EGF Mapping and Ablation Therapy for Atrial Fibrillation

(RESOLVE-AF Trial)

Recruiting at 30 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

400 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the EGF Mapping and Ablation Therapy for Atrial Fibrillation treatment?

The research highlights that advanced mapping systems, like those used in the EGF Mapping and Ablation Therapy, improve the precision and effectiveness of atrial fibrillation treatment by enhancing the mapping process and enabling complex ablation strategies. These systems help in better understanding and targeting the areas of the heart responsible for irregular heartbeats. ^{1 2 3 4 5}

Is the EGF Mapping and Ablation Therapy for Atrial Fibrillation safe for humans?

The research articles discuss various mapping and ablation tools for atrial fibrillation, highlighting their ability to reduce procedural risks and improve safety. These tools, including novel mapping systems, have been evaluated for their safety in humans, suggesting they are generally safe for use in atrial fibrillation treatment. ^{2 6 7 8 9}

How is the EGF Mapping and Ablation Therapy for Atrial Fibrillation treatment different from other treatments?

The EGF Mapping and Ablation Therapy for Atrial Fibrillation is unique because it uses the Ablacath™ Mapping Catheter and Ablamap® System to precisely map and target areas in the heart for ablation, potentially offering more accurate treatment compared to traditional methods that may not provide such detailed mapping. ^{10 11 12 13 14}

Research Team

Kent Nilsson, MD

Principal Investigator

Piedmont Athens Regional

Lucas Boersma

Principal Investigator

St. Antonius Hospital

Eligibility Criteria

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.

I am over 18 years old or of legal age to consent where I live.

Timeline

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

Treatment Details

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.

Participant Groups

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+

References

1. United States pubmed.ncbi.nlm.nih.gov

Advanced Mapping Systems To Guide Atrial Fibrillation Ablation: Electrical Information That Matters. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

3D Mapping for PVI- Geometry, Image Integration and Incorporation of Contact Force Into Work Flow. [2020]

3. United States pubmed.ncbi.nlm.nih.gov

Electroanatomical mapping of atrial fibrillation: Review of the current techniques and advances. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Validation of a novel spiral mapping catheter for real-time recordings from the pulmonary veins during cryoballoon ablation of atrial fibrillation. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Global multielectrode contact-mapping plus ablation with a single catheter in patients with atrial fibrillation: Global AF study. [2020]

6. England pubmed.ncbi.nlm.nih.gov

Reduced fluoroscopy exposure during ablation of atrial fibrillation using a novel electroanatomical navigation system: a multicentre experience. [2022]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Acute and long-term results of PVI at antrum using a novel high-density mapping catheter without help of 3D electro-anatomic mapping in patients with paroxysmal and chronic atrial fibrillation. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Initial clinical experience of atrial fibrillation ablation guided by a cryoballoon-compatible, magnetic-based circular catheter. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Octogenarian Atrial Fibrillation Ablation with New NavX EnSite "Live View" Tool. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Plug pattern optimization for gamma knife radiosurgery treatment planning. [2019]

11. Japan pubmed.ncbi.nlm.nih.gov

New equipment for a radiation therapy simulator: a device for simplifying irregular field shaping and integrating simulator and therapy machine. [2004]

12. United States pubmed.ncbi.nlm.nih.gov

Dynamic collimator trajectory algorithm for multiple metastases dynamic conformal arc treatment planning. [2018]

13. United States pubmed.ncbi.nlm.nih.gov

A multileaf collimator field prescription preparation system for conventional radiotherapy. [2019]

14. United States pubmed.ncbi.nlm.nih.gov

A multileaf collimator field prescription preparation system for conventional radiotherapy. [2019]