Safety and Feasibility of Electrical Isolation of the Superior Vena Cava for Paroxysmal Atrial Fibrillation (SAFE-SVC)

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.

Study Overview

• Status: Unknown
• Conditions: Paroxysmal Atrial Fibrillation
• Intervention / Treatment: Procedure: SVC isolation

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.

• Study Type: Observational
• Enrollment (Anticipated): 120

Contacts and Locations

• Study Contact: Name: Maria Salomone, MD; Phone Number: +390545217031; Email: msalomone@esrefo.org
• Study Contact Backup: Name: Saverio Iacopino, MD; Phone Number: +390545217228; Email: iacopino@iol.it

Study Locations

• Belgium
  • Brussels, Belgium
    • Not yet recruiting
    • UZ Brussel VUB
    • Contact: GianBattista Chierchia, MD,PhD
• Italy
  • Ravenna
    • Cotignola, Ravenna, Italy, 48033
      • Recruiting
      • Maria Cecilia Hospital
      • Contact: Saverio Iacopino, MD
• Netherlands
  • Nijmegen, Netherlands
    • Not yet recruiting
    • Radboud University
    • Contact: Sjoerd Westra, MD
• Russian Federation
  • Novosibirsk, Russian Federation
    • Not yet recruiting
    • Novosibirsk University
    • Contact: Alexander Romanov, MD,PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients programmed for cryoballoon ablation (CBA) for PAF

Description

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)

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical outcame	Clinical outcome in terms of freedom from atrial fibrillation following ablation.	12 months

Other Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Ettore Sansavini Health Science Foundation
• Investigators: Principal Investigator: Saverio Iacopino, MD, Maria Cecilia Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 7, 2017
• Primary Completion (Anticipated): June 1, 2018
• Study Completion (Anticipated): June 1, 2019

Study Registration Dates

• First Submitted: June 8, 2017
• First Submitted That Met QC Criteria: June 15, 2017
• First Posted (Actual): June 16, 2017

Study Record Updates

• Last Update Posted (Actual): June 16, 2017
• Last Update Submitted That Met QC Criteria: June 15, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: ESREFO 31

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No