Atrial Fibrillation Clinical Trial
— RESOLVE-AFOfficial title:
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 of Atrial Fibrillation and Guide Ablation Therapy.
NCT number | NCT05883631 |
Other study ID # | CP006 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | October 23, 2023 |
Est. completion date | March 31, 2025 |
Verified date | February 2024 |
Source | Cortex |
Contact | Eliza Lawrence |
Phone | 650-933-4490 |
elawrence[@]cortexep.com | |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Recruiting |
Enrollment | 400 |
Est. completion date | March 31, 2025 |
Est. primary completion date | March 31, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Belgium | OLV Hospital Aalst | Aalst | |
Belgium | ZNA Middelheim | Antwerp | |
Belgium | UZ Brussels | Jette | Brussels |
Czechia | Neuron Medical | Brno | |
Czechia | IKEM (Institute for Clinical and Experimental Medicine) | Praha | |
Czechia | Na Homolce Hospital | Praha | |
Netherlands | Maastricht UMC+ | Maastricht | |
Netherlands | St. Antonius Hospital | Nieuwegein | Utrecht |
Netherlands | Erasmus MC | Rotterdam | |
United States | Piedmont Health | Athens | Georgia |
United States | Evergreen Health Research/Overlake Medical Center | Bellevue | Washington |
United States | University of Virginia | Charlottesville | Virginia |
United States | University of Illinois Health | Chicago | Illinois |
United States | Ascension Medical Group | Jacksonville | Florida |
United States | Mount Sinai | New York | New York |
United States | Banner Health | Phoenix | Arizona |
United States | Sequoia Heart and Vascular Institute | Redwood City | California |
United States | Beaumont Health | Royal Oak | Michigan |
United States | University of Utah | Salt Lake City | Utah |
United States | Pacific Heart Institute | Santa Monica | California |
Lead Sponsor | Collaborator |
---|---|
Ablacon, Inc. |
United States, Belgium, Czechia, Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Freedom from documented AF episodes lasting > 30 seconds (with or without AAD) following the index procedure through 12-months | Evaluated by assessing rate of subjects free from AF following index procedure through 12 months with or without AAD | 12 months | |
Primary | 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 | 7 days | |
Primary | Demonstrate the predictive value of EGF phenotype for ablation outcome | Evaluated through the comparison ablation outcomes between redo and de novo AF subjects | 12 months | |
Secondary | 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 | 30 days | |
Secondary | Overall reduction in burden of AF for subset of patients with implantable loop recorder | Evaluation of patient freedom from AF | 12 months | |
Secondary | Overall procedure time, fluoro time, total EGF-guided mapping time, total EGF-guided ablation time | Evaluation of index or repeat procedure times | Index or Repeat Procedure |
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