Catheter Ablation for Atrial Fibrillation

(PulseSmart Trial)

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

135 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment Pulsed Field (PF) /Radiofrequency (RF) Catheter ablation for atrial fibrillation?

Research shows that pulsed field ablation (PFA) is a promising alternative to traditional thermal methods for treating atrial fibrillation, with studies indicating it may offer safety advantages and potentially reduce complications while maintaining effectiveness. ^{1 2 3 4 5}

Is catheter ablation for atrial fibrillation safe?

Pulsed field ablation (PFA) for atrial fibrillation is generally considered safe, with fewer adverse events compared to traditional thermal methods like radiofrequency ablation (RFA). PFA avoids some common complications such as esophageal injury and pulmonary vein stenosis, though there is a risk of coronary artery spasms. ^{1 6 7 8 9}

How is pulsed field ablation treatment for atrial fibrillation different from other treatments?

Pulsed field ablation (PFA) is unique because it uses high-frequency electrical pulses to target and ablate heart tissue, which can selectively affect the heart muscle while sparing nearby tissues. This method is different from traditional thermal ablation techniques and may offer improved safety and effectiveness for treating atrial fibrillation. ^{1 2 5 10 11}

What is the purpose of this trial?

The purpose of this study is to demonstrate safety and effectiveness of the Biosense Webster (BWI) ablation system (THERMOCOOL SMARTTOUCH surround flow \[STSF\] catheter and TRUPULSE generator) when used for isolation of the atrial pulmonary veins (PVs) in treatment of participants with paroxysmal atrial fibrillation (PAF), an irregular heart rate that causing abnormal blood flow.

Research Team

Biosense Webster, Inc. Clinical Trial

Principal Investigator

Biosense Webster, Inc.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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

Findings from Research

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 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) 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) 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]

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]

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]

References

1. England 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. [2023]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Initial experience with pulsed field ablation for atrial fibrillation. [2022]

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

Perspectives on pulsed field ablation: how to judge endpoints. [2023]

4. Australia pubmed.ncbi.nlm.nih.gov

Pulsed Field Ablation of Atrial Fibrillation: An Initial Australian Single-Centre Experience. [2023]

5. United States 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. [2022]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of Pulsed Field Ablation in Atrial Fibrillation: A Systematic Review. [2023]

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

Coronary Artery Spasm During Pulsed Field vs Radiofrequency Catheter Ablation of the Mitral Isthmus. [2023]

8. Netherlands 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. [2023]

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

Early complications of pulmonary vein catheter ablation for atrial fibrillation: a multicenter prospective registry on procedural safety. [2016]

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

Pulsed Field Ablation: a Novel Therapeutic Tool for Catheter-Based Treatment of Atrial Fibrillation. [2022]

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

Early recurrences predict late therapy failure after pulsed field ablation of atrial fibrillation. [2023]