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Recruiting NCT07390214

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

No phase Interventional Atrial Fibrillation - Symptomatic

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Dual Energy ablation with RF/PFA: Re-PVI and substrate modification of low voltage areas, CF-guided RFC: Re-PVI and substrate modification of low voltage areas.
Who it may be relevant to
Registry conditions: Atrial Fibrillation - Symptomatic. Basic parameters: 18 years — 85 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Germany
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

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

Primary outcome measures

  • Primary Endpoint [Time frame: Within the study duration of 1 Year]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Germany · 1 center
  • Cardioangiologisches Centrum Bethanien, Frankfurt am Main, 60431 — Frankfurt am Main

Identifiers

NCT: NCT07390214 · Study Protocol Version 1.3

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