Paroxysmal Atrial Fibrillation
Conditions
Brief 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.
Interventions
PROCEDURESVC 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
Sponsors
Ettore Sansavini Health Science Foundation
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Written informed consent 2. Consecutive patients programmed for cryoballoon ablation (CBA) for PAF will be prospectively enrolled in our study
Exclusion criteria
1. Age younger than 18 years 2. Severe valve disease (MI or AI \> ¾) 3. Uncontrolled heart failure, 4. Contraindication to general anaesthesia/ deep procedural sedation 5. Left atrial thrombus at the pre-procedural transesophageal echocardiogram (TEE)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| SVC isolation using a dedicated cryoballoon device | During procedure | feasibility and safety of superior vena cava (SVC) isolation added to standard pulmonary vein isolation using the cryoballoon in patients with paroxysmal atrial fibrillation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical outcame | 12 months | Clinical outcome in terms of freedom from atrial fibrillation following ablation. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Clinically relevant abnormalities | 12 months | Detection of clinically relevant abnormalities on physical examinations, vital signs, 2D echocardio, 12 lead ECG, and laboratory routine tests. |
Countries
Belgium, Italy, Netherlands, Russia
Contacts
Primary ContactMaria Salomone, MD
Backup ContactSaverio Iacopino, MD
Outcome results
None listed