Cryoballoon Ablation for Persistent Atrial Fibrillation

(PIVoTAL-IDE Trial)

Not currently recruiting at 17 trial locations

Overseen By Arash Aryana, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Dignity Health Medical Foundation

Must be taking: Antiarrhythmics

Disqualifiers: Long-standing AF, Stroke, Heart failure, 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 whether combining two procedures—pulmonary vein isolation (PVI) and posterior wall isolation (PWI)—can better prevent the return of atrial fibrillation (AF), an irregular heartbeat, compared to PVI alone. The researchers aim to determine if performing both procedures together will prevent AF recurrence for at least a year after treatment. Individuals with persistent AF for more than 7 days who have not responded to medication might be suitable candidates for this study. As an unphased trial, it offers patients the chance to contribute to innovative research that could enhance treatment options for AF.

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

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this cryoballoon ablation technique is safe for atrial fibrillation patients?

Research has shown that treating both the pulmonary veins and the back wall of the heart with cryoballoon ablation can reduce the recurrence of atrial fibrillation (AF). This treatment does not significantly increase the risk of other heart rhythm issues, such as atrial flutter. Studies indicate that this combined approach lowers AF recurrence, with safety comparable to treating only the pulmonary veins. Patients generally tolerate both procedures well, with no major safety differences between them. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the potential of cryoballoon ablation for persistent atrial fibrillation because it offers a more targeted approach compared to traditional treatments like medication or radiofrequency ablation. The Cryoballoon PVI + Posterior Wall Isolation technique is unique because it combines pulmonary vein isolation with posterior wall isolation, which may enhance the effectiveness of the procedure. This approach uses the Arctic Front Advance Cryoablation System, which freezes cardiac tissue to disrupt erratic electrical signals more precisely. By potentially improving the efficiency and success rates of atrial fibrillation ablation, this technique might offer a more effective option for patients with persistent atrial fibrillation.

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

This trial will compare two treatment approaches for persistent atrial fibrillation: Cryoballoon PVI + Posterior Wall Isolation and Standard Cryoballoon Pulmonary Vein Isolation (PVI). Research has shown that combining cryoballoon pulmonary vein isolation (PVI) with posterior wall isolation (PWI) can be more effective than using PVI alone in reducing the recurrence of atrial fibrillation (AF), a type of irregular heartbeat. Some studies found that adding PWI to PVI significantly lowers the chances of AF returning. One study, in particular, noted a clear reduction in AF recurrence with this combination compared to PVI alone. However, not all studies agree, as some found no improvement in preventing irregular heartbeats. Overall, evidence suggests that adding PWI might enhance the effectiveness of cryoballoon PVI in managing persistent AF. ^{3 4 6 7 8}

Who Is on the Research Team?

Arash Aryana, MD

Principal Investigator

Mercy General Hospital and Dignity Health Medical Foundation

Are You a Good Fit for This Trial?

This trial is for adults over 18 with persistent atrial fibrillation (AF) that lasts more than 7 days and hasn't improved with certain medications. Candidates should be undergoing their first catheter ablation, but prior treatment for a different heart rhythm issue is okay. People can't join if they have long-standing AF, reversible causes of AF, recent serious cardiovascular events, specific heart diseases or conditions, severe heart failure, a very large left atrium, blood clots in the heart, pregnancy or life expectancy less than one year.

Inclusion Criteria

I have had a continuous episode of AFib lasting more than 7 days.

All patients must understand the requirements of the study and be willing to comply with the post-study follow-up requirements

I have AFib symptoms that didn't improve with at least one heart rhythm medication.

Exclusion Criteria

I have a history of thickened heart muscles.

I have not had a stroke, heart attack, or severe chest pain in the last 2 months.

