AI Mapping and Ablation for Atrial Fibrillation

(IMPRoVED-AF Trial)

Recruiting at 7 trial locations

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Vektor Medical

Disqualifiers: Long-standing AF, Poor ECG quality, Pregnancy, others

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

Compensation: Varies

Number of Visits: 1

384 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of this clinical trial is to compare the use of the Vektor Computational ECG Mapping System (vMap®) with pulmonary vein isolation (PVI), to using PVI alone, to treat Atrial Fibrillation (AF) in adults. Participants will have a 50/50 or 1 out of 2 chance of being placed in the treatment or control arm. The control arm of the study involves PVI alone for ablation procedure(s). The treatment arm involves the use of vMap mapping in addition to PVI to plan ablation procedure(s).

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

The trial information does not specify whether you need to stop taking your current medications. Please consult with the trial coordinator or your doctor for guidance.

What data supports the effectiveness of the treatment Pulmonary Vein Isolation, vMap® for atrial fibrillation?

Recent studies show that advanced mapping systems, like those used in Pulmonary Vein Isolation, help doctors better understand and treat atrial fibrillation by improving the visualization of heart electrical activity, which can lead to safer and more effective treatments. ^{1 2 3 4 5}

Is the AI Mapping and Ablation for Atrial Fibrillation treatment safe for humans?

Studies show that advanced mapping systems used in ablation procedures, like the ones for atrial fibrillation, are generally safe. They help reduce risks by improving precision and minimizing radiation exposure during the procedure. ^{4 5 6 7 8}

How is the treatment vMap® for atrial fibrillation different from other treatments?

The vMap® treatment for atrial fibrillation is unique because it uses advanced electroanatomic mapping systems to create a detailed 3D map of the heart's electrical activity, helping doctors precisely target areas for ablation (a procedure to destroy small areas of heart tissue causing irregular heartbeats). This approach improves the accuracy and safety of the procedure compared to traditional methods. ^{2 5 9 10 11}

Eligibility Criteria

This trial is for adults with Atrial Fibrillation who are eligible for an ablation procedure. Specific eligibility criteria details were not provided, so interested individuals should contact the study organizers to learn more about who can participate.

Inclusion Criteria

Subject has recent 12-lead electrogram data of AF recorded on the electrogram recording system or standalone ECG system in digitized format

Subject is able and willing to comply with the protocol requirements and has been informed of the nature of the study

I have been diagnosed with ongoing or recurring atrial fibrillation.

Exclusion Criteria

Inability to obtain ECG prior to or during the clinical ablation procedure or unacceptable ECG data quality

I have a heart rhythm problem that is not persistent or recurring AF.

I have a health condition that may make joining this study risky.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Interventional Procedure

Participants undergo ablation procedures with or without the vMap® system

1 day

1 visit (in-person)

Follow-up

Participants are monitored for freedom from AF and other outcomes

12 months

Regular follow-up visits

Treatment Details

Interventions

• Pulmonary Vein Isolation
• vMap®

Trial Overview The study compares two approaches to treat Atrial Fibrillation: one group receives a standard treatment called Pulmonary Vein Isolation (PVI), while the other group gets PVI plus a new technique using vMap® mapping system to guide the procedure.

Participant Groups

Group I: vMap®+PVI Experimental Treatment 1 Intervention

Subjects in this arm will be treated with the use of the vMap® system in addition to pulmonary vein isolation.

Group II: PVI Alone Active Control 1 Intervention

Subjects in this arm will be treated with pulmonary vein isolation alone.

Who Is Running the Clinical Trial?

Vektor Medical

Lead Sponsor

Trials

1

Recruited

230+

Veranex Switzerland SA

Industry Sponsor

References

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

Ablation in Persistent Atrial Fibrillation Using Stochastic Trajectory Analysis of Ranked Signals (STAR) Mapping Method. [2021]

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

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

3. Netherlands pubmed.ncbi.nlm.nih.gov

Mapping techniques for atrial fibrillation ablation. [2016]

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

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

5. Netherlands pubmed.ncbi.nlm.nih.gov

Novel noncontact charge density map in the setting of post-atrial fibrillation atrial tachycardias: first experience with the Acutus SuperMap Algorithm. [2021]

6. Germany pubmed.ncbi.nlm.nih.gov

First clinical experience using a novel high-resolution electroanatomical mapping system for left atrial ablation procedures. [2019]

7. Japan pubmed.ncbi.nlm.nih.gov

Three-dimensional electroanatomic mapping systems in catheter ablation of atrial fibrillation. [2019]

8. England pubmed.ncbi.nlm.nih.gov

Acute safety, effectiveness, and real-world clinical usage of ultra-high density mapping for ablation of cardiac arrhythmias: results of the TRUE HD study. [2020]

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

Multimodal Examination of Atrial Fibrillation Substrate: Correlation of Left Atrial Bipolar Voltage Using Multi-Electrode Fast Automated Mapping, Point-by-Point Mapping, and Magnetic Resonance Image Intensity Ratio. [2019]

10. England pubmed.ncbi.nlm.nih.gov

Electro-anatomic mapping systems in arrhythmias. [2022]

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

Initial experience in the use of integrated electroanatomic mapping with three-dimensional MR/CT images to guide catheter ablation of atrial fibrillation. [2006]