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

  • STATUS
    Recruiting
  • End date
    Sep 30, 2023
  • participants needed
    108
  • sponsor
    AZ Sint-Jan AV
Updated on 9 August 2022
fibrillation
pulmonary vein isolation

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.

Details
Condition Paroxysmal Atrial Fibrillation
Treatment PVI, PVI + SVC
Clinical Study IdentifierNCT04602169
SponsorAZ Sint-Jan AV
Last Modified on9 August 2022

Eligibility

Yes No Not Sure

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
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