REFOCUS-AF - "RepEat Ablation With AFFERA vs. COntact Force-Guided RF Catheters for Optimal OUtcomes in Symptomatic AF".

Cardioangiologisches Centrum Bethanien

Status: Enrolling

Conditions: Atrial Fibrillation - Symptomatic

Treatments: Procedure: CF-guided RFC: Re-PVI and substrate modification of low voltage areas; Procedure: Dual Energy ablation with RF/PFA: Re-PVI and substrate modification of low voltage areas

Study type: Interventional

Funder types: Other

Identifiers

NCT07390214

Study Protocol Version 1.3

Details and patient eligibility

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

CF-guided RFC: Re-PVI and substrate modification of low voltage areas

Experimental group

Description:

Patient get intervention via Contact force guided radiofrequency ablation

Treatment:

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 group

Description:

Patient will get Intervenstion via Large footprint PFA/RFC catheter (Sphere 9)

Treatment:

Procedure: Dual Energy ablation with RF/PFA: Re-PVI and substrate modification of low voltage areas