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

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.

Study Overview

• Status: Recruiting
• Conditions: Atrial Fibrillation Ablation; Persistent and Long Lasting or Chronic Atrial Fibrillation; Linear Left Atrial Ablation; Daily Transtelephonic Electrocardiogram
• Intervention / Treatment: Other: Radiofrequency ablation of heart atrial tissue.

• Study Type: Interventional
• Enrollment (Estimated): 176
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: José Luis Merino Llorens, MD, PhD; Phone Number: 441301 +34 912071301; Email: lapaz@arritmias.net

Study Locations

• Spain
  • Madrid, Spain
    • Recruiting
    • La Paz University Hospital - IdiPaz
    • Contact: José Luis Merino, MD; Phone Number: +34 912071301; Email: lapaz@arritmias.net
    • Sub-Investigator: Sergio Castrejón Castrejón

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pulmonary veins isolation plus linear left atrial ablation.	Other: Radiofrequency ablation of heart atrial tissue.; Ablation with radiofrequency, advances techniques: contact force-guided, improved tissue temperature sensors, automark algorithms.
Active Comparator: Pumonary veins isolation only.	Other: Radiofrequency ablation of heart atrial tissue.; Ablation with radiofrequency, advances techniques: contact force-guided, improved tissue temperature sensors, automark algorithms.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Complications.	Complications associated to the ablation procedure.	through study completion, 1year follow-up

Collaborators and Investigators

• Sponsor: Hospital Universitario La Paz

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2023
• Primary Completion (Estimated): May 1, 2026
• Study Completion (Estimated): May 1, 2026

Study Registration Dates

• First Submitted: January 8, 2024
• First Submitted That Met QC Criteria: February 26, 2024
• First Posted (Actual): March 4, 2024

Study Record Updates

• Last Update Posted (Actual): March 4, 2024
• Last Update Submitted That Met QC Criteria: February 26, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Disease Attributes; Arrhythmias, Cardiac; Atrial Fibrillation; Recurrence
• Other Study ID Numbers: 6270

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No