Atrial FibrillationNCT00369330
KONVERT-AF - Relevance of Point in Time for Conversion of Acute Atrial Fibrillation
A study testing external electrical cardioversion in people with Atrial Fibrillation, run by Atrial Fibrillation Network at 1 site in Germany.
Trial summary
To investigate if in acute symptomatic atrial fibrillation (AF) the early (>2 hrs but within 12 hrs of the beginning of the arrhythmia) electrical cardioversion leads to a longer recurrence-free interval than the delayed cardioversion (> 36 hrs but < 48 hrs after the beginning of the arrhythmia) within the first 3… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- external electrical cardioversion
- Type of treatment
- Medical device
- How many people
- 0 participants
- Where
- 1 siteGermany
- Study dates
- Sep 2006to not given
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- documented AF that began between 2 and 8 hrs before randomization
- indication for electrical cardioversion.
- age above 18 yrs
- written informed consent
Who cannot join
- AF caused by not adequately treated reversible conditions(e.g. myocardial infarction, thyrotoxicosis, ethanol intoxication, infection, pericarditis, surgery)
- newly initiated (i.e. within 7 days before randomization) antiarrhythmic agents of class I, II and/or III
- catheter ablation of AF within 3 months before randomization
- pacemaker or icd
- myocardial infarction within 3 months before randomization
- urgent need to cardioversion of AF because of associated potentially dangerous symptoms such as chest pain, syncope, dyspnea
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- contraindications for therapy with vitamin k-antagonists
- intracardial thrombus
- primary indication for pharmacological cardioversion
- in females: pregnancy, lactation period or no sufficient contraception within last 3 months
Trial locations and contacts
1 site in 1 country.
Germany1 site
Medizinische Klinik und Poliklinik II, University Hospital of Bonn
Bonn, 53105
About this study
Official title: Prospective, Randomized Parallel-group Study for Evaluation of Impact of Early Versus Delayed Cardioversion of Acute Atrial Fibrillation on Further Clinical Course
To investigate if in acute symptomatic atrial fibrillation (AF) the early (>2 hrs but within 12 hrs of the beginning of the arrhythmia) electrical cardioversion leads to a longer recurrence-free interval than the delayed cardioversion (> 36 hrs but < 48 hrs after the beginning of the arrhythmia) within the first 3 months after cardioversion.
Read the detailed description
So far it is unknown if early or delayed cardioversion is most beneficial for patient outcome and which strategy is best to prevent recurrence of AF. The KONVERT-AF trial investigates if in acute symptomatic AF the early (>2 hrs but within 12 hrs of the beginning of the arrhythmia) electrical cardioversion leads to a longer recurrence-free interval than the delayed cardioversion (> 36 hrs but < 48 hrs after the beginning of the arrhythmia) within the first 3 months after cardioversion. Primary endpoint is the time to the first recurrence of AF. The KONVERT-AF trial will be conducted as prospective, randomized, non-blinded multicentre study. It is planned to include 380 patients in 10-20 recruitment centres.
- Conditions
- Atrial Fibrillation
- Being tested
- external electrical cardioversion
- Keywords
- atrial fibrillation, early cardioversion, electrical cardioversion
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
external electrical cardioversionDevice
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2006 (estimated)
- Study startSep 2006
Why it stopped: withdrawn because of insufficient financial capacities
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.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Atrial Fibrillation Network
- Sponsor type
- University, hospital or other
- Collaborators
- German Federal Ministry of Education and Research
- Investigators
- Thorsten Lewalter, MD, Principal investigator, Medizinische Klinik und Poliklinik II - Universitätsklinikum Bonn, Bonn, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00369330
- Sponsor's protocol ID
- AFNET-B03
- Status last verified
- Aug 2006
- First submitted
- 28 Aug 2006
- Last updated
- 3 Sep 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Randomized Parallel-group Study for Evaluation of Impact of Early Versus Delayed Cardioversion of Acute Atrial Fibrillation on Further Clinical Course
- ClinicalTrials.gov ID
- NCT00369330
- Acronym / sponsor ID
- AFNET-B03
- Conditions
- Atrial Fibrillation
- Keywords
- atrial fibrillation, early cardioversion, electrical cardioversion
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: withdrawn because of insufficient financial capacities
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Atrial Fibrillation NetworkUniversity, hospital or other
- Collaborators
- German Federal Ministry of Education and Research
- Study start
- Sep 2006
- First posted
- 29 Aug 2006 (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.
To investigate if in acute symptomatic atrial fibrillation (AF) the early (>2 hrs but within 12 hrs of the beginning of the arrhythmia) electrical cardioversion leads to a longer recurrence-free interval than the delayed cardioversion (> 36 hrs but < 48 hrs after the beginning of the arrhythmia) within the first 3 months after cardioversion.
Detailed description
So far it is unknown if early or delayed cardioversion is most beneficial for patient outcome and which strategy is best to prevent recurrence of AF. The KONVERT-AF trial investigates if in acute symptomatic AF the early (>2 hrs but within 12 hrs of the beginning of the arrhythmia) electrical cardioversion leads to a longer recurrence-free interval than the delayed cardioversion (> 36 hrs but < 48 hrs after the beginning of the arrhythmia) within the first 3 months after cardioversion. Primary endpoint is the time to the first recurrence of AF. The KONVERT-AF trial will be conducted as prospective, randomized, non-blinded multicentre study. It is planned to include 380 patients in 10-20 recruitment centres.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- documented AF that began between 2 and 8 hrs before randomization
- indication for electrical cardioversion.
- age above 18 yrs
- written informed consent
Key exclusion criteria (10 listed)
- AF caused by not adequately treated reversible conditions(e.g. myocardial infarction, thyrotoxicosis, ethanol intoxication, infection, pericarditis, surgery)
- newly initiated (i.e. within 7 days before randomization) antiarrhythmic agents of class I, II and/or III
- catheter ablation of AF within 3 months before randomization
- pacemaker or icd
- myocardial infarction within 3 months before randomization
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 |
|---|---|---|
| external electrical cardioversion | Device | – |
Primary outcome
Not reported in the source record.
6 secondary outcomes
Number of electrical cardioversion because of AF
Need to initiate or change medical antiarrhythmic treatment because of recurrence of AF
Number and length of stay of hospitalization because of cardiovascular reasons
Number of thromboembolic events
Number of therapy non-responder and early recurrence of AF
AF burden
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2012.
- Homepage of german atrial fibrillation networkLink provided by the sponsor.
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Atrial Fibrillation (AF)
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.
Thorsten Lewalter, MD principal investigator
Medizinische Klinik und Poliklinik II - Universitätsklinikum Bonn, Bonn, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing external electrical cardioversion in people with Atrial Fibrillation, run by Atrial Fibrillation Network 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 4 inclusion and 10 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: withdrawn, as of the sponsor's last update on 3 Sep 2012. 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 was withdrawn before enrolling participants, so there are no results.
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?
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 3 Sep 2012.