Arrhythmia, Arrhythmias, Cardiac, Atrial Arrhythmia, Atrial Fibrillation, Atrial Fibrillation Paroxysmal, Atrial Fibrillation, Paroxysmal or Persistent, Atrial Fibrillation, Persistent, Atrial Flutter, Atrial Tachycardia
Conditions
Brief summary
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.
Detailed description
Subjects with all types of AF who are candidates for catheter ablation of their AF. The study will enroll up to 400 subjects in 25 centers globally.
Interventions
DEVICEElectrographic Flow (EGF) mapping and ablation of EGF-identified sources of Atrial Fibrillation
In addition to standard touch-up of pulmonary vein isolation, subjects receive targeted source ablation guided by Electrographic Flow™ (EGF) mapping. EGF mapping enables the full spatiotemporal reconstruction of organized atrial electrical wavefront propagation to identify active sources or origins of excitation that may trigger atrial fibrillation (AF). EGF-identified sources with activity above the threshold (≥ 25%) are considered significant and targeted with radiofrequency ablation. The procedure concludes when all EGF-identified sources are eliminated, defined as reducing source activity below the threshold.
DEVICEElectrographic Flow (EGF) mapping (no ablation)
In addition to standard pulmonary vein isolation (PVI), subjects receive Electrographic Flow™ (EGF) mapping. PVI may be performed using any commercially available platform/catheter. EGF mapping enables the full spatiotemporal reconstruction of organized atrial electrical wavefront propagation to identify active sources or origins of excitation that may trigger atrial fibrillation (AF). EGF-identified sources with activity above the threshold (≥ 25%) are marked as relevant; however, no EGF-guided ablations are performed during this index procedure. If subjects have AF recurrence after the 90-day blanking period, they may undergo a recurrence procedure and EGF-guided ablation.
Sponsors
Ablacon, Inc.
Cortex
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Suitable candidate for intra-cardiac mapping and ablation of atrial arrhythmias including atrial fibrillation, atrial flutter and/or atrial tachycardia 2. Above eighteen (18) years of age or of legal age to give informed consent specific to state and national law 3. Left atrial (LA) diameter ≤ 5.5 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with 12-month freedom from AF recurrence (with or without AADs) | From 90 days to 12 months after index procedure | This measure represents the number of subjects with freedom from documented episodes of atrial fibrillation (AF) recurrence lasting longer than 30 seconds from the 90-day post-procedure blanking period through 12 months of follow-up (with or without AADs). |
| Number of participants with freedom from a composite of serious adverse events (SAEs) occurring within 7 days from the index procedure | From index procedure to 7 days after index procedure | Evaluated by assessing combined rate of SAE composite as adjudicated by a CEC for relatedness to device or procedure |
| Demonstrate the predictive value of electrographic flow (EGF) phenotyping for ablation outcome | 12 months | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall procedure time, fluoro time, total EGF-guided mapping time, total EGF-guided ablation time | Index or Repeat Procedure | Evaluation of index or recurrence procedure data |
| Number of participants with freedom from a composite of SAE occurring within 30 days from post-index ablation procedure | From index procedure to 30 days after index procedure | Evaluated by assessing combined rate of SAE composite as adjudicated by a CEC for relatedness to device or procedure |
| Overall reduction in burden of AF for subset of patients with implantable loop recorder | From 90 days to 12 months after index procedure | Evaluation of patient's freedom from AF based on recordings of implantable loop recorders |
Countries
Belgium, Czechia, Netherlands, United States
Outcome results
None listed