Paroxysmal Atrial Fibrillation Clinical Trial
— SAFE-SVCOfficial title:
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.
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.
Status | Recruiting |
Enrollment | 120 |
Est. completion date | June 2019 |
Est. primary completion date | June 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility |
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) |
Country | Name | City | State |
---|---|---|---|
Belgium | UZ Brussel VUB | Brussels | |
Italy | Maria Cecilia Hospital | Cotignola | Ravenna |
Netherlands | Radboud University | Nijmegen | |
Russian Federation | Novosibirsk University | Novosibirsk |
Lead Sponsor | Collaborator |
---|---|
Ettore Sansavini Health Science Foundation |
Belgium, Italy, Netherlands, Russian Federation,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Clinically relevant abnormalities | Detection of clinically relevant abnormalities on physical examinations, vital signs, 2D echocardio, 12 lead ECG, and laboratory routine tests. | 12 months | |
Primary | 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 | |
Secondary | Clinical outcame | Clinical outcome in terms of freedom from atrial fibrillation following ablation. | 12 months |
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