PVI vs PVI + OPTIMA Ablation for Atrial Fibrillation

(OPTIMA Trial)

Overseen By Hugh Calkins, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Johns Hopkins University

Must be taking: Anticoagulants

Disqualifiers: Pregnancy, Obesity, Low GFR, others

Stay on Your Current Meds You can continue your current medications while participating

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

Compensation: Varies

Number of Visits: 6

200 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method called OPTIMA for treating persistent atrial fibrillation (AF). It aims to better target problem areas in the heart to improve treatment success for patients who haven't responded well to other treatments.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, it mentions that participants should be on systemic anticoagulation (blood thinners) or have no issues starting it.

Is PVI with OPTIMA ablation safe for humans?

Research studies have evaluated the safety of pulmonary vein isolation (PVI) with various techniques, including voltage-guided and ablation index-guided methods, in treating atrial fibrillation. These studies generally suggest that PVI, whether alone or with additional techniques, is considered safe for humans. ^{1 2 3 4 5}

How is the PVI + OPTIMA ablation treatment different from other treatments for atrial fibrillation?

The PVI + OPTIMA ablation treatment is unique because it combines standard pulmonary vein isolation (PVI) with OPTIMA-guided catheter ablation, which may target specific areas in the heart more precisely. This approach aims to improve the effectiveness of the treatment by addressing additional sources of atrial fibrillation beyond the pulmonary veins. ^{6 7 8 9 10}

What data supports the effectiveness of the treatment OPTIMA-guided catheter ablation for atrial fibrillation?

Research shows that pulmonary vein isolation (PVI) is a standard and effective treatment for atrial fibrillation, and improvements in PVI techniques, such as using advanced catheters, have been shown to enhance outcomes. Studies comparing different PVI methods suggest that incorporating additional techniques, like voltage-guided ablation, may improve the effectiveness of the treatment. ^{2 7 10 11 12}

Who Is on the Research Team?

David Spragg, MD

Principal Investigator

Johns Hopkins University

Are You a Good Fit for This Trial?

This trial is for adults over 18 with persistent atrial fibrillation who are referred for catheter ablation, can undergo MRI scans, and are on or can start anticoagulation therapy. It's not suitable for pregnant women, those over 300 lbs, with severe kidney issues (GFR <30), no evidence of left atrial fibrosis on MRI, or have had AF for more than 3 years.

Inclusion Criteria

I understand and can agree to the study's procedures and risks.

The MRI scan should show signs of scarring in the left atrium.

I was referred to Johns Hopkins for a special heart rhythm correction procedure.

Exclusion Criteria

I am not pregnant, as the study requires an MRI with a contrast agent not safe during pregnancy.

You weigh more than 300 pounds and cannot have an MRI scan.

I cannot have an MRI due to my irregular heartbeat.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-procedure Assessment

Patients undergo pre-procedure imaging and rhythm assessment, including LGE-MRI and Ziopatch

1 week

1 visit (in-person)

Ablation Procedure

Patients undergo either standard PVI or PVI+OPTIMA ablation for atrial fibrillation

1 day

1 visit (in-person, hospital stay)

Post-procedure Monitoring

Overnight monitoring in the hospital following ablation

1 day

1 visit (in-person, hospital stay)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including rhythm assessment with Ziopatch at 3, 6, and 12 months

12 months

3 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• OPTIMA-guided catheter ablation
• Standard PVI

Trial Overview The study compares two procedures in treating persistent atrial fibrillation: the standard Pulmonary Vein Isolation (PVI) and PVI combined with OPTIMA-guided catheter ablation. Patients will be randomly assigned to one of these treatments and followed up at intervals to assess effectiveness and any complications.

How Is the Trial Designed?

Group I: OPTIMA Ablation Experimental Treatment 1 Intervention

Patients in this arm will receive standard PVI ablation and supplemental ablation of reentrant driver sites identified by OPTIMA analysis as sites likely supportive of persistent atrial fibrillation.

Group II: Standard Ablation (PVI) Active Control 1 Intervention

Patients in this arm will receive standard ablation for atrial fibrillation (wide-area circumferential ablation to achieve pulmonary vein isolation \[PVI\]).

