AzTrials
AzTrials

Atrial Fibrillation (AF)IMPRoVED-AFNCT06935591

Artificial Intelligence Mapping and Ablation of Non-Pulmonary Vein Electrical Drivers of AF Study

A study testing Pulmonary Vein Isolation and vMap® + Pulmonary Vein Isolation in people with Atrial Fibrillation (AF), run by Vektor Medical at 13 sites in 2 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 22 years and older
Conditions the study is for
Atrial Fibrillation (AF)
What is being tested?
Pulmonary Vein Isolation and vMap® + Pulmonary Vein Isolation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
423 participants
Where
13 sitesin 2 countries
Study dates
27 Jun 2025to Dec 2027
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 22 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subjects diagnosed with persistent (not longstanding) AF or recurrent AF, as defined for this study.
  • Subject has a recent 12-lead electrogram data of AF (including baseline, pacing and clinical arrhythmia) recorded on the electrogram recording system (e.g., Bard, Boston-Scientific, St. Paul, MN or Prucka, GE Medical) or standalone ECG system (e.g., GE Muse, Minnesota, or CardioCard (Nasiff, NY) in digitized format.
  • The following data elements can be abstracted from the patient medical records or confirmed and documented prior to the scheduled procedure (to be inputted in vMap®):
  • Atrial fibrillation type
  • Atrial characteristics: geometry (normal, left and/or right atrial enlargement), Utah classification, prior ablation modality (e.g., radiofrequency, cryoablation, pulsed field ablation), prior ablation lesion location(s).
  • Subject is ≥ 22 years of age at time of enrollment/consent.
  • Subject is indicated to undergo an ablation procedure at the medical discretion of the Investigator.
  • Subject is able and willing to comply with the protocol requirements, has been informed of the nature of the study,

Who cannot join

  • Subjects with arrhythmias other than persistent or recurring AF as defined for this study, including long-standing persistent atrial fibrillation (persistent AF lasting ≥ 1 year from diagnosis).
  • Inability to obtain ECG prior to or during the clinical ablation procedure; or unacceptable ECG data quality such as low ECG signal-to-noise ratio or lack of ECG data in one or more leads.
  • Subjects who are participating in another clinical investigation with an investigational drug or device at the time of enrollment or planned participation at any time during this clinical investigation.
  • Subjects who have a known or suspected medical condition that, in the opinion of the Investigator, may put the subject at risk for participation in this clinical investigation.
  • Subjects who are pregnant as confirmed by the institution's standard pre-surgery practice.
  • Subject has had prior PVI and all four pulmonary veins are confirmed to be isolated based on voltage readings during the study index procedure.

Trial locations and contacts

13 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

13 sites in 2 countries

United States12 sites, 12 recruiting

  • Piedmont Heart of Athens

    Athens, Georgia, 30606

    Caryn Bernstein, 404-605-5688, caryn.bernstein@piedmont.org

    Kent Nilsson, MD

    Not yet recruiting

  • Piedmont Heart Institute

    Atlanta, Georgia, 30309

    Caryn Bernstein, 404-605-5688, caryn.bernstein@piedmont.org

    Sandeep Goyal, MD

    Recruiting

  • BayCare Health System

    Clearwater, Florida, 33759

    Andrea Daigneault, 727-461-8510, andrea.daigneault@baycare.org

    Vaibhav Moondra, MD

    Recruiting

  • OhioHealth

    Columbus, Ohio, 43202

    Reem Bekheet, 937-218-3542, Reem.Bekheet@ohiohealth.com

    Anish Amin, MD

    Recruiting

  • Indiana University

    Indianapolis, Indiana, 46202

    Collin Lamothe, 317-274-0963, clamothe@iu.edu

    Mithilesh Das, MD

    Recruiting

  • Baptist Health Jacksonville

    Jacksonville, Florida, 32207

    Smitha Gubbi, 904-202-7069, smitha.gubbi@bmcjax.com

    Matthew S McKillop, MD

    Recruiting

  • Arrhythmia Research Group - St. Bernards

    Jonesboro, Arkansas, 72401

    Kayla Rubino, 870-935-6729, krubino@dnairresearch.com

    Devi Nair, MD

    Recruiting

  • Baptist Health Lexignton

    Lexington, Kentucky, 40503

    Gwyndolyn Middleton, 859-260-4445, gmiddlet@bhsi.com

    Franklin Gonzalez, 859-260-3197, franklin.echevarriagonzalez@bhsi.com

    Recruiting

  • Penn Presbyterian

    Philadelphia, Pennsylvania, 19104-4238

    Katie Shoemaker, 215-662-8562, katie.shoemaker@pennmedicine.upenn.edu

    Benjamin D'Souza, MD

    Recruiting

  • USF Health

    Tampa, Florida, 33606

    Jacky He, 813-396-0410, jackyhe@usf.edu

    Executive Director, Clinical Operations, 813-974-3823, karlnosk@usf.edu

    Recruiting

  • University of Toledo Medical Center

    Toledo, Ohio, 43614

    Christina Sattler, 419-383-6225, Christina.Sattler@utoledo.edu

    Abhishek Maan, MD

    Not yet recruiting

  • Westchester Medical Center

    Valhalla, New York, 10595

    Corazon De La Pena, 914-493-2483, corazon.delapena@wmchealth.org

    Sei Iwai, MD

    Recruiting

Other trials in United States

Germany1 site, 1 recruiting

  • German Heart Center

    Munich, 80636

    Sabine Brandhorst, +49 89 1218-3093, brandhorst@dhm.mhn.de

    Isabel Deisenhofer, Prof. Dr. med.

