Pulsed ElectRic FiEld Versus Cryoballoon for PAF

NCT07100834 | Completed DMC

• 1 other identifier: EC-2023-208
• Study Type: interventional
• Target: 269
• Locations: 5 countries
• Sites: 6

Brief Summary

This study has been designed to compare the success rate of two different commercially available ablation technologies, namely PFA and Cryo. Both technologies are standard of care ablation procedures. An ablation is a procedure where a small piece of tissue of the heart, that. causes an irregular heartbeat, is heated or frozen (cryo-ablation) using a special type of catheter. Once you have signed this consent to take part of the study, you will be randomly assigned to one of the two ablation strategies (PFA versus Cryo). Randomization is a method that helps prevent any possible influence of human choices on clinical results and improve objectivity in research. The day of the procedure you will be undergo AF catheter ablation via either PFA or Cryo based on the results of randomization. Although both devices that will be used in this study are commercially approved, assessing the incidence of arrhythmia recurrence after ablation during follow-up is considered the investigational portion of the study. "Investigational" means that recurrence data will be collected after the cardiac ablation procedure and compared amongst the two standard of care ablation methods used to treat AF. This study will investigate how well PFA and Cryo work to prevent recurrences of atrial arrhythmias and if there are any differences between the two technologies

Conditions

Atril Fibrillation; Cardiac Arrhythmia; Paroxysmal Atrial Fibrillation (PAF)

Keywords

atrial fibrillation; ablation; pulsed field ablation; cryoablation; cryoballoon; paroxysmal atrial fibrillation

Outcome Measures

Primary Outcomes (1)

• Primary Efficacy Endpoint

  the primary efficacy endpoint will be the incidence of any atrial tachyarrhythmia (AF, atrial flutter, atrial tachycardia) lasting \>30s during at least 1 year of follow-up. Recurrences occurring within the first 90 days post-ablation (the so-called "blanking period") will not be considered for primary efficacy endpoint measurement.

  0-36 months

Study Arms (2)

Pulsed Field Ablation

EXPERIMENTAL

The FARAPULSE™ Pulsed Field Ablation System (Boston Scientific, Inc.) is a CE-marked system consisting of the FARASTAR™ Pulsed Field Ablation Generator that is used with the FARAWAVE™ Pulsed Field Ablation Catheter for cardiac tissue ablation

Device: Single-Shot Pulsed Field Ablation (FARAPULSE™ Pulsed Field Ablation System)

Cryoballoon Ablation

ACTIVE COMPARATOR

The Arctic Front Advance PRO, POLARx and Polarx FIT Balloon Catheters are CE-marked cryoablation systems consisting of a cryoballoon device, which is used in conjunction with a CryoConsole, a steerable sheath, and a circular mapping catheter

Device: Single-Shot Cryoballoon Devices (Arctic Front Advance PRO, Medtronic Inc., Minneapolis, MN, USA; POLARx and POLARx FIT Balloon Catheter, Marlborough, MA, USA)

Interventions

Single-Shot Pulsed Field Ablation (FARAPULSE™ Pulsed Field Ablation System) DEVICE

The FARAPULSE™ Pulsed Field Ablation System (Boston Scientific, Inc.) is a CE-marked system consisting of the FARASTAR™ Pulsed Field Ablation Generator that is used with the FARAWAVE™ Pulsed Field Ablation Catheter for cardiac tissue ablation

Pulsed Field Ablation

Single-Shot Cryoballoon Devices (Arctic Front Advance PRO, Medtronic Inc., Minneapolis, MN, USA; POLARx and POLARx FIT Balloon Catheter, Marlborough, MA, USA) DEVICE

The Arctic Front Advance PRO, POLARx and FIT Balloon Catheters are CE-marked cryoablation systems consisting of a cryoballoon device, which is used in conjunction with a CryoConsole, a steerable sheath, and a circular mapping catheter

Cryoballoon Ablation

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of recurrent symptomatic non-valvular paroxysmal AF (PAF);
• Age 18 through 75 years-old on the day of enrollment;
• Willing and capable of providing written informed consent;
• Willing and capable of complying with all pre-, post- and follow-up testing andrequirements.

You may not qualify if:

• AF secondary to electrolyte imbalance, thyroid disease, valvular disease, or reversible or non-cardiac cause;
• Previous left atrium (LA) ablation or surgery;
• Previously diagnosed with persistent AF (greater than \[\>\] 7 days in duration);
• Severe dilatation of the LA (LAD \>50 millimeter (mm) antero-posterior diameter in case of transthoracic echocardiography (TTE));
• Pregnant or lactating (current or anticipated) at the time of catheter ablation;
• Current enrollment in any other study protocol where testing or results from that study may interfere with the procedure or outcome measurements for this study;
• Any other conditions such as, mental illness, addictive disease, terminal illness with a life expectancy of less than two years, extensive travel away from the research center that may lead to non-compliance with the protocol procedure or follow up.

Sponsors & Collaborators

• Universitair Ziekenhuis Brussel: lead

Study Sites (6)

Universitair Ziekenhuis Brussel

Brussels, Belgium

Location

Department of Cardiovascular Diseases, University Hospital Center Zagreb

Zagreb, Croatia

Location

9. First Department of Cardiology, National and Kapodistrian University of Athens Medical School, Hippokration General Hospital

Athens, Greece

Location

Maria Cecilia Hospital

Cotignola, Italy

Location

Ospedale Fatebenefratelli Isola Tiberina-Gemelli Isola

Roma, Italy

Location

Department of Cardiology, Medical University of Lublin

Lublin, Poland

Location

MeSH Terms

Conditions

Arrhythmias, Cardiac; Atrial Fibrillation

Condition Hierarchy (Ancestors)

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

Study Officials

• Domenico G Della Rocca, MD, PhD

  Universitair Ziekenhuis Brussel

  PRINCIPAL INVESTIGATOR

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: Department Director

Model Details: This is a singlecenter, prospective, randomized, non-inferiority, parallel-group, investigator-initiated trial with blinded endpoint assessment in which up to 202 paroxysmal AF patients will be randomly assigned to receive cryoballoon (Group Cryo; n=101) or pulsed electric field (PEF)-(Group PFA; n=101) ablation for pulmonary vein isolation (PVI).

Study Record Dates

• First Submitted: July 27, 2025
• First Posted: August 3, 2025
• Study Start: September 27, 2023
• Primary Completion: May 30, 2024
• Study Completion: June 30, 2025
• Last Updated: August 3, 2025

Record last verified: 2025-07

Locations

PL (1); IT (2); GR (1); BE (1); CR (1)