who cannot join
- severe pulmonary or renal disease
- contraindications to magnetic resonance imaging
- valvular disease
- previous cardiac surgery
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Dept. of Cardiology, Copenhagen University Hospital Hvidovre
Hvidovre, 2650
About this study
Official title: Atrial and Ventricular Volume and Function In Atrial Fibrillation - A Magnetic Resonance Imaging Study
The main objectives in this study were to examine the cardiac structural and functional changes in patients with persistent and permanent AF, with the aim of improving our understanding of the underlying pathophysiological mechanisms. In addition we aimed to identify variables predictive of recurrent AF.
- Conditions
- Atrial Fibrillation
- Being tested
- cardioversion
- Keywords
- atrial volume, ventricular volume, atrial function, ventricular function, magnetic resonance imaging, cardioversion, natriuretic peptides
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cardioversionProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2005 (estimated)
- Study startJan 2001
- Study completionJan 2003
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 Atrial FibrillationStudies of the same condition, open and under way.
- 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
- Natural history
- Time perspective
- Prospective
- Enrolment
- 60 participants
Sponsor and investigators
- Lead sponsor
- Hvidovre University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- The Foundation of 17.12.1981, AP Moeller Foundation, Danish Hospital Foundation for Medical Research, Region of Copenhagen, Danish Heart Foundation, Copenhagen Hospital Corporation
- Investigators
- Susette Krohn Therkelsen, MD, phd, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00209911
- Sponsor's protocol ID
- susette_phd
- Status last verified
- Jan 2001
- First submitted
- 13 Sep 2005
- Last updated
- 21 Sep 2005
- Results posted
- No
Publications
Therkelsen SK, Groenning BA, Svendsen JH, Jensen GB. Atrial and ventricular volume and function in persistent and permanent atrial fibrillation, a magnetic resonance imaging study. J Cardiovasc Magn Reson. 2005;7(2):465-73. doi: 10.1081/jcmr-200053618.
PubMed 15881530
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Atrial and Ventricular Volume and Function In Atrial Fibrillation - A Magnetic Resonance Imaging Study
- ClinicalTrials.gov ID
- NCT00209911
- Acronym / sponsor ID
- susette_phd
- Conditions
- Atrial Fibrillation
- Keywords
- atrial volume, ventricular volume, atrial function, ventricular function, magnetic resonance imaging, cardioversion, natriuretic peptides
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 60 participants
- Lead sponsor
- Hvidovre University HospitalUniversity, hospital or other
- Collaborators
- The Foundation of 17.12.1981, AP Moeller Foundation, Danish Hospital Foundation for Medical Research, Region of Copenhagen, Danish Heart Foundation, Copenhagen Hospital Corporation
- Study start
- Jan 2001
- Study completion
- Jan 2003
- First posted
- 21 Sep 2005 (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 main objectives in this study were to examine the cardiac structural and functional changes in patients with persistent and permanent AF, with the aim of improving our understanding of the underlying pathophysiological mechanisms. In addition we aimed to identify variables predictive of recurrent AF.
Study design
- Observational model
- Natural history
- Time perspective
- Prospective
Who may qualify
- Ages
- 0 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- -
Key exclusion criteria (4 listed)
- severe pulmonary or renal disease
- contraindications to magnetic resonance imaging
- valvular disease
- previous cardiac surgery
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 |
|---|---|---|
| cardioversion | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2005.
- Background: PubMed 15881530Therkelsen SK, Groenning BA, Svendsen JH, Jensen GB. Atrial and ventricular volume and function in persistent and permanent atrial fibrillation, a magnetic resonance imaging study. J Cardiovasc Magn Reson. 2005;7(2):465-73. doi: 10.1081/jcmr-200053618.
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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.
Susette Krohn Therkelsen, MD, phd principal investigator
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 Hvidovre University Hospital at 1 site in Denmark.
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 1 inclusion and 4 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: stopped early, as of the sponsor's last update on 21 Sep 2005. 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 Denmark. 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 was stopped early. Results are not available in the source record.
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 NCT00209911, 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 21 Sep 2005.