Catheter Ablation for Atrial Fibrillation

(PulseSmart Trial)

Not currently recruiting at 6 trial locations

Overseen By Study Contact

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Biosense Webster, Inc.

Must not be taking: Anticoagulants

Disqualifiers: Thyroid disease, Heart failure, Pregnancy, others

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

Compensation: Varies

Number of Visits: 1

Duration: 1 week

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method for treating paroxysmal atrial fibrillation (PAF), a condition where the heart beats irregularly and affects blood flow. The study tests the safety and effectiveness of a special catheter system that uses energy to isolate certain veins in the heart. Known as Pulsed Field (PF) / Radiofrequency (RF) Catheter ablation, this method targets the heart tissue causing the irregular heartbeat. People diagnosed with symptomatic PAF who have struggled with standard medications might be suitable candidates. The goal is to determine if this treatment can reduce symptoms and improve heart function. As an unphased trial, this study offers patients the chance to contribute to groundbreaking research that could lead to new treatment options.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, it mentions that participants should have failed at least one Class I or Class III antiarrhythmic drug, which suggests that some medication changes might be necessary. Please consult with the trial coordinators for specific guidance.

What prior data suggests that this ablation system is safe for treating paroxysmal atrial fibrillation?

Research has shown that pulsed field ablation (PFA) and radiofrequency (RF) catheter ablation are generally safe for treating atrial fibrillation. Studies have found that PFA is well-tolerated and causes less unintended harm to surrounding tissues compared to other methods. Over 17,000 patients have undergone PFA, and it maintains a good safety record with no major concerns.

Early studies in humans report positive safety results with PFA. Specifically, one study found PFA to be both effective and safe in a group of Japanese patients, suggesting it could be a reliable option for different populations.

Overall, both PFA and RF ablation are effective and safe for treating atrial fibrillation, with PFA being a promising alternative due to its lower risk of harming nearby tissues. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about pulsed field (PF) and radiofrequency (RF) catheter ablation for atrial fibrillation because they offer a unique approach compared to traditional methods like antiarrhythmic drugs or standard RF ablation alone. Unlike standard treatments that either use medication or heat to modify heart tissue, this combination uses both electrical pulses and heat to create precise lesions within the heart, targeting the problematic areas causing irregular heartbeats. This dual-energy approach is believed to enhance precision and potentially reduce the risk of damage to surrounding tissues, making it a promising option for patients with drug-resistant atrial fibrillation.

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

This trial will evaluate the effectiveness of a combined Pulsed Field (PF) and Radiofrequency (RF) Ablation System for treating paroxysmal atrial fibrillation (PAF). Research has shown that pulsed field ablation (PFA) and radiofrequency ablation (RFA) effectively treat PAF, a type of irregular heartbeat. Studies have found PFA to be 63.5% effective after one year. Another study found that both PFA and RFA had similar success rates after 12 months. Many patients reported a better quality of life after PFA treatment. While some studies showed PFA to be more effective, it also carried a higher risk of certain complications compared to other methods. Overall, both treatments have shown promising results in managing PAF symptoms. ^{6 7 8 9 10}

Who Is on the Research Team?

Biosense Webster, Inc. Clinical Trial

Principal Investigator

Biosense Webster, Inc.

Are You a Good Fit for This Trial?

This trial is for individuals with paroxysmal atrial fibrillation (PAF), which is an irregular heartbeat that disrupts normal blood flow. Participants must have symptoms that haven't improved with medication. Specific eligibility details are not provided, but typically participants should be adults in stable health condition.

Inclusion Criteria

Able and willing to comply with all pre-procedure, post-procedure, and follow-up testing and visit requirements

I have been diagnosed with PAF and had at least one AF episode in the last year.

I've had a bad reaction or no improvement from a specific heart rhythm medication.

Exclusion Criteria

I have had previous ablation or surgery for atrial fibrillation.

