NCT06383975 VEin of MArshall Ethanolization Vs Extended Pulmonary Vein PULSEd Field Ablation After Failed PVI for Persistent AF
| NCT ID | NCT06383975 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Sebastien Knecht |
| Condition | Persistent Atrial Fibrillation |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2024-05-15 |
| Primary Completion | 2027-04-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 100 participants in total. It began in 2024-05-15 with a primary completion date of 2027-04-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
Eligibility Criteria
Inclusion Criteria: * 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) Exclusion Criteria: * 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
Contact & Investigator
Sébastien Knecht, MD, PhD
PRINCIPAL INVESTIGATOR
AZ Sint-Jan Brugge AV
Frequently Asked Questions
Who can join the NCT06383975 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Persistent Atrial Fibrillation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06383975 currently recruiting?
Yes, NCT06383975 is actively recruiting participants. Contact the research team at emma.christiaen@azsintjan.be for enrollment information.
Where is the NCT06383975 trial being conducted?
This trial is being conducted at Bruges, Belgium.
Who is sponsoring the NCT06383975 clinical trial?
NCT06383975 is sponsored by Sebastien Knecht. The principal investigator is Sébastien Knecht, MD, PhD at AZ Sint-Jan Brugge AV. The trial plans to enroll 100 participants.
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