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

AZ Sint-Jan AV

Status: Enrolling

Conditions: Paroxysmal Atrial Fibrillation

Treatments: Procedure: PVI + SVC; Procedure: PVI

Study type: Interventional

Funder types: Other

Identifiers

NCT04602169

2721

Details and patient eligibility

About

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.

Enrollment: 108 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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108 participants in 2 patient groups

PVI only group

Active Comparator group

Description:

Patients allocated to this group will receive PV re-isolation alone

Treatment:

Procedure: PVI

PVI + SVC group

Active Comparator group

Description:

Patients allocated to this group will receive PV re-isolation with SVC isolation.

Treatment:

Procedure: PVI + SVC