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RESOLVE-AF: Clinical Evaluation of the Ablacath™ Mapping Catheter and Ablamap® System Utilizing Electrographic Flow (EGF) Mapping to Resolve Extra-PV Sources of Atrial Fibrillation and Guide Ablation Therapy.

RESOLVE-AF: Testing a new system to help treat atrial fibrillation.

Recruiting
18-80 years
All
Phase N/A

This study tests a special tool called the Ablacath™ Mapping Catheter and the Ablamap® System to help treat atrial fibrillation (AF). AF is a condition where the heart beats irregularly. The study aims to show how safe and effective these tools are by checking them in up to 400 patients from 25 places worldwide. Patients must be suitable for heart mapping and ablation, which is a treatment to fix heart rhythm problems. They need to be over 18 and meet certain heart size requirements.

Some people can’t join, like those with reversible AF, recent heart surgery, or certain heart conditions. The study involves a 12-month follow-up after the treatment. Participants will have their heart's electric signals mapped to guide the treatment.

  • The study lasts for 12 months with follow-ups.
  • Up to 400 subjects will participate globally.
  • Participants must not have certain heart conditions or recent surgeries.
Study details
    Atrial Fibrillation
    Atrial Fibrillation
    Persistent
    Atrial Fibrillation Paroxysmal
    Arrhythmia
    Arrhythmias
    Cardiac
    Atrial Flutter
    Atrial Fibrillation
    Paroxysmal or Persistent
    Atrial Arrhythmia
    Atrial Tachycardia

NCT05883631

Cortex

3 November 2024

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