Atrial FibrillationRESOLVE-AFNCT05883631
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.
A study testing Electrographic Flow (EGF) mapping and ablation of EGF-identified sources of Atrial Fibrillation and Electrographic Flow (EGF) mapping (no ablation) in people with Atrial Fibrillation and Atrial Fibrillation, Persistent, run by Cortex at 24 sites in 4 countries.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Atrial Fibrillation, Atrial Fibrillation, Persistent, Atrial Fibrillation Paroxysmal
- What is being tested?
- Electrographic Flow (EGF) mapping and ablation of EGF-identified sources of Atrial Fibrillation and Electrographic Flow (EGF) mapping (no ablation)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 24 sitesin 4 countries
- Study dates
- 23 Oct 2023to Jan 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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)
Show all 11Show fewer
- 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
Trial locations and contacts
24 sites in 4 countries.
24 sites in 4 countries
United States15 sites
Piedmont Health
Athens, Georgia, 30606
Evergreen Health Research/Overlake Medical Center
Bellevue, Washington, 98004
University of Alabama
Birmingham, Alabama, 35233
Grandview Medical Center
Birmingham, Alabama, 35243
University of Virginia
Charlottesville, Virginia, 22908
Ohio State University
Columbus, Ohio, 43210
Inova Health
Falls Church, Virginia, 22042
Florida Heart Rhythm Specialists
Fort Lauderdale, Florida, 33308
Colorado Heart
Golden, Colorado, 80402
Ascension Medical Group
Jacksonville, Florida, 32204
Mount Sinai Hospital
New York, New York, 10029
Banner Health
Phoenix, Arizona, 85006
Sutter Health Sequoia Heart and Vascular Institute
Redwood City, California, 94062
Beaumont Health
Royal Oak, Michigan, 48073
Pacific Heart Institute
Santa Monica, California, 90404
Belgium3 sites
OLV Hospital Aalst
Aalst, 9300
ZNA Middelheim
Antwerp, 2020
ZOL
Genk, 3600
Czechia3 sites
Neuron Medical
Brno, 625 00
IKEM (Institute for Clinical and Experimental Medicine)
Prague, 140 21
Na Homolce Hospital
Prague, 150 00
Netherlands3 sites
Amsterdam UMC (location AMC)
Amsterdam, North Holland, 1105AZ
St. Antonius Hospital
Nieuwegein, Utrecht, 3435CM
Erasmus MC
Rotterdam, 3015GD
About this study
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.
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.
Read the detailed 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.
- Conditions
- Atrial Fibrillation, Atrial Fibrillation, Persistent, Atrial Fibrillation Paroxysmal, Arrhythmia, Arrhythmias, Cardiac, Atrial Flutter
- Being tested
- Electrographic Flow (EGF) mapping and ablation of EGF-identified sources of Atrial Fibrillation, Electrographic Flow (EGF) mapping (no ablation)
- Medical subject headings
- Atrial Fibrillation, Arrhythmias, Cardiac, Atrial Flutter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electrographic Flow (EGF) mapping and ablation of EGF-identified sources of Atrial FibrillationDevice
Also called OptiMap™ System
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.
Electrographic Flow (EGF) mapping (no ablation)Device
Also called OptiMap™ System
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Electrographic Flow (EGF) mapping and ablation of EGF-identified sources of Atrial Fibrillation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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
Measured: From index procedure to 7 days after index procedure
Demonstrate the predictive value of electrographic flow (EGF) phenotyping for ablation outcome
Measured: 12 months
Secondary outcomes (3)
Number of participants with 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
Measured: From index procedure to 30 days after index procedure
Overall reduction in burden of AF for subset of patients with implantable loop recorder
Evaluation of patient's freedom from AF based on recordings of implantable loop recorders
Measured: From 90 days to 12 months after index procedure
Overall procedure time, fluoro time, total EGF-guided mapping time, total EGF-guided ablation time
Evaluation of index or recurrence procedure data
Measured: Index or Repeat Procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2023
- Study start23 Oct 2023
- Primary completionJan 2026 (estimated)
- Study completionJan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cortex
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Ablacon, Inc.