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials

2,366

Recruited

15,160,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Published Research Related to This Trial

In a study of 124 patients with atrial fibrillation, those who underwent pulmonary vein isolation (PVI) plus ablation of low-voltage areas (LVAs) had a significantly higher rate of being free from atrial arrhythmia recurrence after one procedure compared to those receiving conventional PVI with or without linear ablation (68% vs. 42%).

The LVA ablation group also showed a higher percentage of patients free from arrhythmia recurrence during a 7-day Holter monitoring period at 12 months (90% vs. 72%), indicating that this tailored approach may enhance long-term outcomes without increasing procedure duration or complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Individually tailored vs. standardized substrate modification during radiofrequency catheter ablation for atrial fibrillation: a randomized study. Kircher, S., Arya, A., Altmann, D., et al.[2019]

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 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]

Both the Smart Touch and nMARQ catheters were effective in achieving pulmonary vein isolation (PVI) in patients with atrial fibrillation, with similar long-term success rates observed in both groups over follow-up periods of around 18-19 months.

The nMARQ catheter had a shorter procedural time for paroxysmal atrial fibrillation, although there was a 2.7% need to switch to the Smart Touch catheter to complete PVI in some cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Radiofrequency Ablation of Atrial Fibrillation: Nonrandomized Comparison of Circular versus Point-by-Point "Smart" Ablation for Achieving Circumferential Pulmonary Vein Isolation and Curing Arrhythmic Symptoms. Rosso, R., Chorin, E., Levi, Y., et al.[2022]

In a study of 384 patients with atrial fibrillation, the second-generation pulmonary vein ablation catheter (PVAC Gold) achieved a 70.7% success rate in maintaining freedom from AF in patients with paroxysmal AF and 61.9% in those with persistent AF after one year.

The procedure had a low complication rate, with only four early complications reported, including one case of posterior cerebral infarction, but no instances of phrenic nerve palsy or esophageal injury, indicating a favorable safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Circumferential pulmonary vein isolation with second-generation multipolar catheter in patients with paroxysmal or persistent atrial fibrillation: Procedural and one-year follow-up results. Spitzer, SG., Leitz, P., Langbein, A., et al.[2018]

In a study of 201 atrial fibrillation patients (121 paroxysmal and 80 persistent), those who received extra extended antrum ablation (EAA) in addition to cryoballoon ablation showed significantly higher rates of being free from atrial fibrillation compared to those who only had pulmonary vein isolation (PVI), with rates of 90.1% vs. 80.2% for paroxysmal AF and 90.0% vs. 75.0% for persistent AF.

The EAA procedure, based on electrophysiological substrate mapping, was found to be effective in improving outcomes without increasing complication rates compared to the PVI-only group, indicating its safety and efficacy in enhancing AF treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of extended antrum ablation based on substrate mapping plus pulmonary vein isolation in the treatment of atrial fibrillation. Chen, L., Chen, JQ., Zou, T., et al.[2022]

Pulmonary vein isolation (PVI) significantly increases the chances of remaining free from atrial fibrillation (AF) at 12 months, with 77% of patients achieving this compared to only 29% in those receiving medical therapy, based on a meta-analysis of 6 trials involving 693 patients.

While PVI does carry a risk of major complications (2.6%), this risk is comparable to other interventional procedures, and PVI also leads to fewer hospitalizations for cardiovascular issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pulmonary vein isolation for the maintenance of sinus rhythm in patients with atrial fibrillation: a meta-analysis of randomized, controlled trials. Piccini, JP., Lopes, RD., Kong, MH., et al.[2022]

In patients with paroxysmal or persistent atrial fibrillation, combining pulmonary vein isolation (PVI) with posterior wall isolation (PWI) using cryoballoon ablation significantly improved long-term freedom from recurrent atrial fibrillation (74.3% vs. 46.0%) and all atrial tachyarrhythmias (71.4% vs. 38.1%) compared to PVI alone.

Despite longer procedure times and the need for adjunct radiofrequency in some cases, the safety profile was similar between PVI alone and PVI+PWI, indicating that the enhanced efficacy of PVI+PWI does not come at the cost of increased adverse events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcomes of adjunct posterior wall isolation in atrial fibrillation patients with cardiac implantable electronic devices. Aryana, A., Thiemann, AM., Pujara, DK., et al.[2023]

Lower ablation index (AI) targets for pulmonary vein isolation (PVI) in patients with paroxysmal atrial fibrillation (AF) were found to be as effective as higher targets, with no significant differences in first-pass PVI rates or recurrence of atrial tachyarrhythmia after one year.

