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Clinical Trial Details — Status: Recruiting

Administrative data

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

Study information

Verified date February 2024
Source Cortex
Contact Eliza Lawrence
Phone 650-933-4490
Email elawrence@cortexep.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

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

Study Design


Intervention

Device:
EGF-Mapping and EGF-Guided Ablation of AF Sources
Ablacath™ Mapping Catheter, Ablacath™ Mapping Catheter Accessory Cables, Ablamap® System inclusive of Amplifier, Monitor/Workstation with installed Ablamap® Software
EGF-Mapping of AF Sources (no ablation)
Ablacath™ Mapping Catheter, Ablacath™ Mapping Catheter Accessory Cables, Ablamap® System inclusive of Amplifier, Monitor/Workstation with installed Ablamap® Software

Locations

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

Sponsors (1)

Lead Sponsor Collaborator
Ablacon, Inc.

Countries where clinical trial is conducted

United States,  Belgium,  Czechia,  Netherlands, 

Outcome

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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