Extended Ablation Versus Pulmonary Vein Isolation to Treat Persistent Atrial Fibrillation

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorCharles University, Czech Republic

About this trial

The aim is to determine the effect of extended ablation (pre-specified linear PF/RF lesion set) in addition to PVI in symptomatic persistent AF patients on AF/AT/AFL recurrence. The study is designed as multicenter, randomized trial. Eligible patients are patients with persistent AF (but not long-standing persistent AF) planned for a first-ever AF ablation procedure. Patients will be randomly assigned 1:1 either to: i) PVI-only, or ii) PVI-plus arms. Patients in both groups will undergo catheter ablation using an ablation system capable of performing PF and RF ablation (Sphere-9, Affera, Medtronic). Patients randomized to the PVI-only arm will undergo only PVI. Patients randomized to the PVI-plus arm will undergo PVI plus linear lesions (roof, bottom line, lateral or anterior MI line, and septal line in the LA; intercaval line and cavotricuspid line in the RA). The primary endpoint will be freedom from recurrent AF/AT/AFL, assessed as time-to-first recurrence in the period of 12 months after randomization (post 2-month blanking period). Secondary clinical endpoints will be 1) 12-month differences in AF/AT/AFL burden, 2) AF/AFL/AT-related outcomes (hospitalization or emergency visits), 3) Quality of life according to the AFEQT questionnaire score at 12 months, 4) MACE defined as cardiovascular death, stroke, myocardial infarction, or hospitalization for heart failure. Secondary endpoints will be evaluated throughout the entire (minimum 12-month) follow-up period.

Eligibility criteria

Qualifiers

symptomatic persistent AF

≥1 episode of persistent AF in the last 12 months

signed informed consent

Disqualifiers

first-manifested AF, paroxysmal AF, long-standing persistent AF, permanent AF

SR on admission without Class I/III AADs

AF of secondary cause (e.g. hyperthyroidism)

any previous LA ablation

Trial design

Treatments tested in this trial

  • PVI-plus
  • PVI-only

Treatment groups

450 Participants
are divided into 2 treatment groups

Locations

This trial has no locations

Sponsors and collaborators

Charles University, Czech Republic

Lead sponsor

University Hospital Prague (IKEM), Prague, Czech Republic

Collaborator

University Hospital Olomouc

Collaborator

Cardiocenter Podlesí, Trinec, Czech Republic

Collaborator

Faculty Hospital Kralovske Vinohrady

Collaborator