An interventional study of Intervention and Control in Atrial Fibrillation, Persistent, sponsored by Aarhus University Hospital. Not yet recruiting at 3 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-02-28.
Sponsored by Aarhus University Hospital · Not applicable, Interventional, and Treatment
Pulmonary vein re-isolation plus Vein of Marshall ethanol ablation in combination with block of mitral and tricuspid isthmuses and dome line will be compared to pulmonary vein re-isolation alone in patients undergoing re-ablation for persistent atrial fibrillation in this investigator initiated, randomized, patient-assessor blinded multicenter trial. Patients are followed with standard ECG at 3 months, with standard ECG, 5-days' ECG monitoring and quality of life assessment after 12 months, with standard ECG and quality of life assessment after 24 months, through patient files at 60 months after the ablation.
Primary endpoint: Change in AFEQT score between baseline and 12 months.
This study is a prospective, patient and assessor blinded, 1:1 randomized superiority trial.
Consecutive patients referred for re-ablation of symptomatic PsAF after previous PVI will be included. All preoperative procedures will be conducted according to the department's standard operational procedures for AF ablation. In all patients, an electro anatomical map (CARTO™, Biosense Webster, Diamond Bar, CA, or EnSite X™, Abbott Laboratories, Abbott Park, IL) of the LA with a multipolar mapping catheter (PENTARAY™ or OCTARAY™, Biosense Webster, Diamond Bar, CA, or Advisor™ HD Grid, Abbott Laboratories, Abbott Park, IL) will be constructed and reconnection of PVs will be assessed in sinus rhythm. If reconnection is present, re-PVI will be performed and confirmed with the multipolar mapping catheter. Patients in atrial fibrillation will undergo cardioversion to sinus rhythm prior to mapping. After mapping and confirming isolation of the PVs, patients will be randomized using the Redcap Database software to intervention or control. The intervention group will undergo VOM ethanol ablation including supplementary LA and coronary sinus ablation, if needed to achieve mitral isthmus block plus creation of dome line and cavotricuspid isthmus (CTI) block. VOM ablation, mitral and CTI ablation and dome line will not be performed in control group and patients in control group will undergo no further ablation. The energy source used will be radiofrequency ablation or pulsed field ablation, at the discretion of the physician. However, radiofrequency should be preferred near coronary arteries. For dome line, focal PFA is preferred. All post-procedural work-up and follow-up will be the same for both randomization groups and assessment of outcomes will be performed by personnel blinded to randomization.
Patients are followed with standard ECG at 3 months, with standard ECG, 5-days' ECG monitoring and quality of life assessment after 12 months, with standard ECG and quality of life assessment after 24 months, through patient files at 60 months after the ablation.
Primary endpoint: Change in AFEQT score between baseline and 12 months.
3,957 studies on the registry are indexed under Atrial Fibrillation; 933 are open to participants now.
This study's planned enrollment of 180 is above the median of 145 across 2,437 interventional studies indexed under Atrial Fibrillation.
Browse Atrial Fibrillation studies →Aarhus University Hospital is the lead sponsor of 295 studies on the registry; 81 are open to participants now.
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Exclusion Criteria:
pulmonary vein re-isolation plus Vein of Marshall ethanol ablation in combination with block of mitral and tricuspid isthmuses and dome line
Procedure: Intervention
pulmonary vein re-isolation
Procedure: Control
pulmonary vein re-isolation plus Vein of Marshall ethanol ablation in combination with block of mitral and tricuspid isthmuses and dome line
pulmonary vein re-isolation
Change in Atrial fibrillation effect on quality of life (AFEQT) score
A score with a scale from 0 to 100. The higher score signifies less disability
Time frame: between baseline and 12 months
Freedom from documented atrial arrhythmia
As documented on a standard ECG or Holter, after 3 months blanking period, on or off antiarrhythmic drugs
Time frame: 12, 24 and 60 months
Freedom from documented persistent atrial arrhythmia
duration 7 days or longer or cardioverted, after 3 months blanking period, on or off antiarrhythmic drugs
Time frame: at 12 and 24 months and 5 years
Freedom from direct-current cardioverted atrial arrhythmia
after 3 months blanking period, on or off antiarrhythmic drugs
Time frame: at 12 and 24 months and 5 years
Number of direct current-cardioversions and sustained atrial arrhythmia episodes
after 3 months blanking period, on or off antiarrhythmic drugs
Time frame: at 12 and 24 months and 5 years
Freedom from accepted chronic atrial fibrillation
i.e. when cardioversion is not considered or indicated
Time frame: at 12 and 24 months and 5 years.
Freedom from re-ablation procedure
reablation procedure because of atrial arrhythmia
Time frame: at 12 and 24 months and 5 years.
Change in Atrial fibrillation effect on quality of life (AFEQT) score
A score with a scale from 0 to 100. The higher score signifies less disability
Time frame: between baseline and 24 months and between baseline and 5 years.
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Start is estimated for Mar 2025; primary completion for Oct 2029, 55 months later.
Of 789 non-industry interventional studies with no phase under Atrial Fibrillation, half reached primary completion within 39 months of starting (the median), counting those still running; a quarter within 21 and three quarters within 59. This study's planned 55 months is above that.
Counting every sponsor, half of 1,031 studies reached it within 34 months; a quarter within 18 and three quarters within 54.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.
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