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Clinical Trials/NL-OMON56533
NL-OMON56533
Recruiting
Not 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 enrollmentTBD
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Conditionsatrial fibrillationirregular heartrhythm10007521

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
atrial fibrillation
Sponsor
Cortex Inc.
Enrollment
60
Status
Recruiting
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
last year
Study Type
Interventional

Investigators

Sponsor
Cortex Inc.

Eligibility Criteria

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)

Outcomes

Primary Outcomes

Not specified

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