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.

NCT05883631 | Active Not Recruiting FDA Device

• 1 other identifier: CP006
• Study Type: interventional
• Target: 400
• Locations: 4 countries
• Sites: 24

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (3)

• 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

Secondary Outcomes (3)

• Number of participants with freedom from a composite of SAE occurring within 30 days from post-index ablation procedure

  From index procedure to 30 days after index procedure

• Overall reduction in burden of AF for subset of patients with implantable loop recorder

  From 90 days to 12 months after index procedure

• Overall procedure time, fluoro time, total EGF-guided mapping time, total EGF-guided ablation time

  Index or Repeat Procedure

Study Arms (2)

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.

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

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.

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

Interventions

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.

Also known as: OptiMap™ System

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

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.

Also known as: OptiMap™ System

De Novo Arm: Electrographic Flow (EGF) mapping

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Suitable candidate for intra-cardiac mapping and ablation of atrial arrhythmias including atrial fibrillation, atrial flutter and/or atrial tachycardia
• Above eighteen (18) years of age or of legal age to give informed consent specific to state and national law
• 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)

You may not qualify if:

• De Novo paroxysmal AF
• AF from a reversible cause (e.g., surgery, hyperthyroidism, sarcoidosis, or pericarditis, etc.)
• 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)
• Presence of transvenous pacing or defibrillator leads or an atrial leadless pacemaker
• Myocardial infarction within the past 90 days
• Severe valvular disease or prosthetic valve(s)
• Contraindication to therapeutic anticoagulation
• Decompensated heart failure or New York Heart Association (NYHA) Functional Class IV
• Positive pregnancy test
• Any other contraindication to an intracardiac mapping and ablation of atrial arrhythmias
• Enrollment in another investigational study evaluating another device, biologic or drug

Sponsors & Collaborators

• Cortex: lead
• Ablacon, Inc.: collaborator

Study Sites (24)

University of Alabama

Birmingham, Alabama, 35233, United States

Location

Grandview Medical Center

Birmingham, Alabama, 35243, United States

Location

Banner Health

Phoenix, Arizona, 85006, United States

Location

Sutter Health Sequoia Heart and Vascular Institute

Redwood City, California, 94062, United States

Location

Pacific Heart Institute

Santa Monica, California, 90404, United States

Location

Colorado Heart

Golden, Colorado, 80402, United States

Location

Florida Heart Rhythm Specialists

Fort Lauderdale, Florida, 33308, United States

Location

Ascension Medical Group

Jacksonville, Florida, 32204, United States

Location

Piedmont Health

Athens, Georgia, 30606, United States

Location

Beaumont Health

Royal Oak, Michigan, 48073, United States

Location

Mount Sinai Hospital

New York, New York, 10029, United States

Location

Ohio State University

Columbus, Ohio, 43210, United States

Location

University of Virginia

Charlottesville, Virginia, 22908, United States

Location

Inova Health

Falls Church, Virginia, 22042, United States

Location

Evergreen Health Research/Overlake Medical Center

Bellevue, Washington, 98004, United States

Location

OLV Hospital Aalst

Aalst, 9300, Belgium

Location

ZNA Middelheim

Antwerp, 2020, Belgium

Location

ZOL

Genk, 3600, Belgium

Location

Neuron Medical

Brno, 625 00, Czechia

Location

IKEM (Institute for Clinical and Experimental Medicine)

Prague, 140 21, Czechia

Location

Na Homolce Hospital

Prague, 150 00, Czechia

Location

Amsterdam UMC (location AMC)

Amsterdam, North Holland, 1105AZ, Netherlands

Location

St. Antonius Hospital

Nieuwegein, Utrecht, 3435CM, Netherlands

Location

Erasmus MC

Rotterdam, 3015GD, Netherlands

Location

MeSH Terms

Conditions

Atrial Fibrillation; Arrhythmias, Cardiac; Atrial Flutter

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Kent Nilsson, MD

  Piedmont Athens Regional

  PRINCIPAL INVESTIGATOR

• Lucas Boersma, Prof. MD.

  St. Antonius Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2023
• First Posted: June 1, 2023
• Study Start: October 23, 2023
• Primary Completion: January 1, 2026
• Study Completion: January 1, 2026
• Last Updated: April 13, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (3); US (15); BE (3); NL (3)