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

Paroxysmal Atrial Fibrillation Clinical Trial

— SAFE-SVC  

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03190096
• Other study ID #: ESREFO 31
• Status: Recruiting
• Phase: N/A
• First received: June 8, 2017
• Last updated: June 15, 2017
• Start date: June 7, 2017
• Est. completion date: June 2019

Study information

• Verified date: June 2017
• Source: Ettore Sansavini Health Science Foundation
• Contact: Maria Salomone, MD
• Phone: +390545217031
• Email: msalomone[@]esrefo.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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)

Related Conditions & MeSH terms

• Atrial Fibrillation
• Paroxysmal Atrial Fibrillation

Intervention

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

Locations

Country	Name	City	State
Belgium	UZ Brussel VUB	Brussels
Italy	Maria Cecilia Hospital	Cotignola	Ravenna
Netherlands	Radboud University	Nijmegen
Russian Federation	Novosibirsk University	Novosibirsk

Sponsors (1)

Lead Sponsor	Collaborator
Ettore Sansavini Health Science Foundation

Countries where clinical trial is conducted

Belgium,  Italy,  Netherlands,  Russian Federation, 

Outcome

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