Left Atrial Posterior Wall and PV Isolation Using Cryoballoon for Treatment of Persistent AF

Summary

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.

Conditions

• Persistent Atrial Fibrillation

Interventions

PROCEDURE

Standard Cryoballoon Pulmonary Vein Isolation (PVI)

Arctic Front Advance cryoballoon ablation system to ablate the pulmonary veins to achieve PVI alone

DEVICE

Cryoballoon PVI + Posterior Wall Isolation

Arctic Front Advance Cardiac Cryoballoon Ablation System to ablate the pulmonary veins and the left atrial posterior wall to achieve PVI + posterior wall isolation within the region of the pulmonary venous component

Sponsors & Collaborators

• Mercy General Hospital and Dignity Health Medical Foundation

  collaborator UNKNOWN

• Beth Israel Deaconess Medical Center

  collaborator OTHER

• UC Health Medical Center

  collaborator UNKNOWN

• MedStar Georgetown University Hospital and Medical Center

  collaborator UNKNOWN

• Tampa Cardiac Specialists

  collaborator UNKNOWN

• Bethesda North Hospital

  collaborator UNKNOWN

• Brigham and Women's Hospital

  collaborator OTHER

• Texas Cardiac Arrhythmia Institute At St. Davids Medical Center

  collaborator UNKNOWN

• St. Luke's Hospital and Health Network, Pennsylvania

  collaborator OTHER

• Sarasota Memorial Health Care System

  collaborator OTHER

• Nebraska Methodist Hospital-Methodist Physicians Clinic

  collaborator UNKNOWN

• Dignity Health Medical Foundation

  lead OTHER

Principal Investigators

• Arash Aryana, MD · Mercy General Hospital and Dignity Health Medical Foundation

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-04-30

Primary Completion

2024-04-30

Completion

2024-12-31

FDA Device

Yes

Countries

• United States

Study Locations