RESOLVE-AF: Clinical Evaluation of the Ablacath™ Mapping Catheter and Ablamap® System Utilizing Electrographic Flow (EGF) Mapping to Resolve Extra-PV Sources of Atrial Fibrillation and Guide Ablation Therapy.

Atrial Fibrillation Clinical Trial

— RESOLVE-AF  

Official 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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05883631
• Other study ID #: CP006
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Arrhythmia
• Arrhythmias, Cardiac
• Atrial Arrhythmia
• Atrial Fibrillation
• Atrial Fibrillation Paroxysmal
• Atrial Fibrillation, Persistent
• Atrial Flutter
• Atrial Tachycardia
• Tachycardia

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