Atrial Fibrillation - SymptomaticREFOCUS-AFNCT07390214
REFOCUS-AF - "RepEat Ablation With AFFERA vs. COntact Force-Guided RF Catheters for Optimal OUtcomes in Symptomatic AF".
A study testing Dual Energy ablation with RF/PFA: Re-PVI and substrate modification of low voltage areas and CF-guided RFC: Re-PVI and substrate modification of low voltage areas in people with Atrial Fibrillation - Symptomatic, run by Cardioangiologisches Centrum Bethanien at 1 site in Germany.
Trial summary
This is a prospective, randomized (1:1), pilot study enrolling 200 patients with symptomatic atrial fibrillation or atrial tachycardia (AF/AT) recurrence requiring repeat ablation following a single prior PVI procedure for AF. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Atrial Fibrillation - Symptomatic
- What is being tested?
- Dual Energy ablation with RF/PFA: Re-PVI and substrate modification of low voltage areas and CF-guided RFC: Re-PVI and substrate modification of low voltage areas
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteGermany
- Study dates
- 15 Dec 2025to 30 Mar 2029
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with symptomatic non-valvular AF or AT recurrences despite of one previous PVI (+/- cavotricuspid isthmus ablation) catheter ablation for AF.
- Age 18-85 years Willing and able to comply with the study protocol Willing and able to operate a device for rhythm monitoring
Who cannot join
- Patients with contraindications to catheter ablation or inability to provide informed consent Patients who underwent PVI + (ablation of additional RA/LA substrates/areas) Patients who did not undergo PVI before Patients who underwent more than one prior PVI/Re-PVI Patients with left atrial size > 55mm Patients with longstanding persistent AF > 12 months duration Prior surgical AF ablation Contraindications for repeat ablation Prior implantable loop recorder History of mitral valve surgery Severe mitral valve regurgitation Inability to be treated with oral anticoagulation Presence of intracardiac thrombi Chronic obstructive pulmonary disease or Asthma treated with long acting bronchodilatators Obstructive sleep apnea syndrome requiring CPAP mask ventilation Pregnancy Participation in other clinical studies Unwilling to follow the study protocol and to attend follow-up visits
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Cardioangiologisches Centrum Bethanien, Frankfurt am Main, 60431
Frankfurt am Main, Hesse, 60431
Julian Chun, Professor, +49 69 945028 ext. 0, j.chun@ccb.de
Boris Schmidt, Professor, +49 69 945028 ext. 0, b.schmidt@ccb.de
About this study
This is a prospective, randomized (1:1), pilot study enrolling 200 patients with symptomatic atrial fibrillation or atrial tachycardia (AF/AT) recurrence requiring repeat ablation following a single prior PVI procedure for AF.
- Conditions
- Atrial Fibrillation - Symptomatic
- Being tested
- Dual Energy ablation with RF/PFA: Re-PVI and substrate modification of low voltage areas, CF-guided RFC: Re-PVI and substrate modification of low voltage areas
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dual Energy ablation with RF/PFA: Re-PVI and substrate modification of low voltage areasProcedure or surgery
Re-PVI
CF-guided RFC: Re-PVI and substrate modification of low voltage areasProcedure or surgery
Re-PVI
| Study group | Role | What they receive |
|---|---|---|
| CF-guided RFC: Re-PVI and substrate modification of low voltage areas | Experimental | Patient get intervention via Contact force guided radiofrequency ablation Receives: Procedure: CF-guided RFC: Re-PVI and substrate modification of low voltage areas |
| Dual Energy ablation with RF/PFA: Re-PVI and substrate modification of low voltage ath | Experimental | Patient will get Intervenstion via Large footprint PFA/RFC catheter (Sphere 9) Receives: Procedure: Dual Energy ablation with RF/PFA: Re-PVI and substrate modification of low voltage areas |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Endpoint
Complete re-pulmonary vein isolation (re-PVI), Bidirectional conduction block across linear lesions, Complete substrate elimination (defined as: voltage abatement and/or loss of capture).
