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

NCT ID: NCT03190096

Last Updated: 2017-06-16

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 120 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-06-07
• Study Completion Date: 2019-06-30

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.

Conditions

Paroxysmal Atrial Fibrillation

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Interventions

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

Intervention Type: PROCEDURE

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ettore Sansavini Health Science Foundation

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Saverio Iacopino, MD

Role: PRINCIPAL_INVESTIGATOR

Maria Cecilia Hospital

Locations

UZ Brussel VUB

Brussels, , Belgium

Site Status: NOT_YET_RECRUITING

Maria Cecilia Hospital

Cotignola, Ravenna, Italy

Site Status: RECRUITING

Radboud University

Nijmegen, , Netherlands

Site Status: NOT_YET_RECRUITING

Novosibirsk University

Novosibirsk, , Russia

Site Status: NOT_YET_RECRUITING

Countries

Belgium; Italy; Netherlands; Russia

Central Contacts

Maria Salomone, MD

Role: CONTACT

msalomone@esrefo.org

+390545217031

Saverio Iacopino, MD

Role: CONTACT

iacopino@iol.it

+390545217228

Facility Contacts

GianBattista Chierchia, MD,PhD

Role: primary

Saverio Iacopino, MD

Role: primary

Sjoerd Westra, MD

Role: primary

Alexander Romanov, MD,PhD

Role: primary

Other Identifiers

ESREFO 31

Identifier Type: -

Identifier Source: org_study_id