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NCT Number: NCT07390214

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

Recruiting

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Key information

Conditions

Atrial Fibrillation - Symptomatic

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Procedure

Re-PVI

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

Procedure

Re-PVI

Primary outcomes

  1. Primary Endpoint

    Time frame: Within the study duration of 1 Year

    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).

Study contacts

Contact information is provided by the study sponsor or research team.

Boris Schmidt, Professor

CONTACT

[email protected]

+49 69 945028

Julian Chun, Professor

CONTACT

[email protected]

+49 69 945028

Sponsors and collaborators

Lead sponsor

Cardioangiologisches Centrum Bethanien

Other

Registry information

Acronym: REFOCUS-AF

Important dates

Study start
2025
Primary completion
2028
Study completion
2029
First posted
Feb 5, 2026
Registry last updated
Feb 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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