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

20 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 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 data supports the effectiveness of the treatment PVS-PVI targeted ablation and Wide area circumferential ablation (WACA) for atrial fibrillation?

Research shows that pulmonary vein isolation (PVI), a key part of the treatment, is effective in relieving symptoms of atrial fibrillation. Additionally, combining PVI with other techniques, like posterior wall isolation, can improve outcomes for patients with persistent atrial fibrillation. ^{1 2 3 4 5}

How is PVS-PVI targeted ablation different from other treatments for atrial fibrillation?

PVS-PVI targeted ablation is unique because it focuses on isolating the pulmonary veins (PVI) to prevent erratic electrical signals that cause atrial fibrillation, and it may include additional targeted therapy to improve outcomes. This approach is different from standard PVI alone, which may not address all sources of atrial fibrillation. ^{2 5 6 7 8}

What is the purpose of this trial?

The purpose of this study is to compare procedural times and Radiofrequency (RF)applications required for Pulmonary vein myocardial sleeves targeted pulmonary vein ablation (PVS-PVI) , to compare the efficacy of PVS-PVI , to compare the safety of PVS-PVI and to assess other clinical outcomes of PVS-PVI in individuals with symptomatic paroxysmal Atrial fibrillation (AF) using Omnipolar Technology with conventional Wide area circumferential ablation (WACA).

Research Team

Ramesh Hariharan, D, MRCP,FACC, FHRS

Principal Investigator

The University of Texas Health Science Center, Houston

Eligibility Criteria

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.

My atrial fibrillation can be treated or reversed.

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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 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]

References

1. England 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. [2022]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Pulmonary vein isolation plus adjunctive therapy for the treatment of atrial fibrillation: a systematic review and meta-analysis. [2023]

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

Pulmonary vein isolation with complex fractionated atrial electrogram ablation for paroxysmal and nonparoxysmal atrial fibrillation: A meta-analysis. [2021]

4. United States 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. [2022]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Computerized three-dimensional potential mapping with a multielectrode basket catheter can be useful for pulmonary vein electrical disconnection. [2018]

6. United States 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. [2018]

7. England pubmed.ncbi.nlm.nih.gov

Circumferential pulmonary vein isolation: wait or stop early after initial successful pulmonary vein isolation? [2022]

8. United States 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. [2012]