Using a lower AI target significantly reduced the ablation time compared to higher targets, suggesting a more efficient procedure without compromising safety or efficacy in treating paroxysmal AF.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tailored Target Ablation Index Guided Pulmonary Vein Isolation in Treating Paroxysmal Atrial Fibrillation: A Single Center Randomized Study in Asian Population (AI-Asian-I). Xiong, Q., Liao, J., Chen, W., et al.[2022]

Recent innovations in catheter-based ablation for atrial fibrillation, such as advanced radiofrequency catheters and single-shot balloon catheters, have improved the efficiency and effectiveness of pulmonary vein isolation procedures.

New technologies like pulsed field ablation (PFA) and esophageal protection devices are being developed to enhance safety by minimizing collateral damage and reducing complications, indicating a promising future for atrial fibrillation treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Innovations in atrial fibrillation ablation. Kim, JA., Khan, K., Kherallah, R., et al.[2023]

The novel irrigated multielectrode ablation catheter successfully isolated 100% of targeted pulmonary veins in 25 patients with paroxysmal atrial fibrillation, demonstrating high acute efficacy with a mean procedure time of 110 minutes and no complications.

The procedure was safe, with no cases of acute pulmonary vein stenosis detected, and showed improved efficiency over time, with reduced procedure and fluoroscopy times after a short learning curve.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Initial results of using a novel irrigated multielectrode mapping and ablation catheter for pulmonary vein isolation. Shin, DI., Kirmanoglou, K., Eickholt, C., et al.[2016]

In a multicenter trial involving 51 patients with paroxysmal atrial fibrillation, FIRM-guided ablation without pulmonary vein isolation (PVI) showed significantly lower long-term success rates (31.3%) compared to PVI (80%) after 12 months.

The study highlighted that while FIRM-guided ablation successfully eliminated AF rotors, it was not as effective as PVI, reinforcing the importance of PVI as the standard treatment for paroxysmal AF.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Focal Impulse and Rotor Modulation Ablation vs. Pulmonary Vein isolation for the treatment of paroxysmal Atrial Fibrillation: results from the FIRMAP AF study. Tilz, RR., Lenz, C., Sommer, P., et al.[2022]

Citations

1. England pubmed.ncbi.nlm.nih.gov

Individually tailored vs. standardized substrate modification during radiofrequency catheter ablation for atrial fibrillation: a randomized study. [2019]

2. 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]

3. 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]

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

Radiofrequency Ablation of Atrial Fibrillation: Nonrandomized Comparison of Circular versus Point-by-Point "Smart" Ablation for Achieving Circumferential Pulmonary Vein Isolation and Curing Arrhythmic Symptoms. [2022]

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

Circumferential pulmonary vein isolation with second-generation multipolar catheter in patients with paroxysmal or persistent atrial fibrillation: Procedural and one-year follow-up results. [2018]

6. Portugal pubmed.ncbi.nlm.nih.gov

Efficacy of extended antrum ablation based on substrate mapping plus pulmonary vein isolation in the treatment of atrial fibrillation. [2022]

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

Pulmonary vein isolation for the maintenance of sinus rhythm in patients with atrial fibrillation: a meta-analysis of randomized, controlled trials. [2022]

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

Outcomes of adjunct posterior wall isolation in atrial fibrillation patients with cardiac implantable electronic devices. [2023]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Tailored Target Ablation Index Guided Pulmonary Vein Isolation in Treating Paroxysmal Atrial Fibrillation: A Single Center Randomized Study in Asian Population (AI-Asian-I). [2022]

10. Netherlands pubmed.ncbi.nlm.nih.gov

Innovations in atrial fibrillation ablation. [2023]

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

Initial results of using a novel irrigated multielectrode mapping and ablation catheter for pulmonary vein isolation. [2016]

12. England pubmed.ncbi.nlm.nih.gov

Focal Impulse and Rotor Modulation Ablation vs. Pulmonary Vein isolation for the treatment of paroxysmal Atrial Fibrillation: results from the FIRMAP AF study. [2022]