I have severe heart failure.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo catheter ablation for pulmonary vein isolation (PVI) and may receive additional posterior wall isolation (PWI) based on randomization

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with clinic visits and heart event monitoring

12 months

3 visits (in-person) at 3, 6, and 12 months; heart event monitor for 7-14 days before each visit

Long-term monitoring

Participants' atrial fibrillation recurrence and other health metrics are tracked to assess long-term outcomes

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Cryoballoon PVI + Posterior Wall Isolation
• Standard Cryoballoon Pulmonary Vein Isolation (PVI)

Trial Overview The study tests if doing two procedures together—freezing to isolate pulmonary veins (PVI) and the back wall of the left upper chamber of the heart (PWI)—is better at preventing AF from coming back after one year compared to just PVI alone.

How Is the Trial Designed?

Group I: Cryoballoon PVI + Posterior Wall Isolation Experimental Treatment 1 Intervention

Cryoballoon pulmonary vein isolation in conjunction with posterior wall isolation using the Arctic Front Advance Cryoablation System family of cardiac ablation catheters

Group II: Standard Cryoballoon Pulmonary Vein Isolation (PVI) Active Control 1 Intervention

Standard cryoballoon pulmonary vein isolation alone using the Arctic Front Advance Cryoablation System family of cardiac ablation catheters

Who Is Running the Clinical Trial?

Dignity Health Medical Foundation

Lead Sponsor

Trials

3

Recruited

230+

Sarasota Memorial Health Care System

Collaborator

Trials

5

Recruited

770+

Nebraska Methodist Hospital-Methodist Physicians Clinic

Collaborator

Trials

1

Recruited

150+

Mercy General Hospital and Dignity Health Medical Foundation

Collaborator

Trials

1

Recruited

150+

Beth Israel Deaconess Medical Center

Collaborator

Trials

872

Recruited

12,930,000+

UC Health Medical Center

Collaborator

Trials

1

Recruited

150+

MedStar Georgetown University Hospital and Medical Center

Collaborator

Trials

1

Recruited

150+

Tampa Cardiac Specialists

Collaborator

Trials

1

Recruited

150+

Bethesda North Hospital

Collaborator

Trials

1

Recruited

150+

Brigham and Women's Hospital

Collaborator

Trials

1,694

Recruited

14,790,000+

Citations

1. heartrhythmopen.com heartrhythmopen.com/article/S2666-5018(24)00445-8/fulltext

Adjunctive posterior wall isolation for patients with ... Our findings support that adjunctive PWI to PVI is an effective strategy compared with PVI alone for reducing ATA recurrence in patients with PeAF without ...

2. heartrhythmjournal.com heartrhythmjournal.com/article/S1547-5271(25)02760-2/abstract

Concomitant Cryoballoon Pulmonary Vein and Posterior ... This study investigated the outcomes of cryoballoon PVI with concomitant 'direct' posterior wall isolation (PWI) versus PVI alone in patients ...

3. jamanetwork.com jamanetwork.com/journals/jama/fullarticle/2800186

Effect of Catheter Ablation Using Pulmonary Vein Isolation ... Among patients with persistent AF undergoing first-time catheter ablation, the addition of PWI to PVI did not improve freedom from atrial arrhythmias compared ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/33602399/

Concomitant Pulmonary Vein and Posterior Wall Isolation ... PVI+PWI using the cryoballoon is associated with a significant reduction in atrial fibrillation recurrence, but similar safety, as compared with PVI alone.

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40840576/

Results from the Left Atrial Posterior Wall Isolation In ... Objective: This study investigated the outcomes of cryoballoon PVI with concomitant 'direct' posterior wall isolation (PWI) versus PVI alone in ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10809755/

Safety and Effectiveness of Adjunctive Posterior Wall ... Adjunctive PWI in addition to PVI can be achieved with lower AF recurrence but with a nonsignificant increase in atrial flutter/AT recurrence.

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S000291492300526X

Safety and Effectiveness of Adjunctive Posterior Wall ... This meta-analysis of 11 RCTs with 1,612 patients with AF showed significantly reduced AF recurrence without any difference in all atrial ...

8. jacc.org jacc.org/doi/10.1016/j.jacc.2025.03.515

Pulsed Field Ablation for Persistent Atrial Fibrillation The first large prospective study of PFA to treat PerAF using a strategy of PVI and posterior wall isolation, revealed favorable safety and effectiveness ...