Ablation Procedures for Atrial Fibrillation

(PVS-PVI Trial)

Overseen By Alejandro V Margenat

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: The University of Texas Health Science Center, Houston

Must be taking: Class I, Class III

Must not be taking: Anticoagulants

Disqualifiers: Persistent AF, Congenital heart disease, others

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

Compensation: Varies

Number of Visits: 4

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new approach to treat atrial fibrillation (AF), a condition where the heart beats irregularly. Researchers aim to determine if a targeted ablation procedure, called PVS-PVI, is more effective and safer than the standard WACA method. The trial seeks individuals who have experienced noticeable AF episodes and have either tried medication without success or prefer not to use medication. Participants will help compare these two procedures to identify the best way to manage AF symptoms. As an unphased trial, this study offers an opportunity to contribute to innovative research that could enhance AF 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 symptomatic paroxysmal AF that is not controlled by at least one Class I or Class III antiarrhythmic medication, or have an intolerance or preference not to use these medications.

What prior data suggests that these ablation procedures are safe for atrial fibrillation?

Research has shown that PVS-PVI targeted ablation is generally safe. Studies involving over 17,000 patients have found this method to have a good safety record. It typically avoids much of the harm associated with traditional heat-based ablation, reducing the likelihood of damage to nearby tissues.

The safety of Wide Area Circumferential Ablation (WACA) has also been studied. Data indicate that serious complications are rare. For instance, some reports show that only a few patients experienced temporary nerve issues. This suggests that while risks exist, they are relatively low.

Both treatments have been tested and are generally well-tolerated by most patients. These findings may help ease safety concerns for those considering joining a trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the PVS-PVI targeted ablation for atrial fibrillation because it offers a more precise approach to tackling this heart rhythm disorder. Unlike traditional ablation techniques that broadly target areas around the pulmonary veins, PVS-PVI focuses specifically on isolating the pulmonary vein sleeves, which are key to triggering atrial fibrillation. This targeted methodology potentially improves outcomes by reducing the likelihood of arrhythmia recurrence and minimizing damage to surrounding heart tissue. This precision could lead to better long-term results with fewer complications compared to existing ablation methods.

What evidence suggests that this trial's ablation procedures could be effective for atrial fibrillation?

This trial will compare two treatments for paroxysmal atrial fibrillation (AF), a condition characterized by irregular heartbeats. Participants in one arm will receive PVS-PVI, which has shown a 63.5% success rate in preventing irregular heartbeats one year after treatment. The other arm will involve WACA, which demonstrated even higher effectiveness, with 81.6% of patients free from irregular heartbeats a year after the procedure. Both treatments isolate the pulmonary veins, often the cause of AF, to help stabilize the heart's rhythm. These methods offer different approaches to managing AF symptoms, each with varying success rates. ^{1 4 6 7 8}

Who Is on the Research Team?

Ramesh Hariharan, D, MRCP,FACC, FHRS

Principal Investigator

The University of Texas Health Science Center, Houston

Are You a Good Fit for This Trial?

This trial is for individuals with symptomatic paroxysmal Atrial Fibrillation (AF), a type of irregular heartbeat. Participants should be suitable candidates for the ablation procedures being tested. Specific inclusion and exclusion criteria details are not provided, but typically these would relate to overall health status and any contraindications for the procedures.

Inclusion Criteria

I have AFib that hasn't improved with at least one medication, or I can't tolerate the medication.

I am capable of understanding and agreeing to the trial's terms.

A minimum of one documented AF episode via 12-lead ECG, Holter monitor, or loop recorder

Exclusion Criteria

I have had a procedure to correct heart rhythm problems.

I have a serious heart valve problem.

Pregnancy

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo pulmonary vein ablation using either PVS-PVI or WACA techniques

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Monthly remote monitoring and in-clinic visits every 3 months

What Are the Treatments Tested in This Trial?

Interventions

• PVS-PVI targeted ablation
• Wide area circumferential ablation (WACA)

Trial Overview The study compares two types of heart ablation techniques: PVS-PVI that targets pulmonary vein myocardial sleeves using Omnipolar Technology, and conventional WACA. It aims to evaluate which method is more effective in terms of procedure time, safety, number of RF applications needed, and other clinical outcomes.

How Is the Trial Designed?

Group I: PVS-PVI Experimental Treatment 1 Intervention

Group II: WACA Active Control 1 Intervention

Who Is Running the Clinical Trial?

The University of Texas Health Science Center, Houston

Lead Sponsor

Trials

974

Recruited

361,000+

Published Research Related to This Trial

In a study of 126 patients with paroxysmal atrial fibrillation, incorporating high dominant frequency (DF) sites during pulmonary vein isolation (PVI) led to a higher success rate in maintaining freedom from atrial arrhythmias, achieving 78.7% efficacy compared to 66.1% with conventional methods.

