Farapulse Catheter System for Atrial Fibrillation

(PROSPECT Trial)

Recruiting at 4 trial locations

Overseen By Joshua Wiener, BA

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Vivek Reddy

Disqualifiers: Active infection, Pregnancy, Severe cardiomyopathy, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: 1 day

275 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial evaluates the safety and effectiveness of the Farapulse Catheter System for individuals with atrial fibrillation, a common heart rhythm issue. Participants will undergo a procedure using this system to manage their irregular heartbeat. The trial seeks individuals with atrial fibrillation who plan to have a procedure to control it, particularly if other treatments have been ineffective. As a Phase 4 trial, this research aims to understand how the already FDA-approved and effective treatment benefits a broader range of patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you are on antiarrhythmic drugs that have been ineffective or not preferred, the trial involves catheter ablation as an alternative treatment.

What is the safety track record for the Farapulse Catheter System?

Research has shown that the Farapulse Catheter System is generally safe for treating atrial fibrillation. Studies in Europe have found it effective and safe for most patients. In one study, only 2.3% of patients experienced safety issues, including a few cases of heart inflammation (pericarditis), a heart attack, and some minor problems. Another study reported a 2.4% rate of safety events, with no serious issues like vein narrowing or nerve damage.

These results suggest that the Farapulse Catheter System is well-tolerated, with only a small number of patients experiencing significant problems. However, discussing potential risks with a healthcare provider before joining a clinical trial is always important. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

The Farapulse Catheter System is unique because it employs a novel mechanism called pulsed-field ablation to treat atrial fibrillation. Unlike traditional treatments that use thermal energy, such as radiofrequency or cryoablation, the Farapulse system uses electrical pulses to selectively target and ablate heart tissue. This method potentially reduces damage to surrounding tissues and decreases the risk of complications. Researchers are excited about this treatment because it could offer a safer and more precise alternative for patients with atrial fibrillation.

What evidence suggests that the Farapulse Catheter System is effective for atrial fibrillation?

Research has shown that the Farapulse Catheter System effectively treats atrial fibrillation (AF), a condition where the heart beats irregularly. One study reported that about 80.8% of patients with paroxysmal AF (a type of irregular heartbeat that starts and stops suddenly) were successfully treated after one year. For those with non-paroxysmal AF (a more continuous form), the success rate was 67.7%. Another study found a success rate of 63.5% for persistent AF, indicating promising results for this treatment. Overall, the Farapulse Catheter System has proven safe and effective in managing AF symptoms. Participants in this trial will receive treatment using the Farapulse Catheter System. ^{2 3 6 7 8}

Who Is on the Research Team?

Vivek Reddy, MD

Principal Investigator

The Mount Sinai Hospital, Icahn School of Medicine

Are You a Good Fit for This Trial?

Adults diagnosed with atrial fibrillation, who've had an ECG or symptoms in the past year, can join this trial. They must be planning a catheter ablation procedure and have or will get a device to record heart rhythm. People with life-limiting conditions, active infections, recent heart procedures, pregnancy, or those in other trials can't participate.

Inclusion Criteria

Able and willing to provide written consent and comply with all testing and follow-up requirements

I have been diagnosed with atrial fibrillation in the past.

I've had a catheter ablation for a heart rhythm problem that wasn't AF.

Exclusion Criteria

Significant congenital anomaly or medical problem that in the opinion of the investigator would preclude an ablation procedure

I have a current blood clot in my heart's left atrium.

Life expectancy or other disease processes likely to limit survival to less than 12 months

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo the FARAPULSE catheter ablation procedure for atrial fibrillation

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the ablation procedure

12 months

Regular follow-up visits

Optional Sub-study

Participants may opt into a sub-study evaluating the effects of low-dose colchicine on pericardial inflammation

3 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Farapulse Catheter System

Trial Overview The trial is testing the FARAPULSE catheter system for treating atrial fibrillation during standard ablation procedures. It involves using the FARAWAVE catheter with the FARASTAR generator to see if it's safe and effective.

How Is the Trial Designed?

Group I: Patients with Atrial Fibrillation Experimental Treatment 2 Interventions

All patients will receive treatment using the Farapulse catheter system (Farawave catheter used in combination with the Farastar generator).

Who Is Running the Clinical Trial?

Vivek Reddy

Lead Sponsor

Trials

23

Recruited

5,700+

Boston Scientific Corporation

Industry Sponsor

Trials

758

Recruited

867,000+

Michael F. Mahoney

Boston Scientific Corporation

Chief Executive Officer since 2016

MBA from Wake Forest University, BBA in Finance from the University of Iowa

Kenneth Stein

Boston Scientific Corporation

Chief Medical Officer since 2020

MD from Harvard Medical School, MMSc in Clinical Investigation from Harvard-MIT Division of Health Sciences and Technology

Published Research Related to This Trial

Catheter ablation is a standard and effective treatment for rhythm control in patients with atrial fibrillation (AF), helping to restore normal heart rhythm.

