A prospective, single arm, multi-center, clinical evaluation of the Ablacath* Mapping Catheter and Ablamap® System utilizing Electrographic Flow (EGF) mapping to resolve extra-pulmonary vein sources Atrial Fibrillation sources and guide ablation therapy.

Recruiting

• Conditions: atrial fibrillation; irregular heartrhythm; 10007521

• Registration Number: NL-OMON56533
• Lead Sponsor: Cortex Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 60

Inclusion Criteria

1 Suitable candidate for intra-cardiac mapping and ablation of atrial
fibrillation
2 Atrial fibrillation documented by electrocardiographic data (e.g., ECG,
Holter, rhythm strips, loop recorder) within 6 months prior to the index
ablation procedure
3 Above eighteen (18) years of age or of legal age to give informed consent
specific to state and national law
4 Left atrial (LA) diameter <= 6.5 cm or LA volume index <= 50 mL/m2 (use
whichever measure is available or if both available, use the lesser of the two
to qualify)

Exclusion Criteria

1. De Novo paroxysmal AF
2. AF from a reversible cause (e.g., surgery, hyperthyroidism, sarcoidosis, or
pericarditis, etc.)
3. Cardiac surgery or intervention within the past 90 days (e.g. percutaneous
coronary intervention, ablation for ventricular arrhythmias, left atrial
appendage occlusion devices, atrial septal defect closure devices,
transcatheter aortic valve replacement)
4. Presence of transvenous pacing or defibrillator leads or an atrial leadless
pacemaker
5. Myocardial infarction within the past 90 days
6. Severe valvular disease or prosthetic valve(s)
7. Contraindication to therapeutic anticoagulation
8. Decompensated heart failure or New York Heart Association (NYHA) Functional
Class IV
9. Positive pregnancy test
10. Any other contraindication to an intracardiac mapping and ablation of
atrial arrhythmias
11. Enrollment in another investigational study evaluating another device,
biologic or drug

Study & Design

• Study Type: Interventional
• Study Design: Not specified