Clinical trial NCT04529785: 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 PV Isolation
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Paroxysmal Atrial Fibrillation
Lead sponsor: AZ Sint-Jan AV
Sponsor class: OTHER
First posted: 2020-08-28
Enrollment: 100
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: 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 criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Patients with persistent atrial fibrillation
* Previous ablation with isolation of the SVC, roofline, mitral line or previous vein of Marshal ethanol infusion
* Left atrial thrombus. Left atrial appendage thrombus can be determined by preprocedural imaging: CT, transesophageal echocardiography 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 percutaneous transluminal coronary angioplasty/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 during the study.
* 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.
* International Normalized Ratio 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
measure: Safety (complications)
timeFrame: During procedure
Secondary outcomes:
measure: Total procedural time
timeFrame: During procedure
measure: Fluoroscopy time
timeFrame: During procedure
measure: RF ablation time
timeFrame: During procedure
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: