Tailored Catheter Ablation for Atrial Fibrillation

(RESTART Trial)

Not currently recruiting at 20 trial locations

Overseen By Dan Guerrero

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Volta Medical

Must be taking: Anticoagulants

Disqualifiers: Obesity, Heart failure, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 1-2 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to assist individuals with atrial fibrillation (AF) using a technique called catheter ablation. It tests a specific algorithm combined with repeat catheter ablation for those whose AF returned after a previous ablation. The researchers aim to determine if this approach can better manage AF symptoms. Individuals who underwent a previous ablation for AF but still experience symptoms may be suitable for this trial, particularly if their AF recurred within the last year despite treatment. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could enhance AF management.

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 prior data suggests that this catheter ablation technique is safe for atrial fibrillation?

Research shows that catheter ablation is generally safe for treating atrial fibrillation (AF). Studies have found that this procedure, when performed at experienced centers, is both safe and effective, even for individuals with complex heart issues. Data indicates that the chances of complications or death from the procedure are low and have decreased over the past ten years.

One study found that about 52% of patients were free from AF without needing extra medication a year after the procedure. Another study reported that after 12 months, 76% to 79% of patients remained free from AF. These findings suggest that many people do well after the treatment.

Evidence suggests that most patients handle catheter ablation well, with a good chance of reducing or stopping AF. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about tailored catheter ablation for atrial fibrillation because it offers a more personalized approach to treatment. Unlike standard treatments that use medication or generic ablation procedures, this method customizes the ablation process to each patient’s unique heart anatomy and electrical activity. This tailored approach aims to improve efficacy and reduce recurrence rates, potentially leading to better long-term outcomes for patients with atrial fibrillation. By focusing on individual variations, it could offer more precise and effective management of the condition.

What evidence suggests that this catheter ablation technique is effective for atrial fibrillation?

Research has shown that catheter ablation, the treatment under study in this trial, effectively treats atrial fibrillation (AF). One study found that 52.4% of patients who underwent the procedure did not experience an irregular heartbeat after 12 months. Another study showed that catheter ablation reduced the recurrence of AF by 48% over four years. For patients requiring multiple procedures, the success rate reached 67% after up to four attempts. These findings suggest that catheter ablation can significantly lower the chances of AF returning. ^{3 6 7 8 9}

Are You a Good Fit for This Trial?

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

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Catheter Ablation

Trial Overview The 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.

How Is the Trial Designed?

Group I: Treatment Group Experimental Treatment 1 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

Who Is Running the Clinical Trial?

Volta Medical

Lead Sponsor

Trials

6

Recruited

1,300+

Published Research Related to This Trial

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

Pulmonary vein isolation (PVI) significantly increases the chances of remaining free from atrial fibrillation (AF) at 12 months, with 77% of patients achieving this compared to only 29% in those receiving medical therapy, based on a meta-analysis of 6 trials involving 693 patients.

While PVI does carry a risk of major complications (2.6%), this risk is comparable to other interventional procedures, and PVI also leads to fewer hospitalizations for cardiovascular issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pulmonary vein isolation for the maintenance of sinus rhythm in patients with atrial fibrillation: a meta-analysis of randomized, controlled trials. Piccini, JP., Lopes, RD., Kong, MH., et al.[2022]

Patients with atrial fibrillation (AF) who underwent pulmonary vein isolation plus additional atrial ablations (PVI+) had a significantly higher rate of maintaining normal sinus rhythm in the first year compared to those who only had PVI, with a relative risk of 1.10 based on 21 randomized controlled trials and 3 non-randomized trials.

The most notable improvement was seen with PVI+ left atrial linear ablations, which showed a relative risk of 1.16, indicating that this specific approach may enhance the effectiveness of AF treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative effectiveness of catheter ablation strategies for rhythm control in patients with atrial fibrillation: a meta-analysis. Assasi, N., Xie, F., Blackhouse, G., 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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Innovations in atrial fibrillation ablation. Kim, JA., Khan, K., Kherallah, R., et al.[2023]

In a study of 486 patients with persistent and long-standing persistent atrial fibrillation (AF) treated with cryoballoon ablation, the procedure demonstrated a high acute success rate of 97.6% for pulmonary vein isolation (PVI).

The procedure was found to be safe, with a low complication rate of 4.3%, and showed reasonable mid-term success rates for freedom from AF, with 63.9% of patients remaining event-free at 12 months.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pulmonary vein isolation cryoablation for patients with persistent and long-standing persistent atrial fibrillation: Clinical outcomes from the real-world multicenter observational project. Tondo, C., Iacopino, S., Pieragnoli, P., et al.[2018]

Citations

1. jamanetwork.com jamanetwork.com/journals/jama/fullarticle/2800186

Effect of Catheter Ablation Using Pulmonary Vein Isolation ... After 12 months, 89 patients (52.4%) assigned to PVI with PWI were free from recurrent atrial arrhythmia without antiarrhythmic medication after ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10460603/

The Effectiveness of Ablation Therapy for Atrial Fibrillation The initial results of the CABANA study revealed a noteworthy reduction of 48% in AF recurrence during a 48-month observation period [7,12].

3. jacc.org jacc.org/doi/10.1016/j.jacadv.2024.101200

Incremental Efficacy for Repeat Ablation Procedures ... After 1 to 4 ablations, the success rate of the cohort was also 67%. Figure 4 shows the arrhythmia-free survival after 1, 2, 3, and 4 ablation ...

4. heartrhythmjournal.com heartrhythmjournal.com/article/S1547-5271(25)02379-3/fulltext

One-year outcomes of a conformable single-shot pulsed ... To determine 1-year outcomes of a single-shot, all-in-one mapping and ablation PFA catheter for treating paroxysmal atrial fibrillation (PAF).

5. ahajournals.org ahajournals.org/doi/10.1161/circep.114.001672

Five-Year Follow-Up After Catheter Ablation of Persistent ... Based on Holter ECG results, 171 of 493 patients (34.6%) showed recurrent arrhythmia in long-term outcome, which was classified as PAF in 48 patients (28.1%) ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/30593868/

Safety and outcomes of catheter ablation for atrial ... When performed at experienced centers, AF ablation is safe and effective even among patients with the most complex forms of CHD.

7. heartrhythmjournal.com heartrhythmjournal.com/article/S1547-5271(25)00125-0/fulltext

Safety and efficacy of catheter ablation for atrial fibrillation ... This study aimed to assess the safety and feasibility of catheter ablation for AF in an ADSC in a non-hospital setting.

8. ahajournals.org ahajournals.org/doi/10.1161/CIRCULATIONAHA.123.064959

Safety and Effectiveness of Pulsed Field Ablation to Treat ... As shown in Figure S5, there was no significant center variation in outcomes; the 12-month freedom from atrial arrhythmia ranged between 76% and 79% across the ...

9. jacc.org jacc.org/doi/10.1016/j.jacc.2023.03.418

Procedure-Related Complications of Catheter Ablation for ... Procedure-related complications and mortality rates associated with catheter ablation of AF are low and have declined in the past decade.