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Added Value of Vein of Marshal Ethanol Infusion Compared to Superior Vena Cava Isolation Alone in Patients Undergoing Repeat Ablation for Recurrent Paroxysmal Atrial Fibrillation Despite Durable Pulmonary Vein Isolation

Who is this study for? Patients undergoing repeat ablation for recurrent paroxysmal atrial fibrillation despite durable pulmonary vein isolation
Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Belgium
AZ Sint-Jan Brugge-Oostende AV
RECRUITING
Bruges
Contact Information
Primary
Michelle Lycke, MSc, PhD
michelle.lycke@azsintjan.be
+32 50 45 32 93
Time Frame
Start Date: 2020-09-11
Estimated Completion Date: 2027-12-31
Participants
Target number of participants: 100
Treatments
Active_comparator: SVC only
Patients in Group 1 will receive an SVC isolation only
Active_comparator: SVC isolation with substrate modification and VoM inf
Patients in Group 2 will receive an SVC isolation with substrate modification and vein of Marshal ethanol infusion
Related Therapeutic Areas
Sponsors
Leads: AZ Sint-Jan AV

This content was sourced from clinicaltrials.gov