Pulse Field Ablation for Atrial Fibrillation

(AdmIRE Trial)

Recruiting at 33 trial locations

Overseen By Reecha Sharma

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Biosense Webster, Inc.

Must be taking: Antiarrhythmics

Disqualifiers: Persistent AF, Heart failure, Thromboembolic event, others

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

Compensation: Varies

Number of Visits: 2

Duration: 1 week

362 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests a new method to treat patients with irregular heartbeats who haven't improved with drugs. The treatment works by stopping abnormal signals in the heart.

Do I need to stop my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. However, since participants must have failed at least one Class I or Class III antiarrhythmic drug, it might be necessary to discuss your current medications with the trial team.

What data supports the effectiveness of the VARIPULSE™ Catheter treatment for atrial fibrillation?

Pulsed field ablation, which is used in the VARIPULSE™ Catheter, is a promising new method for treating atrial fibrillation. It uses high-frequency electrical pulses to target heart tissue and may improve safety by limiting damage to surrounding tissues. This technique is part of ongoing research to enhance the effectiveness and safety of catheter-based treatments for atrial fibrillation. ^{1 2 3 4 5}

Is Pulse Field Ablation generally safe for humans?

The safety of pulsed field ablation, which uses high-voltage electrical fields, is still being studied, and its safety compared to traditional methods is not yet known. ^{1 6 7 8 9}

How is the VARIPULSE™ Catheter treatment for atrial fibrillation different from other treatments?

The VARIPULSE™ Catheter uses pulsed field ablation, which delivers high-frequency electrical pulses to target and ablate cardiac tissue, potentially reducing damage to surrounding tissues compared to conventional thermal ablation methods. ^{1 3 4 10 11}

Research Team

Biosense Webster Inc. Clinical Trial

Principal Investigator

Biosense Webster, Inc.

Eligibility Criteria

This trial is for individuals who have symptomatic paroxysmal atrial fibrillation, have had at least one documented AF episode in the past year, and failed at least one antiarrhythmic drug. It's not for those with persistent AF, previous ablations for AF, severe heart conditions like unstable angina or severe mitral regurgitation, or women who are pregnant.

Inclusion Criteria

You have had at least one documented episode of atrial fibrillation within the past year.

You have tried at least one specific type of medication for heart rhythm problems and it didn't work.

You have experienced at least two episodes of symptomatic AF in the last six months before joining the study.

Exclusion Criteria

Anticipated cardiac transplantation, cardiac surgery, or other major surgery within the next 12 months

You have been diagnosed with atrial fibrillation that has lasted for more than 7 days.

You have atrial fibrillation caused by problems with your body's electrolytes, thyroid, or other non-heart-related issues.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo PFA ablation using a circular multi-electrode pulsed electrical field catheter and multichannel generator

1 week

1 visit (in-person)

Initial Follow-up

Participants are monitored for primary adverse events post catheter insertion

1 week

1 visit (in-person)

Long-term Follow-up

Participants are monitored for freedom from atrial tachyarrhythmia and quality of life improvements

12 months

Periodic visits (in-person and virtual)

Treatment Details

Interventions

• VARIPULSE™ Catheter

Trial Overview The trial tests the VARIPULSE™ Catheter with TRUPULSE™ Generator system's safety and effectiveness in isolating pulmonary veins to treat atrial fibrillation over a period of 12 months.

Participant Groups

Group I: Treatment Group Experimental Treatment 1 Intervention

PFA ablation using a circular multi-electrode pulsed electrical field catheter and multichannel generator

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

Ablation of paroxysmal atrial fibrillation (PAF) using a contact force (CF)-assisted catheter and a 3D mapping system without x-ray exposure was found to be safe and effective in a study involving 342 patients, with no significant differences in success rates compared to traditional x-ray methods.

The study demonstrated that while using the CF-assisted technique, the average fluoroscopy time during ablation was significantly lower (0 minutes) compared to the x-ray group (7.6 minutes), indicating a substantial reduction in radiation exposure without compromising the effectiveness of the procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reconstruction left atrium and isolation pulmonary veins of paroxysmal atrial fibrillation using single contact force catheter with zero x-ray exposure: A CONSORT Study. Zhang, JQ., Yu, RH., Liang, JB., et al.[2022]

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]

Pulsed field ablation achieved a 100% pulmonary vein isolation rate in 191 atrial fibrillation patients, demonstrating its efficacy as a safe and effective treatment option.

The procedure was streamlined to reduce average procedure times significantly, from 46 minutes to 38 minutes, while maintaining safety with no further strokes and a low incidence of silent cerebral injury.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

5S Study: Safe and Simple Single Shot Pulmonary Vein Isolation With Pulsed Field Ablation Using Sedation. Schmidt, B., Bordignon, S., Tohoku, S., et al.[2022]

References

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

Pulsed Field or Conventional Thermal Ablation for Paroxysmal Atrial Fibrillation. [2023]

2. Germany pubmed.ncbi.nlm.nih.gov

[Catheter ablation for atrial fibrillation - standard of care and future perspectives]. [2022]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Right atrial mapping and linear ablation for paroxysmal atrial fibrillation. [2019]

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

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

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

Catheter ablation of atrial fibrillation: for whom and how? [2008]

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

Safety of Catheter Ablation for Atrial Fibrillation in Patients With Prior Cerebrovascular Events. [2021]

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

Reconstruction left atrium and isolation pulmonary veins of paroxysmal atrial fibrillation using single contact force catheter with zero x-ray exposure: A CONSORT Study. [2022]

8. 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]

9. England pubmed.ncbi.nlm.nih.gov

Cryoballoon ablation beyond pulmonary vein isolation in the setting of persistent atrial fibrillation. [2022]

10. Portugal pubmed.ncbi.nlm.nih.gov

Atrial fibrillation ablation using simultaneous multielectrode application of radiofrequeney energy. [2010]

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

5S Study: Safe and Simple Single Shot Pulmonary Vein Isolation With Pulsed Field Ablation Using Sedation. [2022]