NL-OMON56533RecruitingNot Applicable
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. - RESOLVE-AF TRIA
Cortex Inc.0 sites60 target enrollmentStarted: TBDLast updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 60
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 18 to 99 (—)
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
- •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
- •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
Investigators
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