Cryoballoon Isolation of Superior Vena Cava in Paroxysmal Atrial Fibrillation

Atrial Fibrillation Clinical Trial

— CISPAF  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05081310
• Other study ID #: SVC001
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 1, 2021
• Est. completion date: July 30, 2024

Study information

• Verified date: November 2023
• Source: University of Zagreb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: July 30, 2024
• Est. primary completion date: July 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Device:
• superior vena cava isolation
SVC isolation by the means of cryoballoon
• pulmonary vein isolation
conventional pulmonary vein isolation by the means of cryoballoon

Locations

Country	Name	City	State
Croatia	KBC Zagreb	Zagreb

Sponsors (1)

Lead Sponsor	Collaborator
University of Zagreb

Country where clinical trial is conducted

Croatia, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	safety	adverse events during the procedure (specials consideration on phrenic nerve palsy) and after the procedure (groin hematoma, pericardial effusion, etc)	one year