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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment method for Atrial Fibrillation (AF), a condition characterized by an irregular heartbeat, using the Vektor Computational ECG Mapping System (vMap®). Researchers aim to determine if adding vMap® to the standard treatment, known as pulmonary vein isolation (PVI), proves more effective than PVI alone. Participants will receive either the standard PVI treatment or PVI with the vMap® technology. The trial seeks adults with persistent or recurrent AF who are scheduled for an ablation procedure, a treatment to correct irregular heartbeats. As an unphased trial, it offers participants the chance to contribute to innovative research that could enhance future AF treatments.

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 prior data suggests that the vMap® system is safe for treating Atrial Fibrillation?

Research shows that the vMap system is a non-invasive tool that creates a 3D map of the heart to identify areas causing arrhythmias. Studies have found that patients tolerate this system well, and it is FDA-cleared, indicating approval for use in other treatments and its safety for humans. Previous studies have not reported any major safety concerns when vMap is used with pulmonary vein isolation (PVI). This combination aims to improve outcomes for people with atrial fibrillation, a type of irregular heartbeat. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the AI Mapping and Ablation technique for atrial fibrillation because it combines advanced technology with traditional methods to potentially improve outcomes. Unlike the standard pulmonary vein isolation (PVI) treatment, which focuses solely on isolating problematic veins, the vMap® system uses AI to create a detailed map of the heart's electrical activity. This allows for more precise targeting of abnormal heart rhythms. By integrating AI mapping with PVI, this approach may offer better accuracy and effectiveness, reducing the likelihood of atrial fibrillation returning.

What evidence suggests that the vMap® system is effective for treating Atrial Fibrillation?

In this trial, participants will join different treatment arms to evaluate the effectiveness of using the vMap system with Pulmonary Vein Isolation (PVI) for Atrial Fibrillation (AF). Research has shown that patients receiving additional treatment guided by vMap had an 87.5% success rate in remaining free from all irregular heartbeats. vMap, a non-invasive tool, creates a detailed map of the heart to identify problem areas, aiding doctors in targeting treatment more accurately. This combination shows promise for effectively managing AF. ^{1 2 4 6 7}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Veranex

Collaborator

Trials

4

Recruited

80+

Citations

1. dicardiology.com dicardiology.com/content/new-data-demonstrates-vmaps-use-associated-significantly-improved-outcomes-atrial

New Data Demonstrates vMap's Use Associated with ... The study found that additional AF driver site ablation guided by the vMap system was associated with an 87.5% freedom from all atrial ...

2. health.ucsd.edu health.ucsd.edu/news/press-releases/2022-02-14-remapping-atrial-fibrillation-treatment/

Remapping Atrial Fibrillation Treatment - UC San Diego Health vMap is a non-invasive, computational mapping system that produces a three-dimensional, interactive map of arrhythmia hotspots anywhere in the heart.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9509662/

Forward-Solution Noninvasive Computational Arrhythmia ... The VMAP study was a blinded, multicenter evaluation with final data analysis performed by an independent core laboratory. Eligible episodes ...

4. vektormedical.com vektormedical.com/news?b5d8c2bd_page=2

News New Study Demonstrates vMap Associated with Significantly Improved Outcomes in Atrial Fibrillation Treatment. Use of vMap during complex atrial fibrillation ...

5. businesswire.com businesswire.com/news/home/20250709915203/en/First-Patients-Enrolled-in-IMPRoVED-AF-Study-Using-vMap-a-Non-Invasive-ECG-Based-Tool-Designed-to-Guide-More-Effective-AF-Ablation

First Patients Enrolled in IMPRoVED-AF Study Using vMap ... vMap was invented to help physicians improve ablation outcomes for patients suffering from arrhythmias, such as atrial fibrillation and ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06935591

Study Details | NCT06935591 | Artificial Intelligence ... The study is designed to compare clinical outcomes following use of an FDA-cleared/commercially available forward-solution computational 12-lead ECG mapping ...

7. hmpgloballearningnetwork.com hmpgloballearningnetwork.com/site/eplab/news/vektor-medical-announces-post-market-study-evaluating-benefit-ai-powered-analysis

Vektor Medical Announces Post-Market Study Evaluating ... vMap is the only FDA-cleared, non-invasive AI-based solution for mapping arrhythmias, utilizing just a 12-lead ECG. vMap localizes arrhythmia ...