NCT07156877Recruiting
Assessment of Pulmonary Vein Isolation Using a Balloon Catheter With Pulsed Field Energy in Atrial Fibrillation
IsoLation of PuLmonary Vein oUtcome Using a coMbIned Pulse Field Energy and ballooN cAtheTEr in Atrial Fibrillation
Source: ClinicalTrials.gov · Last updated 12 May 2026
Brief summary (registry, in English)
The goal of this clinical trial is to evaluate whether pulsed field ablation (PFA) using the novel VOLT catheter is as safe and effective as conventional thermal ablation (radiofrequency or cryotherapy) for the treatment of atrial fibrillation (AF) in adult patients undergoing their first pulmonary vein isolation (PVI). The main questions it aims to answer are: * Is PFA with the VOLT catheter non-inferior to thermal ablation in preventing recurrence of atrial tachyarrhythmias 2-12 months after the procedure? * Is PFA with the VOLT catheter associated with fewer or comparable serious complications (such as cardiac tamponade, stroke, or phrenic nerve injury)? Researchers will compare the outcomes between patients receiving PFA with the VOLT catheter and those treated with thermal ablation techniques to see if PFA offers comparable or potentially better safety and efficacy. Participants will: * Be randomly assigned (1:1) to receive either pulsed field ablation (PFA) or thermal ablation (radiofrequency or cryotherapy). * Undergo standard follow-up visits at 2-3 months, 6 months, and 12 months post-ablation. * Have repeated ECGs and Holter monitoring to assess heart rhythm. * Complete quality of life questionnaires at baseline, 3, 6, and 12 months. * Use a home ECG device (Kardia Mobile) weekly during the final 3 months of the study. The study includes 136 adults (≥18 years) with paroxysmal or persistent AF, in two participating hospitals. The total study duration is 3 years, including a 2-year enrollment period and 1-year follow-up per participant.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 136 (estimated)
- First submitted
- 7 Aug 2025
- Start date
- 5 Dec 2025
- Primary completion date
- 31 Dec 2028
- Lead sponsor
- Sebastien Knecht
- Diseases
- Atrial fibrillation
- NCT number
- NCT07156877
What you commit to
- Study type: Interventional
- Planned participants: 136
- From 5 Dec 2025 to the primary completion date, 31 Dec 2028
- 2 sites in 1 country
- 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
- Prior pulmonary vein (PV) stenosis or stenting
- Myocardial infarction occurring within three months prior to informed consent
- Current use of triple antithrombotic therapy
- Stroke or transient ischemic attack (TIA) within three months before consent
Other illness
- History of left atrial (LA) ablation or surgery involving the LA
- Presence of thrombus within the heart chambers
- Known allergy or contraindication to anticoagulant medication or contrast agents
- History of mitral valve surgery
- Significant mitral valve disease
- Cardiac surgery within the past three months or a scheduled cardiac surgery or TAVI
- Major congenital heart abnormalities
- Congestive heart failure classified as NYHA class III or IV
- Active systemic infections
- History of cryoglobulinemia
- Diagnosed cardiac amyloidosis
Lab values
- Left ventricular ejection fraction (LVEF) less than 35%
- Severe chronic kidney disease (eGFR below 30 ml/min)
Other
- Persistent atrial fibrillation (AF) lasting longer than 12 months
- AF resulting from temporary or reversible causes
- Existing paralysis of one side of the diaphragm
- Diagnosed hypertrophic cardiomyopathy (wall thickness exceeding 1.7 cm)
- Uncontrolled hyperthyroidism
- Current pregnancy
- Estimated life expectancy under one year, as judged by the treating physician
- Enrollment in another clinical study that may interfere with this trial's outcomes
- Inability or unwillingness to adhere to study requirements and follow-up visits
Who the study is looking for
- Paroxysmal or persistent atrial fibrillation documented on a 12 lead electrocardiogram or Holter monitor (lasting ≥30 seconds) within the last 24 months.
- Candidate for ablation based on current AF guidelines
- Continuous anticoagulation with Vitamin-K-Antagonists or a non-vitamin K antagonist anticoagulant (NOAC) for ≥4 weeks prior to the ablation; or a transesophageal echocardiogram (TEE) and/or computed tomography (CT) that excludes left atrial thrombus ≤48 hours before ablation
- Age of 18 years or older on the date of consent
- Informed consent as documented by signature
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Az Sint-Jan Brugge Av Coordinator of this site? Confirm its status | Bruges | Belgium | Recruiting |
| UZ Brussel Coordinator of this site? Confirm its status | Jette | Belgium | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.