Cryoballoon Ablation for Persistent Atrial Fibrillation

(PIVoTAL-IDE Trial)

Recruiting at 16 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

153 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study it to learn whether pulmonary vein isolation (PVI) along with isolation of the posterior left atrial wall (PWI) in the region of the pulmonary venous component will reduce the likelihood of atrial fibrillation (AF) recurrence in patients with persistent atrial fibrillation at 12 months, after a single ablation procedure, in comparison to PVI alone. The investigator hypothesizes that the combination of PVI + PWI will result in a significant reduction in recurrence of atrial fibrillation at 12 months after ablation.

Research Team

Arash Aryana, MD

Principal Investigator

Mercy General Hospital and Dignity Health Medical Foundation

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+