NCT03190096

Safety and Feasibility of Electrical Isolation of the Superior Vena Cava for Paroxysmal Atrial Fibrillation

Safety and Feasibility of Electrical Isolation of the Superior Vena Cava in Addition to Pulmonary Vein Ablation for Paroxysmal Atrial Fibrillation Using the Cryoballoon: the SAFE-SVC Study.

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 120 (estimated)
• Sponsor: Ettore Sansavini Health Science Foundation · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The present study is designed as a observational prospective, multicentre, international. The main aim of this study is to evaluate the safety and feasibility of SVC isolation with the CB in a prospective manner.

Detailed description

Consecutive patients programmed for cryoballoon ablation (CBA) for PAF will be prospectively enrolled in our study. After PVI is obtained and proven by entrance- and exit block, the SVC will be mapped for potentials. If the SVC exhibits electrical activity, isolation will be attempted performing a single maximum 180 seconds balloon application. A single 180 seconds application is known to produce a durable lesion. Performing a combined approach (PVI together with SVC isolation) using the same cryoballoon requires no additional vascular access. Therefore no significant raise in complications is to be expected. During a second generation CBA the described rate of complications is to be estimated around 2%. Transient phrenic nerve palsy in 7.2 %, but reversible in virtually all patients within the end of the procedure. To prevent nervous injury the phrenic nerve (PN) will be tested during ablation of the SVC, in the same fashion as performed systematically during ablation of the right sided pulmonary veins.

Conditions

• Paroxysmal Atrial Fibrillation

Interventions

Type	Name	Description
PROCEDURE	SVC isolation	After PVI ablation SVC will be performed. The CB will be retrieved to the right atrium and the achieve catheter will be advanced in the SVC. The CB will be inflated in the right atrium and advanced towards the ostium of the SVC to occlude the vessel

Timeline

• Start date: 2017-06-07
• Primary completion: 2018-06-01
• Completion: 2019-06-01
• First posted: 2017-06-16
• Last updated: 2017-06-16

Locations

4 sites across 4 countries: Belgium, Italy, Netherlands, Russia