Atrial Fibrillation (AF)ILLUMINATE-AFNCT07156877
Assessment of Pulmonary Vein Isolation Using a Balloon Catheter With Pulsed Field Energy in Atrial Fibrillation
A study testing Pulsed Field Ablation (PFA) with VOLT Catheter and Thermal Ablation (Radiofrequency or Cryoablation) in people with Atrial Fibrillation (AF), run by Sebastien Knecht at 2 sites in Belgium.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation (AF)
- What is being tested?
- Pulsed Field Ablation (PFA) with VOLT Catheter and Thermal Ablation (Radiofrequency or Cryoablation)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 136 participants
- Where
- 2 sitesBelgium
- Study dates
- 5 Dec 2025to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- History of left atrial (LA) ablation or surgery involving the LA
- Persistent atrial fibrillation (AF) lasting longer than 12 months
- AF resulting from temporary or reversible causes
- Presence of thrombus within the heart chambers
- Prior pulmonary vein (PV) stenosis or stenting
- Existing paralysis of one side of the diaphragm
Show all 26Show fewer
- Known allergy or contraindication to anticoagulant medication or contrast agents
- History of mitral valve surgery
- Significant mitral valve disease
- Myocardial infarction occurring within three months prior to informed consent
- Current use of triple antithrombotic therapy
- 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
- Left ventricular ejection fraction (LVEF) less than 35%
- Diagnosed hypertrophic cardiomyopathy (wall thickness exceeding 1.7 cm)
- Severe chronic kidney disease (eGFR below 30 ml/min)
- Uncontrolled hyperthyroidism
- Stroke or transient ischemic attack (TIA) within three months before consent
- Active systemic infections
- History of cryoglobulinemia
- Diagnosed cardiac amyloidosis
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium2 sites, 2 recruiting
- Recruiting
AZ Sint-Jan Brugge AV
Bruges, 8000
Emma Christiaen, +3250453293, emma.christiaen@azsintjan.be
Sébastien Knecht, MD, PhD
- Recruiting
UZ Brussel
Jette, 1090
Ileana Smets, MSc, +32 2 477 5660, HRMC.Research@uzbrussel.be
Jean Baptiste Chierchia, MD, PhD
About this study
Official title: IsoLation of PuLmonary Vein oUtcome Using a coMbIned Pulse Field Energy and ballooN cAtheTEr in Atrial Fibrillation
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:
Read more
- 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.
- Conditions
- Atrial Fibrillation (AF)
- Being tested
- Pulsed Field Ablation (PFA) with VOLT Catheter, Thermal Ablation (Radiofrequency or Cryoablation)
- Keywords
- Atrial fibrillation, Pulmonary vein isolation, Pulsed field ablation
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulsed Field Ablation (PFA) with VOLT CatheterProcedure or surgery
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.
Thermal Ablation (Radiofrequency or Cryoablation)Procedure or surgery
Participants in this arm will receive PVI using established thermal ablation techniques, either:
- Radiofrequency ablation, a point-by-point technique using heat delivered through a catheter tip guided by mapping systems, or
- Cryoballoon ablation, which uses freezing energy delivered via a balloon catheter.
The choice between RF and cryoablation is at the discretion of the treating physician, in line with standard care.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Pulsed Field Ablation (PFA) with VOLT Catheter |
| 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. Receives: Procedure: Thermal Ablation (Radiofrequency or Cryoablation) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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:
- Cardiac tamponade requiring pericardiocentesis
- Persistent phrenic nerve palsy lasting more than 24 hours
- Serious vascular complications requiring intervention
- Stroke/transient ischemic attack
- Atrio-esophageal fistula
- Death The safety endpoint is assessed during catheter ablation, until discharge, and during the following 30 days. Information on safety events are collected throughout the trial by the investigators or their designees. All primary safety events will be reviewed and adjudicated by the clinical events committee members.
