92 Participants Needed

Tailored Catheter Ablation for Atrial Fibrillation

(RESTART Trial)

Recruiting at 18 trial locations
DG
Overseen ByDan Guerrero
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Volta Medical
Must be taking: Anticoagulants
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 3 JurisdictionsThis treatment is already approved in other countries

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?

Catheter ablation, including pulmonary vein isolation (PVI), is a common treatment for atrial fibrillation, but complication rates can vary. A study of 641 procedures found that while it is generally safe, there are risks of complications, and these can depend on various factors.16789

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

I have been on blood thinners like warfarin or NOAC for more than 4 weeks.
I have had symptoms of AF that lasted even 3 months after my last AF treatment.
Patients must be able and willing to provide written informed consent to participate in the clinical trial
See 2 more

Exclusion Criteria

I have a history of abnormal blood clotting or bleeding.
I currently have an acute Covid-19 infection with fever or inflammation.
I have severe lung disease or chronic respiratory symptoms.
See 28 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo catheter ablation using Volta's VX1 algorithm after AF recurrence

1-2 weeks

Follow-up

Participants are monitored for freedom from AF episodes for 1 year after the procedure

1 year

Treatment Details

Interventions

  • Catheter Ablation
Trial OverviewThe study tests a tailored repeat catheter ablation approach using Volta's VX1 algorithm in patients whose AF returned after initial treatment. It's an international multi-center trial that isn't randomized; all participants receive the intervention to see how well it works.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Treatment GroupExperimental Treatment1 Intervention
Patients undergoing catheter ablation that qualify after initial screening.

Catheter Ablation is already approved in European Union, United States, Canada for the following indications:

🇪🇺
Approved in European Union as Pulmonary Vein Isolation (PVI) for:
  • Symptomatic paroxysmal or persistent atrial fibrillation
  • Heart failure with reduced left ventricular fraction
🇺🇸
Approved in United States as Pulmonary Vein Isolation (PVI) for:
  • Symptomatic paroxysmal or persistent atrial fibrillation
  • Heart failure with reduced left ventricular fraction
🇨🇦
Approved in Canada as Pulmonary Vein Isolation (PVI) for:
  • 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

Trials
6
Recruited
1,300+

Findings from Research

The STOP Persistent AF trial showed that cryoballoon ablation is a safe and effective treatment for patients with drug-refractory persistent atrial fibrillation, achieving a 54.8% success rate in maintaining freedom from AF, AFL, or AT at 12 months.
With only one primary safety event reported (0.6% rate), the procedure demonstrated a favorable safety profile, alongside significant improvements in quality of life as measured by the AFEQT and SF-12 questionnaires.
Cryoballoon ablation of pulmonary veins for persistent atrial fibrillation: Results from the multicenter STOP Persistent AF trial.Su, WW., Reddy, VY., Bhasin, K., et al.[2021]
Recent innovations in catheter-based ablation for atrial fibrillation, such as advanced radiofrequency catheters and single-shot balloon catheters, have improved the efficiency and effectiveness of pulmonary vein isolation procedures.
New technologies like pulsed field ablation (PFA) and esophageal protection devices are being developed to enhance safety by minimizing collateral damage and reducing complications, indicating a promising future for atrial fibrillation treatment.
Innovations in atrial fibrillation ablation.Kim, JA., Khan, K., Kherallah, R., et al.[2023]
The novel irrigated multielectrode ablation catheter successfully isolated 100% of targeted pulmonary veins in 25 patients with paroxysmal atrial fibrillation, demonstrating high acute efficacy with a mean procedure time of 110 minutes and no complications.
The procedure was safe, with no cases of acute pulmonary vein stenosis detected, and showed improved efficiency over time, with reduced procedure and fluoroscopy times after a short learning curve.
Initial results of using a novel irrigated multielectrode mapping and ablation catheter for pulmonary vein isolation.Shin, DI., Kirmanoglou, K., Eickholt, C., et al.[2016]

References

Cryoballoon ablation of pulmonary veins for persistent atrial fibrillation: Results from the multicenter STOP Persistent AF trial. [2021]
Innovations in atrial fibrillation ablation. [2023]
Initial results of using a novel irrigated multielectrode mapping and ablation catheter for pulmonary vein isolation. [2016]
Comparative effectiveness of catheter ablation strategies for rhythm control in patients with atrial fibrillation: a meta-analysis. [2021]
First data on cardiac mapping and outcome of pulmonary vein isolation using a novel ablation catheter with tip mini electrodes. [2019]
Complications of catheter ablation for atrial fibrillation: incidence and predictors. [2022]
Pulmonary vein isolation cryoablation for patients with persistent and long-standing persistent atrial fibrillation: Clinical outcomes from the real-world multicenter observational project. [2018]
Pulmonary vein isolation for the maintenance of sinus rhythm in patients with atrial fibrillation: a meta-analysis of randomized, controlled trials. [2022]
Acute results of pulmonary vein isolation in patients with paroxysmal atrial fibrillation using a single mesh catheter. [2009]
Burden-based classification of atrial fibrillation predicts multiple-procedure success of pulmonary vein isolation. [2020]