Farapulse Catheter System for Atrial Fibrillation

(PROSPECT Trial)

Recruiting at 1 trial location

Overseen By Jerome A Tonog, MD

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

Trial Summary

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 data supports the effectiveness of the Farapulse Catheter System treatment for atrial fibrillation?

Research shows that catheter ablation, a similar treatment to the Farapulse Catheter System, can improve symptoms and reduce the risk of heart failure and death in atrial fibrillation patients. It is also associated with better long-term outcomes and quality of life, especially in patients with heart failure. ^{1 2 3 4 5}

How is the Farapulse Catheter System treatment for atrial fibrillation different from other treatments?

The Farapulse Catheter System is unique because it uses a non-thermal method to treat atrial fibrillation, unlike traditional treatments that often rely on heat (radiofrequency) or cold (cryoballoon) to create lesions in the heart tissue. This novel approach may reduce the risk of damage to surrounding tissues. ^{6 7 8 9 10}

What is the purpose of this trial?

The purpose of this pragmatic study is to evaluate the safety, performance and effectiveness of the FARAPULSE catheter system (FARAWAVE catheter used in combination with the FARASTAR generator), to treat patients with atrial fibrillation during clinically-indicated ablation procedures

Research Team

Vivek Reddy, MD

Principal Investigator

The Mount Sinai Hospital, Icahn School of Medicine

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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

Findings from Research

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Catheter ablation for atrial fibrillation is associated with lower incidence of heart failure and death. [2021]

2. England 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. [2013]

3. Singapore 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. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Catheter Ablation of Atrial Fibrillation in Heart Failure: from Evidences to Guidelines. [2021]

5. United States 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. [2022]

6. Germany pubmed.ncbi.nlm.nih.gov

[Catheter ablation of atrial fibrillation : Status quo]. [2020]

7. Czech Republic pubmed.ncbi.nlm.nih.gov

[Catheter ablation of chronic atrial fibrillation using circumferential and complex linear lesions in the left atrium: modes of arrhythmia termination and long-term clinical outcome]. [2007]

8. United States pubmed.ncbi.nlm.nih.gov

Real-world outcomes, complications, and cost of catheter-based ablation for atrial fibrillation: an update. [2018]

9. China pubmed.ncbi.nlm.nih.gov

A randomized prospective comparison of CartoMerge and CartoXP to guide circumferential pulmonary vein isolation for the treatment of paroxysmal atrial fibrillation. [2008]

10. Germany pubmed.ncbi.nlm.nih.gov

Newer generation cryoballoon vs. contact force-sensing radiofrequency ablation catheter in the ablation of paroxysmal atrial fibrillation. [2022]