Clinical trial NCT03190096: Safety and Feasibility of Electrical Isolation of the Superior Vena Cava for Paroxysmal Atrial Fibrillation
Official 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.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Paroxysmal Atrial Fibrillation
Lead sponsor: Ettore Sansavini Health Science Foundation
Sponsor class: OTHER
First posted: 2017-06-16
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients programmed for cryoballoon ablation (CBA) for PAF

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.

Eligibility criteria: 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)

Primary outcomes:
measure: SVC isolation using a dedicated cryoballoon device
timeFrame: During procedure
Secondary outcomes:
measure: Clinical outcame
timeFrame: 12 months
Other outcomes:
measure: Clinically relevant abnormalities
timeFrame: 12 months
Locations:
city: Brussels
country: Belgium
facility: UZ Brussel VUB
city: Cotignola
country: Italy
facility: Maria Cecilia Hospital
state: Ravenna
city: Nijmegen
country: Netherlands
facility: Radboud University
city: Novosibirsk
country: Russian Federation
facility: Novosibirsk University
Study officials:
affiliation: Maria Cecilia Hospital
name: Saverio Iacopino, MD
role: PRINCIPAL_INVESTIGATOR
References: