Atrial FibrillationPVI-MODENCT07456540
Comparison of Available Standard Pulse Field Ablation Methods for Pulmonary Vein Isolation for Treatment of Atrial Fibrillation
A study testing Pulse field ablation Systems in people with Atrial Fibrillation, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
The goal of this cluster randomization study is to evaluate currently used standard methods for pulse field ablation in patients with irregular heart rhythm also called atrial fibrillation (AF) who are treated at Rigshospitalet and Gentofte Hospital in Copenhagen, Denmark. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Pulse field ablation Systems
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,125 participants
- Where
- 1 siteDenmark
- Study dates
- 15 Feb 2026to 30 Apr 2030
- 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
- 18 years or older
- Planned Catheter Ablation of Atrial Fibrillation with Pulmonary Vein Isolation
Who cannot join
- Opt out of data collection
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site
Rigshospitalet
Copenhagen, 2100
Peter K Jacobsen, MD, 35456752, dketik@dketik.dk
About this study
Official title: Comparison of Available Standard Methods for Pulmonary Vein Isolation for Ablation Treatment of Atrial Fibrillation
The goal of this cluster randomization study is to evaluate currently used standard methods for pulse field ablation in patients with irregular heart rhythm also called atrial fibrillation (AF) who are treated at Rigshospitalet and Gentofte Hospital in Copenhagen, Denmark.
A cluster randomization study tests standardized treatments by rotating the treatments over time periods. All patients will be treated with the specific standard treatment of the period and will be informed about the study. The patient will have the option to decline their participatiion in the study in writing and their data will not be collected.
Read more
The main purpose of the study is to investigate whether one of more of the systems are more efficient in preventing AF or atrial flutter during the following 12 months. Additionally, the safety of the systems are compared to see if one or more are more efficient in preventing complications 30 days after the ablation procedure.
The patients will receive standard treatment according to the cluster at the time of their ablation and data for up to 12 months post procedure will be collected by medicial chart review.
- Conditions
- Atrial Fibrillation
- Being tested
- Pulse field ablation Systems
- Keywords
- Atrial Fibrillation, AF, Ablation, pulmonary vein isolation, PVI
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulse field ablation SystemsDevice
Pulse field ablation Systems
| Study group | Role | What they receive |
|---|---|---|
| FARAPULSE and FARAVIEW | Active comparator | PFA system Receives: Device: Pulse field ablation Systems |
| VARIPULSE | Active comparator | PFA system Receives: Device: Pulse field ablation Systems |
| PULSE-SELECT and AFFERA | Active comparator | PFA system Receives: Device: Pulse field ablation Systems |
| Arctic Front Advance Cardiac Cryoablation Catheter | Active comparator | Ablation system Receives: Device: Pulse field ablation Systems |
| VOLT | Active comparator | PFA system Receives: Device: Pulse field ablation Systems |
What is being measured
The primary outcome is the main question the study is designed to answer.
Atrial fibrillation or atrial flutter
Relapse atrial fibrillation or flutter meassured remote (Loop or watch) or in clinic (EKG)
Measured: 12 months post procedure
Atrial fibrillation or atrial flutter
Relapse atrial fibrillation or flutter meassured remote (Loop or watch) or in clinic (EKG)
Measured: 6 months post procedure
Atrial fibrillation or atrial flutter
Relapse atrial fibrillation or flutter meassured remote (Loop or watch) or in clinic (EKG)
Measured: 3 months post procedure
Secondary outcomes (9)
Hospitalization due to atrial fibrillation or flutter
Hospitalization due to atrial fibrillation or flutter including DC cardioversion
Measured: 12 months post procedure
Hospitalization due to atrial fibrillation or flutter
Hospitalization due to atrial fibrillation or flutter including DC cardioversion
Measured: 6 months post procedure
Patient reported outcome measures
Patient reported symptoms and quality of life (Questionnaires)
Measured: 12 month
Patient reported outcomes measures
Patient reported symptoms and quality of life (Questionnaires)
Measured: 6 month
Patient reported outcomes measures
Patient reported symptoms and quality of life (Questionnaires)
Measured: 3 month
Antiarrhythmic medications
Use of antiarrhythmic medications
Measured: 12 months post procedure
Antiarrhythmic medications
Use of antiarrhythmic medications
Measured: 6 months post procedure
Duration of the procedure
The duration of the ablation procedure
Measured: Post procedure
Safety of the system
The frequency of procedure-related complications
Measured: 30 days post procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2026
- Study start15 Feb 2026 (estimated)
- Primary completion30 Apr 2030 (estimated)
- Study completion30 Apr 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- 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
- 1,125 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peter Karl Jacobsen, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Peter K Jacobsen, MD, PhD, Principal investigator, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07456540
- Sponsor's protocol ID
- PVI-MODE
- Acronym
- PVI-MODE
- Status last verified
- Mar 2026
- First submitted
- 26 Jan 2026
- Last updated
- 6 Mar 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 6 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Available Standard Methods for Pulmonary Vein Isolation for Ablation Treatment of Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT07456540
- Acronym / sponsor ID
- PVI-MODE / PVI-MODE
- Conditions
- Atrial Fibrillation
- Keywords
- Atrial Fibrillation, AF, Ablation, pulmonary vein isolation, PVI
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,125 participants (estimated)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- 15 Feb 2026 (estimated)
- Primary completion
- 30 Apr 2030 (estimated)
- Study completion
- 30 Apr 2030 (estimated)
- First posted
- 6 Mar 2026 (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 cluster randomization study is to evaluate currently used standard methods for pulse field ablation in patients with irregular heart rhythm also called atrial fibrillation (AF) who are treated at Rigshospitalet and Gentofte Hospital in Copenhagen, Denmark.
