Sign in

NCT05883631Active, not recruiting

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.

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.

Source: ClinicalTrials.gov · Last updated 13 Apr 2025

Brief summary (registry, in English)

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 (registry)
Active, not recruiting
Study type
Interventional
Enrollment
400 (estimated)
First submitted
22 May 2023
Start date
23 Oct 2023
Primary completion date
Jan 2026
Lead sponsor
Cortex
NCT number
NCT05883631

What you commit to

  • Study type: Interventional
  • Planned participants: 400
  • From 23 Oct 2023 to the primary completion date, Jan 2026
  • 24 sites in 4 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • AF from a reversible cause (e.g., surgery, hyperthyroidism, sarcoidosis, or pericarditis, etc.)
  • Enrollment in another investigational study evaluating another device, biologic or drug

Other illness

  • 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)
  • Myocardial infarction within the past 90 days
  • Severe valvular disease or prosthetic valve(s)
  • Decompensated heart failure or New York Heart Association (NYHA) Functional Class IV
  • Any other contraindication to an intracardiac mapping and ablation of atrial arrhythmias

Other

  • De Novo paroxysmal AF
  • Presence of transvenous pacing or defibrillator leads or an atrial leadless pacemaker
  • Contraindication to therapeutic anticoagulation
  • Positive pregnancy test

Who the study is looking for

  • 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)

Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (24)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
OLV Hospital Aalst
Coordinator of this site? Confirm its status
AalstBelgiumUnknown status
ZNA Middelheim
Coordinator of this site? Confirm its status
AntwerpBelgiumUnknown status
ZOL
Coordinator of this site? Confirm its status
GenkBelgiumUnknown status
Neuron Medical
Coordinator of this site? Confirm its status
BrnoCzechiaUnknown status
Na Homolce Hospital
Coordinator of this site? Confirm its status
PragueCzechiaUnknown status
IKEM Institute for Clinical and Experimental Medicine
Coordinator of this site? Confirm its status
PragueCzechiaUnknown status
Amsterdam UMC, location AMC
Coordinator of this site? Confirm its status
AmsterdamNetherlandsUnknown status
St. Antonius Hospital
Coordinator of this site? Confirm its status
NieuwegeinNetherlandsUnknown status
Erasmus MC
Coordinator of this site? Confirm its status
RotterdamNetherlandsUnknown status
Piedmont Health
Coordinator of this site? Confirm its status
AthensUnited StatesUnknown status
Evergreen Health Research/Overlake Medical Center
Coordinator of this site? Confirm its status
BellevueUnited StatesUnknown status
Grandview Medical Center
Coordinator of this site? Confirm its status
BirminghamUnited StatesUnknown status
University of Alabama
Coordinator of this site? Confirm its status
BirminghamUnited StatesUnknown status
University of Virginia
Coordinator of this site? Confirm its status
CharlottesvilleUnited StatesUnknown status
Ohio State University
Coordinator of this site? Confirm its status
ColumbusUnited StatesUnknown status
Inova Health
Coordinator of this site? Confirm its status
Falls ChurchUnited StatesUnknown status
Florida Heart Rhythm Specialists
Coordinator of this site? Confirm its status
Fort LauderdaleUnited StatesUnknown status
Colorado Heart
Coordinator of this site? Confirm its status
GoldenUnited StatesUnknown status
Ascension Medical Group
Coordinator of this site? Confirm its status
JacksonvilleUnited StatesUnknown status
Mount Sinai Hospital
Coordinator of this site? Confirm its status
New YorkUnited StatesUnknown status
Banner Health
Coordinator of this site? Confirm its status
PhoenixUnited StatesUnknown status
Sutter Health Sequoia Heart and Vascular Institute
Coordinator of this site? Confirm its status
Redwood CityUnited StatesUnknown status
Beaumont Health
Coordinator of this site? Confirm its status
Royal OakUnited StatesUnknown status
Pacific Heart Institute
Coordinator of this site? Confirm its status
Santa MonicaUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.