Measured: From ablation until 30 days post ablation
Procedure duration (minutes)
Total procedure duration (minutes)
Measured: Day of ablation procedure
Secondary outcomes (7)
Left atrial dwelling time (minutes)
Time the catheter remains inside the left atrium during the ablation procedure (minutes)
Measured: Day of ablation procedure
Fluoroscopy time (minutes)
Total fluoroscopy time (minutes)
Measured: 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 (%)
Measured: 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 (%)
Measured: From ablation until 12 months post ablation
Proportion of patients undergoing a repeat ablation (%)
Proportion of patients undergoing a repeat ablation (%)
Measured: 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)
Measured: 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
Measured: 3, 6 and 12 months post ablation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2025
- Study start5 Dec 2025
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial Fibrillation (AF)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 136 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sebastien Knecht
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sebastien Knecht, AZ Sint-Jan AV
- Investigators
- Sébastien Knecht, MD, PhD, Principal investigator, AZ Sint-Jan Brugge AV
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07156877
- Sponsor's protocol ID
- ILLUMINATE-AF
- Acronym
- ILLUMINATE-AF
- Status last verified
- May 2026
- First submitted
- 7 Aug 2025
- Last updated
- 12 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IsoLation of PuLmonary Vein oUtcome Using a coMbIned Pulse Field Energy and ballooN cAtheTEr in Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT07156877
- Acronym / sponsor ID
- ILLUMINATE-AF / ILLUMINATE-AF
- Conditions
- Atrial Fibrillation (AF)
- Keywords
- Atrial fibrillation, Pulmonary vein isolation, Pulsed field ablation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 136 participants (estimated)
- Lead sponsor
- Sebastien KnechtUniversity, hospital or other
- Study start
- 5 Dec 2025 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 5 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pulsed Field Ablation (PFA) Arm - VOLT Catheter | Experimental | Procedure: Pulsed Field Ablation (PFA) with VOLT CatheterParticipants 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 | Procedure: Thermal Ablation (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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (26 listed)
- History of left atrial (LA) ablation or surgery involving the LA
- Persistent atrial fibrillation (AF) lasting longer than 12 months
- AF resulting from temporary or reversible causes
- Presence of thrombus within the heart chambers
- Prior pulmonary vein (PV) stenosis or stenting
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pulsed Field Ablation (PFA) with VOLT CatheterParticipants 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. | Procedure or surgery | Pulsed Field Ablation (PFA) Arm - VOLT Catheter |
| Thermal Ablation (Radiofrequency or Cryoablation)Participants in this arm will receive PVI using established thermal ablation techniques, either: * Radiofrequency ablation, a point-by-point technique using heat delivered through a catheter tip guided by mapping systems, or * Cryoballoon ablation, which uses freezing energy delivered via a balloon catheter. The choice between RF and cryoablation is at the discretion of the treating physician, in line with standard care. | Procedure or surgery | Thermal Ablation Arm - Radiofrequency or Cryoablation |
Primary outcome
Time to first recurrence of any atrial tachyarrhythmia
Time frame: Between 2 and 12 months post ablation
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.
Number of safety events, composite of cardiac tamponade, phrenic nerve palsy, vascular complications, stroke/transient ischemic attack, atrio-esophageal fistula and death
Time frame: From ablation until 30 days post ablation
The primary safety endpoint is a composite of: 1. Cardiac tamponade requiring pericardiocentesis 2. Persistent phrenic nerve palsy lasting more than 24 hours 3. Serious vascular complications requiring intervention 4. Stroke/transient ischemic attack 5. Atrio-esophageal fistula 6. Death The safety endpoint is assessed during catheter ablation, until discharge, and during the following 30 days. Information on safety events are collected throughout the trial by the investigators or their designees. All primary safety events will be reviewed and adjudicated by the clinical events committee members.
Procedure duration (minutes)
Time frame: Day of ablation procedure
Total procedure duration (minutes)
7 secondary outcomes
Left atrial dwelling time (minutes)
Time frame: Day of ablation procedure
Fluoroscopy time (minutes)
Time frame: Day of ablation procedure
AF burden: percentage of time in AF on 7 day Holter (%)
Time frame: Before ablation, and 6 months and 12 months post ablation
Proportion of patients with recurrence of any atrial tachyarrhythmia including during the blanking period (%)
Time frame: From ablation until 12 months post ablation
Proportion of patients undergoing a repeat ablation (%)
Time frame: From ablation until 12 months post ablation
Quality of life changes, assessed using the 36-Item Short Form Survey Instrument (SF-36)
Time frame: 3, 6 and 12 months post ablation
Quality of life changes, assessed using the AF Symptom Checklist
Time frame: 3, 6 and 12 months post ablation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2026.
- Individual participant dataSharing planned: No
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ATRIAL APPENDAGE CLOSURE for ATRIAL FIBRILLATION, Atrial Fibrillation (AF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sébastien Knecht, MD, PhD principal investigator
AZ Sint-Jan Brugge AV
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pulsed Field Ablation (PFA) with VOLT Catheter and Thermal Ablation (Radiofrequency or Cryoablation) in people with Atrial Fibrillation (AF), run by Sebastien Knecht at 2 sites in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Emma Christiaen, PhD (+32 50453293, emma.christiaen@azsintjan.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to first recurrence of any atrial tachyarrhythmia (time frame: Between 2 and 12 months post ablation). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2026.