NCT07390214Recruiting
REFOCUS-AF - "RepEat Ablation With AFFERA vs. COntact Force-Guided RF Catheters for Optimal OUtcomes in Symptomatic AF".
Source: ClinicalTrials.gov · Last updated 5 Feb 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 200 (estimated)
- First submitted
- 29 Jan 2026
- Start date
- 15 Dec 2025
- Primary completion date
- 30 Jun 2028
- Lead sponsor
- Cardioangiologisches Centrum Bethanien
- Diseases
- Atrial fibrillation
- NCT number
- NCT07390214
What you commit to
- Study type: Interventional
- Planned participants: 200
- From 15 Dec 2025 to the primary completion date, 30 Jun 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to 85 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Cardioangiologisches Centrum Bethanien, Frankfurt am Main, 60431 Coordinator of this site? Confirm its status | Frankfurt am Main | Germany | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.