The review covers the latest techniques and technologies used in AF catheter ablation, including different energy forms and procedural methods, ensuring comprehensive understanding for optimal patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Catheter ablation of atrial fibrillation : Status quo]. Jilek, C., Lewalter, T.[2020]

In a study of 25,439 patients who underwent their first direct current cardioversion for atrial fibrillation, catheter ablation (CAF) was linked to a significant reduction in all-cause death and cardiovascular death, with hazard ratios of 0.69 and 0.68, respectively.

CAF was also associated with a lower risk of developing heart failure (HR 0.76), but it did not reduce the risk of stroke or thromboembolism, suggesting that while CAF improves survival outcomes, it may not affect all complications of atrial fibrillation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Catheter ablation for atrial fibrillation is associated with lower incidence of heart failure and death. Modin, D., Claggett, B., Gislason, G., et al.[2021]

In a study of 174 atrial fibrillation patients, those who underwent catheter ablation had significantly lower rates of total mortality (0.74% vs. 2.95% per year) and cardiovascular death (0% vs. 1.77% per year) compared to those who received only medication.

Catheter ablation not only reduced mortality but also the risk of ischemic stroke/transient ischemic attack, highlighting its efficacy in improving long-term cardiovascular outcomes for high-risk patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Successful catheter ablation reduces the risk of cardiovascular events in atrial fibrillation patients with CHA2DS2-VASc risk score of 1 and higher. Lin, YJ., Chao, TF., Tsao, HM., et al.[2013]

In a review of six randomized controlled trials involving 1212 patients, catheter ablation as a first-line treatment for atrial fibrillation significantly reduced the recurrence of atrial tachyarrhythmias compared to antiarrhythmic drugs, with a risk ratio of 0.63.

Patients undergoing catheter ablation also experienced fewer symptomatic atrial tachyarrhythmias, while the safety profile showed no significant difference in overall or cardiovascular adverse events between the two treatment options.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of Catheter Ablation vs Antiarrhythmic Drugs as Initial Therapy for Management of Symptomatic Paroxysmal Atrial Fibrillation: A Meta-Analysis. Razzack, AA., Lak, HM., Pothuru, S., et al.[2022]

In a study of 3318 patients with early-stage atrial fibrillation, those who underwent catheter ablation had a significantly lower risk of adverse clinical outcomes, including death, stroke, and heart failure hospitalization, compared to those receiving only medical therapy.

Catheter ablation also led to improved quality of life scores after one year, indicating that it not only reduces serious health risks but also enhances patients' overall well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Catheter ablation improves outcomes and quality of life in Japanese patients with early-stage atrial fibrillation: A retrospective cohort study. Seki, Y., Fujisawa, T., Ikemura, N., et al.[2022]

Citations

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

One-year outcomes of a conformable single-shot pulsed ... The large lattice PFA catheter was efficient, safe, and effective in treating PAF. The observed high PVI durability translated to clinical ...

2. academic.oup.com academic.oup.com/europace/article/27/9/euaf182/8244658

one-year outcomes of the FARADISE registry | EP Europace At 1-year, clinical effectiveness was 80.8% for paroxysmal AF and 67.7% for non-paroxysmal AF, with no difference within indication by lesion ...

3. jacc.org jacc.org/doi/10.1016/j.jacc.2025.03.515

Pulsed Field Ablation for Persistent Atrial Fibrillation Primary effectiveness was 63.5% (57.3% lower confidence limit) at 1 year, with 8.5% patients having a single, isolated atrial fibrillation ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S0735109725059911

Pulsed Field Ablation for Persistent Atrial Fibrillation Primary effectiveness was 63.5% (57.3% lower confidence limit) at 1 year, with 8.5% patients having a single, isolated atrial fibrillation ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT06765356

Study Details | NCT06765356 | Pragmatic Evaluation of a ... In observational European studies of the FARAPULSE catheter system, the technology has proved quite safe and effective in treating most patients with AF. It is ...

6. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf23/P230030B.pdf

Pulsed Field Ablation System Device - accessdata.fda.gov The applicant performed the ADVENT IDE Trial to establish a reasonable assurance of safety and effectiveness of catheter ablation with the FARAPULSE PFA System ...

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

Safety and Effectiveness of Pulsed Field Ablation to Treat ... But most importantly, the primary effectiveness outcome of freedom from AF/AFL/AT recurrence >30 seconds postblanking was 78.1% after a single ablation ...

8. news.bostonscientific.com news.bostonscientific.com/2025-04-24-Second-phase-of-ADVANTAGE-AF-study-of-FARAPULSE-TM-Pulsed-Field-Ablation-System-meets-primary-safety-and-efficacy-endpoints

Second phase of ADVANTAGE AF study of FARAPULSE ... A safety event rate of 2.4% and no reports of pulmonary vein stenosis, atrio-esophageal fistula or phrenic nerve palsy which met the performance ...