Trial Summary
What is the purpose of this trial?
Demonstrate the safety and effectiveness of the Ablacath™ Mapping Catheter and Ablamap® System in patients with all types of atrial fibrillation (AF) including paroxysmal or persistent or long-standing persistent, undergoing and De Novo or Redo procedures. Phenotype patients and demonstrate the prognostication power of Electrographic Flow (EGF®) maps among all subjects using 12-month follow-up outcomes following EGF-guided mapping and ablation.
Research Team
KN
Kent Nilsson, MD
Principal Investigator
Piedmont Athens Regional
LB
Lucas Boersma
Principal Investigator
St. Antonius Hospital
Eligibility Criteria
This trial is for adults who can legally consent and are suitable candidates for heart mapping and ablation therapy to treat various types of atrial arrhythmias, including different forms of atrial fibrillation, flutter, and tachycardia.Inclusion Criteria
I am a good candidate for a procedure to correct irregular heartbeats.
I am over 18 years old or of legal age to consent where I live.
Treatment Details
Interventions
- Ablacath™ Mapping Catheter (Procedure)
- Ablacath™ Mapping Catheter Accessory Cables (Procedure)
- Ablamap® System inclusive of Amplifier, Monitor/Workstation with installed Ablamap® Software (Procedure)
Trial OverviewThe trial tests the Ablacath™ Mapping Catheter and Ablamap® System's safety and effectiveness in creating Electrographic Flow (EGF) maps to guide treatment for all types of atrial fibrillation during initial or repeat procedures.
Participant Groups
2Treatment groups
Experimental Treatment
Group I: Redo Arm: Electrographic Flow (EGF) mapping and guided ablation of EGF-identified sourcesExperimental Treatment1 Intervention
Subjects with paroxysmal, persistent or long-standing persistent atrial fibrillation (AF) coming in for a redo AF procedure.
Group II: De Novo Arm: Electrographic Flow (EGF) mappingExperimental Treatment1 Intervention
Subjects with persistent or long-standing persistent atrial fibrillation (AF), coming in for a De Novo pulmonary vein isolation procedure.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of VirginiaCharlottesville, VA
University of Illinois HealthChicago, IL
Ohio State UniversityColumbus, OH
Evergreen Health Research/Overlake Medical CenterBellevue, WA
More Trial Locations
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Who Is Running the Clinical Trial?
Cortex
Lead Sponsor
Trials
2
Patients Recruited
490+
Ablacon, Inc.
Industry Sponsor
Trials
4
Patients Recruited
600+