Clinical trial NCT04602169: Added Value of SVC Isolation in Patients With Pulmonary Vein Reconnection Undergoing Repeat Ablation for Recurrent Paroxysmal AF
Official title: Added Value of Superior Vena Cava Isolation in Patients With Pulmonary Vein Reconnection Undergoing Repeat Ablation for Recurrent Paroxysmal Atrial Fibrillation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Paroxysmal Atrial Fibrillation
Lead sponsor: AZ Sint-Jan AV
Sponsor class: OTHER
First posted: 2020-10-26
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Recurrence of atrial tachyarrhythmia 1 year after the index ablation
timeFrame: 1 year after ablation
measure: Safety measured by procedural complications
timeFrame: From time of ablation to 1 month post procedure
Secondary outcomes:
measure: Total procedure time
timeFrame: At time of ablation
measure: Fluoroscopy time
timeFrame: At time of ablation
measure: RF ablation time
timeFrame: At time of ablation
measure: Atrial volume
timeFrame: At time of ablation
measure: SVC width
timeFrame: At time of ablation
measure: phrenic nerve width
timeFrame: At time of ablation
Other outcomes:
Locations:
city: Brugge
country: Belgium
facility: AZ Sint-Jan Brugge-Oostende AV
state: Please Select
Study officials:
affiliation: AZ Sint-Jan AV
name: Sébastien Knecht, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: