Tailored Catheter Ablation for Atrial Fibrillation
(RESTART Trial)
Trial Summary
What is the purpose of this trial?
This trial is testing a computer program combined with a medical procedure to help patients whose irregular heartbeat has returned. The program helps doctors find and fix the problem areas in the heart more effectively.
Do I need to stop my current medications for the trial?
The trial protocol does not specify if you need to stop taking your current medications, but you must continue taking anticoagulation medication like warfarin or NOAC for more than 4 weeks before the procedure.
What data supports the effectiveness of the treatment Catheter Ablation, Pulmonary Vein Isolation (PVI), Catheter Ablation for Atrial Fibrillation?
Research shows that Pulmonary Vein Isolation (PVI) is a key part of catheter ablation, which is effective in controlling atrial fibrillation (a heart rhythm disorder). Studies indicate that PVI is a standard and effective treatment for atrial fibrillation, although it can be complex and time-consuming.12345
Is catheter ablation for atrial fibrillation generally safe for humans?
How is catheter ablation for atrial fibrillation different from other treatments?
Catheter ablation for atrial fibrillation, specifically through pulmonary vein isolation (PVI), is unique because it targets the pulmonary veins to stop irregular heartbeats by isolating the areas that trigger them. This approach is different from medications, as it physically alters the heart tissue to prevent abnormal rhythms, offering a more direct and potentially long-lasting solution for patients whose symptoms do not improve with drugs.123410
Eligibility Criteria
This trial is for adults over 21 with recurrent Atrial Fibrillation (AF) after previous catheter or surgical ablation. Participants must have had symptomatic AF in the last year and been on anticoagulants like warfarin or NOACs for at least 4 weeks. Exclusions include severe heart failure, recent clots, major lung disease, very dilated Left Atrium, pregnancy, and certain other health conditions.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo catheter ablation using Volta's VX1 algorithm after AF recurrence
Follow-up
Participants are monitored for freedom from AF episodes for 1 year after the procedure
Treatment Details
Interventions
- Catheter Ablation
Catheter Ablation is already approved in European Union, United States, Canada for the following indications:
- Symptomatic paroxysmal or persistent atrial fibrillation
- Heart failure with reduced left ventricular fraction
- Symptomatic paroxysmal or persistent atrial fibrillation
- Heart failure with reduced left ventricular fraction
- Symptomatic paroxysmal or persistent atrial fibrillation
- Heart failure with reduced left ventricular fraction
Find a Clinic Near You
Who Is Running the Clinical Trial?
Volta Medical
Lead Sponsor