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Atrial FibrillationRESTARTNCT05477147

Re-Ablation Using a Tailored Approach Targeting EGM-Dispersion

A study testing Catheter Ablation in people with Atrial Fibrillation, run by Volta Medical at 19 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Multi-center, international, non-randomized clinical trial evaluating the use of Volta's VX1 algorithm as used in combination with repeat catheter ablation after AF recurrence after previous catheter ablation. 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?
Catheter Ablation
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
96 participants
Where
19 sitesin 4 countries
Study dates
17 Mar 2023to 30 Sep 2025
Phase
Interventional
Are there results?
None posted in the registry

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

Who may be able to join

  • Patients 21 years of age or older indicated for redo AF ablation
  • Previous catheter or surgical ablation for paroxysmal AF, persistent AF, or long-standing persistent AF
  • Documented symptomatic AF recurrences that occurred within the last 12 months and persisted beyond 3 months after the last AF ablation procedure
  • Continuous anticoagulation with warfarin (INR 2-3) or NOAC for > 4 weeks prior to ablation
  • Patients must be able and willing to provide written informed consent to participate in the clinical trial

Who cannot join

  • Previous ablation procedure-related complication (e.g. fistula, perforation, etc.)
  • First AF ablation procedure indication was persistent AF lasting longer than 24 months
  • Long-standing persistent AF recurrence prior to study redo procedure
  • Previous AF ablation using VX1 software
  • Severe obesity (BMI > 50)
  • Very dilated Left Atrium (LA) (e.g. LA diameter > 55 mm and/or LA surface > 40 cm2 determined by 2D echocardiography)
Show all 31Show fewer
  • Patients with AF secondary to an obvious reversible cause
  • Inadequate anticoagulation as defined in the inclusion criteria
  • LA thrombus on Transesophageal Echocardiography (TEE)* or CT Scan prior to procedure
  • Contraindications to anticoagulation (heparin, warfarin or NOAC)
  • Patients who are or may potentially be pregnant
  • Any cardiac surgery except catheter ablation within the past 2 months (60 days) (includes PCI)
  • Myocardial infarction within the past 2 months (60 days)
  • Previous AV valve surgery
  • Patient diagnosed with hypertrophic cardiomyopathy
  • History of blood clotting or bleeding abnormalities
  • Documented arterial thromboembolic event (including TIA) within the past 12 months (365 days)
  • Rheumatic Heart Disease
  • Cardiac Sarcoidosis
  • Chronic severe Heart Failure (NYHA functional class IV and/or LVEF < 25%)
  • Awaiting cardiac transplantation or other cardiac surgery within the next 12 months (365 days)
  • Unstable angina within the past month
  • Acute illness or active systemic infection or sepsis
  • AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause
  • Diagnosed atrial myxoma
  • Significant severe pulmonary disease (e.g. patients with restrictive pulmonary disease, constrictive or chronic obstructive pulmonary disease in GOLD stage IV) or any other disease or malfunction of the lungs or respiratory system that produces chronic symptoms (e.g. unstable or untreated sleep apnea)
  • Significant congenital anomaly or medical problem that in the opinion of the investigator would preclude enrollment
  • Enrollment in an investigational study evaluating another device, biologic, or drug
  • Presence of intramural thrombus, tumor or other abnormality or condition that precludes vascular access, or manipulation of the catheter
  • Life expectancy or other disease processes likely to limit survival to less than 12 months
  • Acute Covid-19 infection (fever and/or biological inflammatory syndrome, and positive test documented)

Trial locations and contacts

19 sites in 4 countries.

19 sites in 4 countries

United States15 sites

  • Grandview Medical Center

    Birmingham, Alabama, 35243

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02241

  • The Ohio State University

    Columbus, Ohio, 43210

  • Northshore University Health System

    Evanston, Illinois, 60201

  • Northwestern University

    Evanston, Illinois, 60208

  • Inova Fairfax Hospital

    Fairfax, Virginia, 22042

  • Houston Methodist Research Institute

    Houston, Texas, 77030

  • Ascension St. Vincent's Hospital

    Jacksonville, Florida, 32204

  • Arrhythmia Research Group

    Jonesboro, Arkansas, 72401

  • Loyola University

    Maywood, Illinois, 60152

  • Northwell Health System

    New York, New York, 11030

  • Kansas City Cardiac Arrhythmia Research LLC

    Overland Park, Kansas, 66211

  • Penn Presbyterian Medical Center

    Philadelphia, Pennsylvania, 19104

  • Allegheny Health Network

    Pittsburgh, Pennsylvania, 15212

  • Washington University

    St Louis, Missouri, 63130

Other trials in United States

France2 sites

  • Hôpital Privé Jacques Cartier

    Massy, 91300

  • Clinique Pasteur

    Toulouse, 31076

Other trials in France

Belgium1 site

  • OLV Aalst

    Aalst, 9300

Other trials in Belgium

Germany1 site

  • Deutsches Herzzentrum München

    München, 80636

Other trials in Germany

About this study

Multi-center, international, non-randomized clinical trial evaluating the use of Volta's VX1 algorithm as used in combination with repeat catheter ablation after AF recurrence after previous catheter ablation.

Being tested
Catheter Ablation
Keywords
Atrial fibrillation, AF, Artificial intelligence, Catheter Ablation, 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.

  • Catheter AblationDevice

    Cardiac catheter ablation for recurrent AF after previous ablation (catheter or surgical).

Study groups in NCT05477147
Study groupRoleWhat they receive
Treatment GroupExperimentalPatients undergoing catheter ablation that qualify after initial screening.
Receives: Device: Catheter Ablation

What is being measured

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

  1. Freedom from AF

    Percent of patient free from recurrent AF episodes of >30 seconds at 1 year after 1 study redo procedure

    Measured: 1 year

Timeline

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

  1. First posted28 Jul 2022
  2. Study start17 Mar 2023
  3. Primary completion7 May 2025
  4. Study completion30 Sep 2025

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
96 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05477147
Sponsor's protocol ID
CLIPL-01-003
Acronym
RESTART
Status last verified
Dec 2025
First submitted
25 Jul 2022
Last updated
9 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • Hummel JD, Zei PC, Metzl M, Deisenhofer I, Rashid H, Morales G, Horvilleur J, Mountantonakis S, Albenque JP, Vasaiwala S, De Potter T, Lador A, Magnano A, Chicos AB, Silverstein J, Guerrero D, Beguin S, El-Benna A, Nguyen-Tu MS, Lotteau S, Milpied P, Durdez TM, Kalifa J, Bars C, Seitz J, D'Souza B, Cooper DH, Nair D, Lakkireddy D. Reablation of atrial fibrillation targeting electrogram dispersion in patients with isolated veins: The RESTART trial. Heart Rhythm. 2026 May;23(5):1083-1090. doi: 10.1016/j.hrthm.2026.01.042. Epub 2026 Feb 2.

    PubMed 41638617

Questions about this trial

What is this clinical trial studying?

A study testing Catheter Ablation in people with Atrial Fibrillation, run by Volta Medical at 19 sites in 4 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 5 inclusion and 31 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: finished, as of the sponsor's last update on 9 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 19 sites in United States, France, Belgium, 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Freedom from AF (time frame: 1 year). 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 NCT05477147, which also lists 1 linked publication.

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 9 Dec 2025.

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