CISPAF: Cryoballoon Isolation of Superior Vena Cava in Paroxysmal Atrial Fibrillation
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
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N/A |
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 Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: SVC arm Patients who will receive SVC isolation by the means of cryoballoon after the PVI procedure |
Device: superior vena cava isolation
SVC isolation by the means of cryoballoon
|
Active Comparator: PVI arm Patients who will receive convectional cryoballoon PVI procedure |
Device: pulmonary vein isolation
conventional pulmonary vein isolation by the means of cryoballoon
|
Outcome Measures
Primary Outcome Measures
- efficacy [one year]
percentage 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
- 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)
Eligibility Criteria
Criteria
Inclusion Criteria:
- paroxysmal atrial fibrillation scheduled for cryoballoon the ablation of atrial fibrillation (indication not related to the study)
Exclusion Criteria:
persistent atrial fibrillation
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renal failure
-
contrast allergy
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | KBC Zagreb | Zagreb | Croatia | 10000 |
Sponsors and Collaborators
- University of Zagreb
Investigators
- Principal Investigator: Vedran Velagic, MD, PhD, Clinical Hospital Centre Zagreb
Study Documents (Full-Text)
None provided.More Information
Publications
- Iacopino S, Osório TG, Filannino P, Artale P, Sieira J, Ströker E, Bala G, Overeinder I, Hacioglu E, Călburean 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.
- Overeinder I, Osório TG, Călburean PA, Bisignani A, Bala G, Sieira J, Ströker 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.
- 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.
- SVC001