The modified PVI approach also resulted in fewer repeat procedures (6.6% vs 23%), indicating that targeting high-frequency AF nests may enhance the long-term effectiveness of the treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A prospective, randomized comparison of modified pulmonary vein isolation versus conventional pulmonary vein isolation in patients with paroxysmal atrial fibrillation. Lin, YJ., Chang, SL., Lo, LW., et al.[2012]

A meta-analysis of 8 studies showed that adding complex fractionated atrial electrogram (CFAE) ablation to pulmonary vein isolation (PVI) significantly improves freedom from atrial tachyarrhythmia (AT) in patients with nonparoxysmal atrial fibrillation (AF), with a relative risk of 1.32.

In contrast, for patients with paroxysmal AF, the addition of CFAE ablation did not provide any significant benefit over PVI alone, indicating that this combined approach may be more effective for nonparoxysmal cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pulmonary vein isolation with complex fractionated atrial electrogram ablation for paroxysmal and nonparoxysmal atrial fibrillation: A meta-analysis. Hayward, RM., Upadhyay, GA., Mela, T., et al.[2021]

A meta-analysis of 46 trials involving 8,500 participants found that adding autonomic modulation or hybrid ablation to pulmonary vein isolation (PVI) significantly reduces the recurrence of atrial arrhythmia by 53.1% and 59.1%, respectively, compared to PVI alone.

These findings suggest that adjunctive therapies can enhance the effectiveness of PVI in treating atrial fibrillation, but further large-scale studies are needed to confirm these results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pulmonary vein isolation plus adjunctive therapy for the treatment of atrial fibrillation: a systematic review and meta-analysis. Bussa, R., Nudy, M., Ahmed, M., et al.[2023]

In a study of 486 patients with persistent and long-standing persistent atrial fibrillation (AF) treated with cryoballoon ablation, the procedure demonstrated a high acute success rate of 97.6% for pulmonary vein isolation (PVI).

The procedure was found to be safe, with a low complication rate of 4.3%, and showed reasonable mid-term success rates for freedom from AF, with 63.9% of patients remaining event-free at 12 months.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pulmonary vein isolation cryoablation for patients with persistent and long-standing persistent atrial fibrillation: Clinical outcomes from the real-world multicenter observational project. Tondo, C., Iacopino, S., Pieragnoli, P., et al.[2018]

In a study of 161 patients with atrial fibrillation, pulmonary vein isolation (PVI) using a multi-electrode radiofrequency ablation (PVAC) showed a comparable success rate to conventional point-by-point RF ablation (CPVI) after 3 years, with success rates of 65% and 55% respectively.

Most recurrences of atrial fibrillation occurred within the first year after the procedure for both PVAC and CPVI, indicating that early monitoring is crucial for managing potential relapses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Duty-cycled multi-electrode radiofrequency vs. conventional irrigated point-by-point radiofrequency ablation for recurrent atrial fibrillation: comparative 3-year data. De Greef, Y., Buysschaert, I., Schwagten, B., et al.[2022]

In a study of 390 patients with persistent atrial fibrillation, combining pulmonary vein isolation (PVI) with posterior wall isolation (PWI) using cryoballoon ablation resulted in significantly greater isolation of the posterior wall and total left atrial area compared to PVI alone.

Patients undergoing PVI+PWI experienced higher rates of atrial fibrillation termination and lower recurrence of atrial arrhythmias after 12 months, indicating that this combined approach is both safe and more effective than PVI alone.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Posterior wall isolation using the cryoballoon in conjunction with pulmonary vein ablation is superior to pulmonary vein isolation alone in patients with persistent atrial fibrillation: A multicenter experience. Aryana, A., Baker, JH., Espinosa Ginic, MA., 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 ... Efficacy outcomes were acute PVI and 12-month freedom from atrial arrhythmias (AA), after 90-day blanking. Optional invasive remapping at 75 ...

2. 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 ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5633714/

The Short and Long-Term Efficacy of Pulmonary Vein Isolation ... Outcome data concerning the freedom from AF after PVI for PAF were available in all studies. The pooled 12-month and 62-month success rate for 9 observational ...

4. ahajournals.org ahajournals.org/doi/10.1161/circep.109.923771

Long-Term Outcome After Successful Catheter Ablation of ... AF freedom off AAD was 85% at 3 years and 71% at 5 years, with an approximate 7% per year late recurrence rate after the first year. Patients ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S0828282X25001771

Effectiveness of a Standardized Approach to Repeat ... A comprehensive protocol for repeat PAF ablation resulted in arrhythmia-free survival at 1-year in 53% of patients. Durably isolated PVs were observed in 26.5%.

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

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

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10743921/

Atrial Fibrillation Ablation: Current Practice and Future ... Data on the safety of CB-based AF ablation report an incidence of major complications ranging from 2.0 to 7.5% [69,70]. Of note, the incidence ...

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

Safety and Effectiveness of Pulsed Field Ablation to Treat ... The primary effectiveness outcome was freedom from clinical documented atrial arrhythmia (AF/atrial flutter/atrial tachycardia) of ≥30 seconds on the basis of ...