EGF Mapping and Ablation Therapy for Atrial Fibrillation

(RESOLVE-AF Trial)

Not currently recruiting at 32 trial locations

Overseen By Kent Nilsson, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Cortex

Disqualifiers: De novo paroxysmal AF, Reversible AF, Recent cardiac surgery, Severe valvular disease, Decompensated heart failure, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1 week

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new tool for treating atrial fibrillation (AF), a heart condition that causes an irregular and often rapid heartbeat. Researchers aim to determine if the Ablacath™ Mapping Catheter and Ablamap® System can safely and effectively guide doctors during heart procedures to correct AF. The study includes two groups: one for individuals undergoing their first procedure and another for those needing a repeat procedure. Individuals with persistent AF planning to undergo a specific medical procedure may be suitable candidates for this trial. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could enhance heart procedure outcomes.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the Ablacath™ Mapping Catheter and Ablamap® System are safe for atrial fibrillation patients?

Research has shown that the Ablacath™ Mapping Catheter and Ablamap® System are generally safe for people with atrial fibrillation (AF). Studies have tested these tools in patients and found them to be well-tolerated, with serious side effects being rare. Most participants did not report severe problems during these studies. Prospective trial participants might find this information reassuring regarding the safety of these devices. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the EGF Mapping and Ablation Therapy for atrial fibrillation because it introduces a novel way to pinpoint and treat erratic heart signals. Unlike traditional ablation methods that rely on anatomical markers, this therapy uses Electrographic Flow (EGF) mapping to identify specific electrical sources causing atrial fibrillation. This precise targeting could lead to more effective treatments with potentially fewer side effects. By focusing on the actual electrical disturbances rather than just isolating the pulmonary veins, this method aims to improve the accuracy and success rates of ablation procedures.

What evidence suggests that the Ablacath™ Mapping Catheter and Ablamap® System are effective for atrial fibrillation?

This trial will evaluate the effectiveness of the Ablacath™ Mapping Catheter and Ablamap® System in treating atrial fibrillation (AF). Participants in the De Novo Arm will undergo Electrographic Flow (EGF) mapping during a pulmonary vein isolation procedure. Meanwhile, those in the Redo Arm will receive EGF mapping and guided ablation of EGF-identified sources during a redo AF procedure. Research has shown that this system can effectively identify problem areas in the heart. Specifically, one study indicated that it identified issues in 60% of patients needing a second procedure, and 95% of these areas were successfully treated. This technology aims to improve results by allowing for precise and personalized treatment. ^{1 5 6 7 8}

Who Is on the Research Team?

Kent Nilsson, MD

Principal Investigator

Piedmont Athens Regional

Lucas Boersma

Principal Investigator

St. Antonius Hospital

Are You a Good Fit for This Trial?

This trial is for adults who can legally consent and are suitable candidates for heart mapping and ablation therapy to treat various types of atrial arrhythmias, including different forms of atrial fibrillation, flutter, and tachycardia.

Inclusion Criteria

I am a good candidate for a procedure to correct irregular heartbeats.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo Electrographic Flow (EGF) mapping and ablation therapy for atrial fibrillation

1 week

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

Regular visits as per protocol

Post-procedure monitoring

Monitoring for serious adverse events within 7 to 30 days post-procedure

30 days

What Are the Treatments Tested in This Trial?

Interventions

• Ablacath™ Mapping Catheter
• Ablacath™ Mapping Catheter Accessory Cables
• Ablamap® System inclusive of Amplifier, Monitor/Workstation with installed Ablamap® Software

Trial Overview The trial tests the Ablacath™ Mapping Catheter and Ablamap® System's safety and effectiveness in creating Electrographic Flow (EGF) maps to guide treatment for all types of atrial fibrillation during initial or repeat procedures.

How Is the Trial Designed?

Group I: Redo Arm: Electrographic Flow (EGF) mapping and guided ablation of EGF-identified sources Experimental Treatment 1 Intervention

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

Group II: De Novo Arm: Electrographic Flow (EGF) mapping Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Cortex

Lead Sponsor

Trials

2

Recruited

490+

Ablacon, Inc.

Industry Sponsor

Trials

4

Recruited

600+

Citations

1. mountsinai.org mountsinai.org/clinical-trials/resolve-af-clinical-evaluation-of-ablacath-mapping-catheter-ablamap-system-utilizing-electrographic-flow-egf-mapping-to-resolve-extra-pv-sources-of-atrial-fibrillation-guide-ablation-therapy

RESOLVE-AF: Clinical Evaluation of the Ablacath ... Summary: Demonstrate the safety and effectiveness of the Ablacath™ Mapping Catheter and Ablamap® System in patients with all types of atrial fibrillation (AF) ...

2. jacc.org jacc.org/doi/10.1016/j.jacep.2024.03.040

A Randomized Trial of Electrographic Flow-Guided Redo ... In nonparoxysmal AF patients undergoing redo ablation, EGF mapping identified AF sources in 60% of patients, and could be successfully ablated in 95%.

3. onderzoekmetmensen.nl onderzoekmetmensen.nl/en/node/56533/pdf

A prospective, single arm, multi-center, clinical evaluation ... Demonstrate clinical safety and effectiveness of the Ablacath* Mapping Catheter and Ablamap® System in patients with paroxysmal (Redo only) or ...

4. dicardiology.com dicardiology.com/content/cortex-announces-resolve-af-trial-evaluating-electrographic-flow-egf-mapping-use-atrial

Cortex Announces RESOLVE-AF Trial Evaluating ... EGF Mapping system aims to improve patient outcomes by enabling precise and personalized ablation strategies.

5. clinicaltrials.gov clinicaltrials.gov/study/NCT05883631

Study Details | NCT05883631 | RESOLVE-AF ... Demonstrate the safety and effectiveness of the Ablacath™ Mapping Catheter and Ablamap® System in patients with all types of atrial fibrillation (AF) ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05883631?term=resolve-af&rank=1

Clinical Evaluation of the Ablacath™ Mapping Catheter ... Demonstrate the safety and effectiveness of the Ablacath™ Mapping Catheter and Ablamap® System in patients with all types of atrial fibrillation ( AF ) ...

7. withpower.com withpower.com/trial/phase-atrial-fibrillation-8-2023-490d1

EGF Mapping and Ablation Therapy for Atrial Fibrillation ... These tools, including novel mapping systems, have been evaluated for their safety in humans, suggesting they are generally safe for use in atrial fibrillation ...

8. trialx.com trialx.com/clinical-trials/listings/217108/resolve-af-clinical-evaluation-of-the-ablacathtm-mapping-catheter-and-ablamap-system-utilizing-electrographic-flow-egf-mapping-to-resolve-extra-pv-sources-of-atrial-fibrillation-and-guide-ablation-therapy/

RESOLVE-AF: Clinical Evaluation of the Ablacath ... Demonstrate the safety and effectiveness of the Ablacath™ Mapping Catheter and Ablamap® System in patients with all types of atrial fibrillation ...