Safety and Feasibility of Electrical Isolation of the Superior Vena Cava for Paroxysmal Atrial Fibrillation
SAFE-SVC
1 other identifier
observational
120
4 countries
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jun 2017
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 7, 2017
CompletedFirst Submitted
Initial submission to the registry
June 8, 2017
CompletedFirst Posted
Study publicly available on registry
June 16, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2019
CompletedJune 16, 2017
June 1, 2017
12 months
June 8, 2017
June 15, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Clinical outcame
12 months
Other Outcomes (1)
Clinically relevant abnormalities
12 months
Interventions
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
Eligibility Criteria
Patients programmed for cryoballoon ablation (CBA) for PAF
You may qualify if:
- Written informed consent
- Consecutive patients programmed for cryoballoon ablation (CBA) for PAF will be prospectively enrolled in our study
You may not qualify if:
- Age younger than 18 years
- Severe valve disease (MI or AI \> ¾)
- Uncontrolled heart failure,
- Contraindication to general anaesthesia/ deep procedural sedation
- Left atrial thrombus at the pre-procedural transesophageal echocardiogram (TEE)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
UZ Brussel VUB
Brussels, Belgium
Maria Cecilia Hospital
Cotignola, Ravenna, 48033, Italy
Radboud University
Nijmegen, Netherlands
Novosibirsk University
Novosibirsk, Russia
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Saverio Iacopino, MD
Maria Cecilia Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 8, 2017
First Posted
June 16, 2017
Study Start
June 7, 2017
Primary Completion
June 1, 2018
Study Completion
June 1, 2019
Last Updated
June 16, 2017
Record last verified: 2017-06
Data Sharing
- IPD Sharing
- Will not share