Measured: Within the study duration of 1 Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2026
- Study start15 Dec 2025
- Primary completion30 Jun 2028 (estimated)
- Study completion30 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial Fibrillation - SymptomaticStudies 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
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cardioangiologisches Centrum Bethanien
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Julian Chun, Professor, Principal investigator, MVZ CCB Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07390214
- Sponsor's protocol ID
- Study Protocol Version 1.3
- Acronym
- REFOCUS-AF
- Status last verified
- Jan 2026
- First submitted
- 29 Jan 2026
- Last updated
- 5 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- REFOCUS-AF - "RepEat Ablation With AFFERA vs. COntact Force-Guided RF Catheters for Optimal OUtcomes in Symptomatic AF".
- ClinicalTrials.gov ID
- NCT07390214
- Acronym / sponsor ID
- REFOCUS-AF / Study Protocol Version 1.3
- Conditions
- Atrial Fibrillation - Symptomatic
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Cardioangiologisches Centrum BethanienUniversity, hospital or other
- Study start
- 15 Dec 2025 (actual)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 30 Mar 2029 (estimated)
- First posted
- 5 Feb 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.
This is a prospective, randomized (1:1), pilot study enrolling 200 patients with symptomatic atrial fibrillation or atrial tachycardia (AF/AT) recurrence requiring repeat ablation following a single prior PVI procedure for AF.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CF-guided RFC: Re-PVI and substrate modification of low voltage areas | Experimental | Procedure: CF-guided RFC: Re-PVI and substrate modification of low voltage areasPatient get intervention via Contact force guided radiofrequency ablation |
| Dual Energy ablation with RF/PFA: Re-PVI and substrate modification of low voltage ath | Experimental | Procedure: Dual Energy ablation with RF/PFA: Re-PVI and substrate modification of low voltage areasPatient will get Intervenstion via Large footprint PFA/RFC catheter (Sphere 9) |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with symptomatic non-valvular AF or AT recurrences despite of one previous PVI (+/- cavotricuspid isthmus ablation) catheter ablation for AF.
- Age 18-85 years Willing and able to comply with the study protocol Willing and able to operate a device for rhythm monitoring
Key exclusion criteria (1 listed)
- Patients with contraindications to catheter ablation or inability to provide informed consent Patients who underwent PVI + (ablation of additional RA/LA substrates/areas) Patients who did not undergo PVI before Patients who underwent more than one prior PVI/Re-PVI Patients with left atrial size > 55mm Patients with longstanding persistent AF > 12 months duration Prior surgical AF ablation Contraindications for repeat ablation Prior implantable loop recorder History of mitral valve surgery Severe mitral valve regurgitation Inability to be treated with oral anticoagulation Presence of intracardiac thrombi Chronic obstructive pulmonary disease or Asthma treated with long acting bronchodilatators Obstructive sleep apnea syndrome requiring CPAP mask ventilation Pregnancy Participation in other clinical studies Unwilling to follow the study protocol and to attend follow-up visits
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 |
|---|---|---|
| Dual Energy ablation with RF/PFA: Re-PVI and substrate modification of low voltage areasRe-PVI | Procedure or surgery | Dual Energy ablation with RF/PFA: Re-PVI and substrate modification of low voltage ath |
| CF-guided RFC: Re-PVI and substrate modification of low voltage areasRe-PVI | Procedure or surgery | CF-guided RFC: Re-PVI and substrate modification of low voltage areas |
Primary outcome
Primary Endpoint
Time frame: Within the study duration of 1 Year
Complete re-pulmonary vein isolation (re-PVI), Bidirectional conduction block across linear lesions, Complete substrate elimination (defined as: voltage abatement and/or loss of capture).
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 5 Feb 2026.
- Individual participant dataSharing planned: Undecided
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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.
Julian Chun, Professor principal investigator
MVZ CCB Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dual Energy ablation with RF/PFA: Re-PVI and substrate modification of low voltage areas and CF-guided RFC: Re-PVI and substrate modification of low voltage areas in people with Atrial Fibrillation - Symptomatic, run by Cardioangiologisches Centrum Bethanien at 1 site in Germany.
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: looking for participants now, as of the sponsor's last update on 5 Feb 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 Germany. 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 Julian Chun, Professor (+49 69 945028 ext. 0, j.chun@ccb.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Endpoint (time frame: Within the study duration of 1 Year). 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 5 Feb 2026.