Trials / Recruiting
RecruitingNCT06291506
SUbstrate Ablation in Persistent Atrial Fibrillation for Elimination of Recurrences (SUPAFER).
: 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.
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 176 (estimated)
- Sponsor
- Hospital Universitario La Paz · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Antecedents: electrical isolation of pulmonary veins is the standard treatment for patients with atrial fibrillation. However, its efficacy is lower in persistent and chronic forms of this arrhythmia compared to paroxysmal atrial fibrillation. Many complementary techniques have been proposed, that added to pulmonary veins isolation, may reduce the recurrence rate of atrial fibrillation. However, none of them has obtained consistent results. Linear ablation aims to parcellate and modify the left atrial substrate responsible for atrial fibrillation maintenance. Previous studies have offered contradictory results using linear ablation. Methods: SUPAFER is a multicenter, 1:1 randomized clinical trial that compares the efficacy of pulmonary veins isolation alone vs pulmonary vein isolation plus an specific protocol of left atrial linear ablation. Contrary to previous studies, the specific SUPAFER linear ablation is systematic, homogeneous and target atrial areas that have not been systematically ablated in previous trials. The trial aims at demonstrating the superiority of the combined ablative approach during 1-year follow-up. Daily transtelephonic ECG samples a 30 days continuous ECG monitoring are used to maximize de detection of recurrences, even asymptomatic.
Conditions
- Persistent and Long Lasting or Chronic Atrial Fibrillation
- Atrial Fibrillation Ablation
- Linear Left Atrial Ablation
- Daily Transtelephonic Electrocardiogram
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Radiofrequency ablation of heart atrial tissue. | Ablation with radiofrequency, advances techniques: contact force-guided, improved tissue temperature sensors, automark algorithms. |
Timeline
- Start date
- 2023-05-01
- Primary completion
- 2026-05-01
- Completion
- 2026-05-01
- First posted
- 2024-03-04
- Last updated
- 2024-03-04
Locations
1 site across 1 country: Spain
Source: ClinicalTrials.gov record NCT06291506. Inclusion in this directory is not an endorsement.