Atrial Fibrillation (AF)FOLLOW-AFNCT07471308
P-wave Duration and Local Potential as Predictors of AF Recurrence Following Pulmonary Vein Isolation
An observational study of Atrial Fibrillation (AF) and Atrial Fibrillation Patients Treated With the FARAPULSE™ PFA System, run by CathVision ApS at 1 site in United States.
Trial summary
Atrial fibrillation (AF) is the most prevalent sustained cardiac arrhythmia worldwide and is associated with substantial morbidity, mortality, and healthcare utilization. Catheter ablation, most commonly pulmonary vein isolation (PVI), is an established rhythm control strategy for AF4. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Atrial Fibrillation (AF), Atrial Fibrillation Patients Treated With the FARAPULSE™ PFA System, Atrial Fibrillation (Paroxysmal)
- What is being tested?
- AF Recurrence RIsk Assessment post pulmonary vein isolation
- Type of treatment
- Medical device
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Apr 2026to 15 Nov 2026
- Phase
- Observational
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Outpatient EHR
Who may be able to join
- Age ≥ 21 years
- Paroxysmal or persistent atrial fibrillation
- Underwent pulmonary vein isolation using pulse field ablation
- Patient record with pre-/post-ablation 12-lead ECGs and intra-procedural unipolar electrograms
Who cannot join
- Incomplete patient record:
- Lack of 12-leads ECG recording or intracardiac electrograms
- Lack of post-procedure follow-up assessment
- Follow-up was less than 6 months
- Cardiac recording data incomplete or not of sufficient quality
- Cardiac anatomical variation such as Left Common, or Right Accessory
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Validation of an Algorithm Designed to Predict the Recurrence of AF After Pulmonary Vein Isolation Using P-wave Duration and Procedural Unipolar Atrial Local Potential Measurements
Atrial fibrillation (AF) is the most prevalent sustained cardiac arrhythmia worldwide and is associated with substantial morbidity, mortality, and healthcare utilization. Catheter ablation, most commonly pulmonary vein isolation (PVI), is an established rhythm control strategy for AF4.
Despite technological advances and the emergence of pulse field ablation (PFA), long-term AF recurrence after a first ablation procedure remains frequent, occurring in approximately 30-50% of patients5. Post-ablation follow-up strategies, including visit frequency, rhythm monitoring intensity, and Antiarrhythmic Drug management, vary widely across providers and institutions and are largely guided by subjective assessment rather than objective, science-based recurrence risk estimation6. In parallel, asymptomatic (silent) AF recurrence is exacerbated following ablation, limiting the reliability of symptom-driven follow-up7.
Read more
FOLLOW-AF is a retrospective, observational cohort study designed to validate the FollowGenius algorithm and evaluate the diagnostic performance in predicting AF recurrence based on atrial remodeling and vein isolation.
The cohort will be patients with paroxysmal or persistent AF who underwent PVI with the PFA modality.
Read the detailed description
Atrial fibrillation (AF) is the most prevalent sustained cardiac arrhythmia worldwide and is associated with substantial morbidity, mortality, and healthcare utilization.3 Catheter ablation, most commonly pulmonary vein isolation (PVI), is an established rhythm control strategy for symptomatic AF.4 Historically, this has been achieved using radiofrequency and thermal energy. However, more recently a new energy source known as pulsed field ablation (PFA) has been introduced. As PFA is tissue selective, it preserves the function of nearby structures such as the esophagus and phrenic nerve making it safer to use. As PFA is delivered in short bursts of high energy, it is also more efficient and leads to shorter procedures.
Despite technological advances and the emergence of pulse field ablation (PFA), long-term AF recurrence after a first ablation procedure remains frequent, occurring in approximately 30-50% of patients.5 Post-ablation follow-up strategies, including visit frequency, rhythm monitoring intensity, and anticoagulation management, vary widely across providers and institutions and are largely guided by subjective assessment rather than objective, science-based recurrence risk estimation.6 In parallel, asymptomatic (silent) AF recurrence is exacerbated following ablation, limiting the reliability of symptom-driven follow-up.7
The underlying causes of AF recurrence are broadly driven by two distinct, yet complementary, mechanisms:
- Atrial Substrate Modification (Remodeling): Many patients have pre-existing atrial myopathy or remodeling due to long-standing hypertension, heart failure, or AF itself. This "diseased substrate" is prone to initiating and sustaining new AF triggers outside the pulmonary veins. P-wave duration, a simple, non-invasive marker from the surface ECG, is a well-established surrogate for this electrical and structural remodeling.2,9,10
- PVI Isolation (Reconnection): The primary goal of ablation is to create durable, transmural lesions to isolate the pulmonary veins. If lesions are incomplete, electrical reconnection often occurs, allowing the original AF triggers to re-initiate arrhythmia. Residual local potentials measured during the ablation procedure are a suggested marker of incomplete lesion formation, predicting non-durability.1,11,12
Pulmonary vein isolation status is acquired by measuring the intra-cardiac residual electrical activity (local potential) in the vein, after PFA application. Residual local potentials will be extracted by the PF Analyzer module of the ECGenius™ System. Isolation status is defined based on thresholds from literature.