    Recruiting

Other trials in Germany

About this study

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).

Read the detailed description

This is a post-market, prospective, multi-center, two-arm randomized-controlled clinical study. Subjects will be randomized in a 1:1 ratio into two arms: a treatment arm (use of vMap® system in addition to pulmonary vein isolation [vMap®+PVI]) and a control arm (PVI alone). The study is designed to compare clinical outcomes following use of an FDA-cleared/commercially available forward-solution computational 12-lead ECG mapping system (vMap®) for identifying/mapping for subjects who are indicated to undergo ablation procedures for persistent and recurrent AF in accordance with standard of care practices.

Being tested
Pulmonary Vein Isolation, vMap® + Pulmonary Vein Isolation
Keywords
Atrial Fibrillation, Pulmonary Vein Isolation, Ablation
Medical subject headings
Atrial Fibrillation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Pulmonary Vein IsolationProcedure or surgery

    Subjects will receive treatment for Atrial Fibrillation with Pulmonary Vein Isolation per standard of care.

  • vMap® + Pulmonary Vein IsolationDevice

    Subjects will receive treatment for Atrial Fibrillation with the use of the vMap® system and Pulmonary Vein Isolation.

Study groups in NCT06935591
Study groupRoleWhat they receive
vMap®+PVIExperimentalSubjects in this arm will be treated with the use of the vMap® system in addition to pulmonary vein isolation.
Receives: Device: vMap® + Pulmonary Vein Isolation
PVI AloneActive comparatorSubjects in this arm will be treated with pulmonary vein isolation alone.
Receives: Procedure: Pulmonary Vein Isolation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Freedom from AF

    The achievement of freedom from AF for subjects on or off antiarrhythmic drug (AAD) therapy at 12 months.

    Measured: 12 months post procedure

Secondary outcomes (6)

  1. Freedom from AF and AT

    Freedom from both AF and AT for subjects on and off antiarrhythmic drug (AAD) therapy at 12 months.

    Measured: 12 months post procedure

  2. Total Procedure Time

    Defined as the time from completing intravascular access (successful placement of all vascular sheaths) to initiating hemostasis (time at which the first vascular sheath is removed from the subject).

    Measured: Interventional Procedure

  3. Total vMap® Mapping Time

    Defined as time from entering the ECG and patient characteristics into the vMap® and ending with display of the 3-dimensional mapping result, prior to delivery of the first ablation.

    Measured: Interventional Procedure

  4. AF Burden

    AF burden as a proportion of time before versus after the ablation procedure, excluding the 'blanking period'.

    Measured: 12 months post procedure

  5. Spontaneous AF Termination

    Proportion of subjects whose AF terminated spontaneously upon and after the first ablation lesion and before achieving hemostasis without cardioversion.

    Measured: Interventional Procedure

  6. Total Fluoroscopy Dose

    Defined as the cumulative dose-area product (DAP) for the procedure.

    Measured: Interventional Procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Apr 2025
  2. Study start27 Jun 2025
  3. Primary completionOct 2027 (estimated)
  4. Study completionDec 2027 (estimated)

Resources

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
Randomised
Intervention model
Parallel groups
Model description
This is a post-market, prospective, multi-center, two-arm randomized-controlled clinical study. Subjects will be randomized in a 1:1 ratio into two arms: a treatment arm (use of vMap® system in addition to pulmonary vein isolation \[vMap®+PVI\]) and a control arm (PVI alone). The study is designed to compare clinical outcomes following use of an FDA-cleared/commercially available forward-solution computational 12-lead ECG mapping system (vMap®) for identifying/mapping for subjects who are indicated to undergo ablation procedures for persistent and recurrent AF in accordance with standard of care practices.
Masking
None (open label)
Enrolment
423 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06935591
Sponsor's protocol ID
23-VM-1001
Acronym
IMPRoVED-AF
Status last verified
Mar 2026
First submitted
8 Apr 2025
Last updated
16 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes

Questions about this trial

What is this clinical trial studying?

A study testing Pulmonary Vein Isolation and vMap® + Pulmonary Vein Isolation in people with Atrial Fibrillation (AF), run by Vektor Medical at 13 sites in 2 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 8 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 16 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in United States, Germany. 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?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Freedom from AF (time frame: 12 months post procedure). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06935591.

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 16 Mar 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in