A cluster randomization study tests standardized treatments by rotating the treatments over time periods. All patients will be treated with the specific standard treatment of the period and will be informed about the study. The patient will have the option to decline their participatiion in the study in writing and their data will not be collected.
The main purpose of the study is to investigate whether one of more of the systems are more efficient in preventing AF or atrial flutter during the following 12 months. Additionally, the safety of the systems are compared to see if one or more are more efficient in preventing complications 30 days after the ablation procedure.
The patients will receive standard treatment according to the cluster at the time of their ablation and data for up to 12 months post procedure will be collected by medicial chart review.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| FARAPULSE and FARAVIEW | Active comparator | Device: Pulse field ablation SystemsPFA system |
| VARIPULSE | Active comparator | Device: Pulse field ablation SystemsPFA system |
| PULSE-SELECT and AFFERA | Active comparator | Device: Pulse field ablation SystemsPFA system |
| Arctic Front Advance Cardiac Cryoablation Catheter | Active comparator | Device: Pulse field ablation SystemsAblation system |
| VOLT | Active comparator | Device: Pulse field ablation SystemsPFA system |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 18 years or older
- Planned Catheter Ablation of Atrial Fibrillation with Pulmonary Vein Isolation
Key exclusion criteria (1 listed)
- Opt out of data collection
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 |
|---|---|---|
| Pulse field ablation SystemsPulse field ablation Systems | Device | Arctic Front Advance Cardiac Cryoablation Catheter, FARAPULSE and FARAVIEW, PULSE-SELECT and AFFERA, VARIPULSE, VOLT |
Primary outcome
Atrial fibrillation or atrial flutter
Time frame: 12 months post procedure
Relapse atrial fibrillation or flutter meassured remote (Loop or watch) or in clinic (EKG)
Atrial fibrillation or atrial flutter
Time frame: 6 months post procedure
Relapse atrial fibrillation or flutter meassured remote (Loop or watch) or in clinic (EKG)
Atrial fibrillation or atrial flutter
Time frame: 3 months post procedure
Relapse atrial fibrillation or flutter meassured remote (Loop or watch) or in clinic (EKG)
9 secondary outcomes
Hospitalization due to atrial fibrillation or flutter
Time frame: 12 months post procedure
Hospitalization due to atrial fibrillation or flutter
Time frame: 6 months post procedure
Patient reported outcome measures
Time frame: 12 month
Patient reported outcomes measures
Time frame: 6 month
Patient reported outcomes measures
Time frame: 3 month
Antiarrhythmic medications
Time frame: 12 months post procedure
Antiarrhythmic medications
Time frame: 6 months post procedure
Duration of the procedure
Time frame: Post procedure
Safety of the system
Time frame: 30 days post procedure
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 6 Mar 2026.
- Individual participant dataSharing planned: No
Related trials for Atrial Fibrillation
Active, not recruiting
Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
Active, not recruitingObservational study
Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
Concomitant Procedures, Atrial Fibrillation
Active, not recruiting
CONVERGE Post-Approval Study (PAS)
Chronic Atrial Fibrillation
Recruiting
Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
Ischemic Stroke, Atrial Fibrillation
RecruitingPhase 2
Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation
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.
Peter K Jacobsen, MD, PhD principal investigator
Copenhagen University Hospital, Rigshospitalet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pulse field ablation Systems in people with Atrial Fibrillation, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
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 2 inclusion and 1 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: opening soon, as of the sponsor's last update on 6 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. 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 Peter K Jacobsen, MD, DMSc (35456752, Peter.Karl.Jacobsen@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Atrial fibrillation or atrial flutter (time frame: 12 months post procedure). 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 6 Mar 2026.