STOP AF First Post-Approval Study

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

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

Study Overview

• Status: Recruiting
• Conditions: Paroxysmal Atrial Fibrillation
• Intervention / Treatment: Device: Arctic Front™ Cardiac Cryoablation Catheter

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.

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: Jennifer Diouf; Email: jen.r.diouf@medtronic.com
• Study Contact Backup: Name: Libby Bergmann; Phone Number: (214) 356-4144; Email: libby.bergmann@medtronic.com

Study Locations

• United States
  • Alaska
    • Anchorage, Alaska, United States, 99508
      • Active, not recruiting
      • Alaska Heart Institute
  • Connecticut
    • Stamford, Connecticut, United States, 06905-5522
      • Recruiting
      • Cardiology Associates of Fairfield County
      • Contact: Joseph Tiano, MD
      • Principal Investigator: Joseph Tiano, MD
  • District of Columbia
    • Washington D.C., District of Columbia, United States, 20010
      • Recruiting
      • MedStar Washington Hospital Center
      • Principal Investigator: Sarfraz Durrani, MD
      • Contact: Sarfraz Durrani, MD
  • Florida
    • Clearwater, Florida, United States, 33756
      • Recruiting
      • BayCare Medical Group Cardiology
      • Contact: Andrea Tordini, MD
      • Principal Investigator: Andrea Tordini, MD
    • Davie, Florida, United States, 33328
      • Recruiting
      • Heart Rhythm Solutions
      • Contact: Awais Humayun, MD
      • Principal Investigator: Awais Humayun, MD
  • Iowa
    • West Des Moines, Iowa, United States, 50266
      • Recruiting
      • Iowa Heart
      • Contact: Denise Sorrentino, MD
      • Principal Investigator: Denise Sorrentino, MD
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70808
      • Withdrawn
      • Our Lady of The Lake
  • Massachusetts
    • North Dartmouth, Massachusetts, United States, 02747
      • Recruiting
      • Southcoast Health System
      • Principal Investigator: Nitesh Sood, MD
      • Contact: Nitesh Sood, MD
  • Michigan
    • Detroit, Michigan, United States, 48202-2608
      • Recruiting
      • Henry Ford Heart & Vascular
      • Principal Investigator: Waddah Maskoun, MD
      • Contact: Waddah Maskoun, MD
  • Ohio
    • Cincinnati, Ohio, United States, 45219
      • Recruiting
      • The Lindner Research Center
      • Contact: Daniel Beyerbach, MD
      • Principal Investigator: Daniel Beyerbach, MD
  • Tennessee
    • Germantown, Tennessee, United States, 38138
      • Recruiting
      • Stern Cardiovascular Foundation
      • Contact: Eric Johnson, MD
      • Principal Investigator: Eric Johnson, MD
    • Memphis, Tennessee, United States, 38104-6638
      • Withdrawn
      • University of Tennessee Methodist Physicians
  • Texas
    • Dallas, Texas, United States, 75231
      • Recruiting
      • Texas Health Research and Education Institute
      • Contact: Charles Lampe, MD
      • Principal Investigator: Charles Lampe, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Subjects ≥ 18 years of age (or minimum age as required by local regulations) who have a recommendation for a pulmonary vein ablation with the Arctic Front™ cardiac cryoablation catheter System.

Description

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:

1. 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)
2. 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

3. 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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Freedom from Atrial Fibrillation (AF) /Atrial Flutter (AFL) /Atrial Tachycardia (AT)	Estimate the 36-month freedom from Atrial Fibrillation (AF) /atrial flutter (AFL) /Atrial Tachycardia (AT) recurrence using the Arctic Front™ cardiac cryoablation catheter System.	36 months
Freedom from Primary Safety Events	Estimate primary safety Adverse Event (AE) rates for cryoablation using the Arctic Front™ cardiac cryoablation catheter System through 12-months.	12 months

Collaborators and Investigators

• Sponsor: Medtronic Cardiac Ablation Solutions
• Investigators: Study Director: Khaldoun Tarakji, MD, Medtronic CAS Chief Medical Officer

Study record dates

Study Major Dates

• Study Start (Actual): April 28, 2022
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): April 1, 2028

Study Registration Dates

• First Submitted: January 27, 2022
• First Submitted That Met QC Criteria: January 27, 2022
• First Posted (Actual): February 7, 2022

Study Record Updates

• Last Update Posted (Actual): July 22, 2026
• Last Update Submitted That Met QC Criteria: July 20, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Arrhythmias, Cardiac; Pathological Conditions, Signs and Symptoms; Atrial Fibrillation
• Other Study ID Numbers: STOP AF First PAS

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No