Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SVC isolation | Procedure | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| SVC isolation using a dedicated cryoballoon device | feasibility and safety of superior vena cava (SVC) isolation added to standard pulmonary vein isolation using the cryoballoon in patients with paroxysmal atrial fibrillation | During procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical outcame | Clinical outcome in terms of freedom from atrial fibrillation following ablation. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Clinically relevant abnormalities | Detection of clinically relevant abnormalities on physical examinations, vital signs, 2D echocardio, 12 lead ECG, and laboratory routine tests. | 12 months |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Patients programmed for cryoballoon ablation (CBA) for PAF
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Maria Salomone, MD | Contact | +390545217031 | msalomone@esrefo.org | |
| Saverio Iacopino, MD | Contact | +390545217228 | iacopino@iol.it |
| Name | Affiliation | Role |
|---|---|---|
| Saverio Iacopino, MD | Maria Cecilia Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UZ Brussel VUB | Not yet recruiting | Brussels | Belgium |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
Not provided
Not provided
Not provided
Not provided
Not provided
| Maria Cecilia Hospital | Recruiting | Cotignola | Ravenna | 48033 | Italy |
|
| Radboud University | Not yet recruiting | Nijmegen | Netherlands |
|
| Novosibirsk University | Not yet recruiting | Novosibirsk | Russia |
|
| D013568 |
| Pathological Conditions, Signs and Symptoms |