Added Value of SVC Isolation in Patients With Pulmonary Vein Reconnection Undergoing Repeat Ablation for Recurrent Paroxysmal AF

Not Applicable

• Conditions: Paroxysmal Atrial Fibrillation
• Interventions: Procedure: PVI; Procedure: PVI + SVC

• Registration Number: NCT04602169
• Lead Sponsor: AZ Sint-Jan AV

Brief Summary

Redo procedures after CLOSE-guided pulmonary vein isolation (PVI) for atrial fibrillation (AF) occur in 10% of patients. In case of pulmonary vein (PV) reconnection, electrophysiologists may re-isolate the pulmonary veins with or without the ablation of other commonly known PV-triggers. The superior vena cava (SVC) is one of the most common non PV-triggers for atrial tachyarrhythmias. SVC electrical isolation can be reached by circular radiofrequency-ablation under close monitoring of the phrenic nerve. However, it's added value remains unclear.

With this prospective, randomized, controlled, unblinded, mono-center study, the investigators aim to evaluate the 1-year recurrence rate in paroxysmal AF patients with reconnected pulmonary veins during a redo ablation with PV re-isolation or PV re-isolation with SVC isolation.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-10-20
• Study First Submitted QC: 2020-10-20
• Study First Posted: 2020-10-26
• Study Start: 2020-11-16
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-02
• Last Update Posted: 2022-08-03
• Primary Completion: 2023-09-30
• Study Completion: 2023-09-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 108

Inclusion Criteria

• Patients older than 18 years
• Patients scheduled for a repeat ablation of PAF after a previous PVI
• PV reconnection (in ≥1 PV's) found during procedure at the time of randomization

Exclusion Criteria

• Patients with persistent AF
• Patients with durable PVI (no PVR)
• Previous ablation with isolation of the SVC, roofline, mitral line or previous vein of Marshal ethanol infusion
• Left atrial thrombus. LAA thrombus can be determined by preprocedural imaging: CT, TEE 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 PTCA/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 between signing the informed consent form and the index ablation.
• 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.
• INR 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PVI only group	PVI	Patients allocated to this group will receive PV re-isolation alone
PVI + SVC group	PVI + SVC	Patients allocated to this group will receive PV re-isolation with SVC isolation.

Primary Outcome Measures

Name	Time	Method
Recurrence of atrial tachyarrhythmia 1 year after the index ablation	1 year after ablation	Measured on 72hr Holter monitoring
Safety measured by procedural complications	From time of ablation to 1 month post procedure	Occurence of procedural complications post procedure

Secondary Outcome Measures

Name	Time	Method
Atrial volume	At time of ablation	Evaluation of the atrial volume (ml)
Total procedure time	At time of ablation	Difference in total procedure time between groups
Fluoroscopy time	At time of ablation	Difference in fluoroscopy time between groups
RF ablation time	At time of ablation	Difference in RF ablation time between groups
SVC width	At time of ablation	Evaluation of the SVC width (mm)
phrenic nerve width	At time of ablation	Evaluation of the phrenic nerve width (mm)

Trial Locations

Locations (1)

AZ Sint-Jan Brugge-Oostende AV; 🇧🇪 Brugge, Please Select, Belgium