Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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:
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:
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pulsed Field Ablation (PFA) Arm - VOLT Catheter | Experimental | 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. |
|
| Thermal Ablation Arm - Radiofrequency or Cryoablation | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pulsed Field Ablation (PFA) with VOLT Catheter | Procedure | Participants in this arm will undergo pulmonary vein isolation (PVI) using the VOLT catheter, a novel single-shot ablation device that delivers pulsed field energy (a non-thermal ablation method). The catheter features a balloon-in-basket design and enables electro-anatomical mapping. The procedure is performed under conscious sedation or general anesthesia and follows standard PVI protocols adapted for the PFA technology. |
| Measure | Description | Time Frame |
|---|---|---|
| Time to first recurrence of any atrial tachyarrhythmia | The primary endpoint is the time to first recurrence of any atrial tachyarrhythmia (AF and/or organized atrial tachyarrhythmia) after 12 months following the ablation procedure, as detected on repetitive Holter and home monitoring. During the first 2 months after the procedure (blanking period), recurrent AF or atrial tachycardia will be treated with antiarrhythmic drugs or cardioversion as needed, and won't be considered treatment failure. Atrial tachyarrhythmia recurrence is defined as continuous arrhythmia lasting 30 seconds or longer. Potential arrhythmia events will be independently reviewed and adjudicated by a clinical events committee comprised of 3 experienced electrophysiologists who are blinded to treatment allocation. | Between 2 and 12 months post ablation |
| Number of safety events, composite of cardiac tamponade, phrenic nerve palsy, vascular complications, stroke/transient ischemic attack, atrio-esophageal fistula and death | The primary safety endpoint is a composite of:
| From ablation until 30 days post ablation |
| Procedure duration (minutes) | Total procedure duration (minutes) | Day of ablation procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Left atrial dwelling time (minutes) | Time the catheter remains inside the left atrium during the ablation procedure (minutes) | Day of ablation procedure |
| Fluoroscopy time (minutes) | Total fluoroscopy time (minutes) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Emma Christiaen, PhD | Contact | +32 50453293 | emma.christiaen@azsintjan.be |
| Name | Affiliation | Role |
|---|---|---|
| Sébastien Knecht, MD, PhD | AZ Sint-Jan Brugge AV | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AZ Sint-Jan Brugge AV | Recruiting | Bruges | 8000 | Belgium |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Thermal Ablation (Radiofrequency or Cryoablation) | Procedure | Participants in this arm will receive PVI using established thermal ablation techniques, either:
The choice between RF and cryoablation is at the discretion of the treating physician, in line with standard care. |
|
| Day of ablation procedure |
| AF burden: percentage of time in AF on 7 day Holter (%) | AF burden: percentage of time in AF on 7 day Holter (%) | Before ablation, and 6 months and 12 months post ablation |
| Proportion of patients with recurrence of any atrial tachyarrhythmia including during the blanking period (%) | Proportion of patients with recurrence of any atrial tachyarrhythmia including during the blanking period (%) | From ablation until 12 months post ablation |
| Proportion of patients undergoing a repeat ablation (%) | Proportion of patients undergoing a repeat ablation (%) | From ablation until 12 months post ablation |
| Quality of life changes, assessed using the 36-Item Short Form Survey Instrument (SF-36) | Quality of life changes at 3, 6 and 12 months compared with baseline, assessed using the 36-Item Short Form Survey Instrument (SF-36) | 3, 6 and 12 months post ablation |
| Quality of life changes, assessed using the AF Symptom Checklist | Quality of life changes at 3, 6 and 12 months compared with baseline, assessed using the AF Symptom Checklist | 3, 6 and 12 months post ablation |
| UZ Brussel | Recruiting | Jette | 1090 | Belgium |
|
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D051183 | Desmoglein 1 |
| D003452 | Cryosurgery |
| ID | Term |
|---|---|
| D051182 | Desmogleins |
| D051181 | Desmosomal Cadherins |
| D015820 | Cadherins |
| D015815 | Cell Adhesion Molecules |
| D008562 | Membrane Glycoproteins |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D008565 | Membrane Proteins |
| D000954 | Antigens, Surface |
| D000941 | Antigens |
| D001685 | Biological Factors |
| D001324 | Autoantigens |
| D055011 | Ablation Techniques |
| D013514 | Surgical Procedures, Operative |
Not provided
Not provided