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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SVC arm | Experimental | Patients who will receive SVC isolation by the means of cryoballoon after the PVI procedure |
|
| PVI arm | Active Comparator | Patients who will receive convectional cryoballoon PVI procedure |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| superior vena cava isolation | Device | SVC isolation by the means of cryoballoon |
| |
| Measure | Description | Time Frame |
|---|---|---|
| efficacy | 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) | one year |
| Measure | Description | Time Frame |
|---|---|---|
| feasibility | 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. | during the procedure |
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Inclusion Criteria:
Exclusion Criteria:
persistent atrial fibrillation
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| Name | Affiliation | Role |
|---|---|---|
| Vedran Velagic, MD, PhD | Clinical Hospital Centre Zagreb | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| KBC Zagreb | Zagreb | 10000 | Croatia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33447964 | Background | Overeinder I, Osorio TG, Calburean PA, Bisignani A, Bala G, Sieira J, Stroker E, Al Houssari M, Mojica J, Boveda S, Paparella G, Brugada P, de Asmundis C, Chierchia GB. Comparison between superior vena cava ablation in addition to pulmonary vein isolation and standard pulmonary vein isolation in patients with paroxysmal atrial fibrillation with the cryoballoon technique. J Interv Card Electrophysiol. 2021 Dec;62(3):579-586. doi: 10.1007/s10840-020-00932-6. Epub 2021 Jan 15. | |
| 32250512 |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| pulmonary vein isolation |
| Device |
conventional pulmonary vein isolation by the means of cryoballoon |
|
| safety | adverse events during the procedure (specials consideration on phrenic nerve palsy) and after the procedure (groin hematoma, pericardial effusion, etc) | one year |
| Background |
| Wei HQ, Guo XG, Sun Q, Yang JD, Xie HY, Cao ZJ, Chen YQ, Zhang S, Wu S, Ma J. Electrical isolation of the superior vena cava using second-generation cryoballoon in patients with atrial fibrillation. J Cardiovasc Electrophysiol. 2020 Jun;31(6):1307-1314. doi: 10.1111/jce.14477. Epub 2020 Apr 11. |
| 32253600 | Background | Iacopino S, Osorio TG, Filannino P, Artale P, Sieira J, Stroker E, Bala G, Overeinder I, Hacioglu E, Calburean PA, Paparella G, Brugada P, de Asmundis C, Chierchia GB. Safety and feasibility of electrical isolation of the superior vena cava in addition to pulmonary vein ablation for paroxysmal atrial fibrillation using the cryoballoon: lessons from a prospective study. J Interv Card Electrophysiol. 2021 Mar;60(2):255-260. doi: 10.1007/s10840-020-00740-y. Epub 2020 Apr 6. |
| D013568 |
| Pathological Conditions, Signs and Symptoms |