SUbstrate Ablation in Persistent Atrial Fibrillation for Elimination of Recurrences (SUPAFER).

Atrial Fibrillation Ablation Clinical Trial

— SUPAFER  

Official title:

: 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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06291506
• Other study ID #: 6270
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2023
• Est. completion date: May 1, 2026

Study information

• Verified date: February 2024
• Source: Hospital Universitario La Paz
• Contact: José Luis Merino Llorens, MD, PhD
• Phone: +34 912071301
• Email: lapaz[@]arritmias.net
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 176
• Est. completion date: May 1, 2026
• Est. primary completion date: May 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Atrial Fibrillation
• Atrial Fibrillation Ablation
• Recurrence

Intervention

Other:
• Radiofrequency ablation of heart atrial tissue.
Ablation with radiofrequency, advances techniques: contact force-guided, improved tissue temperature sensors, automark algorithms.

Locations

Country	Name	City	State
Spain	La Paz University Hospital - IdiPaz	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Universitario La Paz

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recurrences of sustained >30 secons atrial arrhythmias measured by daily ECG samples (Kardia Alivecor) and 30 days continuous Holter.	Atrial fibrillation, atrial tachycardia (atrial flutter).	through study completion, 1 year follow-up
Secondary	Acute intraprocedure efficacy.	Rate of: AF termination to sinus rhythm, organization to atrial tachycardia and non inducibility of AF or atrial tachycardia.	during the ablation procedure and up to 2 months blanking perior
Secondary	Complications.	Complications associated to the ablation procedure.	through study completion, 1year follow-up