Paroxysmal Atrial Fibrillation
Conditions
Brief summary
The superior vena cava (SVC) is one of the most common non pulmonary vein (PV)-triggers for atrial tachyarrhythmias. SVC electrical isolation can be reached by circular radiofrequency (RF)-ablation under close monitoring of the phrenic nerve. However, adding substrate modification and vein of Marshal (VoM) ethanol infusion to the ablation procedure might substantially improve long-term outcomes. The aim of this study is to evaluate the recurrence rate 1 year after the index ablation in patients undergoing a redo ablation for recurrent paroxysmal atrial fibrillation (PAF) despite durable pulmonary vein isolation (PVI) with either SVC isolation alone or with substrate modification including vein of Marshal ethanolisation in addition to SVC isolation alone
Interventions
PROCEDURESVC only
Patients allocated to this arm will receive an RF ablation with the isolation of the SVC alone
PROCEDURESVC isolation with substrate modification and vein of Marshal ethanol infusion
Patients allocated to this arm will receive an RF ablation with the isolation of the SVC, substrate modification and vein of Marshal ethanol infusion
Sponsors
AZ Sint-Jan AV
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients older than 18 years * Patients scheduled for a repeat ablation of PAF after a previous PVI * Confirmation of lasting pulmonary vein isolation at the time of randomization
Exclusion criteria
* Patients with persistent atrial fibrillation * Previous ablation with isolation of the SVC, roofline, mitral line or previous vein of Marshal ethanol infusion * Left atrial thrombus. Left atrial appendage thrombus can be determined by preprocedural imaging: CT, transesophageal echocardiography or MRI. * Left ventricular ejection fraction \<35%. * Cardiac surgery within the previous 90 days. * Expecting cardiac transplantation or other cardiac surgery within 180 days. * Coronary percutaneous transluminal coronary angioplasty/stenting within the previous 90 days or myocardial infarction within the previous 60 days. * Documented history of a thromboembolic event within the previous 90 days. * Diagnosed atrial myxoma. * Significant restrictive, constrictive, or chronic obstructive pulmonary disease with chronic symptoms. * Significant congenital anomaly or medical problem that in the opinion of the investigator would preclude enrollment * Women who are pregnant or who plan to become pregnant during the study. * Acute illness or active infection at time of index procedure * Advanced renal insufficiency * Unstable angina. * History of blood clotting or bleeding abnormalities. * Contraindication to anticoagulation. * Life expectancy less than 1 year. * Presence of a condition that precludes vascular access. * International Normalized Ratio greater than 3.5 within 24 hours of procedure - for patients taking warfarin. * Patient cannot be removed from antiarrhythmic drugs for reasons other than AF. * Unwilling or unable to provide informed consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recurrence of atrial tachyarrhythmia 1 year after the index ablation | 1 year | Comparison of the prevalence of atrial tachyarrhythmia recurrence 1 year after the index ablation between groups |
| Safety (complications) | During procedure | Comparison of the number of procedural complications between groups |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total procedural time | During procedure | Comparison of the procedural time between groups |
| Fluoroscopy time | During procedure | Comparison of the fluoroscopy time between groups |
| RF ablation time | During procedure | Comparison of the radiofrequency time between groups |
Countries
Belgium
Contacts
CONTACTMichelle Lycke, MSc, PhD
PRINCIPAL_INVESTIGATORSébastien Knecht, MD, PhD
AZ Sint-Jan AV
Outcome results
None listed