Atrial FibrillationCOMPANION AINCT06056271
Clinical and Healthcare Outcomes From Real-World Use in the United States of a Companion AI During AF Ablation
An observational study of Atrial Fibrillation, run by Volta Medical at 4 sites in United States.
Trial summary
Observational, multi-center, clinical device registry for US patients with a primary goal to observe the clinical outcomes in patients who are mapped with Volta Medical's VX1 or AF-Xplorer systems during AF ablation procedures. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- AF Ablation
- Type of treatment
- Medical device
- How many people
- 400 participants
- Where
- 4 sitesUnited States
- Study dates
- 19 Mar 2024to Dec 2027
- Phase
- Observational
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients indicated for ablation for atrial fibrillation
Who may be able to join
- Patients 21 years of age or older who is:
- indicated for AF ablation or
- Who has received an AF-ablation with the past 24 months where VX1 was used or
- Patients are receiving or received a catheter ablation procedure for AF according to current guidelines
- Patients must be able and willing to provide written informed consent to participate in the clinical trial
Who cannot join
- Patients not indicated or were not indicated for catheter ablation according to current guidelines
- Patients with AF secondary to an obvious reversible cause
- Patients who are or may potentially be pregnant
- Enrollment in an investigational study evaluating another non-VX1 investigational device, biologic, or drug
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States4 sites, 4 recruiting
- Recruiting
Ohio State University
Columbus, Ohio, 43210
- Recruiting
Endeavor Health
Evanston, Illinois, 60201
Research Coordinator, mdurante@northshore.org
- Recruiting
Northwell Health
New York, New York, 10075
- Recruiting
Kansas City Cardiac Arrhythmia Research LLC
Overland Park, Kansas, 66211
Donita Atkins, donita.atkins@hcahealthcare.com
Dhanunjaya Lakkireddy, MD
About this study
Observational, multi-center, clinical device registry for US patients with a primary goal to observe the clinical outcomes in patients who are mapped with Volta Medical's VX1 or AF-Xplorer systems during AF ablation procedures.
- Conditions
- Atrial Fibrillation
- Being tested
- AF 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.
AF AblationDevice
Percutaneous, catheter-based ablation of atrial fibrillation
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Clinical Efficacy Outcome
Percentage of subjects free from clinically significant AF or atrial arrhythmia recurrences, after one or multiple ablation procedures, stratified by type of clinical workflow and ablation history.
Measured: 12 and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2023
- Study start19 Mar 2024
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Volta Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Heart Rhythm Clinical and Research Solutions, LLC
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06056271
- Sponsor's protocol ID
- CLIPL-01-005
- Acronym
- COMPANION AI
- Status last verified
- Dec 2025
- First submitted
- 20 Sep 2023
- Last updated
- 10 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Healthcare Outcomes From Real-World Use in the United States of a Companion AI During AF Ablation
- ClinicalTrials.gov ID
- NCT06056271
- Acronym / sponsor ID
- COMPANION AI / CLIPL-01-005
- Conditions
- Atrial Fibrillation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Volta MedicalIndustry (pharma, biotech, devices)
- Collaborators
- Heart Rhythm Clinical and Research Solutions, LLC
- Study start
- 19 Mar 2024 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 28 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Observational, multi-center, clinical device registry for US patients with a primary goal to observe the clinical outcomes in patients who are mapped with Volta Medical's VX1 or AF-Xplorer systems during AF ablation procedures.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients indicated for ablation for atrial fibrillation
Key inclusion criteria (5 listed)
- Patients 21 years of age or older who is:
- Patients are receiving or received a catheter ablation procedure for AF according to current guidelines
- Patients must be able and willing to provide written informed consent to participate in the clinical trial
Key exclusion criteria (4 listed)
- Patients not indicated or were not indicated for catheter ablation according to current guidelines
- Patients with AF secondary to an obvious reversible cause
- Patients who are or may potentially be pregnant
- Enrollment in an investigational study evaluating another non-VX1 investigational device, biologic, or drug
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AF AblationPercutaneous, catheter-based ablation of atrial fibrillation | Device | – |
Primary outcome
Primary Clinical Efficacy Outcome
Time frame: 12 and 24 months
Percentage of subjects free from clinically significant AF or atrial arrhythmia recurrences, after one or multiple ablation procedures, stratified by type of clinical workflow and ablation history.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2025.
- Individual participant dataSharing planned: No
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Paroxysmal AF
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Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
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Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
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Atrial Fibrillation (AF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation, run by Volta Medical at 4 sites in United States.
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 5 inclusion and 4 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 10 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. 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?
Contact Daniel Guerrero (612-227-1483, daniel.guerrero@volta-medical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Clinical Efficacy Outcome (time frame: 12 and 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Dec 2025.