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Re-ablation of Persistent Atrial Fibrillation

ConditionAtrial Fibrillation, Persistent
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAarhus University Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Previous pulmonary vein isolation for atrial fibrillation

Indication for catheter ablation with at least two episodes of symptomatic PsAF during the last 12 months

Age > 18 years

Expected survival > 12 months

Disqualifiers

Previous extrapulmonary atrial ablation other than cavotricuspid isthmus line, roof- or dome line or posterior wall isolation/ablation

Atypical atrial flutter in addition to atrial fibrillation

Atrial fibrillation secondary to a transient abnormality

Uncontrolled hypertension

Trial design

Design model

Parallel

Treatments tested in this trial

  • Intervention

    Procedure/Surgery

    pulmonary vein re-isolation plus Vein of Marshall ethanol ablation in combination with block of mitral and tricuspid isthmuses and dome line

  • Control

    Procedure/Surgery

    pulmonary vein re-isolation

Treatment groups

180 Participants
are divided into 2 treatment groups
Group A: vein re-isolation plus VOM ablation and block of mitral and tricuspid isthmuses and dome lineExperimental treatment 1 intervention
Group B: vein re-isolationActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

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
2

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
3

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
4

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Aarhus University Hospital

Lead sponsor

Karolinska University Hospital

Collaborator

Leiden University Medical Center

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: