Atrial Fibrillation Clinical Trials

Find Atrial Fibrillation Clinical Trials Near You

IsoLation of PuLmonary Vein oUtcome Using a coMbIned Pulse Field Energy and ballooN cAtheTEr in Atrial Fibrillation

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Belgium
AZ Sint-Jan Brugge AV
RECRUITING
Bruges
UZ Brussel
RECRUITING
Jette
Contact Information
Primary
Emma Christiaen, PhD
emma.christiaen@azsintjan.be
+32 50453293
Time Frame
Start Date: 2025-12-05
Estimated Completion Date: 2028-12-31
Participants
Target number of participants: 136
Treatments
Experimental: Pulsed Field Ablation (PFA) Arm - VOLT Catheter
Participants randomized to this group will undergo pulmonary vein isolation using the novel VOLT catheter, which delivers non-thermal pulsed field energy to ablate heart tissue. The VOLT catheter features a balloon-in-basket design and is compatible with electro-anatomical mapping systems. This technique aims to selectively target heart tissue while minimizing damage to surrounding structures.
Active_comparator: Thermal Ablation Arm - Radiofrequency or Cryoablation
Participants in this group will receive conventional thermal ablation, either using radiofrequency energy (point-by-point ablation guided by mapping) or cryoballoon ablation (freezing tissue using a balloon catheter). These techniques create scar tissue to block abnormal electrical signals causing atrial fibrillation.
Sponsors
Leads: Sebastien Knecht

This content was sourced from clinicaltrials.gov