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| Name | Class |
|---|---|
| Ablacon, Inc. | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| De Novo Arm: Electrographic Flow (EGF) mapping | Experimental | Subjects with persistent or long-standing persistent atrial fibrillation (AF), coming in for a De Novo pulmonary vein isolation procedure. |
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| Redo Arm: Electrographic Flow (EGF) mapping and guided ablation of EGF-identified sources | Experimental | Subjects with paroxysmal, persistent or long-standing persistent atrial fibrillation (AF) coming in for a redo AF procedure. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Electrographic Flow (EGF) mapping and ablation of EGF-identified sources of Atrial Fibrillation | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with 12-month freedom from AF recurrence (with or without AADs) | 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). | From 90 days to 12 months after index procedure |
| Number of participants with freedom from a composite of serious adverse events (SAEs) occurring within 7 days from the index procedure | Evaluated by assessing combined rate of SAE composite as adjudicated by a CEC for relatedness to device or procedure | From index procedure to 7 days after index procedure |
| Demonstrate the predictive value of electrographic flow (EGF) phenotyping for ablation outcome | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with freedom from a composite of SAE occurring within 30 days from post-index ablation procedure | Evaluated by assessing combined rate of SAE composite as adjudicated by a CEC for relatedness to device or procedure | From index procedure to 30 days after index procedure |
| Overall reduction in burden of AF for subset of patients with implantable loop recorder |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kent Nilsson, MD | Piedmont Athens Regional | Principal Investigator |
| Lucas Boersma, Prof. MD. | St. Antonius Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama | Birmingham | Alabama | 35233 | United States | ||
| Grandview Medical Center |
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| Electrographic Flow (EGF) mapping (no ablation) | Device | 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. |
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Evaluation of patient's freedom from AF based on recordings of implantable loop recorders |
| From 90 days to 12 months after index procedure |
| Overall procedure time, fluoro time, total EGF-guided mapping time, total EGF-guided ablation time | Evaluation of index or recurrence procedure data | Index or Repeat Procedure |
| Birmingham |
| Alabama |
| 35243 |
| United States |
| Banner Health | Phoenix | Arizona | 85006 | United States |
| Sutter Health Sequoia Heart and Vascular Institute | Redwood City | California | 94062 | United States |
| Pacific Heart Institute | Santa Monica | California | 90404 | United States |
| Colorado Heart | Golden | Colorado | 80402 | United States |
| Florida Heart Rhythm Specialists | Fort Lauderdale | Florida | 33308 | United States |
| Ascension Medical Group | Jacksonville | Florida | 32204 | United States |
| Piedmont Health | Athens | Georgia | 30606 | United States |
| Beaumont Health | Royal Oak | Michigan | 48073 | United States |
| Mount Sinai Hospital | New York | New York | 10029 | United States |
| Ohio State University | Columbus | Ohio | 43210 | United States |
| University of Virginia | Charlottesville | Virginia | 22908 | United States |
| Inova Health | Falls Church | Virginia | 22042 | United States |
| Evergreen Health Research/Overlake Medical Center | Bellevue | Washington | 98004 | United States |
| OLV Hospital Aalst | Aalst | 9300 | Belgium |
| ZNA Middelheim | Antwerp | 2020 | Belgium |
| ZOL | Genk | 3600 | Belgium |
| Neuron Medical | Brno | 625 00 | Czechia |
| IKEM (Institute for Clinical and Experimental Medicine) | Prague | 140 21 | Czechia |
| Na Homolce Hospital | Prague | 150 00 | Czechia |
| Amsterdam UMC (location AMC) | Amsterdam | North Holland | 1105AZ | Netherlands |
| St. Antonius Hospital | Nieuwegein | Utrecht | 3435CM | Netherlands |
| Erasmus MC | Rotterdam | 3015GD | Netherlands |
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| D001145 | Arrhythmias, Cardiac |
| D001282 | Atrial Flutter |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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