NCT05081310

Cryoballoon Isolation of Superior Vena Cava in Paroxysmal Atrial Fibrillation

Cryoballoon Isolation of Superior Vena Cava in Paroxysmal Atrial Fibrillation - a Randomized Study

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: University of Zagreb · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Atrial Fibrillation

Interventions

Type	Name	Description
DEVICE	superior vena cava isolation	SVC isolation by the means of cryoballoon
DEVICE	pulmonary vein isolation	conventional pulmonary vein isolation by the means of cryoballoon

Timeline

• Start date: 2021-06-01
• Primary completion: 2024-07-30
• Completion: 2024-07-30
• First posted: 2021-10-18
• Last updated: 2023-11-22

Locations

1 site across 1 country: Croatia