Multimodality Prediction of Success of Atrial Fibrillation Rhythm Control Strategy (MULTI-AF)

April 25, 2018 updated by: Maastricht University Medical Center

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 Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

220

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Maastricht, Netherlands
        • Recruiting
        • Maastricht University Medical Centre
        • Contact:
          • Harry J Crijns, Md, PhD
          • Phone Number: 043-3875091

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with persistent atrial fibrillation scheduled for direct current cardioversion.

Description

Inclusion Criteria:

  • Haemodynamic stable patients with persistent AF scheduled for DCC.
  • Written informed consent.
  • Patients > 18 years old.

Exclusion Criteria:

  • 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.
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Maintenance of sinus rhythm after successful direct current cardioversion
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Failure of direct current cardioversion
Time Frame: 1 day
1 day
Cardiovascular mortality
Time Frame: 6 months
6 months
Hospitalisation for cardiovascular events
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Maastricht University Medical Center

Investigators

  • Principal Investigator: H Crijns, MD, PhD, Maastricht University Medical Centre

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2014

Primary Completion (ANTICIPATED)

September 1, 2018

Study Completion (ANTICIPATED)

September 1, 2018

Study Registration Dates

First Submitted

December 9, 2013

First Submitted That Met QC Criteria

December 11, 2013

First Posted (ESTIMATE)

December 12, 2013

Study Record Updates

Last Update Posted (ACTUAL)

April 26, 2018

Last Update Submitted That Met QC Criteria

April 25, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • METC 13-2-033.3

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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