Recruiting

STOP AF

Sponsor:

Medtronic Cardiac Ablation Solutions

Code:

NCT05227053

Conditions

Paroxysmal Atrial Fibrillation

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Arctic Front™ Cardiac Cryoablation Catheter

Study Details

Brief summary:

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

Conditions

Paroxysmal Atrial Fibrillation

Study ID

NCT05227053

Start date

Apr 28, 2022

Status verified date

May, 2026

Completion date

Apr, 2028

Anticipated

Primary completion date

Apr, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

200 participants

Anticipated

Interventions and Outcome Measures

Interventions

Arctic Front™ Cardiac Cryoablation Catheter

Pulmonary vein isolation will be performed with the Arctic Front™ cardiac cryoablation catheter system

Primary outcome measure

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

Central Contacts and Locations

Locations

Cardiology Associates of Fairfield County

Recruiting

Stamford, Connecticut, United States, 06905-5522

Principal Investigator:

Joseph Tiano, MD

MedStar Washington Hospital Center

Recruiting

Washington D.C., District of Columbia, United States, 20010

Principal Investigator:

Sarfraz Durrani, MD

BayCare Medical Group Cardiology

Recruiting

Clearwater, Florida, United States, 33756

Principal Investigator:

Andrea Tordini, MD

Heart Rhythm Solutions

Recruiting

Davie, Florida, United States, 33328

Principal Investigator:

Awais Humayun, MD

Iowa Heart

Recruiting

West Des Moines, Iowa, United States, 50266

Principal Investigator:

Denise Sorrentino, MD

Southcoast Health System

Recruiting

North Dartmouth, Massachusetts, United States, 02747

Principal Investigator:

Nitesh Sood, MD

Henry Ford Heart & Vascular

Recruiting

Detroit, Michigan, United States, 48202-2608

Principal Investigator:

Waddah Maskoun, MD

The Lindner Research Center

Recruiting

Cincinnati, Ohio, United States, 45219

Principal Investigator:

Daniel Beyerbach, MD

Stern Cardiovascular Foundation

Recruiting

Germantown, Tennessee, United States, 38138

Principal Investigator:

Eric Johnson, MD

Texas Health Research and Education Institute

Recruiting

Dallas, Texas, United States, 75231

Principal Investigator:

Charles Lampe, MD

More Information

Sponsor

Medtronic Cardiac Ablation Solutions

Last update posted

Jul 22, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Medtronic Cardiac Ablation Solutions on 2026-07-22.