Current enrollment in an investigational study evaluating another device or drug

I had a minor stroke within the last year.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo ablation using the THERMOCOOL SMARTTOUCH SF Catheter and TRUPULSE Generator for isolation of atrial pulmonary veins

1 week

1 visit (in-person)

Effectiveness Evaluation

Participants are monitored for freedom from atrial arrhythmia based on electrocardiographic data

9 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Pulsed Field (PF) /Radiofrequency (RF) Catheter ablation

Trial Overview The study tests the safety and effectiveness of a new ablation system called THERMOCOOL SMARTTOUCH SF catheter paired with the TRUPULSE generator. This system aims to isolate atrial pulmonary veins to help control irregular heartbeats in PAF patients.

How Is the Trial Designed?

Group I: Pulsed Field (PF)/Radiofrequency (RF) Ablation System Experimental Treatment 1 Intervention

Participants with drug refractory symptomatic PAF who are candidates for atrial fibrillation ablation uses PF and RF energy to produce targeted intracardiac lesions for the treatment of atrial fibrillation.

Who Is Running the Clinical Trial?

Biosense Webster, Inc.

Lead Sponsor

Trials

128

Recruited

37,100+

Dr. Nick West

Biosense Webster, Inc.

Chief Medical Officer

MD from Harvard Medical School

Jasmina Brooks

Biosense Webster, Inc.

Chief Executive Officer since 2023

Bachelor of Science in Biomedical Engineering from Louisiana Tech University

Published Research Related to This Trial

Pulsed-field ablation (PFA) effectively achieved pulmonary vein isolation (PVI) in all 80 pulmonary veins of 20 patients, demonstrating its efficacy in treating atrial fibrillation.

UHDx mapping revealed that PFA creates wide and durable lesions with significant voltage reduction, although early reconnection of pulmonary veins can occur in a small percentage of cases (6.25%).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pulsed-field ablation combined with ultrahigh-density mapping in patients undergoing catheter ablation for atrial fibrillation: Practical and electrophysiological considerations. Gunawardene, MA., Schaeffer, BN., Jularic, M., et al.[2022]

In a study of 100 patients with symptomatic atrial fibrillation, the pulsed field ablation (PFA) catheter demonstrated effective pulmonary vein isolation (PVI) in all cases, confirming its efficacy in treating AF.

The procedure was found to be safe, with only two cases of bleeding at the access site reported, and it was quick to learn, showing no significant difference in procedure times between senior and junior operators.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Initial experience with pulsed field ablation for atrial fibrillation. Magni, FT., Mulder, BA., Groenveld, HF., et al.[2022]

Pulsed field ablation (PFA) using the CENTAURI System achieved 100% pulmonary vein isolation in 82 patients with atrial fibrillation, demonstrating high efficacy with a first-pass isolation rate of 92.2%.

The study reported a favorable safety profile, with only four serious adverse events, indicating that optimized PFA is a viable and safe treatment option for atrial fibrillation when integrated with existing ablation techniques.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pulsed field ablation using focal contact force-sensing catheters for treatment of atrial fibrillation: acute and 90-day invasive remapping results. Anić, A., Phlips, T., Brešković, T., et al.[2023]

In a study of 231 patients undergoing pulsed field ablation for atrial fibrillation, 21% experienced early recurrences of atrial tachyarrhythmia, which were found to be an independent predictor of late recurrence of atrial fibrillation or atrial tachycardia.

The study showed a 1-year freedom from atrial fibrillation or atrial tachycardia rate of 74.2%, with significant differences based on the type of atrial fibrillation, indicating that patients with paroxysmal atrial fibrillation had better outcomes than those with persistent atrial fibrillation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early recurrences predict late therapy failure after pulsed field ablation of atrial fibrillation. Plank, K., Bordignon, S., Urbanek, L., et al.[2023]

Pulsed field ablation (PFA) for atrial fibrillation (AF) was performed safely in 97 patients, with a high success rate of 100% in isolating pulmonary veins and an 87% freedom from atrial arrhythmias at 180 days follow-up.

