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

NCT04602169 | Unknown

• 1 other identifier: 2721
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

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.

Conditions

Paroxysmal Atrial Fibrillation

Outcome Measures

Primary Outcomes (2)

• Recurrence of atrial tachyarrhythmia 1 year after the index ablation

  Measured on 72hr Holter monitoring

  1 year after ablation

• Safety measured by procedural complications

  Occurence of procedural complications post procedure

  From time of ablation to 1 month post procedure

Secondary Outcomes (6)

• Total procedure time

  At time of ablation

• Fluoroscopy time

  At time of ablation

• RF ablation time

  At time of ablation

• Atrial volume

  At time of ablation

• SVC width

  At time of ablation

Study Arms (2)

PVI only group

ACTIVE COMPARATOR

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

Procedure: PVI

PVI + SVC group

ACTIVE COMPARATOR

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

Procedure: PVI + SVC

Interventions

PVI PROCEDURE

PV re-isolation will be conducted according to the CLOSE-protocol. Point-by-point radiofrequency (RF) delivery will be performed aiming for a contiguous circle enclosing all PVs. RF will be delivered in a power-controlled mode (without ramping) using 35-40 Watt. The irrigation rate will be set at 30 ml/min. RF will be delivered until an ablation index (AI) of ≥400 is reached at the posterior wall and ≥550 at the anterior wall. In case of dislocation, a new RF application reaching the AI target will be applied. Maximal intertag distance between two neighboring lesions is 6 mm. In case of intra-esophageal temperature (T°) rise \>38.5°C during posterior LA wall ablation, RF delivery will stopped at an AI of 300. In the absence of first pass isolation, touch-up ablation was applied until PVI. In case of reconnection during the waiting time or during the adenosine test, the site of reconnection will be located and treated with touch-up ablation until adenosine proof PVI is reached.

PVI only group

PVI + SVC PROCEDURE

Patients in this group receive PVI according to the CLOSE protocol. In addition, they will receive an SVC isolation. The circular mapping catheter will be introduced in the superior vena cava to determine baseline electrical activity and to confirm definite entrance and exit block after ablation. Ablation will be performed proximally to the SVC/right atrial junction with the contact force-catheter using circular point-by-point radiofrequency delivery with a power setting of 35W, targeting an AI ≥400. High output (25 mA) pacing will be applied before each RF application to check for phrenic nerve stimulation. In areas of phrenic nerve capture ablation will be avoided even in case of incomplete isolation.

PVI + SVC group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AZ Sint-Jan AV: lead

Study Sites (1)

AZ Sint-Jan Brugge-Oostende AV

Bruges, Please Select, 8000, Belgium

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Sébastien Knecht, MD, PhD

  AZ Sint-Jan AV

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michelle Lycke, MSc, PhD

CONTACT

003250453293; michelle.lycke@azsintjan.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Doctor

Study Record Dates

• First Submitted: October 20, 2020
• First Posted: October 26, 2020
• Study Start: November 16, 2020
• Primary Completion: September 30, 2023
• Study Completion: September 30, 2023
• Last Updated: August 3, 2022

Record last verified: 2022-08

Locations

BE (1)