Actively Recruiting
VEin of MArshall Ethanolization Vs Extended Pulmonary Vein PULSEd Field Ablation After Failed PVI for Persistent AF
Led by Sebastien Knecht · Updated on 2024-10-09
100
Participants Needed
1
Research Sites
154 weeks
Total Duration
On this page
Sponsors
S
Sebastien Knecht
Lead Sponsor
B
Boston Scientific Corporation
Collaborating Sponsor
AI-Summary
What this Trial Is About
The goal of this clinical trial is to compare two ablation techniques to treat patients with persistent atrial fibrillation (irregular and often very rapid heart rhythm). An ablation is a procedure during which some scars are made on the inside of the heart to break up the electrical signals that cause the irregular heartbeat. In this trial researchers will compare a new technique, which uses tiny electric shocks to make the scars, to the standard technique, which uses heat. The main question the trial aims to answer is: • Does the new technique work as well as the standard technique to prevent the irregular heartbeat from returning within one year of the procedure? Participants will: * Undergo an ablation with either the new or the standard technique * Visit the hospital 1, 3, 6, 9 and 12 months after the procedure for a check-up * Wear a device to register their heart rhythm for 24 hours before the 3 month visit and for 72 hours before the 6, 9 and 12 month visit * Record their heart rhythm at home every week * Complete a questionnaire 3, 6, 9 and 12 months after the procedure
CONDITIONS
Official Title
VEin of MArshall Ethanolization Vs Extended Pulmonary Vein PULSEd Field Ablation After Failed PVI for Persistent AF
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Symptomatic persistent atrial fibrillation (AF) despite a first PVI. Persistent AF is defined as the presence of AF lasting ≥7 days (i.e. in case of new onset AF one has to wait for 7 days)
You will not qualify if you...
- Persistent AF lasting ≥ 12 months
- Advanced valvular heart disease
- Left atrial (LA) volume >150mL
- LA diameter (PS-LAX) >60mm
- Septal wall diameter >15mm
- Life expectancy <1 year
- Weight >150 kg
- Any contra indication to catheter ablation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
AZ Sint-Jan Brugge AV
Bruges, Belgium, 8000
Actively Recruiting
Research Team
E
Emma Christiaen
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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