The procedure had a median time of 74 minutes and low complication rates, with only 2% experiencing pseudoaneurysm complications, and no serious adverse events like stroke or pulmonary vein stenosis, indicating PFA's potential as an effective alternative to traditional ablation methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pulsed Field Ablation of Atrial Fibrillation: An Initial Australian Single-Centre Experience. Lee, XW., Freeman, BM., Gunthorpe, NG., et al.[2023]

Pulsed field ablation (PFA) demonstrated a 100% success rate in isolating pulmonary veins in 23 patients, with significantly larger acute antral lesions compared to cryoballoon (CB) ablation, indicating its potential efficacy in treating atrial fibrillation.

While PFA showed no major complications like phrenic nerve injury or bleeding, one patient experienced a stroke, highlighting the need for further studies to assess long-term safety and effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pulsed field ablation for pulmonary vein isolation: real-world experience and characterization of the antral lesion size compared with cryoballoon ablation. Blockhaus, C., Guelker, JE., Feyen, L., et al.[2023]

In a study of 1,011 patients undergoing pulmonary vein radiofrequency catheter ablation for atrial fibrillation, the overall complication rate was 3.9%, indicating a relatively low incidence of early complications associated with this procedure.

No procedure-related deaths occurred, and while some complications like peripheral vascular issues and cardiac tamponade were noted, they were generally manageable, suggesting that the procedure is safe, especially compared to earlier years of AF ablation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early complications of pulmonary vein catheter ablation for atrial fibrillation: a multicenter prospective registry on procedural safety. Bertaglia, E., Zoppo, F., Tondo, C., et al.[2016]

Citations

1. 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 ...

2. ahajournals.org ahajournals.org/doi/10.1161/CIRCEP.124.013465

Long-Term Clinical Benefits of Pulsed Field Ablation in ... The minimal clinically important difference in QoL (≥5-point improvement in AFEQT) was achieved in 85.2% of patients. Patients who were free ...

3. escardio.org escardio.org/The-ESC/Press-Office/Press-releases/Pulsed-field-ablation-was-not-superior-to-radiofrequency-ablation-in-paroxysmal-atrial-fibrillation

Pulsed field ablation was not superior to radiofrequency ... The BEAT-PAROX-AF trial compared PFA with RFA for single-procedure success rates after 12 months and found that PFA was not superior; both ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40257634/

a systematic review and network meta-analysis Conclusion: PFA demonstrated higher efficacy but also a higher risk of complications compared to HPSD and CBA. HPSD showed greater efficacy with ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S2772374724003612

Effectiveness and Safety of Pulsed Field Ablation in ... PFA was associated with a lower incidence of atrial arrhythmia recurrence after 3 months and phrenic nerve paralysis or injury, but a higher risk of cardiac ...

6. nature.com nature.com/articles/s41591-024-03114-3

Safety of pulsed field ablation in more than 17000 patients ... Taken together, these data indicate that PFA demonstrates a favorable safety profile by avoiding much of the collateral damage seen with ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S2666501824002617

Considerations regarding safety with pulsed field ablation ... PFA represents a promising ablation modality for the treatment of atrial fibrillation, with overall favorable safety outcomes observed in initial human studies.

8. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39243306/

Safety, efficacy, and quality of life outcomes of pulsed field ... Conclusions: Similar to outcomes in the global cohort, ablation with the PulseSelect™ PFA catheter was efficient, effective, and safe in a Japanese population, ...

9. 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 ...

10. heartrhythmjournal.com heartrhythmjournal.com/article/S1547-5271(24)02372-5/fulltext

Pulsed-field vs cryoballoon vs radiofrequency ablation The purpose of this study was to compare the procedural and long-term outcomes in patients with persistent AF undergoing PVI using PFA, CBA, or RFA.