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

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 Overview

• Status: Recruiting
• Conditions: Atrial Fibrillation - Symptomatic
• Intervention / Treatment: 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
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Julian Chun, Professor; Phone Number: +49 69 945028; Email: j.chun@ccb.de
• Study Contact Backup: Name: Boris Schmidt, Professor; Phone Number: +49 69 945028; Email: b.schmidt@ccb.de

Study Locations

• Germany
  • Hesse
    • Frankfurt am Main, Hesse, Germany, 60431
      • Recruiting
      • Cardioangiologisches Centrum Bethanien, Frankfurt am Main, 60431
      • Contact: Julian Chun, Professor; Phone Number: +49 69 945028; Email: j.chun@ccb.de
      • Contact: Boris Schmidt, Professor; Phone Number: +49 69 945028; Email: b.schmidt@ccb.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CF-guided RFC: Re-PVI and substrate modification of low voltage areas; Patient get intervention via Contact force guided radiofrequency ablation	Procedure: CF-guided RFC: Re-PVI and substrate modification of low voltage areas; Re-PVI
Experimental: Dual Energy ablation with RF/PFA: Re-PVI and substrate modification of low voltage ath; Patient will get Intervenstion via Large footprint PFA/RFC catheter (Sphere 9)	Procedure: Dual Energy ablation with RF/PFA: Re-PVI and substrate modification of low voltage areas; Re-PVI

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	Within the study duration of 1 Year

Collaborators and Investigators

• Sponsor: Cardioangiologisches Centrum Bethanien
• Investigators: Principal Investigator: Julian Chun, Professor, MVZ CCB Germany

Study record dates

Study Major Dates

• Study Start (Actual): December 15, 2025
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): March 30, 2029

Study Registration Dates

• First Submitted: January 29, 2026
• First Submitted That Met QC Criteria: January 29, 2026
• First Posted (Actual): February 5, 2026

Study Record Updates

• Last Update Posted (Actual): February 5, 2026
• Last Update Submitted That Met QC Criteria: January 29, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: Study Protocol Version 1.3

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No