Re-Ablation Using a Tailored Approach Targeting EGM-Dispersion (RESTART)

December 2, 2025 updated by: Volta Medical
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
96

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Belgium
      • Aalst, Belgium, 9300
        • OLV Aalst
  • France
      • Massy, France, 91300
        • Hôpital Privé Jacques Cartier
      • Toulouse, France, 31076
        • Clinique Pasteur
  • Germany
      • München, Germany, 80636
        • Deutsches Herzzentrum München
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35243
        • Grandview Medical Center
    • Arkansas
      • Jonesboro, Arkansas, United States, 72401
        • Arrhythmia Research Group
    • Florida
      • Jacksonville, Florida, United States, 32204
        • Ascension St. Vincent's Hospital
    • Illinois
      • Evanston, Illinois, United States, 60208
        • Northwestern University
      • Evanston, Illinois, United States, 60201
        • NorthShore University Health System
      • Maywood, Illinois, United States, 60152
        • Loyola University
    • Kansas
      • Overland Park, Kansas, United States, 66211
        • Kansas City Cardiac Arrhythmia Research LLC
    • Massachusetts
      • Boston, Massachusetts, United States, 02241
        • Brigham and Women's Hospital
    • Missouri
      • St Louis, Missouri, United States, 63130
        • Washington University
    • New York
      • New York, New York, United States, 11030
        • Northwell Health System
    • Ohio
      • Columbus, Ohio, United States, 43210
        • The Ohio State University
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Penn Presbyterian Medical Center
      • Pittsburgh, Pennsylvania, United States, 15212
        • Allegheny Health Network
    • Texas
      • Houston, Texas, United States, 77030
        • Houston Methodist Research Institute
    • Virginia
      • Fairfax, Virginia, United States, 22042
        • Inova Fairfax Hospital

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

  1. Previous ablation procedure-related complication (e.g. fistula, perforation, etc.)
  2. First AF ablation procedure indication was persistent AF lasting longer than 24 months
  3. Long-standing persistent AF recurrence prior to study redo procedure
  4. Previous AF ablation using VX1 software
  5. Severe obesity (BMI > 50)
  6. Very dilated Left Atrium (LA) (e.g. LA diameter > 55 mm and/or LA surface > 40 cm2 determined by 2D echocardiography)
  7. Patients with AF secondary to an obvious reversible cause
  8. Inadequate anticoagulation as defined in the inclusion criteria
  9. LA thrombus on Transesophageal Echocardiography (TEE)* or CT Scan prior to procedure
  10. Contraindications to anticoagulation (heparin, warfarin or NOAC)
  11. Patients who are or may potentially be pregnant
  12. Any cardiac surgery except catheter ablation within the past 2 months (60 days) (includes PCI)
  13. Myocardial infarction within the past 2 months (60 days)
  14. Previous AV valve surgery
  15. Patient diagnosed with hypertrophic cardiomyopathy
  16. History of blood clotting or bleeding abnormalities
  17. Documented arterial thromboembolic event (including TIA) within the past 12 months (365 days)
  18. Rheumatic Heart Disease
  19. Cardiac Sarcoidosis
  20. Chronic severe Heart Failure (NYHA functional class IV and/or LVEF < 25%)
  21. Awaiting cardiac transplantation or other cardiac surgery within the next 12 months (365 days)
  22. Unstable angina within the past month
  23. Acute illness or active systemic infection or sepsis
  24. AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause
  25. Diagnosed atrial myxoma
  26. 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)
  27. Significant congenital anomaly or medical problem that in the opinion of the investigator would preclude enrollment
  28. Enrollment in an investigational study evaluating another device, biologic, or drug
  29. Presence of intramural thrombus, tumor or other abnormality or condition that precludes vascular access, or manipulation of the catheter
  30. Life expectancy or other disease processes likely to limit survival to less than 12 months
  31. Acute Covid-19 infection (fever and/or biological inflammatory syndrome, and positive test documented)

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Treatment Group
Patients undergoing catheter ablation that qualify after initial screening.
Device: Catheter Ablation
Cardiac catheter ablation for recurrent AF after previous ablation (catheter or surgical).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Freedom from AF
Time Frame: 1 year
Percent of patient free from recurrent AF episodes of >30 seconds at 1 year after 1 study redo procedure
1 year

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Volta Medical

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 17, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 7, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 30, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 25, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 25, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 28, 2022

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 9, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 2, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CLIPL-01-003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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.

No

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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