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

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: Completed
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Device: Catheter Ablation

• Study Type: Interventional
• Enrollment (Actual): 96
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Aalst, Belgium, 9300
    • OLV Aalst
• France
  • Massy, France, 91300
    • Hopital Prive 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

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Freedom from AF	Percent of patient free from recurrent AF episodes of >30 seconds at 1 year after 1 study redo procedure	1 year

Collaborators and Investigators

• Sponsor: Volta Medical

Study record dates

Study Major Dates

• Study Start (Actual): March 17, 2023
• Primary Completion (Actual): May 7, 2025
• Study Completion (Actual): September 30, 2025

Study Registration Dates

• First Submitted: July 25, 2022
• First Submitted That Met QC Criteria: July 25, 2022
• First Posted (Actual): July 28, 2022

Study Record Updates

• Last Update Posted (Estimated): December 9, 2025
• Last Update Submitted That Met QC Criteria: December 2, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Catheter Ablation; Atrial fibrillation; Ablation; Artificial intelligence; AF
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Arrhythmias, Cardiac; Pathological Conditions, Signs and Symptoms; Atrial Fibrillation; Therapeutics; Surgical Procedures, Operative; Ablation Techniques; Radiofrequency Ablation; Radiofrequency Therapy; Catheter Ablation
• Other Study ID 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