The FollowGenius algorithm is intended to allow AF recurrence risk stratification by providing risk scores (0-100).
FOLLOW-AF is a retrospective, observational cohort study designed to validate the prediction algorithm and evaluate the diagnostic performance in predicting AF recurrence based on atrial remodeling and vein isolation.
The cohort will be patients with paroxysmal or persistent AF who underwent PVI with the PFA modality.
- Conditions
- Atrial Fibrillation (AF), Atrial Fibrillation Patients Treated With the FARAPULSE™ PFA System, Atrial Fibrillation (Paroxysmal), Pulmonary Vein Isolation
- Being tested
- AF Recurrence RIsk Assessment post pulmonary vein isolation
- Keywords
- PVI, PFA, AF, electrophysiology, cardiac ablation, catheter, atrial fibrillation
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AF Recurrence RIsk Assessment post pulmonary vein isolationDevice
AF Recurrence RIsk Assessment post pulmonary vein isolation based on PWD and Residual Local Potentials
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 - Continuous monitoring | Subject with continuous post-procedure monitoring, such as ILR, pacemaker, and CRT device Receives: Device: AF Recurrence RIsk Assessment post pulmonary vein isolation | |
| Cohort 2 - Transient monitoring | Subject with transient monitoring, such as Holter, and tracking devices Receives: Device: AF Recurrence RIsk Assessment post pulmonary vein isolation | |
| Cohort 3 - Punctual monitoring | Subject with punctual monitoring, such as reported symptoms during physician visit Receives: Device: AF Recurrence RIsk Assessment post pulmonary vein isolation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Objective
Evaluate predictive performance of a novel prognostic algorithm (called FollowGenius) combining p-wave duration and procedural unipolar atrial local potential measurements in predicting recurrence of AF after pulmonary vein isolation using PFA.
Measured: 6 months
Secondary outcomes (1)
Secondary Objective
Evaluate agreement between predicted risk and observed recurrence. Evaluate agreement between predicted risk and post-procedural AF burden. Evaluate contribution (weighting) of each individual predictors in AF recurrence risk score.
Evaluate correlation of performance across different sub-group (paroxysmal vs persistent AF, first vs redo ablation, sex, age bands, monitoring modality)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2026
- Study start13 Apr 2026
- Primary completion31 Aug 2026
- Study completion15 Nov 2026 (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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CathVision ApS
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07471308
- Sponsor's protocol ID
- CVFOLLOW-001
- Acronym
- FOLLOW-AF
- Status last verified
- Oct 2026
- First submitted
- 10 Mar 2026
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of an Algorithm Designed to Predict the Recurrence of AF After Pulmonary Vein Isolation Using P-wave Duration and Procedural Unipolar Atrial Local Potential Measurements
- ClinicalTrials.gov ID
- NCT07471308
- Acronym / sponsor ID
- FOLLOW-AF / CVFOLLOW-001
- Conditions
- Atrial Fibrillation (AF), Atrial Fibrillation Patients Treated With the FARAPULSE™ PFA System, Atrial Fibrillation (Paroxysmal), Pulmonary Vein Isolation
- Keywords
- PVI, PFA, AF, electrophysiology, cardiac ablation, catheter, atrial fibrillation
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- CathVision ApSIndustry (pharma, biotech, devices)
- Study start
- 13 Apr 2026 (actual)
- Primary completion
- 31 Aug 2026 (actual)
- Study completion
- 15 Nov 2026 (estimated)
- First posted
- 13 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.
Atrial fibrillation (AF) is the most prevalent sustained cardiac arrhythmia worldwide and is associated with substantial morbidity, mortality, and healthcare utilization. Catheter ablation, most commonly pulmonary vein isolation (PVI), is an established rhythm control strategy for AF4.
Despite technological advances and the emergence of pulse field ablation (PFA), long-term AF recurrence after a first ablation procedure remains frequent, occurring in approximately 30-50% of patients5. Post-ablation follow-up strategies, including visit frequency, rhythm monitoring intensity, and Antiarrhythmic Drug management, vary widely across providers and institutions and are largely guided by subjective assessment rather than objective, science-based recurrence risk estimation6. In parallel, asymptomatic (silent) AF recurrence is exacerbated following ablation, limiting the reliability of symptom-driven follow-up7.
FOLLOW-AF is a retrospective, observational cohort study designed to validate the FollowGenius algorithm and evaluate the diagnostic performance in predicting AF recurrence based on atrial remodeling and vein isolation.
