Extended Ablation Versus Pulmonary Vein Isolation to Treat Persistent Atrial Fibrillation

NCT07424326 | Recruiting DMC

• 1 other identifier: EK-VP/20/00/2026
• Study Type: interventional
• Target: 450
• Locations: 1 country
• Sites: 4

Brief Summary

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) 1) AF/AT/AFL burden during the first 12 months after randomization, 2) 2) Quality of life according to the AFEQT questionnaire score at 12 months, 3) 3) AF/AFL/AT-related outcomes (hospitalization or emergency visits), 4) MACE defined as cardiovascular death, stroke, myocardial infarction, or hospitalization for heart failuree, 5) A composite of pre-specified, procedure-related SAE within 7 days after the procedure, including clinically relevant delayed SAEs adjudicated as related to the index ablation procedure. Secondary endpoints will be evaluated throughout the entire (minimum 12-month) follow-up period.

Conditions

Atrial Fibrillation (AF)

Keywords

persistent atrial fibrillation; catheter ablation; pulmonary vein isolation; pulsed-field ablation; radiofrequency ablation

Outcome Measures

Primary Outcomes (1)

• Freedom from AF, AT and AFL

  An episode of AF/ AT/AFL is defined as either (1) a recording demonstrating at least 30 seconds of continuous interpretable signal during Holter monitoring performed at 3, 6, 9, or 12 months, or (2) a 12-lead ECG demonstrating the arrhythmia throughout the entire tracing, with at least 10 seconds of continuous interpretable signal during scheduled or emergency visits. In addition to a documented AF/AT/AFL episode as defined above, treatment failure (a primary endpoint event) will also be considered to have occurred if, after the end of the blanking period, any of the following occurs: (a) initiation or continuation of a Class I or Class III antiarrhythmic drug, or of sotalol, irrespective of the indication; (b) electrical cardioversion for AF/AT/AFL; (c) a repeat (redo) ablation for AF/AT/AFL. Beta-blockers and calcium-channel blockers do not constitute treatment failure.

  12 months

Secondary Outcomes (5)

• AF/ AT/AFL burden

  12 months

• AF-related clinical outcomes

  36 months

• Quality of life

  12 months

• MACE

  36 months

• A composite of procedure-related SAEs

  1 month

Study Arms (2)

PVI-plus group

EXPERIMENTAL

Patients allocated in the PVI-plus arm will undergo comprehensive ablation consisting of pulmonary vein isolation, roof line, inferior line, mitral ishtmus line, horizontal line in the left atrium, intercaval line, and cavotricuspid line in the right atrium.

Procedure: PVI-plus

PVI-only group

ACTIVE COMPARATOR

Patients allocated in the PVI-only arm will undergo pulmonary vein isolation without any additional ablation lesions.

Procedure: PVI-only

Interventions

PVI-plus PROCEDURE

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).

PVI-plus group

PVI-only PROCEDURE

Patients randomized to the PVI-only arm will undergo only PVI.

PVI-only group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• symptomatic persistent AF
• ≥1 episode of persistent AF in the last 12 months
• signed informed consent

You may not qualify if:

• 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
• severe valvular disease (mitral valve insufficiency ≥3+, moderate or severe aortic stenosis) or history of valvular surgery or intervention
• left ventricular ejection fraction ≤40%
• pulmonary hypertension (estimated systolic pulmonary artery pressure ≥40 mm Hg)
• symptomatic coronary artery disease
• pregnancy
• LA anteroposterior diameter ≥55 mm
• body mass index ≥40 kg/m2
• age ≥80 years
• chronic kidney disease stage 3b or higher
• contraindication to anticoagulation
• general contraindications of catheter ablation

Sponsors & Collaborators

• Charles University, Czech Republic: lead
• University Hospital Olomouc: collaborator
• Cardiocenter Podlesí, Trinec, Czech Republic: collaborator
• Faculty Hospital Kralovske Vinohrady: collaborator
• Institute for Clinical and Experimental Medicine: collaborator

Study Sites (4)

University Hospital Olomouc

Olomouc, Czechia

RECRUITING

IKEM

Prague, 10400, Czechia

RECRUITING

Cardiocenter, 3rd Medical School, Charles University and University Hospital Kralovske Vinohrady

Prague, Czechia

RECRUITING

University Hospital Kralovske Vinohrady

Prague, Czechia

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Pavel Osmancik

CONTACT

00420-267163029; pavel.osmancik@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Technicians and physicians responsible for Holter monitoring analysis will be fully blinded to treatment allocation. CEC will be blinded to the treatment allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: multicenter, randomized controlled trial

Study Record Dates

• First Submitted: February 14, 2026
• First Posted: February 20, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2029
• Last Updated: September 24, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share

Locations

CZ (4)