Ablation technique for persistent atrial fibrillation
: SUbstrate Ablation in Persistent Atrial Fibrillation for Elimination of Recurrences (SUPAFER): a Multicentre Randomized Clinical Trial to Assess Pulmonary Vein Isolation Alone or Combined With Linear Ablation.
This study tests if a new heart procedure that combines a specific ablation technique with standard treatment can help people with long-lasting atrial fibrillation have fewer heart rhythm problems.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 176 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Hospital Universitario La Paz Academic / other |
| Locations | 1 site (Madrid) |
| Trial ID | NCT06291506 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of a specific linear ablation technique combined with standard pulmonary vein isolation in patients with persistent atrial fibrillation. It is a multicenter, randomized trial that aims to determine if this combined approach can reduce the recurrence of atrial fibrillation compared to pulmonary vein isolation alone. The study focuses on patients who have experienced persistent or long-lasting atrial fibrillation and have not responded adequately to other treatments. Participants will be monitored using daily transtelephonic electrocardiograms to assess outcomes.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with documented persistent atrial fibrillation and specific symptomatic or treatment-resistant criteria.
Not a fit: Patients with atrial fibrillation caused by reversible factors or those who have previously undergone similar ablation procedures may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the recurrence of atrial fibrillation in patients with persistent forms of the condition.
How similar studies have performed: Previous studies on linear ablation have shown mixed results, making this approach both novel and potentially promising.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Persistent atrial fibrillation documented with electrocardiogram and defined as: persistent (continuous AF duration \>1 week) or long-lasting persistent (continuous AF duración \>1 year). * One of the following additional criteria: 1)symptomatic AF, 2)recurrence despite antiarrhythmic drugs or after electrical cardioversion, 3)tachymiopathy, 4)heart failure, 5)antiarrhythmic drugs either not tolerated or rejected or considered inadequate by the patient or an electrophysiology specialist, 6)preference for ablation explicitly manifested by the patient. * Age \>=18 years and written informed consent. Exclusion Criteria: * AF with a reversible cause. * Previous pulmonary veins isolation or left atrial linear ablation. * Cardiac surgery, acute coronary syndrome, percutaneous coronary intervention o ischaemic stroke \<1 month before ablation. * Intracranial haemorrhage \<3 months before ablation. * Ablation contraindicated due to 1)absolute contraindication for oral anticoagulants, 2)persistent atrial thrombus, 3)pregnancy, 4)extreme fragility and 5)life expectancy \<1 year.
Where this trial is running
Madrid
- La Paz University Hospital - IdiPaz — Madrid, Spain (Recruiting)
Study contacts
- Study coordinator: José Luis Merino Llorens, MD, PhD
- Email: lapaz@arritmias.net
- Phone: +34 912071301
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.