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Pulsed ElectRic FiEld Versus Cryoballoon for PAF

NCT07100834 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 269

Last updated 2025-08-03

No results posted yet for this study

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)

Interventions

DEVICE

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

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

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

Sponsors & Collaborators

  • Universitair Ziekenhuis Brussel

    lead OTHER

Principal Investigators

  • Domenico G Della Rocca, MD, PhD · Universitair Ziekenhuis Brussel

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-27
Primary Completion
2024-05-30
Completion
2025-06-30

Countries

  • Belgium
  • Croatia
  • Greece
  • Italy
  • Poland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07100834 on ClinicalTrials.gov