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

NCT06291506 | Recruiting DMC

• 1 other identifier: 6270
• Study Type: interventional
• Target: 176
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Acute intraprocedure efficacy.

  during the ablation procedure and up to 2 months blanking perior

• Complications.

  through study completion, 1year follow-up

Study Arms (2)

Pulmonary veins isolation plus linear left atrial ablation.

EXPERIMENTAL

Other: Radiofrequency ablation of heart atrial tissue.

Pumonary veins isolation only.

ACTIVE COMPARATOR

Other: Radiofrequency ablation of heart atrial tissue.

Interventions

Radiofrequency ablation of heart atrial tissue. OTHER

Ablation with radiofrequency, advances techniques: contact force-guided, improved tissue temperature sensors, automark algorithms.

Pulmonary veins isolation plus linear left atrial ablation.; Pumonary veins isolation only.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Universitario La Paz: lead

Study Sites (1)

La Paz University Hospital - IdiPaz

Madrid, Spain

RECRUITING

Central Study Contacts

José Luis Merino Llorens, MD, PhD

CONTACT

+34 912071301; lapaz@arritmias.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant of Cardiology, main coinvestigator, coordinator.

Model Details: 1:1 randomization

Study Record Dates

• First Submitted: January 8, 2024
• First Posted: March 4, 2024
• Study Start: May 1, 2023
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: March 4, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)