Comparing two techniques for treating persistent atrial fibrillation
Comparison Between VEin of MArshall Ethanol Infusion Versus Extended Pulmonary Vein PULSEd Field Ablation After Failed Pulmonary Vein Isolation in Patients with Persistent Atrial Fibrillation
This study is testing two different ways to treat ongoing atrial fibrillation to see which method works better at keeping heart rhythms steady.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | AZ Sint-Jan AV Academic / other |
| Locations | 1 site (Bruges) |
| Trial ID | NCT06383975 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to compare two different ablation techniques for patients suffering from persistent atrial fibrillation, a condition characterized by irregular and rapid heart rhythms. One technique uses pulsed field energy to create scars in the heart, while the other employs traditional radiofrequency ablation. Participants will undergo one of these procedures and will be monitored for one year to assess the effectiveness of each method in preventing the recurrence of atrial fibrillation. Regular check-ups and heart rhythm monitoring will be conducted to gather data on the outcomes.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals experiencing symptomatic persistent atrial fibrillation despite having undergone a previous pulmonary vein isolation procedure.
Not a fit: Patients with persistent atrial fibrillation lasting more than 12 months or those with significant heart conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective treatment option for patients with persistent atrial fibrillation, potentially reducing the recurrence of their condition.
How similar studies have performed: Other studies have shown promise with similar ablation techniques, but this specific comparison of pulsed field ablation and ethanolization is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Bruges
- AZ Sint-Jan Brugge AV — Bruges, Belgium (Recruiting)
Study contacts
- Principal investigator: Sébastien Knecht, MD, PhD — AZ Sint-Jan Brugge AV
- Study coordinator: Emma Christiaen
- Email: emma.christiaen@azsintjan.be
- Phone: 003250453293
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.