Menu
Recruiting NCT05227053

STOP AF First Post-Approval Study

— Observational Paroxysmal Atrial Fibrillation

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Arctic Front™ Cardiac Cryoablation Catheter.
Who it may be relevant to
Registry conditions: Paroxysmal Atrial Fibrillation. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

STOP AF First Post-Approval Study, an Addendum to the Cryo Global Registry

Overview

The STOP AF First PAS is a prospective, global, multi-center, observational trial.

Detailed description

The STOP AF First Post Approval Study (PAS) is a sub-study to the Cryo Global Registry. The STOP AF First PAS is a prospective, global, multi-center, observational trial. The purpose of the study is to describe long-term clinical performance and safety data in the recurrent symptomatic paroxysmal AF population treated with Arctic Front™ and Freezor™ MAX Families of cardiac cryoablation catheters (hereafter referred to as Arctic Front™ Cardiac Cryoablation Catheter System) as an alternative to antiarrhythmic drug therapy as an initial rhythm control strategy. This PAS is a condition of the pre-market approval order (P100010/S110) by the U.S. Food and Drug Administration.

Interventions

  • Device Arctic Front™ Cardiac Cryoablation Catheter
    Pulmonary vein isolation will be performed with the Arctic Front™ cardiac cryoablation catheter system

Primary outcome measures

  • Freedom from Atrial Fibrillation (AF) /Atrial Flutter (AFL) /Atrial Tachycardia (AT) [Time frame: 36 months]
  • Freedom from Primary Safety Events [Time frame: 12 months]

Eligibility criteria

Inclusion criteria

  • Subject has been diagnosed with symptomatic paroxysmal AF
  • Subject is ≥ 18 years of age or minimum age as required by local regulations
  • Planned pulmonary vein isolation (PVI) procedure using the commercially available Arctic Front™ cardiac cryoablation catheter System.
  • Willing to comply with study requirements and give informed consent (defined as legally effective, documented confirmation of a subject's voluntary agreement to participate in this clinical study) or authorization per institution and geographical requirements

Exclusion criteria

History of AF treatment with a class I or III antiarrhythmic drug, including sotalol, with the intention to prevent an AF recurrence1

. Subjects under the following conditions may be included in the study:

  • Temporary treatment with a class I or III AAD (treatment at a therapeutic dose for a period of <4 weeks prior to the index PVI procedure)
  • Recent treatment with a class I or III AAD (within 6 months of the index PVI procedure) at a dose below therapeutic threshold according to the AHA/ACC/HRS Guideline for the Management of Patients with Atrial Fibrillation
  • A subject who has received a chemical cardioversion may be included in the study. This includes a chemical cardioversion prior to enrollment and between enrollment and ablation.
  • Subject has had a prior atrial ablation (except for cavo-tricuspid isthmus (CTI) ablation for AFL)
  • Subject is enrolled in a concurrent study that has not been approved for concurrent enrollment by the global study manager
  • Subject with exclusion criteria required by local law

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United States · 13 centers
  • Alaska Heart Institute — Anchorage
  • Cardiology Associates of Fairfield County — Stamford
  • MedStar Washington Hospital Center — Washington D.C.
  • BayCare Medical Group Cardiology — Clearwater
  • Heart Rhythm Solutions — Davie
  • Iowa Heart — West Des Moines
  • Our Lady of the Lake — Baton Rouge
  • Southcoast Health System — North Dartmouth
  • … and 5 more centers

Identifiers

NCT: NCT05227053 · STOP AF First PAS

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