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

March 12, 2026 updated by: Vektor Medical

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

423

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Munich, Germany, 80636
        • Recruiting
        • German Heart Center
        • Contact:
        • Principal Investigator:
          • Isabel Deisenhofer, Prof. Dr. med.
        • Sub-Investigator:
          • Theresa Reiter, Dr. med.
        • Sub-Investigator:
          • Fabian Bahlke, Dr. med.
        • Sub-Investigator:
          • Madeleine Tydecks, Dr. med.
        • Sub-Investigator:
          • Miruna-Andreea Popa, Dr. med.
        • Sub-Investigator:
          • Mohammad Al Fayad, MD
        • Sub-Investigator:
          • Sarah Lengauer, Dr. med.
        • Sub-Investigator:
          • Jan Syväri, Jr. Doctor
  • United States
    • Arkansas
      • Jonesboro, Arkansas, United States, 72401
        • Recruiting
        • Arrhythmia Research Group - St. Bernards
        • Contact:
        • Principal Investigator:
          • Devi Nair, MD
    • Florida
      • Clearwater, Florida, United States, 33759
        • Recruiting
        • BayCare Health System
        • Principal Investigator:
          • Vaibhav Moondra, MD
        • Contact:
        • Sub-Investigator:
          • Cydney Rebetti, APRN
      • Jacksonville, Florida, United States, 32207
        • Recruiting
        • Baptist Health Jacksonville
        • Principal Investigator:
          • Matthew S McKillop, MD
        • Contact:
        • Sub-Investigator:
          • Steven Ross, MD
        • Sub-Investigator:
          • Christopher Ruisi, MD
      • Tampa, Florida, United States, 33606
        • Recruiting
        • USF Health
        • Principal Investigator:
          • David Wilson, MD
        • Sub-Investigator:
          • Bengt Herweg, MD
        • Contact:
        • Contact:
          • Executive Director, Clinical Operations
          • Phone Number: 813-974-3823
          • Email: karlnosk@usf.edu
        • Sub-Investigator:
          • Christopher Cook, MD
    • Georgia
      • Athens, Georgia, United States, 30606
        • Not yet recruiting
        • Piedmont Heart of Athens
        • Contact:
        • Principal Investigator:
          • Kent Nilsson, MD
      • Atlanta, Georgia, United States, 30309
        • Recruiting
        • Piedmont Heart Institute
        • Principal Investigator:
          • Sandeep Goyal, MD
        • Sub-Investigator:
          • Michael Hoosien, MD
        • Contact:
        • Sub-Investigator:
          • Ashish Bhimani, MD
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Recruiting
        • Indiana University
        • Principal Investigator:
          • Mithilesh Das, MD
        • Contact:
        • Sub-Investigator:
          • John Miller, MD
    • Kentucky
      • Lexington, Kentucky, United States, 40503
        • Recruiting
        • Baptist Health Lexignton
        • Principal Investigator:
          • Gery Tomassoni, MD
        • Sub-Investigator:
          • Johan Aasbo, MD
        • Contact:
        • Contact:
        • Sub-Investigator:
          • John Lee, MD
        • Sub-Investigator:
          • Joel Simon, MD
    • New York
      • Valhalla, New York, United States, 10595
        • Recruiting
        • Westchester Medical Center
        • Principal Investigator:
          • Sei Iwai, MD
        • Contact:
        • Sub-Investigator:
          • Jason Jacobson, MD
        • Sub-Investigator:
          • Daniel Frenkel, MD
        • Sub-Investigator:
          • Rhadames Rojas, MD
        • Sub-Investigator:
          • Subrat Das, MD
        • Sub-Investigator:
          • Sade Solola-Nussbaum, MD
        • Sub-Investigator:
          • Sayaka Larsen, RN
        • Sub-Investigator:
          • Tracey Shannon, NP, RN
        • Sub-Investigator:
          • Nyree Sencion-Akhtar, DNP, FNP-C, RN
    • Ohio
      • Columbus, Ohio, United States, 43202
        • Recruiting
        • OhioHealth
        • Principal Investigator:
          • Anish Amin, MD
        • Contact:
        • Sub-Investigator:
          • Sreedhar Billakanty, MD
        • Sub-Investigator:
          • Auroa Badin, MD
        • Sub-Investigator:
          • Nagesh Chopra, MD
        • Sub-Investigator:
          • Jaret Tyler, MD
        • Sub-Investigator:
          • Ankur Shah, MD
        • Sub-Investigator:
          • Eugene Fu, MD
      • Toledo, Ohio, United States, 43614
        • Not yet recruiting
        • University of Toledo Medical Center
        • Contact:
        • Principal Investigator:
          • Abhishek Maan, MD
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104-4238

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Subjects diagnosed with persistent (not longstanding) AF or recurrent AF, as defined for this study.
  2. 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.

  3. 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).
  4. Subject is ≥ 22 years of age at time of enrollment/consent.
  5. Subject is indicated to undergo an ablation procedure at the medical discretion of the Investigator.
  6. Subject is able and willing to comply with the protocol requirements, has been informed of the nature of the study,

Exclusion Criteria:

  1. 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).
  2. 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.
  3. 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.
  4. 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.
  5. Subjects who are pregnant as confirmed by the institution's standard pre-surgery practice.
  6. Subject has had prior PVI and all four pulmonary veins are confirmed to be isolated based on voltage readings during the study index procedure.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: vMap®+PVI
Subjects in this arm will be treated with the use of the vMap® system in addition to pulmonary vein isolation.
Device: vMap® + Pulmonary Vein Isolation
Subjects will receive treatment for Atrial Fibrillation with the use of the vMap® system and Pulmonary Vein Isolation.
Active Comparator: PVI Alone
Subjects in this arm will be treated with pulmonary vein isolation alone.
Procedure: Pulmonary Vein Isolation
Subjects will receive treatment for Atrial Fibrillation with Pulmonary Vein Isolation per standard of care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Freedom from AF
Time Frame: 12 months post procedure
The achievement of freedom from AF for subjects on or off antiarrhythmic drug (AAD) therapy at 12 months.
12 months post procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Freedom from AF and AT
Time Frame: 12 months post procedure
Freedom from both AF and AT for subjects on and off antiarrhythmic drug (AAD) therapy at 12 months.
12 months post procedure
Total Procedure Time
Time Frame: Interventional Procedure
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).
Interventional Procedure
Total vMap® Mapping Time
Time Frame: Interventional Procedure
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.
Interventional Procedure
AF Burden
Time Frame: 12 months post procedure
AF burden as a proportion of time before versus after the ablation procedure, excluding the 'blanking period'.
12 months post procedure
Spontaneous AF Termination
Time Frame: Interventional Procedure
Proportion of subjects whose AF terminated spontaneously upon and after the first ablation lesion and before achieving hemostasis without cardioversion.
Interventional Procedure
Total Fluoroscopy Dose
Time Frame: Interventional Procedure
Defined as the cumulative dose-area product (DAP) for the procedure.
Interventional Procedure

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total Fluorscopy Time
Time Frame: 1Interventional Procedure
Defined as the total time of fluoroscopy during procedure
1Interventional Procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vektor Medical

Collaborators

Veranex
Veranex Switzerland SA

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 27, 2025

Primary Completion (Estimated)

October 1, 2027

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

April 8, 2025

First Submitted That Met QC Criteria

April 18, 2025

First Posted (Actual)

April 20, 2025

Study Record Updates

Last Update Posted (Actual)

March 16, 2026

Last Update Submitted That Met QC Criteria

March 12, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 23-VM-1001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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