Atrial FibrillationMULTI-AFNCT02009683
Multimodality Prediction of Success of Atrial Fibrillation Rhythm Control Strategy
An observational study of Atrial Fibrillation, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial summary
In this study the investigators aim to build a model to predict the maintenance of sinus rhythm (SR) after successful direct current cardioversion (DCC) incorporating standard predictors such as echocardiographic parameters, clinical parameter and 12-lead ECG parameters and new parameters, including 17-lead ECG… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation
- How many people
- 220 participants
- Where
- 1 siteNetherlands
- Study dates
- May 2014to Sep 2018
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with persistent atrial fibrillation scheduled for direct current cardioversion.
Who may be able to join
- Haemodynamic stable patients with persistent AF scheduled for DCC.
- Written informed consent.
- Patients > 18 years old.
Who cannot join
- Atrial flutter at time of DCC.
- Patients with known oesophageal disease.
- Patients with previous operations on throat or oesophagus.
- Postoperative atrial fibrillation.
- Patients with previous ablation for AF.
- Previous inclusion in this study.
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- Patients on anti-arrhythmic drugs (AAD).
- Patients with pacemakers unable to detect AF and with a regular paced rhythm during AF.
- Planned ablation for AF.
- Myocardial infarction within the last 4 weeks.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Maastricht University Medical Centre
Maastricht
Harry J Crijns, Md, PhD, 043-3875091
About this study
In this study the investigators aim to build a model to predict the maintenance of sinus rhythm (SR) after successful direct current cardioversion (DCC) incorporating standard predictors such as echocardiographic parameters, clinical parameter and 12-lead ECG parameters and new parameters, including 17-lead ECG, Oesophageal-ECG and single nucleotide polymorphisms (SNPs). Using this novel integrated prediction model will help in the identification of patients who will maintain SR after cardioversion. Another innovative aspect of our study is the use of daily rhythm monitoring using a versatile device (MyDiagnostick®). The clinical impact this study will have is that it helps the cardiologist to make a patient tailored strategy in the treatment of AF as advocated by the guidelines and to prevent exposing patients not likely to maintain SR to the potentially harmful side-effect of a rhythm-control strategy.
Primary objectives To show that a model incorporating the novel predictors 17-lead ECG, Oesophageal-ECG and SNPs is superior to existing models in predicting maintenance of sinus rhythm after successful DCC in patients with persistent AF.
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Secondary objectives To assess the predictive value of new predictors (the Oesophageal-ECG, 17-lead ECG and SNPs) for maintenance of SR after successful DCC separately.
To assess the predictive value of new predictors (the Oesophageal-ECG, 17-lead ECG and SNPs) for time to recurrence of AF.
To assess the predictive value of predictors with respect to complete failure of cardioversion.
To assess the predictive value of predictors with respect to cardiovascular morbidity.
Hypothesis The investigators hypothesise that a model incorporating the novel predictors the 17-leads ECG, Oesophageal-ECG and SNPs performs significantly better than existing models using only clinical, echocardiographic and ECG parameters on a standard 12-lead ECG in predicting maintenance of SR after successful DCC. In addition the investigators hypothesise that Oesophageal-ECG is the best single predictor for maintenance of SR after successful DCC.
- Conditions
- Atrial Fibrillation
- Medical subject headings
- Atrial Fibrillation
What is being measured
The primary outcome is the main question the study is designed to answer.
Maintenance of sinus rhythm after successful direct current cardioversion
Measured: 6 months
Secondary outcomes (3)
Failure of direct current cardioversion
Measured: 1 day
Cardiovascular mortality
Measured: 6 months
Hospitalisation for cardiovascular events
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2013 (estimated)
- Study startMay 2014
- Primary completionSep 2018 (estimated)
- Study completionSep 2018 (estimated)
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 Maastricht University Medical CenterThe 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
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- H Crijns, MD, PhD, Principal investigator, Maastricht University Medical Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02009683
- Sponsor's protocol ID
- METC 13-2-033.3
- Acronym
- MULTI-AF
- Status last verified
- Apr 2018
- First submitted
- 9 Dec 2013
- Last updated
- 26 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multimodality Prediction of Success of Atrial Fibrillation Rhythm Control Strategy
- ClinicalTrials.gov ID
- NCT02009683
- Acronym / sponsor ID
- MULTI-AF / METC 13-2-033.3
- Conditions
- Atrial Fibrillation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- Sep 2018 (estimated)
- Study completion
- Sep 2018 (estimated)
- First posted
- 12 Dec 2013 (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.
In this study the investigators aim to build a model to predict the maintenance of sinus rhythm (SR) after successful direct current cardioversion (DCC) incorporating standard predictors such as echocardiographic parameters, clinical parameter and 12-lead ECG parameters and new parameters, including 17-lead ECG, Oesophageal-ECG and single nucleotide polymorphisms (SNPs). Using this novel integrated prediction model will help in the identification of patients who will maintain SR after cardioversion. Another innovative aspect of our study is the use of daily rhythm monitoring using a versatile device (MyDiagnostick®). The clinical impact this study will have is that it helps the cardiologist to make a patient tailored strategy in the treatment of AF as advocated by the guidelines and to prevent exposing patients not likely to maintain SR to the potentially harmful side-effect of a rhythm-control strategy.
Primary objectives To show that a model incorporating the novel predictors 17-lead ECG, Oesophageal-ECG and SNPs is superior to existing models in predicting maintenance of sinus rhythm after successful DCC in patients with persistent AF.
Secondary objectives To assess the predictive value of new predictors (the Oesophageal-ECG, 17-lead ECG and SNPs) for maintenance of SR after successful DCC separately.
To assess the predictive value of new predictors (the Oesophageal-ECG, 17-lead ECG and SNPs) for time to recurrence of AF.
To assess the predictive value of predictors with respect to complete failure of cardioversion.
To assess the predictive value of predictors with respect to cardiovascular morbidity.
Hypothesis The investigators hypothesise that a model incorporating the novel predictors the 17-leads ECG, Oesophageal-ECG and SNPs performs significantly better than existing models using only clinical, echocardiographic and ECG parameters on a standard 12-lead ECG in predicting maintenance of SR after successful DCC. In addition the investigators hypothesise that Oesophageal-ECG is the best single predictor for maintenance of SR after successful DCC.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with persistent atrial fibrillation scheduled for direct current cardioversion.
Key inclusion criteria (3 listed)
- Haemodynamic stable patients with persistent AF scheduled for DCC.
- Written informed consent.
- Patients > 18 years old.
Key exclusion criteria (10 listed)
- Atrial flutter at time of DCC.
- Patients with known oesophageal disease.
- Patients with previous operations on throat or oesophagus.
- Postoperative atrial fibrillation.
- Patients with previous ablation for AF.
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
Maintenance of sinus rhythm after successful direct current cardioversion
Time frame: 6 months
3 secondary outcomes
Failure of direct current cardioversion
Time frame: 1 day
Cardiovascular mortality
Time frame: 6 months
Hospitalisation for cardiovascular events
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2018.
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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.
H Crijns, MD, PhD principal investigator
Maastricht University Medical 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 Maastricht University Medical Center at 1 site in Netherlands.
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 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: status not confirmed, as of the sponsor's last update on 26 Apr 2018. 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 Netherlands. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Theo Lankveld, MD (+31433871611, theo.lankveld@mumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maintenance of sinus rhythm after successful direct current cardioversion (time frame: 6 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 26 Apr 2018.