NCT05005949

Brief Summary

The STOP Persistent AF Post Approval Study (PAS) is a prospective, global, multicenter, observational trial.

Trial Health

82
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
27mo left

Started Aug 2021

Longer than P75 for all trials

Geographic Reach
6 countries

17 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress69%
Aug 2021Jul 2028

First Submitted

Initial submission to the registry

July 29, 2021

Completed
18 days until next milestone

First Posted

Study publicly available on registry

August 16, 2021

Completed
3 days until next milestone

Study Start

First participant enrolled

August 19, 2021

Completed
6.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2028

Last Updated

November 13, 2025

Status Verified

November 1, 2025

Enrollment Period

6.9 years

First QC Date

July 29, 2021

Last Update Submit

November 12, 2025

Conditions

Persistent Atrial Fibrillation

Outcome Measures

Primary Outcomes (2)

  • 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

Interventions

Arctic Front™ Cardiac Cryoablation Catheter SystemDEVICE

Pulmonary vein isolation will be performed with the Arctic Front™ Cardiac Cryoablation Catheter System

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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 may be approached regarding enrollment in this study.

You may qualify if:

  • Subject has been diagnosed with persistent AF.
  • Subject is ≥ 18 years of age or minimum age as required by local regulations.
  • Planned pulmonary vein isolation (PVI) procedure using 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (17)

Hartford Hospital

Hartford, Connecticut, 06102, United States

Location

Cardiology Associates of Fairfield County

Stamford, Connecticut, 06905-5522, United States

Location

BayCare Medical Group Cardiology

Clearwater, Florida, 33756, United States

Location

Heart Rhythms Solutions

Davie, Florida, 33328, United States

Location

Carle Foundation Hospital

Urbana, Illinois, 61801-2500, United States

Location

Henry Ford Heart & Vascular

Detroit, Michigan, 48202-2608, United States

Location

Spectrum Health Hospitals

Grand Rapids, Michigan, 49525-6427, United States

Location

The Lindner Research Center

Cincinnati, Ohio, 45219-2906, United States

Location

Texas Cardiac Arrhythmia Research Foundation

Austin, Texas, 78705-1852, United States

Location

Texas Health Research & Education Institute

Dallas, Texas, 75231, United States

Location

Kepler Universitätsklinikum Med Campus III.

Linz, 4020, Austria

Location

St. Vinzenz-Hospital Köln

Cologne, 50733, Germany

Location

MVZ CCB Frankfurt und Main Taunus

Frankfurt am Main, 60431, Germany

Location

Städtische Kliniken München GmbH - Klinikum Bogenhausen

München, 81925, Germany

Location

Universitaria Pisana - Stabilimento di Cisanello

Pisa, 56124, Italy

Location

Centralny Szpital Kliniczny Uniwersytetu Medycznego w Łodz

Lodz, 92-213, Poland

Location

Liverpool Heart and Chest Hospital NHS Foundation Trust

Liverpool, L14 3PE, United Kingdom

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Khaldoun Tarakji, MD

    Medtronic CAS Chief Medical Officer

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 29, 2021

First Posted

August 16, 2021

Study Start

August 19, 2021

Primary Completion (Estimated)

July 1, 2028

Study Completion (Estimated)

July 1, 2028

Last Updated

November 13, 2025

Record last verified: 2025-11

Locations

AU(1)DE(3)IT(1)US(10)PL(1)GB(1)