NCT07100834Completed
Pulsed ElectRic FiEld Versus Cryoballoon for PAF
Pulsed ElectRic FiEld Versus Cryoballoon to Treat Paroxysmal Atrial Fibrillation (PERFECT-PAF) Randomized Trial
Source: ClinicalTrials.gov · Last updated 3 Aug 2025
Brief summary (registry, in English)
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
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 269 (actual)
- First submitted
- 27 Jul 2025
- Start date
- Sept 2023
- Primary completion date
- May 2024
- Lead sponsor
- Universitair Ziekenhuis Brussel
- Diseases
- Atrial fibrillation
- NCT number
- NCT07100834
What you commit to
- Study type: Interventional
- Participants enrolled: 269
- From Sept 2023 to the primary completion date, May 2024
- 6 sites in 5 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous left atrium (LA) ablation or surgery;
- Previously diagnosed with persistent AF (greater than \[\>\] 7 days in duration);
Other illness
- AF secondary to electrolyte imbalance, thyroid disease, valvular disease, or reversible or non-cardiac cause;
- 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.
Other
- 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;
Who the study is looking for
- 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.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (6)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Universitair Ziekenhuis Brussel Coordinator of this site? Confirm its status | Brussels | Belgium | Unknown status |
| 9. First Department of Cardiology, National and Kapodistrian University of Athens Medical School, Hippokration General Hospital Coordinator of this site? Confirm its status | Athens | Greece | Unknown status |
| Department of Cardiovascular Diseases, University Hospital Center Zagreb Coordinator of this site? Confirm its status | Zagreb | Croatia | Unknown status |
| Maria Cecilia Hospital Coordinator of this site? Confirm its status | Cotignola | Italy | Unknown status |
| Ospedale Fatebenefratelli Isola Tiberina Gemelli Isola Coordinator of this site? Confirm its status | Roma | Italy | Unknown status |
| Department of Cardiology, Medical University of Lublin Coordinator of this site? Confirm its status | Lublin | Poland | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.