The cohort will be patients with paroxysmal or persistent AF who underwent PVI with the PFA modality.
Detailed description
Atrial fibrillation (AF) is the most prevalent sustained cardiac arrhythmia worldwide and is associated with substantial morbidity, mortality, and healthcare utilization.3 Catheter ablation, most commonly pulmonary vein isolation (PVI), is an established rhythm control strategy for symptomatic AF.4 Historically, this has been achieved using radiofrequency and thermal energy. However, more recently a new energy source known as pulsed field ablation (PFA) has been introduced. As PFA is tissue selective, it preserves the function of nearby structures such as the esophagus and phrenic nerve making it safer to use. As PFA is delivered in short bursts of high energy, it is also more efficient and leads to shorter procedures.
Despite technological advances and the emergence of pulse field ablation (PFA), long-term AF recurrence after a first ablation procedure remains frequent, occurring in approximately 30-50% of patients.5 Post-ablation follow-up strategies, including visit frequency, rhythm monitoring intensity, and anticoagulation management, vary widely across providers and institutions and are largely guided by subjective assessment rather than objective, science-based recurrence risk estimation.6 In parallel, asymptomatic (silent) AF recurrence is exacerbated following ablation, limiting the reliability of symptom-driven follow-up.7
The underlying causes of AF recurrence are broadly driven by two distinct, yet complementary, mechanisms:
- Atrial Substrate Modification (Remodeling): Many patients have pre-existing atrial myopathy or remodeling due to long-standing hypertension, heart failure, or AF itself. This "diseased substrate" is prone to initiating and sustaining new AF triggers outside the pulmonary veins. P-wave duration, a simple, non-invasive marker from the surface ECG, is a well-established surrogate for this electrical and structural remodeling.2,9,10
- PVI Isolation (Reconnection): The primary goal of ablation is to create durable, transmural lesions to isolate the pulmonary veins. If lesions are incomplete, electrical reconnection often occurs, allowing the original AF triggers to re-initiate arrhythmia. Residual local potentials measured during the ablation procedure are a suggested marker of incomplete lesion formation, predicting non-durability.1,11,12
Pulmonary vein isolation status is acquired by measuring the intra-cardiac residual electrical activity (local potential) in the vein, after PFA application. Residual local potentials will be extracted by the PF Analyzer module of the ECGenius™ System. Isolation status is defined based on thresholds from literature.
The FollowGenius algorithm is intended to allow AF recurrence risk stratification by providing risk scores (0-100).
FOLLOW-AF is a retrospective, observational cohort study designed to validate the prediction algorithm and evaluate the diagnostic performance in predicting AF recurrence based on atrial remodeling and vein isolation.
The cohort will be patients with paroxysmal or persistent AF who underwent PVI with the PFA modality.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 - Continuous monitoring | – | Device: AF Recurrence RIsk Assessment post pulmonary vein isolationSubject with continuous post-procedure monitoring, such as ILR, pacemaker, and CRT device |
| Cohort 2 - Transient monitoring | – | Device: AF Recurrence RIsk Assessment post pulmonary vein isolationSubject with transient monitoring, such as Holter, and tracking devices |
| Cohort 3 - Punctual monitoring | – | Device: AF Recurrence RIsk Assessment post pulmonary vein isolationSubject with punctual monitoring, such as reported symptoms during physician visit |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Outpatient EHR
Key inclusion criteria (4 listed)
- Age ≥ 21 years
- Paroxysmal or persistent atrial fibrillation
- Underwent pulmonary vein isolation using pulse field ablation
- Patient record with pre-/post-ablation 12-lead ECGs and intra-procedural unipolar electrograms
Key exclusion criteria (6 listed)
- Incomplete patient record:
- Cardiac recording data incomplete or not of sufficient quality
- Cardiac anatomical variation such as Left Common, or Right Accessory
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 |
|---|---|---|
| AF Recurrence RIsk Assessment post pulmonary vein isolationAF Recurrence RIsk Assessment post pulmonary vein isolation based on PWD and Residual Local Potentials | Device | Cohort 1 - Continuous monitoring, Cohort 2 - Transient monitoring, Cohort 3 - Punctual monitoring |
Primary outcome
Primary Objective
Time frame: 6 months
Evaluate predictive performance of a novel prognostic algorithm (called FollowGenius) combining p-wave duration and procedural unipolar atrial local potential measurements in predicting recurrence of AF after pulmonary vein isolation using PFA.
1 secondary outcome
Secondary Objective
Time frame: 6 months
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 20 Oct 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation (AF) and Atrial Fibrillation Patients Treated With the FARAPULSE™ PFA System, run by CathVision ApS at 1 site in United States.
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 4 inclusion and 6 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: under way, not looking for participants, as of the sponsor's last update on 20 Oct 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 United States. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Objective (time frame: 6 months). 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 20 Oct 2026.