Cryoballoon Isolation of Superior Vena Cava in Paroxysmal Atrial Fibrillation

Not Applicable

Active, not recruiting

• Conditions: Atrial Fibrillation
• Interventions: Device: pulmonary vein isolation; Device: superior vena cava isolation

• Registration Number: NCT05081310
• Lead Sponsor: University of Zagreb

Brief Summary

There is still unresolved question whether isolation of superior vena cava (SVC) in conjunction to conventional pulmonary vein isolation (PVI) improves outcomes in the treatment of paroxysmal atrial fibrillation. The investigators are conducting a randomized study to determine if SVC isolation (in addition to pulmonary vein isolation) with the cryoballoon technology can improve freedom from atrial arrhythmias in one year follow up after the ablation.

Detailed Description

Paroxysmal atrial fibrillation can be triggered by non-pulmonary vein foci, like the superior vena cava. There are some older publications showing improved result in terms of freedom from atrial tachycardias when electrical isolation of this vessel utilizing radiofrequency energy is achieved. Recent retrospective studies showed that isolation of superior vena cava by the means of cryoballoon technology is safe and feasible procedure. Furthermore, one retrospective cohort study showed improved outcomes of SVC insolation + PVI versus PVI only strategy. To our knowledge there is still no randomized data that compared SVC isolation + PVI vs PVI only strategy when using cryoballoon technology.

The investigators want to determine if SVC isolation by the means of cryoballoon technology in conjunction with PVI can improve the patients outcomes. Also, there will be focus on the safety of the procedure, especially regarding the right sided phrenic nerve palsy. The primary objective of the study is freedom from atrial arrhythmias defined by standard postprocedural monitoring by ECG and Holter monitors. The investigators are conducting a randomized study with 1:1 randomization and planning to enroll around 100 participants with 1 year follow up. One group will receive conventional cryoballoon pulmonary vein isolation, and other group will receive SVC isolation after the PVI procedure.

Study Timeline

• Study Start: 2021-06-01
• Study First Submitted: 2021-06-07
• Study First Submitted QC: 2021-10-04
• Study First Posted: 2021-10-18
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-20
• Last Update Posted: 2023-11-22
• Primary Completion: 2024-07-30
• Study Completion: 2024-07-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• paroxysmal atrial fibrillation scheduled for cryoballoon the ablation of atrial fibrillation (indication not related to the study)

Exclusion Criteria

persistent atrial fibrillation

• renal failure
• contrast allergy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PVI arm	pulmonary vein isolation	Patients who will receive convectional cryoballoon PVI procedure
SVC arm	superior vena cava isolation	Patients who will receive SVC isolation by the means of cryoballoon after the PVI procedure

Primary Outcome Measures

Name	Time	Method
efficacy	one year	number of patients free of any atrial arrhythmias during the one year of follow up (occurrence of any atrial arrhythmia longer than 30 seconds, detected by Holter EKG or 12 lead EKG will be considered as treatment failure)

Secondary Outcome Measures

Name	Time	Method
feasibility	during the procedure	the success rates of SVC isolation. percentage of patients in whom successful SVC isolation was performed. SVC isolation will be verified by the circular mapping catheter, after the application of cryoballoon lesion. The absence of electrical signals in SVC after the ablation is considered as a successful isolation.
safety	one year	adverse events during the procedure (specials consideration on phrenic nerve palsy) and after the procedure (groin hematoma, pericardial effusion, etc)

Trial Locations

Locations (1)

KBC Zagreb; 🇭🇷 Zagreb, Croatia