Re-Ablation Using a Tailored Approach Targeting EGM-Dispersion
RESTART
1 other identifier
interventional
96
4 countries
19
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable atrial-fibrillation
Started Mar 2023
19 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 25, 2022
CompletedFirst Posted
Study publicly available on registry
July 28, 2022
CompletedStudy Start
First participant enrolled
March 17, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 7, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2025
CompletedDecember 9, 2025
December 1, 2025
2.1 years
July 25, 2022
December 2, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Freedom from AF
Percent of patient free from recurrent AF episodes of \>30 seconds at 1 year after 1 study redo procedure
1 year
Study Arms (1)
Treatment Group
EXPERIMENTALPatients undergoing catheter ablation that qualify after initial screening.
Interventions
Cardiac catheter ablation for recurrent AF after previous ablation (catheter or surgical).
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
- Patients with AF secondary to an obvious reversible cause
- 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
- +15 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Volta Medicallead
Study Sites (19)
Grandview Medical Center
Birmingham, Alabama, 35243, United States
Arrhythmia Research Group
Jonesboro, Arkansas, 72401, United States
Ascension St. Vincent's Hospital
Jacksonville, Florida, 32204, United States
Northshore University Health System
Evanston, Illinois, 60201, United States
Northwestern University
Evanston, Illinois, 60208, United States
Loyola University
Maywood, Illinois, 60152, United States
Kansas City Cardiac Arrhythmia Research LLC
Overland Park, Kansas, 66211, United States
Brigham and Women's Hospital
Boston, Massachusetts, 02241, United States
Washington University
St Louis, Missouri, 63130, United States
Northwell Health System
New York, New York, 11030, United States
The Ohio State University
Columbus, Ohio, 43210, United States
Penn Presbyterian Medical Center
Philadelphia, Pennsylvania, 19104, United States
Allegheny Health Network
Pittsburgh, Pennsylvania, 15212, United States
Houston Methodist Research Institute
Houston, Texas, 77030, United States
Inova Fairfax Hospital
Fairfax, Virginia, 22042, United States
OLV Aalst
Aalst, 9300, Belgium
Hôpital Privé Jacques Cartier
Massy, 91300, France
Clinique Pasteur
Toulouse, 31076, France
Deutsches Herzzentrum München
München, 80636, Germany
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 25, 2022
First Posted
July 28, 2022
Study Start
March 17, 2023
Primary Completion
May 7, 2025
Study Completion
September 30, 2025
Last Updated
December 9, 2025
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will not share