REFOCUS-AF - "RepEat Ablation With AFFERA vs. COntact Force-Guided RF Catheters for Optimal OUtcomes in Symptomatic AF".
Recruiting · NCT07390214 · Interventional (participants receive a specific treatment) · Lead sponsor: Cardioangiologisches Centrum Bethanien
View the official record on ClinicalTrials.gov →Interventions studied
CF-guided RFC: Re-PVI and substrate modification of low voltage areasDual Energy ablation with RF/PFA: Re-PVI and substrate modification of low voltage areas
What this trial is about
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.
Who can take part
Age range
18 Years to 85 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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 is running
1 location listed.
- Cardioangiologisches Centrum Bethanien, Frankfurt am Main, 60431 - Frankfurt am Main, Hesse, Germany