Non Invasive Mapping Before Ablation for Atrial Fibrillation. (AFACART)
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|ClinicalTrials.gov Identifier: NCT02113761|
Recruitment Status : Completed
First Posted : April 15, 2014
Last Update Posted : February 2, 2017
RATIONALE / CONTEXT The ECG records the electrical activity propagating along cardiac cells (from the atria to the ventricles). The standard 12 ECG leads placed on the chest measure the global activation of the heart and do not have the ability to detect small-scale disturbances or to pinpoint ectopic activity. By the 1960s, multiple electrodes were placed around the chest to try to understand the complexity of the distribution of electrical activity in relation to the single cardiothoracic geometry of each individual. The safety of this method is similar to the ECG but its superiority has been demonstrated by the detection of anomalies imperceptible to the standard ECG. The accuracy of the technique in localizing rhythm disturbances is on the order of 5 mm.
OBJECTIVES Main objective: To evaluate the utility of noninvasive mapping during persistent AF electrophysiology procedure
- Compare the effectiveness of noninvasive mapping compared to conventional standard of care methods for AF mapping and ablation procedure.
- Evaluate the absence of recurrence of persistent AF after a follow up of 12 months after the procedure during a scheduled hospitalization.
DIAGRAM OF RESEARCH European Diagnostic Study, feasibility, non-randomized, multi center
RESEARCH PROCEDURES A trained clinical specialist places 252 dry gelled ECG electrodes on the patient's torso. The 252 ECG electrode array is hooked up to the CardioInsight system and body surface ECG recordings are made during the patient's arrhythmia. The patient is then sent to the radiology department for a CT scan (no contrast) to image both the heart and electrodes on the patient's torso. A trained clinical specialist from CardioInsight then segments the CT DICOM images from the CT scan to obtain epicardial anatomy and establish heart-torso geometry.
The electrograms are processed by the system to produce movies of fibrillatory activity (both focal activity, and rotor activity).
PROCEDURAL ENDPOINTS Primary endpoint: Acute AF termination to atrial tachycardia or sinus rhythm
Secondary outcome criteria:
- Reduction in RF time compared to standard of care (historical control - comparable patient population)
- Reduction in procedure time compared to standard of care (historical control - comparable patient population)
- Freedom from persistent AF at the end of the 12 months F/U period STUDY SIZE
The sample size was estimated at 100 patients, with up to 20 patients per center STUDY CENTERS 8 Centers :
- Brugmann - Brussels (Belgium)
- Clinique Pasteur - Toulouse (France)
- Medizinische Klinik und Poliklinik - Mainz (Germany)
- University ed Herzzentrum Freiburg Bad Kozingen (Germany)
- Deutsches Herzzentrum München, Munich (Germany)
- Kerkhoff Klinik, Bad Nauheim, (Germany)
- Sint-Jan Sint-Franciscus Xaverius, Brugge (Belgium)
- Clinique Ambroise Paré, Paris, France
EXPECTED OUTCOME In patients referred for ablation of persistent AF, ECG mapping data will be correlated to the invasive procedure. It is expected that procedure time will be statistically shorter and total RF energy delivery is expected to be smaller than that of standard of care for AF treatment.
|Condition or disease|
|Study Type :||Observational|
|Actual Enrollment :||100 participants|
|Official Title:||Non Invasive Mapping Before Ablation for Atrial Fibrillation: the Afacart Study.|
|Study Start Date :||January 2014|
|Actual Primary Completion Date :||July 2015|
|Actual Study Completion Date :||December 21, 2016|
- radiofrequency duration [ Time Frame: 1 day (At the end of the procedure) ]Radiofrequency duration necessary to terminate atrial fibrillation and total radiofrequency duration
- Atrial fibrillation termination [ Time Frame: At the time of the procedure of catheter ablation ]Amount of patients with AF termination into sinus rhythm or atrial tachycardia during AF ablation.
- Atrial fibrillation recurrence [ Time Frame: One year ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02113761
|Brussels, Belgium, 1020|