: 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
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Spain
La Paz University Hospital - IdiPaz
RECRUITING
Madrid
Contact Information
Primary
José Luis Merino Llorens, MD, PhD
lapaz@arritmias.net
+34 912071301
Time Frame
Start Date: 2023-05-01
Estimated Completion Date: 2026-05-01
Participants
Target number of participants: 176
Treatments
Experimental: Pulmonary veins isolation plus linear left atrial ablation.
Active_comparator: Pumonary veins isolation only.
Related Therapeutic Areas
Sponsors
Leads: Hospital Universitario La Paz

This content was sourced from clinicaltrials.gov