- Responsible party
- Sponsor
- Investigators
- Kent Nilsson, MD, Principal investigator, Piedmont Athens RegionalLucas Boersma, Prof. MD., Principal investigator, St. Antonius Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05883631
- Sponsor's protocol ID
- CP006
- Acronym
- RESOLVE-AF
- Status last verified
- Apr 2025
- First submitted
- 22 May 2023
- Last updated
- 13 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT05883631
- Acronym / sponsor ID
- RESOLVE-AF / CP006
- Conditions
- Atrial Fibrillation, Atrial Fibrillation, Persistent, Atrial Fibrillation Paroxysmal, Arrhythmia, Arrhythmias, Cardiac, Atrial Flutter
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- CortexIndustry (pharma, biotech, devices)
- Collaborators
- Ablacon, Inc.
- Study start
- 23 Oct 2023 (actual)
- Primary completion
- Jan 2026 (estimated)
- Study completion
- Jan 2026 (estimated)
- First posted
- 1 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| De Novo Arm: Electrographic Flow (EGF) mapping | Experimental | Device: Electrographic Flow (EGF) mapping (no ablation)Subjects with persistent or long-standing persistent atrial fibrillation (AF), coming in for a De Novo pulmonary vein isolation procedure. |
| Redo Arm: Electrographic Flow (EGF) mapping and guided ablation of EGF-identified sources | Experimental | Device: Electrographic Flow (EGF) mapping and ablation of EGF-identified sources of Atrial FibrillationSubjects with paroxysmal, persistent or long-standing persistent atrial fibrillation (AF) coming in for a redo AF procedure. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Electrographic Flow (EGF) mapping and ablation of EGF-identified sources of Atrial FibrillationAlso: OptiMap™ SystemIn 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. | Device | Redo Arm: Electrographic Flow (EGF) mapping and guided ablation of EGF-identified sources |
| Electrographic Flow (EGF) mapping (no ablation)Also: OptiMap™ SystemIn 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. | Device | De Novo Arm: Electrographic Flow (EGF) mapping |
Primary outcome
Number of participants with 12-month freedom from AF recurrence (with or without AADs)
Time frame: From 90 days to 12 months after index procedure
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).
Number of participants with freedom from a composite of serious adverse events (SAEs) occurring within 7 days from the index procedure
Time frame: From index procedure to 7 days after index procedure
Evaluated by assessing combined rate of SAE composite as adjudicated by a CEC for relatedness to device or procedure
Demonstrate the predictive value of electrographic flow (EGF) phenotyping for ablation outcome
Time frame: 12 months
3 secondary outcomes
Number of participants with freedom from a composite of SAE occurring within 30 days from post-index ablation procedure
Time frame: From index procedure to 30 days after index procedure
Overall reduction in burden of AF for subset of patients with implantable loop recorder
Time frame: From 90 days to 12 months after index procedure
Overall procedure time, fluoro time, total EGF-guided mapping time, total EGF-guided ablation time
Time frame: Index or Repeat Procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2025.
- Individual participant dataSharing planned: No
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Atrial Fibrillation (AF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kent Nilsson, MD principal investigator
Piedmont Athens Regional
Lucas Boersma, Prof. MD. principal investigator
St. Antonius Hospital
24 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electrographic Flow (EGF) mapping and ablation of EGF-identified sources of Atrial Fibrillation and Electrographic Flow (EGF) mapping (no ablation) in people with Atrial Fibrillation and Atrial Fibrillation, Persistent, run by Cortex at 24 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 13 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in United States, Belgium, Czechia, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with 12-month freedom from AF recurrence (with or without AADs) (time frame: From 90 days to 12 months after index procedure). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2025.