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

NCT07390214 | Recruiting

• 1 other identifier: Study Protocol Version 1.3
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Atrial Fibrillation - Symptomatic

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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

EXPERIMENTAL

Patient get intervention via Contact force guided radiofrequency ablation

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

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

Interventions

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

Re-PVI

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

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

Re-PVI

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

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cardioangiologisches Centrum Bethanien: lead

Study Sites (1)

Cardioangiologisches Centrum Bethanien, Frankfurt am Main, 60431

Frankfurt am Main, Hesse, 60431, Germany

RECRUITING

Study Officials

• Julian Chun, Professor

  MVZ CCB Germany

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Julian Chun, Professor

CONTACT

+49 69 945028; j.chun@ccb.de

Boris Schmidt, Professor

CONTACT

+49 69 945028; b.schmidt@ccb.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2026
• First Posted: February 5, 2026
• Study Start: December 15, 2025
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): March 30, 2029
• Last Updated: February 5, 2026

Record last verified: 2026-01

Locations

DE (1)