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.

Cortex

Status: Active, not recruiting

Conditions: Atrial Tachycardia; Atrial Fibrillation Paroxysmal; Atrial Fibrillation, Persistent; Atrial Flutter; Arrhythmia; Atrial Fibrillation; Arrhythmias, Cardiac; Atrial Arrhythmia; Atrial Fibrillation, Paroxysmal or Persistent

Treatments: Device: Electrographic Flow (EGF) mapping (no ablation); Device: Electrographic Flow (EGF) mapping and ablation of EGF-identified sources of Atrial Fibrillation

Study type: Interventional

Funder types: Industry

Identifiers

NCT05883631

CP006

Details and patient eligibility

About

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.

Full 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.

Enrollment: 400 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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400 participants in 2 patient groups

De Novo Arm: Electrographic Flow (EGF) mapping

Experimental group

Description:

Subjects with persistent or long-standing persistent atrial fibrillation (AF), coming in for a De Novo pulmonary vein isolation procedure.

Treatment:

Device: Electrographic Flow (EGF) mapping (no ablation)

Redo Arm: Electrographic Flow (EGF) mapping and guided ablation of EGF-identified sources

Experimental group

Description:

Subjects with paroxysmal, persistent or long-standing persistent atrial fibrillation (AF) coming in for a redo AF procedure.

Treatment:

Device: Electrographic Flow (EGF) mapping and ablation of EGF-identified sources of Atrial Fibrillation