Repeat ablation with dual-energy (pulsed-field + RF) versus contact-force RF for symptomatic atrial fibrillation
Official title: REFOCUS-AF - "RepEat Ablation With AFFERA vs. COntact Force-Guided RF Catheters for Optimal OUtcomes in Symptomatic AF".
Run by Cardioangiologisches Centrum Bethanien · NCT07390214 · Data updated 2026-11-12
This comparison tests whether repeat pulmonary vein isolation using a dual-energy device (pulsed-field plus radiofrequency) works better than standard contact-force radiofrequency catheters for people with recurrent symptomatic AF or AT after one prior PVI.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 85 Years |
| Sex | All |
| Enrollment | 200 (estimated) |
| Sponsor | Cardioangiologisches Centrum Bethanien Academic / other |
| Locations | 1 site (Frankfurt am Main, Hesse) |
| Status | Recruiting |
| Started | December 15, 2025 |
| Main results expected | June 30, 2028 |
| Study ends | March 30, 2029 |
| Registry record updated | February 5, 2026 |
| Trial ID | NCT07390214 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults 18–85 with symptomatic non-valvular AF or AT recurrence after exactly one prior PVI (with or without prior CTI ablation), who can comply with the protocol and operate a rhythm-monitoring device, are the intended candidates.
✕Probably not a fit
People with longstanding persistent AF >12 months, left atrial size >55 mm, more than one prior PVI or prior surgical AF ablation, contraindications to repeat ablation or anticoagulation, or inability to consent are unlikely to benefit or be eligible.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a prospective, randomized (1:1) pilot study enrolling 200 patients with symptomatic atrial fibrillation or atrial tachycardia recurrence after a single prior pulmonary vein isolation. Participants are randomized to repeat PVI and substrate modification using a dual-energy (pulsed-field plus RF) system or to repeat PVI and substrate modification using contact-force guided radiofrequency catheters. Patients must be 18–85 years old, able to use a rhythm-monitoring device, and meet other inclusion/exclusion criteria. The study will track procedural findings, arrhythmia recurrence on monitoring, and safety events at the single enrolling center in Frankfurt am Main.
Why it matters
Potential benefit: If successful, the dual-energy approach could lower recurrence or improve safety and procedural efficiency for patients needing a repeat ablation.
How similar studies have gone: Pulsed-field ablation has shown promising safety and acute isolation results in recent studies, but using a dual-energy (PFA+RF) approach for repeat ablation is relatively novel and is being explored here.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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
Where it's running
-
Cardioangiologisches Centrum Bethanien, Frankfurt am Main, 60431
Frankfurt am Main, Hesse, Germany Recruiting
Study contacts
- Principal investigator: Julian Chun, Professor — MVZ CCB Germany
- Study coordinator: Julian Chun, Professor
- Email: j.chun@ccb.de
- Phone: +49 69 945028
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.